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Vol. 4, No. 3
November 2000
Natural Medicine LawTM
CHPA DIETARY SUPPLEMENTS SYMPOSIUM
Newsletter
NATURAL PRODUCTS
EXPO EAST
The second Dietary Supplement Outgrowing the Baltimore ConvenSymposium sponsored by the Consumer Healthcare Products Association (formerly Non-Prescription Drug
Manufacturers Association) was held
in Bethesda, Maryland on September 28 and 29. CHPA presented new
marketing information and scientific
research. About 140 persons, including 8 press and 18 CHPA staff
attended. The Federal Office of Dietary Supplements sponsored a scientific panel.
tion Center and the available hotels
this gigantic exposition is moving to
Washington, D.C. in 2001. The
Natural Products Expo may be well
known to some NML readers, but we
have reviewed this typical product
exposition so that all will become
aware of the opportunities presented.
This year, over 21,500 registrants
were coming at the time of the press
briefing, this being 3.3% more than
last year. The number of booths was
up also to 1,756, ranging from
President Michael D. Maves, supplement manufacturers, herbal
M.D., MBA, of CHPA opened the extract makers, organic food, natuprogram asking “Where are we in ral cosmetics, hemp products, and
these unparalleled times?” In March many others.
1999, CHPA decided to bring the
field of dietary supplements into its
Rick Prill, president and COO of
umbrella and began working he said.
Continued on page 12...
There is much promise for self-care
advances and dietary supplements
play a critical role in that. FDA, he
FDA DECIDES TWO
said, has gaps in what the agency
HEALTH CLAIMS
would like to do and what it can to
FDA announced two decisions on
and CHPA is working to help the
health claims that were the subject of
agency loosen up funds.
the Pearson court decision. One proMaves said the industry had its crit- posed claim that stated 0.8 mg of folic
ics – perhaps, unjustified in some acid in a dietary supplement was
cases. “But we need to close gaps more effective in reducing the risk of
so consumers can have confidence.” neural tube defects than a lower
Our commitment to DSHEA will al- amount in foods was not authorized.
low this industry to flourish, Maves Although FDA determined that this
said. Consumers are demanding in- claim could not be appropriately
formation and health care providers qualified without being misleading, the
are engaged. The 40-person staff at agency did provide examples of apCHPA are professionals who will propriate qualified claims.
help to propvide good information.
Continued on page 8....
FDA determined that the second
proposed health claim about dietary
Continued on page 3...
WEIDER AGREES TO
SETTLE FTC CHARGES
Weider Nutrition International,
Inc., based in Salt Lake City, Utah,
has agreed to settle Federal Trade
Commission charges that it made unsubstantiated efficacy and safety
claims in its advertisements for dietary
supplement products called
“PhenCal” and “PhenCal 106.” The
ads claim that PhenCal and PhenCal
106 (collectively, “PhenCal”) were
proven to cause weight loss and to
prevent the regaining of lost weight.
Under the terms of the proposed consent agreement, Weider would be
required to pay $400,000 to the FTC
for consumer redress. In addition,
Weider must possess competent and
reliable scientific evidence when it
makes any weight loss, safety, disease benefit, or comparative claim in
the promotion of its products or programs.
Weider is a leading manufacturer
and marketer of nutritional suppleContinued on page 6...
In This Issue:
CHPA Dietary Supplements Program...........1
Natural Products Expo East.........................1
Weider Settles FTC Charges.......................1
FDA Decides Two Health Claims.................1
FDA Updates Pearson Strategy..................2
Label Statements - 30 day & 403(r)............2
FDA Rules on 3-Omega...............................3
FDA Rules on Folic Acid & Fiber Claims......4
Lord Hunt Boosts Traditional Medicine........5
EPHA Responds to Irish Board....................5
Drug Depletion Liability Issues...................17
Lloyd Library Credits.................................19
EMEA Documents......................................26
Complaince Guide for Botanical Drugs......27
CTS Chemical Echinacea Petition..............29
Descending or Alpha Order Petition..........29
ICHPA Petition to “May Contain”.................29
New Folic Acid Claim Suit.........................30
Interesting 75 Day Notice..........................31
Plant Sterol Health Claim Approved...........31
Meetings of Interest & Phytopharm...........32
Classified Ads...........................................32
Natural Medicine LawTM
Page 2
FDA UPDATES PEARSON
STRATEGY
On October 6, 2000, FDA issued
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a notice it was updating its strategy
to deal with implementing the
Pearson v. Shalala decision concerning the agency process for approval of health claims. The update
is an interim enforcement strategy for
dietary supplement health claims that
do not meet the “significant scientific
agreement” standard of evidence.
And the update changed the way
FDA will respond to the four claims
that were the subject of the Pearson
case as well as to future claims.
FDA has decided to modify its approach to processing new health
claim petitions for dietary supplements so that it can avoid denying all
petitions that do not meet the “significant scientific agreement” standard
and thus cause new First Amendment
challenges. The change in approach
is to exercise enforcement discretion
in “appropriate” circumstances.
FDA defines these circumstances as
being those when four criteria are
met: 1) the health claim petition meets
the requirements of Sec. 101.70; 2)
the scientific evidence supporting the
claim outweighs the scientific evidence against the claim; 3) consumer
health and safety are not threatened;
and 4) the claim meets the general
requirements of Sec. 101.14, except
that the requirement that the evidence
supporting the claim meet the “significant scientific agreement” standard
and that the claim be made in accordance with an authorizing regulation.
immediately upon publication of the
proposal. If the scientific standard is
not met, but the supporting evidence
outweighs the against-the-claim evidence, then FDA will consider
whether qualifying language will permit the claim to be used.
Giving FDA notice of label state-
ments has reached a new level in two
important categories. First, the notice requirements under 21 CFR
101.93 that require manufacturers to
notify FDA 30 days in advance of
In cases where the claim is not supmarketing a dietary supplement have
ported by scientific evidence out
reached 5,891 filings as of Septemweighing the against-the-claim eviber 15, 2000. On that date FDA
dence, or the substance poses a threat
received a filing by SmithKline
to health, or any other criteria are not
Beecham Consumer Healthcare for
met, FDA will deny the petition.
Calcium Carbonate, USP. The comWhen a denial letter is issued, it will
pany says the product label will bear
state the agency’s rationale as to why
the statement “Clinically shown to help
the claim does not meet the scientific
reduce typical PMS (premenstrual
standard and state why the agency
syndrome) symptoms including bloatbelieves the against-the-claim eviing cramps, fatigue, moodiness.” The
dence out weighs the supporting eviproduct on which this statement will
dence, why the claim would be misappear is TUMS Calcium For Life
leading even if qualified, and/or why
PMS Dietary Supplement.
the claim would pose a threat to consumer health or safety.
Second, in terms of FDC Act Section 403(r)(6) filings, there have been
As a matter of timing, FDA said it
395 letters responded to by FDA
would take 190 days after the close
with so-called courtesy letters telling
of the comment period seeking scithe manufacturer that the product is
entific evidence on the claims for the
not a dietary supplement because of
four Pearson claims, but would consome reason in the structure/function
tinue to adhere to the schedule in Sec.
labeling statements proposed in the
101.70(j) for all other claims.
company notices to FDA. The
[ Sec. 101.70(j) provides the agency present letters from FDA are sent to
will acknowledge receipt of a peti- many more FDA personnel and oftion within 15 days, then FDA gets fices than was the case when these
100 days to determine whether to file letters were issued initially. This
the petition, then within 90 days more, means that the potential for FDA folFDA will either deny the petition, or low up is much greater. Whether the
provide a notice that the use of the agency will actually monitor the use
health claim will be published in the of these label statements, remains to
Federal Register. Within 270 days be seen. Here are summaries of the
from the date of publication, FDA will claims and FDA’s recent responses.
publish a final rule or extend the time,
no more than twice, within which it
will publish a final rule. The sections
are part of 21 Code of Federal Regulations — Editor] This FDA notice
to respond to the petitioner. When
was published at 65 F.R. 59855, Oct.
FDA determines that the scientific
6, 2000.
standard is met, the claim may be used
November 2000
Of course, FDA points out that
petitions have to be “filed” to be considered, and then the agency has to
complete its scientific review in order
LABEL STATEMENTS FOR
DIETARY SUPPLEMENTS
Strictly Supplements, Inc., a
Henderson, Nevada company notified FDA of its intent to use the following statements on four different
products. “Natural Mineral Immune
Continued on page 9, column 1....
be presented to FDA for review befiber and reduced risk of colorectal fore the claim can appear on the lacancer could not be authorized be- beling.
cause the results of studies about diOn January 6, 1993, FDA anetary fiber consistently showed a lack
of relationship between dietary fiber nounced its decision not to authorize
supplements and the risk of colorectal the use of three health claims for concancer. Neither could the claim be ventional foods: dietary fiber and canqualified because the suitable evi- cer, antioxidant vitamins and cancer,
dence against the claim outweighed and omega-3 fatty acids and coronary heart disease. The agency folthe evidence for it.
lowed up with a decision not to auFurther, FDA announced that de- thorize the claims in the labeling of
cisions on two other health claims that dietary supplements on October 14,
were also the subject of the court 1993. On that same day, FDA procase, one about omega-3 fatty acids posed to authorize a health claim for
and the other about antioxidants, the relationship between folate and
would be issued no later than Octo- reduced risk of neural tube defects,
ber 24, 2000. FDA has modified its and proposed not to allow such a
approach in processing these claims claim to include a statement that folate
in future new health claim petitions for from one source is more effective than
dietary supplements. If a health claim folate from another source. This promeets the significant scientific agree- posal became final for dietary supplement (SSA) standard of evidence, ments in January 1994, and FDA
the agency will publish a proposal or subsequently issued a final rule auan interim final rule to authorize the thorizing use of the claim on dietary
claim. Rather than denying all peti- supplements and conventional foods
tions that do not meet the SSA stan- on March 5, 1996.
dard, FDA intends to exercise enIn 1998, FDA’s general health
forcement discretion for qualified
health claims for dietary supplements claim regulations for dietary supplewhen the following conditions are met: ments were challenged, as was
¾
The health claim petition FDA’s decision not to authorize the
meets FDA requirements for such four health claims. On January 15,
1999, the U.S. Court of Appeals for
petitions;
¾
The scientific evidence sup- the D.C. Circuit invalidated the reguporting the claim outweighs the sci- lations prohibiting use of the four
health claims and directed FDA to
entific evidence against the claim;
¾
Consumer health and safety reconsider authorization of the claims.
The court also required FDA to
are not threatened; and
¾
The claims meet the general clarify the SSA standard for authorizing health claims, either by issuing
requirements for a health claim.
a regulatory definition of SSA or by
In 1990, FDA adopted the same defining it on a case-by-case basis.
procedure for health claims for di- On March 1, 1999, FDA filed a peetary supplements that Congress had tition for a rehearing by the full Court
prescribed in the Nutrition Labeling of Appeals, which was denied.
and Education Act for conventional
In December 1999, the Federal
foods. This procedure requires that
Register
published FDA’s plans to
the evidence supporting a health claim
November 2000
FDA DECIDES -- Continued from page 1..
Page 3
carry out the court’s decision. Since
the court’s decision, FDA has: Updated scientific evidence on the four
claims (Fall 1999-Spring 2000);
Issued guidance clarifying the SSA
standard (December 22, 1999);
Held a public meeting to solicit input
on changes to health claims regulations on dietary supplements (April
4, 2000); Issued a rule to revoke
the regulations invalidated by the
court decision (0ctober 3, 2000);
Issued a notice updating its implementation strategy (October 6, 2000);
and announced a decision on two of
the four health claims (October 10,
2000).
Details on these decisions may be
found on the FDA Website at
<www.cfsan.fda.gov> under the section “Dietary Supplements” under
“Program Areas.”
FDA RULES ON OMEGA-3
Delayed, but not denied, the omega3 health claim and antioxidant health
claims filed by the Pearson plaintiffs
were ruled upon by FDA on October 24. In a letter to Jonathan W.
Emord, Esq., counsel for the plaintiffs, FDA delayed until October 31
and November 30 its decisions on
these claims.
At the time, Emord noted in a news
memo that “FDA hints that it may
approve a qualified claim for Omega3 Fatty Acids, writing: ‘FDA is in the
process of finalizing its evaluation of
an appropriately qualified claim....’.”
The Court of Appeals decision holding FDA’s denial of four claims as
unconstitutional was made January
15, 1999. Emord said that one year
and nine months is the longest delay
Continued on next page...
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Natural Medicine LawTM
Natural Medicine LawTM
Page 4
Continued from previous page...
any federal agency has made in implementing a decision of a United States
Court of Appeals.
FDA RULES ON FOLIC ACID
AND FIBER
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What FDA had done with the first
two claims — Folic Acid and Fiber
— was done at about 8:00 P.M. on
October 10. FDA rejected the comparative claim for Folic Acid both
under the significant scientific agreement standard and under its interpretation of the Pearson First Amendment standard. Emord said, “FDA
disingenuously replied upon fortified
foods to contend that goods in common form were as effective as supplements in reducing the risk of neural
tube defects. Foods in common form
are not fortified foods, and the reliance is misplaced, misleading, and
dishonest.”
But FDA suggested four new
claims for Folic Acid and said they
would not enforce the rules against
these. Those claims are:
“Example 1: Healthful
diets with adequate folate
may reduce a woman’s
risk of having a child with
a brain or spinal cord
birth defect. The Institute
of Medicine of the National Academy of Sciences recommends that
women capable of becoming pregnant consume 400 mcg folate
daily from supplements,
fortified foods, or both, in
addition to consuming
food folate from a varied
diet.
Example 2: Healthful
diets with adequate folate
may reduce a woman’s
risk of having a child with
a brain or spinal cord defect. The scientific evidence that 400 mcg folic
acid daily reduces the
risk of such defects is
stronger than the evidence for the effectiveness of lower amounts.
This is because most
such test have not looked
at amounts less than 400
mcg folic acid daily.
Example 3: Healthful
diets with adequate folate
may reduce a woman’s
risk of having a child with
a brain or spinal cord defect. Women capable of
becoming
pregnant
should take 400 mcg
folate/day from fortified
foods and/or a supplement, in addition to folate
in food from a varied diet.
It is not known whether the
same level of protection
can be achieved by using
only food that is naturally
rich in folate. Neither is it
known whether lower intakes would be protective
or whether there is a
threshold below which no
protection occurs.
Example 4: Healthful
diets with adequate folate
may reduce a woman’s
risk of having a child with
a brain or spinal cord defect. Women capable of
becoming
pregnant
should take 400 mcg of
folate per day from a
supplement or fortified
foods and consume food
folate from a varied diet.
