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Vol. 9, No. 6
May 2006
Natural Medicine LawTM
FEDS RELEASE EPHEDRA
Another ephedra case is in U.S.
District Court in Utah. The complaint
was filed on April 21, 2006 by Emax
Enterprises against FDA, HHS and
CBP and claims FDA seized ephedra
products contrary to law. CBP is the
U.S. Customs and Border
Protection. The same day the plaintiff
filed a Motion for Preliminary
Injunction and on April 26, the Court
set a hearing for May 2.
However, despite FDA’s previous
adamant refusal to cooperate with
plaintiff, on May 1, FDA and plaintiff
told the court a hearing would not be
needed because they had agreed to
withdraw the Motion and that FDA
had released the detained ephedra
shipment. The parties also agreed
that the release of the detained articles
would not be used to draw adverse
inferences against the FDA or any
federal agency in this matter or any
subsequent action.
Emax is an importation broker,
specialzing in Chinese goods,
including dietary supplements. The
complaint says that FDA’s final ban
on selling ephedrine containing
products issued February 11, 2004
made the sale of ephedrine alkaloidcontaining dietary supplements a
crime. Under the regulation all
ephedrine supplements, regardless of
dose, were deemed adulterated.
FDA offered no evidence that
consumption of 10 mg or less of
ephedrine from naturally occurring
plants was associated with any
serious adverse effects. At the same
See EMAX -- Continued on page 14...
Newsletter
HERBAL MEDICINE
AWARENESS WEEK
RUBIN SETTLES CLAIMS
FOR $225,000
May 19 to 26, 2006 in the U.K. is On March 9, 2006, the
a week packed full of events to
emphasize herbal medicine. The
National Institutes of Medical
Herbalists are having herbal walks,
talks and displays all over England,
Scotland and Wales in 24 cities this
week, where you can spend time with
a practicing herbalist walking the
paths to see where herbs grow and
talk about stress.
Federal
Trade Commission announced it had
settled charges against Jordon Rubin’s
Garden of Life for claiming it had
studies that backed products —
Primal Defense, RM-10, Living
Multi, and FYI. FTC also said if the
company has misrepresented its
financial information, the full judgment
could go to $47 million for the four
products. Rubin authored, “The
Maker’s Diet,” Siloam, 2004.
“A little stress can be good for
you but when it gets excessive, it
can ruin lives. For this year’s
Herbal Medicine Awareness Week,
the nation’s herbalists are aiming
to help you cope with stress and
stress-related illness…the herbal
way. This year the awareness
campaign will focus on the herbal
approach to treating stress-related
conditions, from insomnia to tension
headaches and eczema.
An operation that marketed dietary
supplements sold at Whole Foods
Market, GNC, the Vitamin Shoppe,
and on the Internet settled FTC
charges that it made deceptive
advertising claims about their
supplements. The FTC charged that
Garden of Life, Inc., a dietary
supplement company based in West
Palm Beach, Florida, and its founder
and owner, Jordan S. Rubin, made
unsubstantiated claims that their
Ned Reiter, President of the supplements treated or cured a variety
National Institute of Medical
See GARDEN -- Continued on page 2...
Herbalists, comments: “Herbal
medicine can be remarkably effective In This Issue:
in qualified hands. Many people self
Lose to Emax..........................................1
prescribe but there are several Feds
Herbal Medicine Awareness Week.....................1
Settles Claims........................................1
limitations to do-it-yourself medicine. FTC
Pharmacists Talk Supplements.........................2
Although self-help can be useful in New Dietary Ingredients................................... 3
Section 403 Letters...........................................4
some circumstances, consulting a Herbs Contain Rx Drugs.. .................................5
Adopts Interim Measures........................5
professional herbalist gives access to Canada
Operation Bali Stops Illegal Sales........................5
a safer, individually tailored and more Canada Says Do Not Use “NPN Pending”............6
Dynamic Health Settles Charges.......................11
effective application of herbal Supplementary Guidance on Transition...............13
Sold as Dietary Supplements...............15
medicine. Stress and stress-related Steriods
Genistein Not Hazardous to Humans.................15
Library Photo Credits..............................15
illness can be complicated and we Lloyd
FDA on European Aspartame Study...................17
would advise against relying on over- Trademarks for Guaiacum................................19
Unilever Spends on Hoodia..............................20
the-counter herbal medication without FTC Staff Advises FDA on QHC......................20
See AWARENESS -- Cont’d on page 23...
China Sells Stevia...........................................21
China Sells Wisconsin Ginseng.........................23
Harvesting Health from the Editor.....................24
Page 2
GARDEN -- Cont’d from page 1...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
of ailments, ranging from colds to
cancer, and also made false claims of
clinical proof. The settlement prohibits
deceptive claims about the results of
tests or studies and requires claims
by the defendants to be substantiated
by competent and reliable scientific
evidence.