It is not known whether the
same level of protection
can be achieve by lower
amounts.”
The original claim in the Pearson
November 2000
Photo Courtesy of Lloyd Library and Museum
case was: “0.8 mg of folic acid in a
dietary supplement is more effective
in reducing the risk of neural tube defects that a lower amount in foods in
common form.” Since FDA now
compares this claim to fortified foods,
Emord says FDA is dishonest.
FDA took so much time on this
claim because it wanted to review the
scientific evidence. Going back to
the 1996 authorization of a health
claim for folate and neural tube defects. That evidence convinced FDA
that 800 mcg was not better than 400
mcg. There was a 1993-1996 scientific review and a 1998 scientific
review by IOM/NAS, plus new data
since 1998 that FDA relied upon.
The Fiber claim: “Consumption of
fiber may reduce the risk of colon
cancer” was rejected by FDA based
on a review of scientific evidence
collected in its 1991-1993 review,
Continued on page 6...
Natural Medicine LawTM
L ord
Hunt welcomes MCA
progress and pays tribute to the UK
natural health sector.
sultations the MCA has had with organizations in the natural health sector. It is essential that the UK continues to make a major contribution in
the further European discussions
which will need to take place about
the detail of the content of the proposed directive. The position we take
in negotiations will continue to be informed by consultation and dialogue
with the UK natural health sector.”
The prospect of a European directive which would recognize and regulate traditional herbal remedies has
moved a step closer following the
NOTES FROM EHPA:
September meeting of the European
1. Under Section 12 of the Medicines
Pharmaceutical Committee.
Act 1968 certain simple herbal remedies, consisting only of herbal ingreEU Member States and the Eurodients, are exempted from the norpean Commission agreed on a posimal requirement that medicines should
tion, strongly advocated by the UK,
have a product licence. In other cirthat the development of a directive
cumstances, herbal medicines require
on traditional medicines should be
a product licence.
given a high priority. The European
Commission is expected to bring for2. Dialogue about the need for an
ward consultative proposals shortly.
improved regulatory framework for
traditional herbal remedies was instiLord Hunt, Health Minister, said:
gated in the UK by Lord Hunt’s pre“Over recent months, the UK has
decessor as Health Minister, Baronbeen pressing for early action to proess Hayman, at a meeting with repvide a clear regulatory status in Euresentatives of the UK natural health
ropean law for traditional herbal remsector in March 1999. Since then the
edies, which we know are highly valMedicines Control Agency has held
ued by many consumers. At my reextensive informal discussions on the
quest, the Medicines Control Agency
issue with a number of different inhas taken a leading role in European
terest groups.
discussions to argue the case for a
new directive which would protect
3. The European Commission and
quality and safety standards, safeMember States agreed at a meeting
guard consumer choice and give the
of the European Pharpublic clear information about the
maceutical Committee
product.”
in September last year
to set up a working
“It is now apparent that other Memgroup of Member
ber States and the European ComStates to investigate
mission also share this aim and I very
the possibility of a dimuch welcome the Commission’s inrective for traditiontention to bring forward draft proposally used medicines.
als as soon as possible.”
The working group
first met in April
“The strength of the case we have
2000. The Medibeen able to put forward in Europe
cines Control
has owed much to the extensive conNovember 2000
Agency, representing the UK, was
asked to act as rapporteur for the
group, developing ideas on the possible contents of a directive.
4. At the meeting of the Pharmaceutical Committee on 21 September
2000, the European Commission
outlined progress made by the working group and invited views on the
way forward. The outcome of discussions was a clear agreement that
a directive was needed and that the
Commission would bring forward a
first draft shortly.
5. The primary purpose of the Medicines Control Agency is to safeguard
public health by ensuring that medicines available in the UK meet appropriate standards of safety, quality
and efficacy in accordance with European and UK legal requirements.
This draft news release was obtained from the
European Herbal Practitioners Association.
EHPA RESPONDS TO IRISH
MEDICAL BOARD
The European Herbal Practitioners Association is grateful to the IMB
for its invitation to make a submisContinued on page 7, column 1...
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EUROPEAN SUPPORT
BOOSTS UK
HOPES FOR TRADITONAL
MEDICINES DIRECTIVE
Page 5
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Weider/ FTC - Continued from page 1...
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ments, vitamins and sports nutrition
products. Weider sold PhenCal as an
alternative to a combination of prescription diet drugs (phentermine and
fenfluramine) commonly known as
“Phen-Fen.” Weider advertised in
major newspapers across the United
States. Its newspaper ads touted
PhenCal
as
a
safe
alternative to diet drugs: “YOU NO
LONGER NEED TO CHOOSE
BETWEEN THE DANGERS OF
BEING OVERWEIGHT AND THE
DANGERS OF DIET DRUGS.”
The ads also contained express
claims that PhenCal’s efficacy and
safety have been clinically proven
with statements such as: “Proven Safe
Without a Prescription” and “Proven:
Effective as Prescription Treatments.”
In its promotional brochure, Weider
compared PhenCal to Phen-Fen and
made similar claims that scientific
studies proved PhenCal’s efficacy
and safety.
According to the FTC’s complaint,
Weider did not have a reasonable
basis to substantiate its claims that
PhenCal and PhenCal 106: cause
significant weight loss; significantly
increase a person’s ability to maintain a reduced calorie diet and exercise regimen; significantly reduce food
cravings and eating binges; pevent the
regaining of lost weight; are as effective as the prescription weight loss
treatment Phen-Fen; and are safe
when used to promote or maintain
weight loss.
sions designed to assist the FTC in
monitoring the respondent’s compliance. The Commission vote to accept the proposed consent agreement
for public comment was 5-0. An announcement regarding the proposed
consent agreement will be published
in the Federal Register shortly. The
agreement will be subject to public
comment for 30 days, until November 6, 2000, after which the ComThe complaint further alleges that mission will decide whether to make
Weider’s claims that scientific stud- it final. Comments should be adies prove that PhenCal is effective and dressed to the FTC, Office of the
safe are false. The proposed con- Secretary, 600 Pennsylvania Avenue,
sent agreement, announced today for N.W., Washington, D.C. 20580.
public comment, would prohibit (FTC File No. 982 3035)
Weider from making the specific unsubstantiated claims alleged in the
complaint. The proposed settlement 3-OMEGA CLAIM -- Continued from page 5.
also would require Weider, when
some intervention studies, and obseradvertising any food, drug, dietary
vational studies. Saying “It is well
supplement, or program, to have adrecognized that diets high in fiber-rich
equate scientific evidence before
foods and low in fat are associated
making claims relating to: the safety
with lower incidences of certain types
of such product or program; the efof cancers, including colorectal canfect of such product or program on
cer,” FDA says the studies published
any disease; or the comparative or
recently is more compelling evidence
superior health benefit of such prodagainst a relationship for dietary fiber
uct or program.
and colorectal cancer.
In addition, the proposed settlement
would prohibit Weider from misrepresenting the existence, contents, validity, results, conclusions or interpretations of any test, study or research.
The settlement would allow Weider
to make claims on labels for drugs or
other products that have been approved by the Food and Drug Administration.
Emord points out that the studies
cited by FDA have been severely
criticized and FDA did not evaluate
any of the criticisms in its order. In
deciding that scientific evidence did
not exist to support the claim, Emord
said, “FDA discounted all of the scientific evidence previously submitted
supporting the role of fiber in reducing colorectal cancer risk, and it also
inconsistently maintained its previFurther, the proposed settlement
ously approved fiber/cancer risk rewould require Weider to pay
duction claim continues to be sup$400,000 to the Commission. The
ported by the evidence.
funds will be used for consumer redress or, if that is impractical, the
Emord says that FDA continues to
funds will be paid to the U.S. Trearequire near conclusive proof such as
sury. Finally, the settlement conContinued on pae 7...
tains various record keeping proviNovember 2000
Natural Medicine LawTM
that for new drugs, of a causal connection between nutrients and disease
prevention. “That demand conflicts
with then plain language of the Act
and the intent of Congress,” Emord
claims. “FDA continues to suppress
claims outright in violation of the First
Amendment without the sensitivity to
speech protection that the First
Amendment requires of an agency
that exercises censorship powers.
The Pearson plaintiffs are now evaluating in detail with their science advisors each of FDA’s recently released
decisions and will determine after all
decisions are issued whether new suits
must be filed to contest those decisions and protect First Amendment
rights,” he said.
EPHA to Irish --Continued from page 5....
sion on the future regulation of traditional and alternative medicinal products, including herbal medicinal products. The EHPA response follows
The EHPA is mindful of the requirement on all Member States to
regulate medicinal products (including traditionally used herbal products)
within the general framework of existing EU medicines law (Directive 65/
65 EEC). Whilst the EHPA understands that any change to the existing
law needs to occur within the scope
of agreed European legislation, at this
time it is unclear how soon such a
Traditional Medicines Directive may
be in place. Accordingly, the EHPA
supports a twin-track approach in
which Member States working
through the European Pharmaceutical Committee do all they can to seek
to agree the Traditional Medicines
Directive currently under consideration. On the other hand, if this proves
to be a prolonged process, the
EHPA sees the need for Member
States to take appropriate measures
within an overall European framework for the regulation of the natural
medicines sector at national level. This
possibility was clearly perceived by
the Irish Minister for Health and Children, Minister Martin, when at a recent parliamentary question time, he
called for a new licensing scheme:
The recent debate (on St. Johns
Wort) has highlighted the lack of common approach at EU level to the recognition of traditional medicinal products. While this matter is being addressed by a Working Group set up
by the EU Pharmaceutical Committee last year, I do not anticipate an
early resolution to the difficulties of
harmonisation in this area. I have
therefore asked officials of my Department and the Irish Medicines
Board to investigate the possibility of
an interim solution to the problem in
the form of a simplified licensing
scheme for “traditional and alternative medicinal products” which would
allow such products to be lawfully
marketed in this country. It is to be
hoped that any such interim measures
brought in at national level are those
which ultimately may be adopted by
the EC as a whole and clearly guidance from the Commission should be
sought by Member States acting at
national level. The EHPA welcomes
the possibility that all traditionally used
medicinal products may be included
in such a scheme. By “Traditional
Medicinal Products”, the EHPA
means those that have been in longterm use within any Member State or
are part of a recognised traditional
medicine system outside the EU. In
order to gain the status of “traditionally produced”, it would be necessary for such products to demonstrate
safe long-term usage and an absence
November 2000
of serious scientific concern. In such
cases, the Traditional Medicines Directive can permit individual Member States to introduce a simplified
national registration procedure permitting such products onto the market. Although in the short-term this
would mean Member States might
have different products registered as
traditional, in time it should be possible to harmonise traditional use
throughout the EU.
The demonstration of safe longterm use should be by bibliographical or expert evidence to the effect
that the product in question has been
in use for the required period (which
period to be set by agreement after
full consultation) either within or outside the EU. Such an arrangement
would seem in accord with the call
by the European Parliament (OJEC
no. 305,16/10/87) that the European
Commission develop a scientific approach to herbal medicines which “incorporates centuries of practical experience” in its evaluation procedures. This traditional information, it
is suggested, should form part of a
monograph or SPC data sheet on
each traditional medicine that also includes expert reports and bibliographical reference on the medicinal
use of the traditional medicine in question as well as detailing quality assurance and safety data.
This information should be constantly
updated from a variety of sources including information from other Member States, official adverse-event
warning systems, EP data, WHO
monographs etc. Companies placing
traditional products on the market
should be required to keep adequate
records to enable the immediate tracing and recall of defective or unsafe
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3-OMEGA CLAIM - Continued from page 6...
Page 7
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Page 8
is no fad, but a long time shift,”
Hartman added.
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover.
Photo Courtesy of Lloyd Library and Museum
Why is this happening, he posited?
Hartman says it is because of compression of the sense of time, a loss
of control, aging, spread of information, transformative life experiences,
and frustrations with American health
care. We are moving toward individual wellness regimes. Choice and
how to make choices are important.
Personalization, customization and
empowerment are important. People
are creating their own brand—the
BRAND YOU. “The trusted advocate today is the social network,” he
said. “The mass market is dead, it is
now composed of many little
groups.”
CPHA -- Continued from page 1...
Robert Donovan, a director of
Murdock, Madaus Schwabe, said,
“we see only the tip of the iceberg
these dietary supplements can bring
into the quality of life.” CHPA recognized the 10 year strategic plan of
FDA, but it has to ask what will FDA
do in the next few years.
The keynote speaker was Harvey
Hartman of The Hartman Group (Seattle), who presented a summary of
some recent consumer research findings from the firm’s 8,000 member
dietary supplement panel, groups he
called social network parties, and
home interviews. Hartman said the
consumer was changing dramatically
and “right now they are on a journey
to reach out to a different kind of life
– a higher quality of life.”
Demographics no longer identify the
consumer. Dietary supplements represent a lifestyle change. Consumers
what to participate. There has been
a cultural shift consisting of several
societal factors or influences. “This
EHPA to Irish -- Continued from page 7...
products. In the production of herbal
products, good manufacturing practice should be the order of the day.
Herbal practitioners should be able
to report herbal ADRs using the Irish
yellow card scheme.
It is suggested that the Traditional
Medicines scheme permits simple information accompanying the product
informing the user of the indication(s)
or action(s) of the product. The treatment of serious disease would be precluded, however. Information should
also be provided to inform the user
that “the product is a traditional medicine and that efficacy of the product
has not been clinically proven”. Users should be cautioned to see a doctor if symptoms persist whilst taking
the product.
An important feature of the Traditional Medicine scheme is the appointment of an expert committee to
form a Traditional Medicines Evaluation Board. This Board should comprise representatives of the IMB, as
well as experts from within the field
of herbal medicine including those
Hartman described a globe with a from the herb industry and profescore and a periphery, saying there a sional practitioners of herbal meditwo aspects to both — consumer cine. It is anticipated that this Board
behavior and the dimensions that or- will play a vital role in recommending
ganize the patterns of wellness con- traditional medicine status or othersumptions. His research identified a wise in the formation of a traditional
number of core wellness behaviors, medicines category.
activity areas, such as: nutrition/diet;
body/mind; alternative medicine; The EHPA welcomes and encourknowledge; spirituality; and Earth ages recent moves by the Irish GovWellness. But the core is small and ernment to enable professional herbal
practitioners to gain Statutory Selfsellers need to sell the periphery.
Regulation (SSR) within the RepubFor example, the periphery con- lic. This will enable those herbs which
sumer is one who is a Yoga user, who were considered to have some elesigns up in a local gym to take the ment of risk to be removed from gencourse, while a core Yoga user is one eral sale and be categorised “herbal
who investigates the credentials of the practitioner and POM use only”. The
Continued on page 10...
November 2000
Continued next page...
Natural Medicine LawTM
mal function of the cells in the human
body” and “To help maintain the normal cell function in the human body
take one capsule daily.”
Silvicidal®GS is said to be an oral
spray product and Silvicidal®ND is
described as nasal spray product.
EHPA has introduced a CommonCore Curriculum that requires university-standard training for all herbal
practitioners. The SSR of herbal
practitioners within the Republic will
enable the public to enjoy access to
expert herbal advice and treatment
making use of a full range of herbal FDA replied that since the first two
products are oral or nasal spray
remedies.
products, they are not dietary suppleThe Traditional Medicinal Products ments since they are not products inscheme will presumably be applied tended for ingestion. FDA left hangto Traditional Products placed on “the ing what the company should do
market” as defined in EU law. Herbal about its determination. Dkt 97Spractitioners see patients on a one- 0163, Ltr 383.
to-one basis and provide
Mariposa Botanicals, Inc. of
individualised prescriptions to their
patients. For this reason, it is assumed New York City filed four statements
that these individualised prescriptions for four products saying they would
should not be subject to market bear the following statements:
authorisation and the requirement to Probiotic Digestive Aid — “Supports
be registered as Traditional Medici- healthy digestion;” Glucosamine Sulfate — “Provides nutrition support for
nal Products.
healthy connective tissue and Joint
The European herbal Practitioners function;” Mental Alertness Formula
Association represents the interests — “Supports healthy mental funcof herbal practitioners of several tra- tion;” and Allergy Support Formula
ditions and their patients throughout — “Provides nutritional support for
the EU. It currently has some 1500 people with allergies.” FDA remembers. If there are any questions sponded only to the Allergy Support
about this submission, please contact Formula statement saying that the
the EHPAChairman by E-mail at statement propose for it indicates the
product is intended for use as a drug
<[email protected]>.
and the company should contact the
CDER staff for further assistance.
Dkt.97S-0163, Ltr 384.
LABEL STATEMENTS -- from page 2...
Energizer” and “... effective in energizing the human body’s natural immune system” on Silvicidal®GS;
“Natural Mineral Immune Energizer”
and “.... helps to energize the human
body’s natural immune system” on
Silvicidal®ND; “An all Natural Mineral Immune Energizer” and “.... helps
to energize the human body’s natural
immune system” on Silvicidal®350;
and “Helps Maintain Normal Cell
Function,” “helps maintain the nor-
Intelligent Nutrients, Inc. of
Minneapolis wrote to FDA saying it
would use two statements on its
Green tea polyphenols extract —
“Helps protect the body’s cells and
tissues by neutralizing free radicals,”
and “Helps maintain cardiovascular
health and cholesterol levels.” FDA
responded that the second statement
made the product a treatment for hypercholesterolemia and they should
consult CDER for assistance. Dkt.
November 2000
97S-0163, Ltr. 385.
Wind River Herbs of Alpine,
Wyoming told FDA it would use the
statement “Maintains healthy levels of
candida yeast in women” on its product Women’s Pau D’Arco Blend —
containing Pau D’ Arco, black walnut, calendula, myrrh, echinacea
augustifolia - purpurea, prickly ash
and iomatium. FDA said that the
statement made it clear the product
was to be used to treat candida yeast
infections and that made it a drug. If
the statement is going to be used,
FDA said to consult CDER. Dkt.
97S-0163, Ltr. 386.
NOW Foods of Bloomingdale, Illinois submitted the paragraph statement below for its product Glucose
Metabolic Support:
“Glucose Metabolic Support contains Glucosol™,
a new dietary ingredient
extracted from the herb
Lagestroemia speciosa.
Glucosol™’s active component, corosolic acid, has
been the subject of scientific studies that show it may
support healthy blood
sugar levels by facilitating
the transport of glucose into
cells. We have also included an extract from the
herb Gymnema sylvestre,
a small plant native to India. Extracts of Gymnema
have been used for centuries to support healthy
blood sugar levels and
natural insulin production.”
FDA replied that the statements
“...support healthy blood sugar levels” and “...support healthy blood
sugar levels and natural insulin proContinued on page 11...
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover .
Continued from previous page...
Page 9
Page 10
CHPA -- Continued from page 8...
teacher before signing up. Behaviors overlay patterns
of movement in and out of the core to the periphery.
Periphery was easy to sell two years ago, all you had to
do was make the products available. But today, periphery consumers are more cautious, Harvey said.
Natural Medicine LawTM
unexpected sometimes is in the pharmacy.” The key
behavior factors for the middle and periphery are multivitamins (67%) , organic foods, and heart healthy foods.
People do not know the science, but they know when
they feel better, Hatman’s research shows.
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
Women drive the wellness market. The core is made
up of 83% women; the middle, 79% and the periphery
77%. Dietary supplements are the gateway to wellness,
Hartman said. There are 16 channels of distribution and
the health care practitioner is a growing element.
Consider Starbucks Coffee which started in Seattle.
They did not invent coffee, but they did create a coffee
world, where people will pay $4.00 for a cup of latte,
special spice coffee. It has emotion and ambiance. ConHartman says price plays an important role, but not
sider Dunkin Donuts in Boston. Everybody serves
necessarily supply and demand. If you lower the price,
Dunkin Donuts. They sell an experience.
you may lose business.
Research shows you should not try to sell the core.
Harvey Hartman can be reached at the Hartman
Consumers want atmosphere and emotion, more than
utility. The core accounts for about 14% of the consum- Group, 1621 – 114th Avenue, S.E, #105, Bellevue, WA
ers. The periphery accounts for 30% and those in the 98004 or by E-mail at [email protected] or at
middle, shifting back and forth on wellness issues are 55 the web site www.hartman-group.com
percent of consumers. The middle is too diverse to define. Hartman found that consumers get the most inforContinued on page 20....
mation about products in an atmosphere. “Where it is
November 2000
Natural Medicine LawTM
Page 11
from degeneration....”
duction” make this product a drug and the company should Dkt. 97S-0163, Ltr. 389
consult CDER. Dkt. 97S-0163, Ltr. 387.
Strictly Supplements, Inc. of Las Vegas, Nevada,
Natural Balance, Inc., a company in Castle Rock, wrote FDA to say it would sell a product named Citr-AColorado sent in a three page list of statements it plans to Sol, containing citric acid, water, glycerol and Selegiline
use on a product named No More Aching Joints and an- with the label statement “Helps Maintain Normal Funcother three page list of statements it would use on a product tion of Brain Cells and Promote a Feeling of Well-Being”
named Super Flex®Joint Formula. FDA wrote back and “.... to help maintain the normal function of brain cells,
saying that the product name No More Aching Joints itself which tends to promote the feeling of well-being and ensuggested the product was a drug, and eight separate hances the quality of life....” FDA said that this product
proposed statements for each product made each a drug. violates the FD&C Act because Selegiline is an active
The offending statements were:
ingredient in several approved ANDAs, including
Eldepryl, a prescription drug sold by Somerset PharmaSuper Flex ®Joint Formula
ceuticals. Also, FDA said the statements intended to be
“...reduce joint pain...,” “...reduces inflamma- used made the product a drug. FDA said Citr-A-Sol
tion, repairs joints and muscle issue and restores the con- was a new drug and that Selegiline was not a substance
dition of the cartilage between joints...,” “...reduce pain- that is within the definition of a dietary supplement under
ful joint and muscle inflammation as well as restore healthy the law. Also FDA said Selegiline needed to apply for
connective tissue,” “inhibit the COX-2 enzyme, respon- GRAS status or as an approved food additive. This FDA
sible for back inflammation,” “ ...natural way to reduce courtesy letter was four pages long. Dkt. 97S-0163,
joint pain so you can enjoy life to the fullest with more Ltr. 390.
range of movement and flexibility...,” “reduce inflammation, soreness and stiffness...,” “...get you back in the
Rexall Sundown, Inc. of Boca Raton, Florida, wrote
game so you can engage in activities all day with less FDA that it would market a multiple number of calcium
pain...,” “inhibits the COX-2 enzyme, responsible for products with five different statements on their labels.
painful joint and muscle inflammation....”
FDA responded to the statement for the products named
Natural Oyster Shell Calcium Plus Vitamin D, Calcium
No More Aching Joints
250 Plus Vitamin D, Calcium 500, Calcium 600, Cal“reduce joint pain, increase mobility and improve cium 600 Plus D, Calcium 1200 Plus D (Sundown) sayflexibility...,” “ reduces inflammation, and helps improve ing that “... may support healthy blood pressure functhe condition of joint and muscle tissue...,” “ reduce painful tion” was a drug claims to treat a class of diseases and
joint and muscle inflammation as well as restore healthy this made the products drugs. Dkt. 97S-0163, Ltr. 391.
connective tissue,” “inhibit the COX-2 enzyme responsible for back inflammation,” “.... natural way to reduce
Shaklee Corporation, Inc. of Pleasanton, Califorjoint pain so you can enjoy life to the fullest with more nia, said to FDA it would market a product with 24 separange of movement and flexibility,” “reduce inflammation, rate statements. FDA responded that the statement for
soreness and stiffness,” “inhibits the COX-2 enzyme, CorEnergy — “... retaining normal blood cholesterol levresponsible for painful joint and muscle inflammation.”
els” was one that made that product a drug. The other
Dkt. 97S-0163, Ltr 388.
23 statements were not commented on by FDA. [Claim
Jarrow Formulas, Inc., of Los Angeles, California, writers for dietary supplements would be wise to consult
informed FDA it would use certain rather lengthy state- the statements that FDA has not commented upon and
ments for four different products — Gingko biloba, allowed to pass. To do this, you must obtain copies of
Cogniflex, Vinpocetine, and Lutein. FDA responded that the complete submission to FDA and the FDA response.
the following statements made the products into drugs: Go to the FDA Website or contact NML’s editor for
Gingko — “...increased cerebral circulation...”; more information. — Editor] Dkt. 97S-0163, Ltr. 392.
Cogniflex — “Age associated cognitive decline (AACD)
and compromised brain function...”; Vinpocetine — “By
Tabak’s Health Products of Costa Mesa, Califorreducing platelet aggregation Vinpocetine increases blood nia, sent FDA a letter with 28 pages of attached stateflow to the brain...” ; and Lutein — “...protect the macula
Continued on page 27...
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
LABEL STATEMENTS -- Continued from page 9...
Natural Medicine LawTM
Page 12
NATURAL PRODUCTS EXPO -- Continued from page 1...
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
New Hope Natural Media, told NML there appears to
be a channel shift in the industry as fewer buyers purchase more products. The firm runs the Expo East, Expo
West, and a new Expo Europe, which was conducted in
Amsterdam in June 2000 for the first time. He sees a
large increase in supplement use, then organic foods,
around the U.S. and Europe. New Hope Natural Media has worked with the Federal Trade Commission to
develop an Exhibitions Standards Booklet that is part of
the standards program which was launched in 1994. All
exhibitors’ advertising claims are reviewed by New Hope
staff amd infraction letters are sent back, pointing out
the changes that must be made in order to exhibit at the
next Expo.
Karen Raterman who is Vice President of Editorial
Content for New Hope Media said that consumer interest in natural products is high, but the facts and issues
change almost daily. She said there is evidence that companies are working hard to increase information about
their products.
Katherine DiMatteo, executive director of the Organic
Trade Association, reported on activities in the industry
and in government as she also serves on the Agricultural
Policy Advisory Committee for Trade for the Secretary
of Agriculture. “There has been a wild and woolly ride
for organic products, as it has escalated through unexpected and confusing details, she said. Organic foods
represent only 1% of all foods and fiber products, but it
is getting incredible attentions, she said. “Much information is incorrect, and there is so much that it gives the
appearance of a negative campaign,” she said. “Why so
much attention?”
Organic fiber is a key character in the changes coming,
DiMatteo said, particularly with the wellness trend. The
industry has grown from $6 Billion to $25 Billion in a few
short years and the growth rate is 20% a year. In Europe, similar 20% growth is being achieved, with some
products doing 70 to 80% more each year. “Organic,”
she said, “is a government label, and also a market label.” She said she felt certain the Organic Food Production Act regulations would be completed this year if
for no other reason that the writers wanted to do it before a new administration takes office.
On the government front, the new appropriation for
Agriculture includes $10 million to encourage producers
to change agricultural practices to more environmentally
friendly methods which will help organic farming. President Clinton signed a market order excluding cranberries from the overstock problems of the past few months.
And organic cotton products now may bear the seal,
solving another controversy. The web marketplace is
very active and the U.S. is a trendsetter. The OTA is
working to changes regulations to make sure the standards are followed by the international community.
Robert F. Kennedy, Jr., spoke at the press briefing
about his work selling Keeper Springs bottled water and
other products (they were exhibiting at Expo East), and
he told about the Pace Law School Environmental Legal
Clinic trial teams that he supervises. The Water Keeper
Alliance, a national network of clean water organizations,
was started to raise money for the clean water movement. Kennedy has been working for the Hudson
Riverkeeper for 16 years, where he is the chief prosecuting attorney, and for the National Resources Defense
Council.
Kennedy says he gets 10 third year students each year
at Pace Law School and assigns four cases to each for
prosecution under an 1898 law and a special admissions
order of the courts, allowing students to act as attorneys.
Calling the Farm Bureau an arm of the chemical industry,
Kennedy said the Keeper organizations are taking the
lead in attacking practices of industrial farming in several
states. Attorneys who formerly brought asbestos, tobacco and Dalkon shield cases, are now suing against
corporate farmers in North Carolina, against Perdue and
Tyson chicken operations, which Kennedy called criminal operations. Kennedy said there was more hog waste
being produced in North Carolina than all of the human
waste produced in California and New York combined.
“It is a now a scientific fiction nightmare, and we are suing every corporate factory we can find.” Corporate
farmers in Western states are claiming to be “factories”
to avoid zoning law requirements imposed on farming,
he said.
Loren Israelsen, Esq., president of the LDI Group, spoke
about five issues currently being worked on in the natural
products field. The first he mentioned was “What is the
difference between dietary supplements, conventional food,
medical foods, and drugs.?” The food industry is $450
Billion a year and the drug industry is bigger. FDA is
trying to set the stage for regulating everything with its
January 6 regulation on structure/function .... next page...
November 2000
Israelsen said that as a result of the Cholestin case, and
FDA’s Guidance Policy Statement for new drugs, he and
Mark Blumenthal of the American Botanical Council want
to have a traditional medicine class established for some
supplements. Third, he said the Pearson v. Shalala
case and how to implement it is all about order, safety,
and public confidence in products, and he said that GMPs
would be helpful, but the proposal of three years ago is
being held up by HHS or OMB.