The FTC’s complaint targeted
claims about four dietary
supplements: Primal Defense, RM10, Living Multi, and FYI. According
to the complaint, the defendants
made unsubstantiated advertising
claims that: Primal Defense treats
intractable immune disorders, asthma,
irritable bowel syndrome, chronic
fatigue syndrome, arthritis, lupus,
colds, flu, and Crohn’s disease, and
reduces users’ blood cholesterol
levels; RM-10 treats cancer, helps
lower users’ blood cholesterol levels,
prevents and treats cardiovascular
disease, and treats immune system
disorders; Living Multi reduces the
risk factor for diabetes and prevents
diabetes-related syndromes, reduces
the risk of obesity, and reduces
inflammation; and FYI (For Your
Inflammation) treats and prevents
inflammation, including inflammation
caused by arthritis, inflammatory
bowel disease, sports injuries,
asthma, allergies, fibromyalgia, lupus,
scleroderma, and other inflammatory
conditions.
The FTC also alleged that the
defendants made false claims that
clinical studies prove that:
Primal Defense reduces users’ blood
cholesterol levels by 25 percent or
more; improves users’ energy levels,
memory, and concentration; and
mitigates the symptoms of most
patients with chronic lymphocytic
leukemia stage II; RM-10 treats
immune system disorders and cancer;
May 2006
Living Multi has a proven nutritional
formula; and FYI treats rheumatoid
arthritis and reduces the effects of
inflammation.
Garden of Life and Jordan Rubin will
pay $225,000 in consumer redress
as part of the settlement. If it is found
they misrepresented their financial
status, they will be responsible for the
full judgment of more than $47 million
– the total gross sales of the four
dietary supplements. The settlement
also prohibits the defendants from
making claims similar to the ones
challenged in the FTC’s complaint,
unless they have competent and
reliable scientific evidence
substantiating the claims.
Furthermore, the settlement requires
the defendants to have such evidence
whenever they make any claim about
the health benefits, performance,
efficacy, safety, or side effects of any
food, drug, or dietary supplement, or
any program that includes such a
product. The defendants also are
prohibited from misrepresenting the
results of any test or study when
marketing such products and
programs.
Natural Medicine LawTM
Injunction and other relief was signed
on March 30 as well. The case is
Civil # 06-CV-80226, Southern
District of Florida (West Palm
Beach). Karen Mandel Muoio, Esq.
of Washington, D.C. represented the
FTC and Sean Michael Ellsworth,
Esq. of Ellsworth, Gonzales &
Roppolo of Miami Beach
represented the defendants.
Michael Ostheimer or Karen
Muoio, FTC Staff, 202-326-2699 or
202-326-2491 can tell you more.
w w w. f t c . g o v / o p a / 2 0 0 6 /
03gardenoflife.htm.
PHARMACISTS TALK
Lectures and posters about dietary
supplements took place at the March
17-21, 2006 meeting of the American
Pharmacists Association in San
Francisco. About 7,000 pharmacists
attended. One general talk was
about An Evidence-Based Approach
to Vitamins and Natural Remedies,
one poster by several pharmacists and
a faculty member, and one talk by
NML’s editor to a joint meeting of
APhA and the American Society for
The Commission vote to authorize Pharmacy Law.
staff to file the complaint and
stipulated final order was 5-0. The
The Evidence-Based Approach
complaint and stipulated final order speaker was Karen Shapiro,
were filed in the U.S. District Court Pharm.D. of the Rancho Los Amigos
for the Southern District of Florida National Rehabilitation Center in the
on March 8, 2006 under 15 USC Los Angeles Department of Health
Sec. 53. Summons were issued for Services. Dr. Shapiro’s subjects were
Jordan Rubin and Garden of Life, fish oils, cholesterol-lowering
Inc. on March 13. U.S. Judge products such as oats, psyllium, soy,
Donald M. Middlebrooks set the trial plant sterols, and policosanol, general
for October 30, 2006 in an order multivitamins, and vitamins for
signed March 23, an Order macular degeneration, ginkgo,
approving an earlier filed Stipulation Huperazin A, and natural weight loss
was approved, the case closed on products.
March 30, 2006 by Judge
Middlebrooks. A Stipulated Final
Order and Judgment for Permanent See PHARMACISTS -- Cont’d on page 12...
NEW DIETARY
INGREDIENTS
May 2006
supplement contains one or more new
dietary ingredients that have not been
More 75-day notices are being filed. present in the food supply, but your
A few applicants are filing reformatted notice does not comply as it does not
notices after FDA advises of the contain a description of the new
agency’s concerns. Some of these dietary ingredient., the conditions of
reformatted notices do not have use, the history or other information
enough new data to get FDA to that establishes that it would be
accept the notices. The agency might expected to be safe when used as
have to tell an applicant after the recommended. Because the
resubmission that FDA will not be information submitted is insufficient to
able to review the papers again until allow FDA to make a determination,
new data is submitted. Applicants if the product is marketed without
should call FDA if they do not submitting a notice that meets the
understand what the agency wants requirements of 21 CFR 190.6, the
them to put in the application for a product will be considered to be
NDI. There are ten new notices adulterated and introduction into
summarized in this issue of NML. interstate commerce is prohibited.