The U.S. Pharmacopeia’s plan to establish quality standards and a seal program is a good step, he said. “ Consumers are concerned enough that I regard this as job
number one at the moment,” Israelson added.
Page 13
pliance by January 2001. She said she would mention
the changes from the proposed rule to the final rule,
changes in enforcement planned by FDA, and changes
that allow certain structure/function claims for women’s
products, and examples of claims that are still not allowed.
Compliance for all current claims is January 2001,
Brienza said, but for any new product or new claims,
you must bring them into compliance immediately if you
are relabeling or introducing a product, you have to be in
compliance. If you are a small business (less than 500
employees) you have 18 months from the issue date of
the rule. Disease claims are not permitted on labels, or
flyers, brochures, and things like that. The definition of
disease in the proposed rule was extremely broad, so
that just about any claim became a disease claim. In the
final rule, FDA moved back to the health claim definition
of disease, which is damage to any organ, structure, part,
or system of the body, such that it does not function properly, or a state of health leading to such dysfunction,
for example, hypertension. The definition has never
included diseases from nutrient deficiencies, like scurvy.
And he said it is difficult for consumers to make value
judgments about knowing whether a dietary supplement
will do what its label says it will do. Some manufacturers are selling cheap and do not do the quality control
Avoid the abnormal, Brienza said, do not talk about
they should. Prior to DSHEA there were two Federal sexual dysfunction, do not talk about “correct,” “repair,”
Register notices on dietary supplements, and since and “restore normal blood pressure.” The latter implies
DSHEA there have been 43 notices.
you had high blood pressure. Instead use the magic words
“maintain,” “support,” “normal,” “healthy,” “strengthen,”
An important issue is the presence of antibiotics in food, “ regulate,” “ support,” and remember to accentuate the
since 20% stays in the and 80% goes out, according to a positive and eliminate the negative. Consider claims in
pharmacist Israelsen talked to.
the context of the entire label. This is what the agency
will do under the new final rule.
Omar Waslow, the founder of New York Online, and
Health claims are not the same as structure/function
a consultant on cyberspace, talked about the tremendous opportunities for use of the web to communicate claims. Health claims are allowed on dietary supplements
among interest groups.
and conventional foods. The most famous example is
found on the Cheerios box. There are now 13 health
Structure/Function/Regulatory Update
claims, such as: Oat bran for a healthy heart; Calcium
The continuing education program for retailers had sev- for osteoporosis; and Fiber and cancer. Health claims
eral legal topics presented, although the major portion of require preapproval by FDA. Under the old regime, you
the programs were marketing oriented, with some clini- needed significant scientific agreement, and it usually took
cal results being reviewed by some speakers. One legal about 18 months. Under the new method you do it by
topic was “Structure/Function/Regulatory Update” with petition and you have to have evidence of efficacy from a
Susan Brienza, Ph.D., Esq., Scott Kumpf, Esq., and John certified scientific body, and wait 120 days before using
Swallow, Esq.
the health claim. The new method is much more quicker
process.
Brienza, an attorney with Patton Boggs, LLP, spoke
Much of the regulation is not new. The basic prinabout the January 6, 2000 Final Rule on Structure/Func- ciples are the same. Where did the new rule come from?
tion Claims, saying that everyone must come into comContinued on page 14...
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Natural Medicine LawTM
claims. The industry must exercise some restraint too,
he said. “ I can’t find a rationale for kava kava corn
chips,” he said. But DSHEA carved out an area for
dietary supplements, and we are working through the
processes of defining the law.
Natural Medicine LawTM
Page 14
NATURAL PRODUCTS -- Continued from
page 13...
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
Other implied claims espoused by the new rule are
Basically, it codifies the courtesy letters that FDA sent
included
in the 50 page preamble before the actual reguout informing manufacturers that claims were a disease
claim and there products would be considered an unap- lation of only a page and a half. You must read it all to
proved new drug. An example of drug claims: Echinacea determine the agency’s permission, she said. Disease
helps prevent infection in cold and flu season. The S/F claims include “joint pain,” the name of a disease with
version really conveys the same idea to knowledgeable the name of the product, or a picture of damage such as
consumers: Echinacea boosts your immune system. arrows coming from the head of a woman would imply a
Another example you cannot use for cranberry extract: headache. A simple, temporary headache is still considered a disease, Brienza said.
Cranberry extract prevents bladder
infections or prevents urinary infecYou cannot claim your product
tions. Instead you can say: CranA huge development
is
an alternative to a drug. No
berry extract helps to cleans and
in
the
final
rule
is
“herbal penicillin” can be used on
purify the urinary tract.
a label. There are ten different
that common condiways to imply a disease accordA huge development in the final
tions
of
women
can
ing to FDA’s regulations, she said:
rule is that common conditions of
1) effect on a disease (relief of a
women can be discussed on the
be discussed ...
bronchospasm implies asthsma);
label. We can now label and pro2) sign or symptom of a disease
mote common symptoms of PMS;
however, you may not talk about treating severe depres- (inhibits platelet aggregation implies prevent stroke or heart
sion or severe anxiety. Brienza said FDA recognizes that attack); 3) an abnormal condition associated with a natural
100% of all women go through menopause so claims state (osteoporosis does not affect the majority of
that are support for menopausal women or that help con- people); 4) you cannot refer to disease in product names,
trol hot flashes and mood swings are now allowed. Male you cannot use the heart symbol, you cannot list a well
products do not have the same leeway. Brienza said known drug like aspirin in your product as this will be
with regard to the claim of BPH, only 40 to 50% of men considered an implied disease claim, you cannot cite an
have the problem in older years, so it is not permissible article that has the name of a drug or disease in the title,
to say saw palmetto increases urine flow in men because and most of concern is if you have a joint formula product, with the statement saying “As described in the book
it implies a condition that is not a normal condition.
Arthritis Cure.” The use of the word “disease” or
Some claims are now permitted, such as, “ for occa- “diseased” is forbidden.
sional constipation,” and it is safer to talk about a temPictures and symbols, such as a skeleton with all of
porary condition rather than a long term condition. “Irrithe
joints circles in orange or red, are impermissible for a
table bowel syndrome” is a disease and may not be
mentioned. “For temporary muscle ache after a work- joint product. More curious, a normal EKG tracing
out” is okay, but not “pain relief for migraine headaches.” implies a disease. 5) membership in a product class –
The words “joint inflammation” implies arthritis and is not powerful antioxidant – places the product in the disease
permitted. “Sleep aid” is allowed, but not abnormal con- camp; however, “appetite suppressant” is permissible,
ditions like insomnia. “Antiacid,” “antigas pain,” and unless you are referring to obesity, which is a disease.
sexual performance claims are allowed. Antismoking
Brienza said no. 6 was like “herbal prozac” a substiclaims are yes and no, because smoking is an addiction,
tute
for disease therapy. 7) “Use when taking insulin to
and a claim such as “Aids in quitting smoking” are not
allowed, but you can use words describing temporary maintain blood sugar level” is not permissible. If you
alternative to smoking when you are in a place where drop “when taking insulin” the claim may be used. No. 8
smoking is not permitted. You can also market and label is the body’s response to a disease vector, “helps the
your supplement as a counterbalance to the effect of some body resist infection” is not permitted, but “boosting the
other drug or prescription drug that deletes a nutrient from immune system” is okay unless you go too far, such as
the body. If your product helps renew the potassium “strengthening the immune system in defense of the cold”
Continued on page 15...
level, that is a permissible claim.
November 2000
Natural Medicine LawTM
Page 15
them a little bit about the rule. Kumpf said take the time
becomes a disease claim. The no. 9 category of prohib- to make sure sales and regulatory people know someited claims are those of treatment or prevention of ad- thing about the rule.
verse events such as “reduces symptoms associated with
the flu.” Finally, the catch-all, no. 10, any statement that In research and development, the initial process will be
otherwise affects disease. On this last one, there are no giving to marketing the basic information. There must be
examples.
substantiation for the claims that are used. Marketing
people will further develop the claims. A most important
FDA promises future guidance on the permissible and group to educate are the people in marketing. This is
forbidden claims. A court would give deference to FDA’s more important now than in the past. We cannot say
interpretation of the words used in claims.
just anything we want to under this rule. Another group
needing education are the sales people who see other
“Lowers cholesterol” is a disease claim. But the final ads or commercials, and they want to know why the
rule allows you to claim “ helps to maintain cholesterol company can’t make the same kind of claims.
levels that are already in the normal range.” Also permitted, “improved absentmindedness,” but a claim about
All new labeling must be compliant by February 6.
“memory loss” implies Alzheimer’s disease. Finally, you That is any new product since last February has to be in
may not say “according to the American Cancer Society compliance by next year. Small companies have until
purple tea protects smokers lungs.” You could claim July 2001 to make revisions. Between now and July
purple tea is a wonderful antioxidant.
take a look to see if you are compliant.
A documented mechanism claim is permitted, and you
can get as scientific as you want, Brienza said. But you
cannot talk about a documented mechanism that implies
a disease, such as, “These ingredients work to minimize
carcinogens and mutagens in the body.” This refers to
cancer.
Section 5 literature, or third party literature, can be
used if it is not promotional. Five requirements must be
met and Brienza proposed this topic for Natural Products West. Finally, some cautions. As written, the rule
applies to dietary supplements, not functional foods. Remember the disclaimer that must be in bold. The entire
label must be kept in mind. And remember that FDA
will look at all evidence – ads, web site, the sell pieces of
your distributor. The label can be clean, but the web site
may refer to diseases, making your intended use as a
drug. File a Section 6 notice within thirty days of intended sale. FDA is going from courtesy letters to warning letters. Watch for future FDA guidance in this area.
The review of labels should include a review of advertising as the FDA and FTC have a long-standing agreement for enforcement. Having advertising that is different from the label could cause one agency or the other to
find something wrong.
Resolution of conflicts between sales and others departments is important. The FDA rules lead us to wanting to say things that we have to make sure we have the
science to back up. The things we sell have benefits that
we are not allowed to say. Marketing understands that,
and regulatory people understand that, but we have to
assess the risk in pushing the boundaries.
If claims seem to be outside the bounds of structure/
function, I have to do a risk assessment to determine if
they really have to do that. Generally, this requires
wordsmithing in the proper way to allow us to say what
we want to say. Sometimes the task is to come to some
agreement as to what can be said within the rule. When
FDA disagrees, what happens? In the past we received
courtesy letters, but FDA will no longer use courtesy letters and will issue warning letters. The difference relates
to the severity as the warning letter demands a more
timely response.
Scott Kumpf, Esq., counsel for Natural Balance, spoke
about company internal operations. From the manufacturers perspective, Kumpf explained how to implement
the FDA rule in a common sense way. The first thin that
has to be done is that everyone in the company has to be
educated about the function/structure rule to avoid probFDA lacks resources to deal with all of the problems.
lems. Company executives need to know at least gener- Courtesy letters do not quickly resolve issues. FDA can
ally what the rule is. Kumpf has done seminars to teach
Continued on page 16....
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Continued from page 14....
Natural Medicine LawTM
Page 16
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover.
its on use, Swallow said. The 1997
rule of 8 mg per serving and 24 mg
per day has been withdrawn. OTCs
have levels of 150 mg per day and
FDA did not have a problem with
that. FDA has not started studies to
test the safety of ephedra or on the
issue of whether ephedra does anything harmful to the body.
that it is safe and effective.
The FDA’s AER reporting system
was reviewed by the General Accounting Office, Swallow said. GAO
said FDA did not have sufficient scientific basis for its rule. GAO recommended the rule be withdrawn.
Dr. Steve Kimmel, a cardiac epidemiologist at the University of PennThe scientific community is not sylvania, presented an analysis of
finding a problem with ephedra. FDA’s AERs. He found 20 to 60
With billions of servings, there is very seizures for every 100,000 young
little being reported – 800 submis- people; between 33 and 60 for heart
sions and 13 were used to write the attacks for every 100,000 people;
limits in 1997. Drs. Patricia Daily and and 20 and 60 per 100,000 for
Carol Boozer reported at an August stroke. Approximately 75,000
hearing that no adverse events were people under age 40 have strokes
found when using ephedra products. each year and between 22,000 and
Photo Courtesy of Lloyd Library and Museum
66,000 under age 40 have heart atEphedra is safe, but does it really tacks each year. He compared these
work? Yes, it works!. We have rate of these event reported to FDA
studies to prove it works to manage numbers with assumptions on the
EXPO EAST -Continued from page 15...
fat and obesity. Dr. George Bray ar- conservative side and found that the
seize products, but it has not hapgued for continued access to ephe- expected rate for persons using ephepened very often. There are only a
dra to combat obesity; he said the dra were either below or n the excouple of instances since 1994 where
products were effective and safe. Dr. pected range for the general populathere were seizures and in each case
Arnie Astrup echoed these comments tion.
there was a warning letter.
with tremendous results. Dr. Jay
Hover reported favorably on his cliniEphedra is being blamed wrongly
John Swallow, counsel for
cal studies in Texas.
in a lot of cases. We had an attorney
SilverSage and a member of the Utah
who read the entire file and he did
House of Representatives spoke next.
Responsible industry is working to not find a link to ephedra. On the
When growing up we could not keep
preserve the right of consumers to use other hand, some people abuse epheour calves from breaking through the
ephedra. They are working together dra and these should not be blamed
fence to get hay. We used razor wire
to set standards of 25 mg per serv- on the ephedra.
and the calves were injured getting
ing or 100 mg per day. And they are
the hay. But we finally put the hay on
working on effective warning labels
Ephedra is safe and effective. Ada platform above the heads of the
to advise consumers, and on stop- verse events are due to the failure to
calves in their own pen and none got
ping the elicit sale of products. Many follow industry standards. The industhe hay and none were injured.
organizations are encouraging manu- try has been responsible in developfacturers from selling irresponsible ing the guidelines. It would be a tragSwallow said FDA was trying to
products. DSHEA was landmark edy to lose this ability to share epheimpose unsupported restrictions on
legislation, shifting the burden back dra with people overly aggressive
ephedra which is like putting razor
to the government to prove there are regulatory process.
wire around the fence. We are only
problems.
denying consumers an effective way
Over regulation, contrary to
to manage their weight. He spoke
FDA does not have science be- DSHEA, is like razor wire to farm
in six areas.
hind its actions on ephedra. All over animals. It won’t protect abusers
the world studies are being reported
Continued on next page....
Federal law now has no official limNovember 2000
Natural Medicine LawTM
In answering questions, Brienza
said that FDA’s preamble of January
6 says specifically how cholesterol
claims are to be handled. Swallow
said FDA has the power to regulate
ephedra, but it has not met its burden
of proof. Brienza said that variants
of ephedra, such as hydrochloride,
might have a more potent effect, but
FDA has done no studies. And
Brienza did not know any studies on
natural and synthetic differences.
Swallow said FDA has no ongoing
tests. The states are coming up with
regulations that differ. We also don’t
know if FDA is going to impose a
higher limit. There are no known
problems with the 25/100 limitations,
he said. OTCs are going to 150 mg
without any attention from FDA.
Brienza said if you substitute a substance different from your label, it
would be prosecuted. This is a safeguard for the public.
Swallow said that if you have dialogue about claims with FDA they
may look at all materials you use to
promote the product. They do not
necessarily do this when you send in
the 60 day letter. Any product that
goes to market or significant changes
in labeling needs to be sent to FDA,
whether it complies or not. You need
to send the one page form to FDA,
said Brienza, and you do not send the
labeling or advertising. If you have
no substantiation or not enough substantiation, this could be a felony.
New ingredients are different and require a 75 day letter which we did
not cover today.
Swallow said that Texas, Ohio, and
California labels will require new
modifications including a 12 week limitation warning. Brienza said manufacturers should write disclaimers and
notify distributors of your position.
DRUG DEPLETION: MEDICAL & LIABILITY ISSUES
Derrick M. DeSilva, Jr., M.D. and
Anthony Young, Esq., spoke at the
Natural Products Expo East on an interesting topic. DeSilva, a practicing
physician from Perth Amboy, New
Jersey, a syndicated columnist, and
the radio show host of “Ask the Doctor” on the Talk-America Network,
started with a review of a number of
prescription drugs that cause nutrient
depletion. He claimed he has spent
in excess of 5,000 hours on this in
the last four years. Dr. DeSilva said
that “natural people” and conventional
doctors could be brought together
with this subject.
and cardiovascular disease. An article in NEJM this year said estrogen
had no effect on heart disease. For
osteoporosis, if a prescription medication depletes magnesium, what
happens to calcium? It is also
wasted. And Vitamin D doesn’t
work, DeSilva said.
The estrogen prescription is supposed to prevent osteoporosis, but
people are still getting it on hormones.
One mechanism for how this is happening is the depletion of magnesium.
What is Vitamin B-6 necessary for
when it comes to heart disease, De
Silva asks, and then he answers it is
for lowering homocysteine. Homocysteine will accelerate, damage,
and cause cardiovascular disease. It
is an amino acid that is naturally produced and when elevated it will nick
or accelerate cardiovascular disease.
With estrogens, your homocysteine
level goes up and your Vitamin B-6
level goes down. Maybe you are
accelerating cardiovascular disease,
so DeSilva prescribes B-6, 100 mg,
DeSilva says there is no one way and 250 mg of magnesium twice a
to do things and you need an inte- day with HRT therapy.
grated approach. He likes bringing
Digoxin or Lanoxin are ionotropic
the two schools of medicine together.
drugs
that increase the contractility of
Using prescription medication depletes nutrients, so he prescribes one heart muscle. Hawthorne is also
or two nutrients with each prescrip- ionotropic (heart beats harder) and
chronotropic (heart beats
tion drug that he uses.
sequentually). Atrial fibrilation can
Highlights of what DeSilva said fo- be controlled by Digoxin or Lanoxin
cused on the American Nutraceutical and these are used for congestive
Association of which he is president heart failure. But these drugs deplete
and said that scientific support for his calcium and magnesium necessary for
positions were published in its jour- heart cells to work.
nal and on its web site. The March
DeSilva always recommends cal6, 1999 Drug Topics magazine said
that estrogen or hormone replacement cium and magnesium with his prescriptherapy (HRT) is the number one pre- tions for Digoxin or Lanoxin. Vitascription drug in the U.S. HRT is min B-1 (thiamin) and magnesium are
used for prevention of osteoporosis
Continued on page 18...
November 2000
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover .
because they can access it through
OTCs but it will hurt an obese population because it will deny access to
the one dietary supplement that really will work for them. The true solution is to follow the industry standards. Let DSHEA work and stop
chasing calves.
Page 17
Natural Medicine LawTM
Page 18
NUTRIENT DEPLETION -- Continued from previous page...
the most deficient nutrients in the U.S. today.
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
Beta-blockers like Inderal, propanolol, tenormin, and
Corgard, are used to lower blood pressure or control
heart arrythmias, and if I discharge a heart attack patient
without a beta-blocker, it is malpractice. But betablockers deplete Co-Enzyme Q-10 from the body, and
this is an energy nutrient for the mitachrondria that are
the engine for the cells in the heart that pump the blood.
Co-Q-10 is it gasoline for the engine.
Research has shown that after 5 to 7 years mortality
increases for these patients. Some people say it is the
progression of the disease, which is possible, but after
five years, the levels of Co-Q-10 are depleted in human
myocardial biopsied hearts.
inflammatory drugs should not be sold over-the-counter.
“This is an absolute crime,” DeSilva said. “We are causing an absolute epidemic in this country.”
HMT co-reductase inhibitors — Lipitor, Mevaclor,
Zocor — depletes the body of Co-enzyme Q-10. The
very disease you are trying to control with these is depleting the body with a nutrient critical to cardiac function.
Non-steroidal anti-inflammatories deplete folic acid.
The alternatives are to use them for two weeks or a month,
but not for two years. But glucosamine, chondroitin, arnica, and the MSN should be kicking in at the end of a
couple of months with a reducing dose. Those are the
long-term treatments for arthritis.
Antibiotics require the use of a probiotic or acidophyllis.
Once we replace these nutrients, along with carnitine, Anticonvulsants — Dilantin, phenobarbital, Tegretol, and
thiamin, creatine, torine, and Co-Q-10, cardiac contrac- Mysoline — all deplete folic acid, B-12, calcium and
tility improves. The data will be available shortly.
Vitamin D. Antidepressants deplete Co-Enzyme Q-10
and Vitamin B-2. Migraine headaches are often
Beta-blockers cause people to be pooped, because deficencies of Vitamin B-2. With a base line deficiency
they deplete the gasoline for cells.
of magnesium, the B-2 deficiency makes migraines worse
and you get tired.
Water pills or thiazide diuretics are horrible. They
deplete magnesium, potassium, zinc and sodium. Even
“I make sure that I supplement when I use these medithe potassium sparing diuretics take out Co-Q-10, folic cations. Diabetes medications deplete Co-Q-10, and
acid and calcium.
you get neuropathy. Every pharmaceutical depletes nutrients, DeSilva said. Herb-drug
Loop diuretics are used in congesinteractions need to be known by
tive heart failure, but the medication
Herb-drug interactions health food store owners to help
depletes magnesium, thiamin, and Bneed to be known by health people read something about what
6. These nutrients must be replaced
food store owners to help... they are buying.
or the disease will progress.
Get a book, a kiosk, or someH-2 receptor antagonists —Zantac, Tagamet, Pepcid, thing to let the customer know about the interactions.
all over-the-counter — are used for heartburn, gas, indi- You need to assume some of these responsibilities. “This
gestion and bloating. It might be better to use a probiotic absolutely must be done,” he said.
to replace the flora in the digestive system. These are
nutrient depleting as well. When you change the pH of Anthony Young spoke next. He is counsel to the Amerithe stomach, you kill the flora and get overgrowths of can Herbal Products Association, and a partner with
things that should not be there.
Piper, Marbury, Rudnik and Wolfe, practicing food and
drug law for almost 30 years.
Digestion requires enzymes, acid, biliary gas and stomach juices, plus the critical probiotics. The right bacteria
“I will focus on what retailers may do when consumers
have to be there to digest foods. You do not want the come to ask about supplements and you know that they
are on some drug therapy, being treated by a physician,
food sitting there or you get bloated.
perhaps for a serious disease. What Derrick talked about
in terms of depletion needs to be known by physi- .next page
DeSilva said that these drugs and nonsteroidal antiNovember 2000
Page 8 - Valerian (Valeriana officinalis) from MEDICAL
BOTANY by John Stephenson, M.D. and James Morss Chuchill,
F.L.S. 1829
Ginkgo can have an additive effect with other bloodthinning agents. Kava can potentiate barbituates and garlic
can increase bleeding time of patients on warfarin. We Page 16 - Ginseng (Panax quinquefolium) from THE FAMILY
need to be concerned about these kind of things. You FLORAAND MATERIA MEDICA BOTANICA by Peter P. Good
1847
need to be careful.
Page 26 - Evening Primrose (Oenothera biennis) from AMERI-
FDA is not allowing certain structure/function claims CAN MEDICINAL PLANTS, supra, 1887
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Natural Medicine LawTM
Page 19
cians, so help get it to physicians through their patients.” that deal with issues when you are on drug therapy.
Whether that includes what Derrick was talking about is
“You are not doctors. The customer is someone else’s interesting. FDA was interested in the use for nausea
patient,” he said. You should never discourage custom- with chemotherapy. Physicians are concerned that drugs
ers from seeing doctors, but rather encourage them to have not been tested with supplements, Young said.
see their doctor, “as that protects you in the long run as
you’ll see.” You want to be able to give good informaControlled studies are with several thousand patients
tion about the use of supplements with drug therapy to and that is not the kind of population that a drug gets out
take back to their physician. “Encourage your patient/ to when it is released. When they do go on the market,
customers to report changes to their physician. The new there are adverse effects, and they are recalled.
millenium of this industry is partnering with mainstream
medicine, not war.”
What is the liability for you as a retailer. Any supplement labeled for use with prescription drug therapy is
Customers are not allowing physicians to just say “go most probably misbranded — it should not be making
away, stuff is junk.” They demand their doctors provide that claim. Any recommendations you make to your custhe answers. You who sell or make supplements can be tomers with respect to supplements for drug adverse
helpful. If you have articles about nutrient depletion then events could be characterized as drug claims for the prodpass it along to the doctor through the patient, Young uct. How could that happen?
said.
Under DSHEA, we don’t teach the basics of the food
FDA approval of a product does not mean that it is and drug laws. One of the violations is called misbrandabsolutely safe. We know that most drugs have side ing a product while held for sale. If a product is labeled
effects. “Supplement”doesn’t mean safe; “natural”doesn’t for help support the immune function and you take that
mean safe. I say to my manufacture clients, “don’t talk product and direct it to a consumer saying, “Mrs. Jones
to people as these products are absolutely safe.”
this product is good to prevent pneumona,” you have
turned that product into a drug. Because you have
Drug-food interactions are important. Grapefruit pre- changed the use.
vents certain drugs passing through the liver. Botanical
products, Young said, are the source of 20 to 40% of
In the late 1980s one of the biggest chains selling
pharmaceuticals. Most are physically active and that is supplements was prosecuted just for that. Liability iswhy we can make structure/function claims. Ephedra sues that are a lot bigger for you are when you know a
has several drug ingredients.
person is taking an important and a life sustaining drug,
you may be liable for the consequences that result to that
The principle focus of the medical community is on the patient. The only case on point is the New York City
Continued on page 20...
interactions of botanicals with drug therapy. As they see
the use of these products going up, they are saying “What
is going to happen?” The anesthesiologists said we will
ask patients about ephedra in three days before surgery.
“St. John’s Wort is said to interfer with anti-HIV therapy PHOTOGRAPHS FROM LLOYD LIBRARY AND MUSEUM
— seritonin reuptake inhibitors — those are the drugs Page 4 - Goldenseal (Hydrastis canadensis) from AMERICAN
that help keep those have HIV alive. We do not want to MEDICINAL PLANTS by Charles F. Millspaugh, M.D. 1887
be interfering with that process.”
Natural Medicine LawTM
Page 20
NUTRIENT DEPLETION - Continued from page 19...
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
personal trainer. A lady had hypertension and was taking medication. The trainer gave her an ephedra type
product. The product was labeled, “If you have high
blood pressure, you should consult with your physician,
and she did not.” She had a stroke while working oout
one day, and expired. The family is now suing the trainer,
the gym, and the manufacturers of every product this
person took.
Young added, “You all know what third party literature is”. Derrick’s Journal is third party literature. It
talks about substances and not products. It is peer reviewed. You can display that separate from your supplements to explain the use, but you can’t put a tag on it that
includes your store name, and you can’t put a sticker on
it to direct them to a particular company. That may be
false or misleading, he said. To be continued....
CHPA Program -- Continued from p. 12...
Consumer Panel
Dietary Supplements are a key factor in health care
Finland
27%
France
20%
Germany
29%
Poland
61%
United Kingdom
32%
United States
54%
More likely to treat self first
Finland
21%
France
52%
Germany
32%
Poland
50%
United Kingdom
52%
United States
54%
Always treats with prescription medication
Finland 60%
France 71%
Germany 41%
Poland 65%
United Kingdom 46%
United States 67%
A consumer panel was moderated by Andrew Davis,
General Manager of the Nutritionals Business Unit of
Whitehall-Robins Healthcare. He presented three speakSlaughter said there were 100.4 million users of diers – Edwin P. Slaughter of Prevention Magazine, Linda
etary
supplements every day and 37.2 million users of
Golodner, president of the National Consumers League,
herbal products daily in the United States.
and Harvey Hartman.
Golodner commented about surveys NCL had done
Slaughter spoke about his market research on supplements in the international arena. His surveys in Europe of women. Only a bare majority knows the government
show such information as shown on the following tables. does not regulate herbal products for safety. 53% say
they are not regulated at all. The National Consumers
League is concerned about lack of communication with
doctors on the use of dietary supplements and herbals
More concern with money than health care
for chronic conditions. But there is a heap of informaFinland
70%
tion out there and it needs to be sorted so the consumer
France
74%
does not have to spend time getting what they want.
Germany
67%
Poland
91%
United Kingdom 61%
United States 51%
Less trusting of advice of doctors
Findland 14%
France
9%
Germany 25%
Polaand 25%
United Kingdom 26% & United States 25%
At the question session, Hartman said consumers seek
information, but know little. The question is the level of
knowledge they need. Stores that put nutritionists in them
found they could not take them out. You have to get
information to consumers on consumer terms. Slaughter said products have to sell a benefit. Consumers want
a sense of participation in their health.
The panel was asked how to reconcile the recent de-
November 2000
Continued on next page....
CHPA Program -- Continued from page 20...
Page 21
cer, Echinacea and immune function, flavanoid bioresearch
and phytoestrogen screening and bioassay. He indicated
that “nutrition education does not really modify nutrition
behavior” so the science must be known better. Heber
spends an hour a day on a radio program to give good
scientific information. One reason he does this is because media reports on sensation to create ratings and
sell papers.
cline in sales. Hartman said we are spoiled in an emerging market with expectations. There are more competitors today. Slaughter said that consumers do not understand that you have to take dietary supplements 4 to 6
weeks for them to be effective, and consumers are willing to take them only one month and get no results.
Golodner said maybe they took something and did not
like it, they are evolving. There needs to be a more active role by the health care practitioner. Slaughter was
Robert Russell, M.D. of Tufts University, reported
asked which countries are the growth drivers in the mar- on his research in older adults. He is working with more
ket and he replied that what happens in the U.S. tells the conventional nutrients and botanicals are really unknown.
future for Europe.
The demographic pyramid of living persons in 2030 will
look like the Washington Monument, with about equal
Hartman said consumers are not thinking much about men on the left and women on the right with age group
quality, but looking for a brand that represents quality slices from the bottom to top. Back in 1830 the pyramid
and they seek an emotional tie to the products. Slaugh- looked like an Eqyptian triangle, with the largest number
ter agreed that the brand develops with honest commu- being the new borns and the oldest the ancients. People
nication with consumers, the more information on risk, are living longer.
the more consumer confidence and compliance with use
instructions. Golodner agreed that consumers look to
Russell said caloric intake declines with age and the
brands and said the NCL needs to show that products metabolic rate goes down as well to a point of 1500 to
may differ.
1800 calories per day which means an inadequate amount
of nutrients. Of people over 70 years of age, 98% do
Science Panel
not get adequate vitamin D, 95% do not adequate calcium, 75% do not get B vitamins and vitamin C.
Paul M. Coates, Ph.D., director of the NIH, Office of
Dietary Supplements, introduced the scientific panel of
He said Susan Roberts, M.D. of Tufts did a study of
three speakers. Coates explained that the Office was underfeeding a group of people for several days, then let
working on certain mandated efforts, including exploring them eat anything they wanted. The younger people made
the role of dietary supplements in health, promoting the up for lost calories, the elders continued to under eat for
scientific study of dietary supplements, conducting and about two weeks.
coordinating research, collecting and compiling data, and
providing advice to other HHS agencies. Also Congress
Interest and acceptance of needs in nutrition plays a
has mandated it study chromium in diabetes and zinc in role in chronic disease. RDAs for age groups is being
colds and flu. ODS also has a bioavailablility program, researched today. We know that calcium and vitamin D
the IBIDS resource program, fact sheets on Vitamin and play a role in osteoporosis, that vitamin D intake deminerals, and fact sheets on herbals. The research pro- creases with increasing age because absorption decreases
gram under Dr. Swanson covers biological effects and because of a decrease in vitamin D receptors in the inscientific information and promotion of research. And testine. We know that skin synthesis of the elderly definally he mentioned the four botanical research centers creases because they stay out of the sun more. An 82
supported by ODS and other NIH agencies – NCCAM, year old has only 40% of the capacity to formulate vitaNIGMS, and ORWH.. These are UCLA, University of min D. Older people need parathyrotic hormone as well.
Illinois at Chicago, Purdue University, and University of
Arizona, each receiving $1.5 million a year for 5 years.
Elderly need 1000 mg of calcium per day to maintain
bonedensity.Atropic gastritis (less acid) affects the absorp
David Heber, M.D., of UCLA spoke first about his tion of Vitamin B 12 and the elderly can not get enough
center’s unique research criteria to study multiple ingre- unless it is disconnected from food intake. Vitamin B 12
dients of botanicals. They will research red yeast rice,
Continued on page 22...
green tea, Saint John’s Wort, Soy Isoflavones and canNovember 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Natural Medicine LawTM
Natural Medicine LawTM
Page 22
CHPA Program -- Continued from page 21...
Quality Control Panel
is involved with dementia and high homocystine levels.
But you need to diagnose low vitamin B 12 with in 12
Forouz Ertl, DVM, Executive Vice President of Bomonths because after the body has been at low levels
that long, supplement do not work to restore normalcy. tanicals International/Hauser, Inc spoke first reviewing
the need for monitoring botanical supplies. She said the
Bioavailability of supplements in important to know. negative coverage was 7 to 1 to the good coverage.
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
The simple “more is better” is not good, Russell said.
Ertl said that the Natural Business Journal’s year
2000 overview said that sales were up 5.9%, but she
Joseph V. Rodericks, Ph.D. of the Life Sciences
figured most of that came from three products – gluConsultancy, spoke about the work of the Institute of
cosamine ($340 M, a 40% increase), calcium ($670 M
Medicine/National Academy of Sciences Upper Levels
increase and 18% increase) and SAMe ($100 M as a
Subcommittee. The TUL is the highest level to pose no
new product). Herbs have declined 2.6% , she said,
rise of adverse effects or the tolerable upper level.
and that figure includes soy which is up 200%.
He said there are many risks from the food supply —
natural foods, food additives, contaminants indirectly
added, and plain contaminants. The subcommittee are
not nutrition experts, but risk assessment experts. They
are finding many uncertainties. The upper limits are increasing with age. There are no fixed relationship between effects from lack of nutrients and side effects beyond upper limits – the methodologies are completely
different. Upper limits are not meant to limit clinical
research.
In the question session Rodericks said the subcommittee refused to set an upper limit for betacarotene because of the smokers who used it. Dr. Heber was asked
about using soy in post menopausal cancer survivors. He
said 2/3rds of the world population uses soy. If they get
cancer, it grows slower. In short, soy is safe under 100
mg per day.
Russell was asked if the elderly needed enzyme supplements and he said no and that although they have a decrease they still have plenty left. Heber was asked about
his thoughts on the switch of prescription drugs to overthe-counter drugs and he said he could not recommend
that. Dr. Coates commented on the connection between
cinnamon and diabetes, saying we do not know much
yet.
Botanicals come from 30 countries primarily. There
are ethical and marginal suppliers. She recommended
complying with proposed GMPs, FAC Guidelines,
HACCP, and the trade organization recommendations.
A major focus should be on cultivation. Ertl maintains a
database on nine categories of information – cleanliness/
purity, microbiological, identification, adulteration, potency/marker identification, contaminants, analytical capability, shelf stability, and efficacy through clinical studies.
Scrini Scrinivasan, Ph.D., director of the USP Dietary
Supplements Division, spoke about USP’s development
of monographs and the process used with Pharmaceutical Forum. He said USP had been working on vitamins and minerals in 1990 when Dr. Ralph Shangraw did
dissolution tests showing that some products did not dissolve in the body. By 1994 to 1996 several companies
had reformulated their products.
In 1820 there was 217 monographs in the USP, mostly
botanicals. In 1995 USP adopted a resolution to focus
on botanicals and did not get the cooperation they wanted
from the industry. The standardization of botanicals is
more complex than the standardization of vitamin/minerals. The reference standards needed for botanicals are
more expensive to produce as well, he said.
The afternoon sessions on the first day were three sepaJoseph M. Betz, Ph.D., recently moved from FDA to
rate panels that were conducted two times each. NML
the American Herbal Products Association as the Vice
reports only on the panel on quality control and the panel
President for Scientific Affairs, spoke next. He spoke
on First Amendment issues in this newsletter. There was
about the need to validate AOAC methods used in 90
a panel on structure/function claims also.
countries. FDA uses official methods, peer verified methContinued on page 23...
November 2000
Page 23
CHPA Program -- Continued from page 22...
with the regulations.
ods, methods from peer reviewed literature, and in-house
methods. Anything below official methods resulted in a
Betz said that the digitalis in plaintain issue slowed down
battle of experts in court cases. Betz described the the release of GMPs by FDA for dietary supplements.
AOAC process.
The agency wanted to make sure it was done right. Upton
said that the problem is where the manufacturer validated
Wiliam Obermeyer, PhD. Vice President of by different methods than used by ConsumerLab.com.
ConsumerLab.com spoke about how newspapers do In the case of Trader Joe’s St. John’s Wort, the comseem to emphasize the negative side of his company’s pany used the wrong method to test. The AHPA method
reports about products instead of the positive. But he would show the product was okay.
said, “projecting quality will make a difference in brand
loyalty in the future.” ConsumerLab.com is privately held First Amendment Panel
and there are no manufacturers or retailers who are owners. They get some money from the use of their seal.
Jonathan Emord and Eugene Lambert, both attorneys,
Two thirds of the 200 products they have analyzed have spoke about the First Amendment issues, starting the
passed lab tests. The feed back is good from consumers program with a pretest. Emord gave a history of the
(85%) and health care providers (15%).
underpinnings of the First Amendment from the Roman
Senate to the 1731 Ben Franklin Apology for Printers,
Obermeyer said a lot of products have the right ingre- to 1791 when James Madison said the Amendment was
dients but they do not disintegrate. ConsumerLab.com a static barrier to disarm limited speech. In 1842 the
accepts no samples from manufacturers, it purchases its Supreme Court said in a case that commercial speech
own samples from a variety of sources. The samples are was not protected. But in the 1970s the Supreme began
blinded to experts so they have no idea what they are. to rediscover what the First Amendment was about in
The experts use AOAC, USP, and European Pharma- the Bates case and the Virginia Board of Pharmacy
copeia methods.
case. Finally in 1980, the Central Hudson case set forth
a four part test to determine if a law was unconstitutional
Roy Upton spoke about the American Herbal Phar- barrier to free speech.
macopeia first published in 1995. He said that the dietary supplement industry was asleep from 1976 to 1990
It now is the government’s burden to justify the limitawhen NLEA woke it up. He said in 1991 that he wrote tion of speech under Central Hudson, he said. FDA
a report for the Congressional Research Service about argued in the Pearson v. Shalala case that the company
the International Regulation of Herbs in 1991. The cur- must prove there is a truthful established relationship of
rent edition of the AHPA Herbs of Commerce list has the health claim and the ingredients. These were not esover 1200 herbs.
tablished, and they did not meet the significant scientific
agreement standard, therefore, they were not truthful. The
The American Herbal Pharmacopeia contains identifi- Court of Appeals rejected FDA’s argument.
cation information, microscopic identification, chemical
identification, and photographs of the various forms. They
Eugene Lambert of Covington & burling said the disuse multidisciplinary committees to review monographs. cussion was not purely an intellectual exercise because
Upton said the European Pharmacopeia was followed he and Emord see practical commercial reasons to purby 28 countries.
sue Pearson. The dietary supplements need information for consumers giving reasons for using the products,
In the question session, Obermeyer said that a num- but there is a disconnect in what people need to know
ber of multilevel marketing products had been tested, such and what industry can tell them under the laws. Some
as Amway, Puritans Pride and Shaklee. And he said the people already see that. Benecol got permission to use a
company had not been sued yet. He said also that when claim for “healthy cholesterol.” Companies saw a benCNN ran stories on the results of testing, they got 40 efit of using “heart disease” on labels.
letters, some 20 pages long, complaining about
ConsumerLab.com. Obermeyr said a lot of products
When FDA is faced with Central Hudson they test
are mislabeled – poorly written – and not in compliance
Continued on page 24...
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Natural Medicine LawTM
Page 24
CHPA Program -- Continued from page 23...
all four elements. The argument that if-we-haven’t-approved-it, it is unlawful, get the back of the hand from
every court. FDA gets no pass on whether prohibiting
speech advances the government’s interest and FDA is
pressed on whether there is a “good fit” between the
restriction and governmental interest.
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
Lambert said that disclaimers can be explanations.
“Pearson said to FDA, ‘apply the statute as written,’
not as FDA has interpreted the statute,” Lambert commented. And he added that “significant scientific agreement” means that among experts qualified to evaluate such
claims as the claim is supported by evidence. But FDA
says it will determine whether the relationship is true.
Lambert said Pearson says that the First Amendment
requires FDA to evaluate claims that describe the relationship.
Natural Medicine LawTM
ting health claims under the current situation and told FDA
that companies making less than $100 million a year are
not going to go through that process. Emord said
“Pearson will not stimulate research until FDA shifts to
an accuracy of claim analysis.” And he added, the
Pearson guidance on significant scientific agreement is
dismal. By October 10 FDA has promised to rule on
the four claims, by November 24, FDA is to rule on the
folic acid, B vitamin claim on heart disease, Emord said.
The Court of Appeals will set an argument after October
10, Emord said.
A challenge to the significant scientific agreement standard will be a part of the cases Emord is bringing for his
clients. Emord is waiting on the judge in the Saw Palmetto case where FDA said it was too difficult to contemplate if a health claim could extent to a treatment.
Second Day
Outside of the dietary supplements field, the food industry will not duck the opportunity to use Pearson. But
the Pearson court did not deal with the procedure, which
is a petition is submitted to FDA and it gets 100 days to
review. There must be a rejection or a Notice and Comment Rulemaking started, which lengthens the approval
time to 540 days. Under the FDA Modernization Act,
there is a 75 day premarket notification requirement for
claims; ten were submitted and nine rejected. The only
approval was General Mills whole grain cereals claims.
Day two of the program began with Marjorie Fine,
general counsel of Shaklee Corporation, giving a summary of day one.
Joseph Levitt, director of the Food Center (CFSAN)
was next. One of his claims to fame at FDA is that he
and Michael Maves worked together on the hearing aide
regulation hearing seven years ago and the final rule has
not been promulgated yet. Levitt covered three areas:
1) regulatory update; 2) resources update; and 3) reality
“Recently FDA proposed a tentative final rule on stanol check.
esters for heart disease claims,” Lambert said, which is
Under Regulatory Update, Levitt mentioned that his
a new development. In the states and the Federal Trade
Commission, the test used is “substantial evidence.” FTC priorities were safety, food ingredients, dietary supplewill accept claims that FDA will not approve. The issue ments and food biotechnology. As for dietary suppleat FTC is consumer understanding of claim, not FDA’s ments, the Strategic Plan was announced in January 2000
to deal with implementing DSHEA, restore consumer
understanding.
confidence, strengthen the science-bsed approach to
Lambert said that Pearson precludes FDA from de- regulation, and assure a long-term effort to implement
veloping a more onerous approval standard. But Pearson the law.
does not remove premarket review from health claims,
The Strategic Plan categories deal with safety, labelhe said. “There is little incentive to pursue a health claim
ing,
boundaries, enforcement, science-base and outreach.
unless you have developed intellectual capital.”
During the next two years, the Food Center will speed
Emord added that since the 1962 amendments and the up a market review of certain dietary supplements through
modern NDA process, the FDA has an incentive to pro- a contract with the National Academy of Sciences. This
tect the process from competition. It is relatively idealic is being done with some end of the fiscal year money that
for FDA to dictate the terms on the label and companies became available to FDA. The Strategic Plan impleare willing to spend $500 million to get the claim ap- mentation is being done with the Annual Program Prioriproved. Dr. Rubin projected a $58 million cost for getContinued on page 25...
November 2000
Continued from page 24...
ties and as resources permit. The Yellow Book (program priorities) and Green Book are available. Levitt
admits that when FDA rolled out the Strategic Plan, many
in industry said it was too long, and Levitt said they could
speed it up with more resources.
The Ephedra file is being watched and will be developed into a regulation at some point to deal with the problems in that area, Levitt said.
The Food Center has only five rules pending for the
Federal Register where an agency like EPA has 65 pending. The Food Center Staff is not as large as EPA.
The adverse event reporting backlog is being worked
on, but none of that is available right now. The premarket
notification process are being completed on time. There
were a total of 24 so far this year. Routine compliance is
being enhanced with an internal agreement with the Drug
Center. The two Centers have agreed that if the product
has a drug claim, but is essentially a dietary supplement,
that the Food Center will handle the regulatory and legal
enforcement issues.
By October 10 FDA will issue decisions on the four
heath claims, relative to the significant scientific agreement standard under Pearson, Levitt said. By November 24, two petitions would be decided basically on the
protocol of deciding the significant scientific agreement
question. If yes, the petitions will be approved. If no,
then FDA will decide if the scientific evidence for the
claim outweighs the evidence against, and if yes, the claim
may be approved if there can be a qualified claim. If no,
the claim will be denied.
Levitt said the health claim petition for saw palmetto
was one that claimed to mitigate a disease and FDA
denied it.
For Levitt’s Resource Update, he indicated that there
are only 20 full-time equivalent personnel working on
dietary supplements at FDA. He had asked the Senate
for more money for adverse event reporting upgrades,
but it is not coming yet. The House approved the
expense, the Senate has not. He cautioned that the 10
year plan may not get the money needed to implement
it until the 5th year of the 10 years.
Page 25
public meetings which reflected, he said, an under current of desire for legitimacy. The FDA is not warm
hearted toward some claims, and over the past year there
has been a barrage of articles on challenging products.
FDA has to acknowledge, then address these. The food
companies have an AER system in place. When questioned about safety of dietary supplements, Levitt said, “
Congress passed the law, we have a small staff – we will
do the best we can.” On the “Today” TV show someone said these products are “weak drugs.” Levitt said
FDA has to come to grips with what people says these
are.
Asked about what has happened since the Burton
Hearings in 1999 with the improvements for AER reporting, Levitt reminded the CHPA audience that it asked
for money, but the budget is increasingly earmarked for
other things. One half of the budget in CFSAN is for
food safety, some for food additive review, what is left is
subject to inflationary increases. FDA will have the
same amount of money since 1993. Budgetary considerations must be made for 5% salary increases, and without more money, FDA can not hire people to replace
those who leave by retirement. The agency has 500 to
1,000 fewer people.
Levitt said his top three recommendations to industry,
if he were a consultant, are FDA wants for claims 1) a
strong scientific basis for claims, based on safety and
benefits; 2) be sure the product is what you say it is; and
3) remember FDA wants to know about adverse events.
FDA did get some extra money which it is contracting
for a National Academy of Sciences project to focus on
safety issues.
Steve Mister, CHPA associate general counsel, spoke
about legislation in the states and boards of health. There
are at least 25 issues among the states that have to be
anticipated and dealt with buy companies. The major
trends in the states are adding laws for DSHEA provisions, limitations or labeling on ephedra products, alternative health care licensing, and Proposition 65 in California.
Another speaker was Jagadish Turmella of Nutrabid.
Turmella discussed E-commerce solutions and problems
in the industry. The web is being used to document raw
materials for manufacturers and product orders to retail-
Levitt’s Reality Check included comments about the
November 2000
Continued on page 26...
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Natural Medicine LawTM
Page 26
Natural Medicine LawTM
CHPA Program - Continued from p. 25...
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover.
where people get information. The
ers, but there are other applications, rise of the web is a factor. The most
including private reverse auctions for effective messages are ubiquitous,
buyers, private electronic catalogs for relevant, credible, and actionable.
sellers, and exchange of catalogs by
both.
Sumner said that consumer behavior change was based on media stoThe web can condense a 16 week ries 54% of the time and that media
procurement process into 4 weeks. helped people to understand someThe expansion of the use of the web thing 64% of the time. But she said
is illustrated by electronic products that pharmacists are not very high on
that will move from $61 million, lists of services or persons to work
Turmella said, in 2000 to $1,025 with to sell vitamins.
million in 2004.
She added that consumer confiBowie spoke about FTC actions dence could be improved by getting
and state consumer protection ac- a bully pulpit to build credibility.
tions. “Tell the truth, tell all of the truth
and make sure you are telling the
Steve McNamara, Esq, scattered
truth.” FTC does consumer educa- his remarks around labeling, the web,
tion, industry outreach, and enforce- and FDA’s budget. He said that lament. FTC has checked the web bels are the most important commuwith teaser sites of its own concern- nications, the structure/function claim
ing weight loss and virility plus. And must be right, and there should be a
FTC has done surf days covering disclaimer on every label. He men400 plus sites, resulting with 28% tioned the CHPA petition to remove
changing or closing. FTC is getting certain requirements.
more monetary settlements and traditional orders are not successful.
On the InternetTM, he said there is
FTC recently sued Steve Garvey, a a “ surprising amount of fuzziness
baseball player, and an ad agency for about how far FDA can go. In my
misleading ads.
view the Internet is not labeling.” But
FDA can look at all of your ads to
Answering the question about how
interpret labels. If you incorporate
to promote consumer confidence,
the Website on your label, you are
Bowie said to use the Better Busimaking it part of your label.
ness Bureau’s complaint process and
opinion letters. FTC has about 30
McNamara said we heard about
lawyers in the Division of Advertiswhat FDA is doing, but it is losing
ing Practices and 7 or 8 are working
control over part of what it is supon dietary supplements. He said
posed to do. “There is a great deal
FTC is searching pharmacy webs and
of aggressive promotion where you
wants disclosure of physician licenses.
wonder where the data is,” he said.
Courtesy letters are sent, but no one
Nancy Sumner of New York City
is telling FDA about Internet sites.
spoke about Communicating Health
He said ask Chris Lewis how many
and Nutrition Information to get
enforcement actions FDA is taking.
through to the consumer. This de“ I don’t know of any!” And he
pends on who wants the information,
added, there is no enforcement at all
the attitudes driving the market, and
for cosmetics with skin wrinkle
November 2000
Photo Courtesy of Lloyd Library and Museum
creams, saying that dietary supplements are getting close to this situation.
McNamara said companies could
promote consumer confidence by
getting experts to review their labels
and claims to make sure you are able
to substantiate them.
EMEA DCOUMENTS
The European Agency for the
Evaluation of Medicinal Products has
updated its list of documents available to the public in October 2000.
This 55 page list is available on the
Web at <www.eudra.org/gendocs/
PDFs/GENERAL/cat1000en.pdf>
In the list are reports, reference
identifications, versions, status, classification, languages and document
dates for all.
This list would be essential to monitor European medicinal product approval processes.
Natural Medicine LawTM
ments, sales information and offers.
These were in the form of merge letters mentioning the products 20/20
Caps™ containing Vitamin A, Vitamin C, Zinc, Selenium, bilberry fruit
extract mixed carotinoids, and lutein,
Regucleanse™, Dreamcaps™ containing valerian root extract and Kava
kava extract, EnergyCaps™ containing quarana and ma huang,
HeartShield™ containing CoEnzyme
Q-10, Mega Jointwellness™ containing glucosamine/chondroitin,
Megawellness™ System, Nature’s
Shape™, PotencyPlus™ containing
gingko biloba, A. Sativa, and saw
palmetto extract, ReFaze™ beauty
formula, SlenderBlend™ containing
chromium picolinate, ThinkCaps™
containing gingko, vinpocetine, and
phosphatidyl serine, VitalOne™
containing pine bark extract, grape
seed extract, olive leaf extract, green
tea extract, milk thistle extract, alpha
lipoic acid, Vitamin E, Vitamin C,
Selenium, Folic Acid, mixed
carotinoids, Vitamin B-12, Manganese, Copper, and Zinc, and
ArthritisEase™ with glucosamine sulfate. These merge letters are usually
two pages and contain a gift check
to be used for purchase of a product. FDA said the cover letter did
not certify the information was submitted by a responsible individual who
could certify the accuracy of the information presented, that the information was complete and correct,
and that the notifying firm has substantiation that the statements are
truthful and not misleading. Despite
that deficiency, FDA said certain
statements made the products into
drugs. These included: 20/20 Caps
— “...slow down macular degeneration...” and “...age-related degeneration of the macula...”; Chromium
picolinate — “...help maintain normal blood sugar levels...”;
ThinkCaps™ — “...patients ... who
had moderate to severe cognitive
decline.”
FDA said the description of Arthritis-Ease™ as a “all natural homeopathic remedy” took it outside the
dietary supplement category and
other claims made it a drug. Dkt.
97S-0163, Ltr. 393.
MaxCell Bioscience, Inc., dba
Oasis Wellness Network, in
Broomfield, Colorado, wrote to tell
FDA it would sell its product Plus 5
Mind/Body Formula & High Potency
Antioxidant with seven statements.
FDA wrote back saying that “Helps
maintain healthy cholesterol” and “...
reduces plaque” were statements that
made this product a drug. The product contains gingko, aloe vera, cranberry and cherry concentrates, blueberry concentrate, ginkgo and blueberry concentrates, wolfberry, and
guavea concentrate. Dkt. 97S0163, Ltr. 294
Standard Process, Inc. of
Palmyra, Wisconsin notified FDA it
would sell Super-Eff®, containing a
proprietary blend of cabamide,
Tillandsia usneoides, bovine liver fat
extract, flaxseed oil extract, and
mixed tocopherols with ten separate
statements. FDA wrote to say the
one statement that made the product
a drug was “...help maintain healthy
cholestrol... and help maintain proper
blood flow.” Dkt 97S-0163, Ltr.
395.
POTASSIUM HEALTH CLAIM
Tropicana’s petition for stroke and
HBP nears end of time for approval
on Nov. 2nd. FDA Dkt. 00Q-1582,
July 5, 2000. More in next issue.
November 2000
COMPLIANCE GUIDE FOR
BOTANICAL DRUGS
FDA gave notice in August that it
had prepared for comment only a
Guidance Document for Industry on
Botanical Drug Products. This was
assigned Docket No. 00D-1392 and
comments are being accepted for at
least 60 days. The 40-page document is available on the FDA
Website. The document contains nine
sections, including introduction, background, marketing a botanical drug
under an OTC monograph, marketing a botanical drug under an NDA,
INDS for botanical drugs, INDS for
Phase 1 and Phase 2 clinical studies
of lawfully marketed botanical products, INDS for Phase1 and phase 2
clinical studies of nonmarketed botanical products, INDS for phase 3
clinical studies for all botanical products, and definitions.
The guidance proposes that applicants may submit reduced documentation of preclinical safety and of
chemistry, manufacturing, and controls (CMC) to support an IND for
initial clinical studies of botanicals that
have been legally marketed in the
United States as dietary supplements
or cosmetics without any know safety
concerns.
For this document “botanicals” includes plant materials, algae, macroscopic fungi, and combinations
thereof. But it does not include products fermented with yeast, bacteria,
and other microscopic organisms.
And it does not include highly purified substances derived from botanical sources, such as paclitaxel, and
the document only addresses those
botanical products regulated by
CDER.
Continued on page 28...
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover .
LABEL STATEMENTS -- from page 11...
Page 27
Page 28
Botanical Drugs -- Continued from page 27...
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
The document does not address drugs that contain
animals or animal parts, and/or minerals, either alone or
in combination with botanicals, but the scientific principles
in the guidance may also apply to them. When products
are combined with a synthetic or highly purified drug, the
guidance applies only to the botanical part.
A period of exclusivity was proposed by FDA at three
years from the time of approval in the absence of patent
protection to five years for a new chemical entity.
Natural Medicine LawTM
the company embraced the document in princlple. But
then came the comments and questions.
Pfizer Global Research & Development filed four pages
of comments over the signature of Cheryl Fossum Graham, M.D., who pointed out that the 3 to 5 years is a
period of “date exclusivity” not market exclusivity. She
also asked for further details on the minimum of quality
controls on raw materials and in-process controls.
Indena filed 2 pages of comments from Milan over the
signature of E. M. Martinelli. While making a number of
comments, he said the “Guidance has added flexibility to
Comments are now being filed. The Missouri Botani- the IND requirements and has given to FDA the possical Garden’s Wendy Applequist, Ph.D. was first to file a bility to take into consideration the peculiar aspects of
letter. She cautioned that the nomenclature, authentica- botanical sourcing of drug products.
tion of raw materials, and requirements for uniformity of
source material and drug product could be potential probPharmaprint Botanical Pharmaceuticals of Newport
lems. She said it was strange that proper identification Beach, California, filed 10 pages of detailed comments
was not required for lawfully marketed products in phase over the signature of Stephen J. Currier, Ph.D. Director
1 and phase 2 studies. She had a number of suggestions of Biology.
on these areas.
Botanical Enterprises, Inc. of Rockville, Maryland, filed
An extension of 90 days time to file comments was comments on CMC, preclinical safety assessments, and
made by Sidley & Austin on behalf of an Asian com- in general over the signature of Floyd E. Leders, Jr., Ph.D.
pany.
Andes Pharmacuetical, Inc. of Washington, D.C.filed
The second and third comments were filed by the same comments as Botanical Enterprises, Inc.
Guangzhou International Bioisland Development Company of China, filed comments saying that Integrative PhytoCeutica of New Haven, Connecticut filed 5 pages
Medicine is the direction of medicine in the future, and of comments by Patrick C. Kung, Ph.D. He wrote” “We
Ujnified Medicine would be the result. The comments applaud the tireless efforts for which staff at FDA have
from William Au, president of the company were accom- labored for drafting the document. It is clear that the
panied by technical comments by Hong Zhao, Ph.D. Au document represents a major progress toward finalizing
continued that reductionism has been a key to gaining the Guidance. It would benefit citizens around the world,
useful information, but information overload and over- especially those living in developing countries, as well the
simplification are problems with the process. Au sug- entire pharmaceutical industry.”
gested that there are large differences in how individuals
react to pharmacotherapy.
Oxford Natural Products of Oxford, U.K. wrote proposing whole extract fingerprints utilizing scientific proTsumura & Co. of Tokyo filed comments on CMC cedures. The 3-page letter was signed by Dr. Peter J.
questioning whether FDA would accept inspections by Hylands.
another country as a substitute if the testing and compliance meets GMP and is approved as a drug product in
Banner Pharmacaps, a multi-national company, wrote
that country? Comments on bioavailability, clinical test- FDA a 2-page letter of comments that “when property
ing and marketing were also made. The letter was signed complied with, it will lend legitimacy to the botanical drug
by Hiromi Sasaki, Ph.D.
products and consumers will have faith in the safety and
efficacy of these products.” The letter was signed by
Karen K. Church, RAC, of Ancile Pharmaceuticals in
Continued next page...
San Diego filed 16 pages of comments starting off saying
November 2000
Natural Medicine LawTM
Page 29
Copies can be downloaded over a several hour period
from the FDA Website. An FOI request can be filed
Kamali Chance, Ph.D., R.D.
which may take several weeks to fill. Or subscribers
The Consumer Healthcare Products Association filed may order a hard copy of the above described docua 12-page letter and a copy of the Guidance marked up ments from NML for the price of $ 55.00, plus postage
for changes. This was filed by R. William Soller, Ph.D. and handling.
CHPA supports the FDA approach, citing areas where
it supported FDA specifically. CHPA suggested wordCTS CHEMICAL INDUSTRIES PETITIONS
ing changes, pointed out areas needing clarification, and
suggested FDA consider a similar guidance for non-bo- A GRAS petition has been filed by CTS with FDA for
tanical dietary supplements and somehow confirm that three species of Echinacea as a technical formulation
requests for FDA meetings will be give the same level of aid or binding agent. The petition says the quantity empriority for botanical drug products as for other drugs.
ployed shall range from 3 to 30 mg. per dosage unit.
CV Technologies, Inc of Edmonton Alberta, wrote 3
pages of comments saying it “would like to commend
FDA for the completeness and thoroughness of the draft”
but questioned what “infeasible” meant when identifying
the active constituents of a botanical drug. CVT wanted
FDA to be sure to educate reviewers in the new standards, so they do not revert to the drug standards. The
letter was signed for Jacqueline Jie Shan, Ph.D., Senior
VP for Research and Development.
Labels woould bear the name as “echninacea extract”
which can substitute for povidone, polyethylene glycol,
starch, etc. CTS would use the products containing the
substance in short-term ues products only. Alan D. Kirsh
of Edison, New Jersey filed the petition for the company
located in Israel. FDA Dkt. 00P-1510, Sept. 11, 2000
OPTION TO LIST INGREDIENTS
Ingredients could be listed in descending order of pre-
NIH’s Paul Coates, Ph.D. and Stephen Strauss, M.D. dominance by weight or in alphabetical order on the lafiled a joint letter of 4 pages stating a number of sugges- bel under this petition file by Arnall Golden & Gregory,
an Atlanta firm representing a manufacturer of dietary
tions and some disagreements in the clinical areas.
supplements. The firm lists many reasons why FDA
Bundesfachverband der Arzneimittel-Hersteller, e.V. of should permit its request including the impracticality of
Germany wrote as representative of about 300 compa- listing by weight when a manufacturer uses multiple supnies marketing self-medication products. The associa- pliers or makes minor revisions. The alphabetical listing,
tion asked that for safety information on foreign marketed the petition says, would benfit consumers. The petition is
products that foreign marketing experience be taken into 9 pages long and signed by Alan G. Minsk. FDA
consideration. The letter suggested that the comparison Dkt.00P-1500, September 6, 2000
to drug procedures was much too strong and asked FDA
to consider parts of the German Medicines Law. The
letter suggested standardizing known active constituents,
such as occur with Senna, and there were a number of CHPA PETITIONS TO USE “MAY CONTAIN”
other suggestions. The letter was signed by Dr. Barbara Multiple suppliers are the reason for this Citizen PetiSteinhoff.
tion filed by Consumer Healthcare Products Association. 21 CFR 101.36 and 101.100 require the commno
Lili Zhao filed a facsimile letter from
or usual name of ingredients. Composition of products
[email protected] commenting on pages 5 and
varies from supplier to supplier in the dietary supplement
24 of the Guidance.
field, CHPA says. The drawback is that the consumer
may not purchase the product even though it does not
Star Scientific’s president Paul Perito ask for an extencontain the ingredient. CHPA says it is impractical for
sion of time to file comments. The company is located in
suppliers to have to manufacturer to an exact formula.
Chester, Virginia.
FDA Dkt. 00P-1329, Sept, 8, 2000..
At this point the entire file is slightly over 200 pages.
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Botanical Drugs - Continued from Page 28...
Natural Medicine LawTM
Page 30
PEARSON PLAINTIFFS & OTHERS
SUE FDA AGAIN OVER FOLIC ACID
Dissatisfaction with the FDA’s ruling on Folic Acid (see
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover..
article on page 1), the plaintiffs in the Pearson v.
Shalalah case have filed another suit seeking a declaratory judgment that FDA’s October 10, 2000 decision is
unconstitutional, The plaintiffs now include the original
Pearson group, plus Julian M. Whitaker, M.D., Pure
Encapsulations, Inc., and XCEL Medical Pharmacy, Ltd.
tions are associated with serious developmental disabilities including muscle weakness and/or paralysis, bowel
and bladder incontinence, and intellectual impairment.
While infants with anencephaly usually die shortly after
birth, those with spina bifida usually survive into adulthood with life-long impairments. The Institute of Medicine of the National Academy of Sciences has concluded
that current FDA folic acid fortification has not reduced
the prevalence of NTDs in the United States and that the
evidence of a protective effect from folate supplements
is much stronger that that for food folate.
Jonathan Emord & Associates filed the suite November 13, 2001 in the U.S. District Court for the District of
Columbia. The complaint says the FDA action violates
FDA APPROVES HEALTH CLAIM
the mandate of the earlier Pearson decision on First
FOR PLANT STEROL & ESTERS
Amendment grounds, also on Due Process grounds under the Fifth Amendment, and on grounds that it violates The FDA has authorized use of labeling health claims
the Nutrition Labeling and Education Act and the prohiabout the role of plant sterol or plant stanol esters in rebition on arbitrary and capricious action under the Adducing the risk of coronary heart disease (CHD) for foods
ministrative Procedure Act.
containing these substances. This interim final rule is based
on FDA’s conclusion that plant sterol esters and plant
The Plaintiffs asked the Court to enjoin the FDA from
stanol esters may reduce the risk of CHD by lowering
enforcing the October 10 prohibition against the claim
blood cholesterol levels.
and asked for an expedited review of the complaint.
Emord explained that the plaintiffs had sought to use the
Coronary heart disease, one of the most common and
claim – “0.8 mg of colic acid is more effective in reducing
serious forms of cardiovascular disease, causes more
the risk of neural tub defects than a lower amount in foods
deaths in the U.S. than any other disease. Risk factors
in common form” – but FDA has refused to allow it,
for CHD include high total cholesterol levels and high
even after the U.S. Court of Appeals ruled the suppreslevels of low density lipoprotein (LDL) cholesterol.
sion is unconstitutional.
In the complaint, the plaintiffs say that “Without access
to the Plainti8ff’s truthful and direct claim, fertile woman
unaware of the superior bioavailability of folic acid in
supplements are likely to experience a heightened risk of
an NTD birth, a risk that could be averted were they
simply made aware of the inexpensive expedient of ingesting 0.8 mg of folic acid in a dietary supplement.”
Neural tube defects (NTD), Emord said, specifically
spina bifida and anencephaly, affect approximately 4,000
live births and pregnancies each year in the United States.
Of thee, the Centers for Disease Control and Prevention
report that 1,500 afflicted infants are born with spina
bifida, 1,000 are born with anencephaly, and an estimated
1,500 NTD fetuses are aborted annually. NTDs are
implicated in 1.3% of all infant deaths and are second
only to cardiac defects as then leading cause of perinatal
mortality from all birth defects.
This new health claim is based on evidence that plant
sterol or plant stanol esters may help to reduce the risk
of CHD. Plant sterols are present in small quantities in
many fruits, vegetables, nuts, seeds, cereals, legumes, and
other plant sources. Plant stanols occur naturally in even
smaller quantities from some of the same sources. For
example, both plant sterols and stanols are found in vegetable oils.
Foods that may qualify for the health claim based on
plant sterol ester content include spreads and salad dressings. Among the foods that may qualify for claims based
on plant stanol ester content are spreads, salad dressings, snack bars, and dietary supplements in softgel form.
Foods that carry the claim must also meet the requirements for low saturated fat and low cholesterol, and must
also contain no more than 13 grams of total fat per serving and per 50 grams. However, spreads and salad dress-
Emord explained that “these spinal cord malformaNovember 2000
Continued on page 31...
Natural Medicine LawTM
ings are not required to meet the limit for total fat per 50
grams if the label of the food bears a disclosure statement referring consumers to the Nutrition Facts section
of the label for information about fat content. In addition,
except for salad dressing and dietary supplements, the
food must contain at least 10% of the Reference Daily
Intake (RDI) or Daily Reference Value (DRV) for vitamin A, vitamin C, iron, calcium, protein, or fiber. FDA is
also requiring, consistent with other health claims to reduce the risk of CHD, that the claim state that plant sterol and plant stanol esters should be consumed as part of
a diet low in saturated fat and cholesterol.
Scientific studies show that 1.3 grams per day of plant
sterol esters or 3.4 grams per day of plant stanol esters
in the diet are needed to show a significant cholesterol
lowering effect. In order to qualify for this health claim, a
food must contain at least 0.65 grams of plant sterol esters per serving or at least 1.7 grams of plant stanol esters per serving. The claim must specify that the daily
dietary intake of plant sterol esters or plant stanol esters
should be consumed in two servings eaten at different
times of the day with other foods.
An example of a health claim about the relationship
between plant sterol esters and reduced risk of heart disease is:
Foods containing at least 0.65 grams per serving of plant
sterol esters, eaten twice a day with meals for a daily total
intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of the food] supplies ____ grams
of plant sterol esters.
Page 31
adopted in the final rule.
Written comments will be received until 75 days after
date of publication in the Federal Register and may be
addressed to: Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
The FDA published the Interim Final Rule in 65 Federal
Register 54685, September 8, 2000. The Dockets where
this subject is filed are Dockets 00P-1275 and 00P-1276.
INTERESTING 75-DAY NOTICE
Here is a recently filed 75-day Notice exchange that may
be of interest to NML readers. Back in April, 2000, Isula
Rain, Inc.of Larkspur, California, notified FDA is intended
to market six new dietary supplement products containing
herbs. After reviewing the materials submitted, FDA wrote
that it had “significant concerns about the evidence on
which you rely to support your conclusion that the new
dietary ingredients … will reasonably be expected to be
safe.” The information submitted does not meet the requirements of 21 CFR 190.6(b)(3) because it does not contain a description of the dietary supplements that contain
the new dietary ingredients in the dietary supplements, not
does it describe, in a quantitative manner, the amounts to
be consumed daily.
And FDA said the history of use information is inadequate and the citations in the submission are not explained
as to relevance in determining whether the exposures to
the ingredients would be safe. Therefore, FDA said the
products may be adulterated.
An example of a health claim about the relationship beThe products were: 1) 7-Day Purity Cleanse #1 Extract Herbal
tween plant stanol esters and reduced risk of heart dis- Supplement containing Equisetum bogotense H.B.K., Schkhuria
ease is:
pinnata Lamarck, Oenothera rosea L’Her ex Aiton, and Bursera
Diets low in saturated fat and cholesterol that include two
servings of foods that provide a daily total of at least 3.4
grams of plant stanol esters in two meals may reduce the
risk of heart disease. A serving of [name of the food] supplies ___ grams of plant stanol esters.
graveolens (.H.B.K.) Triana & Planch; 2) (7-Day Digestive
Cleanse #2 Extract Herbal Supplement) containing the new dietary ingredients Mustisia acuminata R. & P., Schkhuria pinnata
Lamarck, Tessaraia integrifolia R.& P., Salvia safittata R. & P.,
Equisetum bogotense H.B.K., and Piper alveolatum Opiz; 3) 7Day Purity Cleanse #3 Extract Herbal Supplement containing
Equisetum bogotense H.B.K., Acicarpha tribuloides Jessieu,
Desmodium mollicum H.B.K. DC, Geranium filipes Killip,
Stachys pusilla (Wedd.) Briquet, Chuquiraga spinosa
Lessing,and Satureja revolute R.& P.; 4) (GBDR Health Extract
Herbal Supplement), containing Equisetum bogotense H.B.K.
and Tessaraia integrifolia R.& P.; 5) (Muscle Joint Health Extract Herbal Supplement) contaniing Equisetum bogotense
H.B.K. and Satureja revolute R.& P.; 6) (Andrean Serenity Extract Herbal Supplement, containing Sanguisorba minor Scopoli
and Perezia corrulescens Wedd. Dkt. 95S-0316, RPT 71
This new health claim interim final rule responds to petitions submitted to the FDA by Lipton (plant sterol esters) and McNeil Consumer Healthcare (plant stanol esters). The FDA is issuing this rule as an interim final rule.
It is effective immediately with an opportunity for the
public to comment. The final rule on this health claim may
differ from this interim rule, and manufacturers would be
required to revise their labeling to conform to any changes
November 2000
Copyright 2000 by Muscatatuck Publishers, Inc. For Information on photocopying, see back cover.
Continued from page 30...
Natural Medicine LawTM
Page 32
Copyright, 2000 by Muscatatuck Publishers, Inc. For Information on Photocopying, see back cover.
MEETINGS OF INTEREST
American Association of Pharmaceutical Scientists will hold a meeting
January 8-10, 2001 on the subject
of Practical Approaches to Current
Pre-Approval Initiatives: GMP and
GLP at the Crystal Gateway Marriott
in Arlington, Virginia. This program
will provide an in-depth review of
pre-approval initiatives. Participants
will gain an understanding of what to
expect with agency audits and how
to prepare for the most successful
outcomes. There is a range of registration fees and more information can
be obtained at the Website:
www.aaps.org/educmeet/pai or call
at 703-920-3230.
In 1999 the Pharmacognosy Congress held in Amsterdam had a large
number of papers presented by
speakers around the world. Now
there is a hard cover book of 256
pages priced at NLG 130 available
from Phytoconsult, c/o Division of
Pharmacognosy, LACDR, Leiden
University, Gorleaus Laboratory,
P.O. Box 9502, 2300 RA Leiden,
The Netherlands. Orders are accepted by Visa or Mastercard with
complete data. To obtain more information, E-mail contacts are
<[email protected]> or
<[email protected]>.
PHYTOPHARM AGREEMENT
This
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evaluating three medicinal plants for
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by FDA in 1997 for some products.
Company information is available on
its Website at:
<www.phytopharm.co.uk>
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November 2000