None of them were accepted as The FDA letter was signed by Susan
J. Walker, M.D. Docket No. 95Sadequate by FDA.
0316, RPT 290, received at the
Aminocare Products, LP of Dockets Office September 9, 2005,
Houston, Texas, filed an NDI notice entered into the docket September
by letter dated May 27, 2005 under 12, 2005, and posted on a web page
21 CFR 190.6 pertaining to new created September 27, 2005.
dietary ingredients, and listed a dietary
OYC International, Inc. of
supplement named, Brain Longevity,
Andover,
Massachusetts, sent a NDI,
containing curcumin, L-alanine, Larginine, Glycine, L-ornithine, L- dated June 16, 2005, to FDA
serine, L-Threonine, L-valine and concerning the ingredient, Elastase
Piperine. The letter claimed that a (Pancreatopeptidase E), to be sold
Google™ search disclosed over in a tablet form. The main ingredient
®
128,0000 products containing amino is Elaszym , discovered in the human
acids, another disclosed over 26,000 pancreas in 1949. The dosage is
curcumin products, and another three tablets daily. The method of
disclosed over 2700 products manufacture was not disclosed and
containing piperine. Based on these some of the clinical evaluation,
circumstances, the letter said, “Given pharmacokinetics and toxicity data
the omnipresent availability and use discussed porcine elastase. Much of
of these ingredients throughout the the background data was published
world, Aminocare believes this in Japanese journals. FDA
product, when used as recommended responded to Ted Kottcamp by letter
in the labeling, to reasonably be of August 9, 2005 from Susan J.
expected to be safe.” FDA reviewed Walker, M.D. stating that the notice
the submission and by letter dated was incomplete because it did not
August 15, 2005 responded to Azad include: (1) a description of the dietary
Rastegar saying that the submission supplement, (2) the level of the dietary
makes clear that the company has ingredient in the dietary supplement,
determined that the dietary and (3) the conditions of use
Page 3
recommended or suggested in the
labeling. FDA’s letter said the cited
references were only abstracts and
these must be accompanied by
reprints or complete copies of the
references, plus translations into
English if any are foreign languages.
In addition, the notice did not include
a documented history of uses of the
new ingredient. The safety data
provided was for Elastase as a drug,
not as a dietary supplement. Based
on the information submitted FDA is
unable to determine if the supplement
will reasonably be determined to be
safe. Marketing of such a product in
interstate commerce is prohibited.
Docket No. 95S-0316, RPT 291,
received at the Dockets Office
September 30, 2005, entered into the
docket September 30, 2005, and
posted on a web page created
October 18, 2005.
Loders Croklaan B. V. of
Wormerveer, The Netherlands, wrote
FDA on June 17, 2005 to send an
NDI notice for PinnoThin™ FFA,
consisting of pine nut oil fatty acids.
The pine nuts are from the Korean
pine (Pinus koraiensis). Its
“applications” were described as
“suitable as ingredient in dietary
supplements in various forms,
including softgels, capsules, and
supplement bars and similar
products. … Loders Croklaan
recommends that dietary supplement
manufacturers formulate products to
provide a daily intake of 3.0 g
PinnoThin™ FFA 30 – 60 min before
See DIETARY INGRED. -- Cont’d on p. 7...
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for
Natural Medicine TiesTM
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Natural Medicine LawTM
Page 4
May 2006
Natural Medicine LawTM
SECTION 403 LETTERS
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
supplements must be ingested. The
Here are a few more Letters of FDA letter did not refer the writer to
any other office in the agency.
Rejection that demonstrate how FDA
Docket. No. 97S-0163, Ltr.857,
is regulating health claims for dietary
received at Dockets Office on
supplements.
February 17, 2006, entered into the
Docket on February 16, 2006, and
Sedona Laboratories, Inc. of
posted on the FDA Website on
Cottonwood, Arizona, write FDA on
March 6, 2006.
December 23, 2005, to give notice
that it would use certain claims for the
Enzymatic Therapy, Inc. of
product iFlora™YC-7, namely, Green Bay. Wisconsin, wrote FDA
“Helps balance normal vaginal on January 7, 2006, stating that it
and intestinal microflora after would soon use certain claims for the
antibiotic use.” The product product, Remifemin® Good Night,
contains seven different bacillus strains namely, “[A]nd a safe alternative
of probiotics in a proprietary blend for women in whom estrogen
and it is packaged in 145 mg therapy is contraindicated.” FDA
vegetarian capsules and bottles of 60 responded by letter of January 26,
capsules. The label claims 15 billion 2006 from Susan J. Walker, M.D. to
cells per capsule. FDA responded Michael P. Devereux, to advise him
to Mo Kang, senior scientist, by letter that the italicized wording made the
of January 12, 2006, from Susan J. product a drug and if this wording is
Walker, M.D. stating that the used the product would be regulated
statement cited above in italics as a drug. FDA did not comment on
suggests that the product is used as a the claims that stated: “Uncontrolled
drug to treat, prevent, or mitigate a reports, postmarketing surveillance,
disease. Therefore, if the claim is and human clinical trials of more than
used, the product will be regulated 2,800 patients demonstrate a low
as a drug. Docket No. 97S-0163, incidence of adverse events (5.4%).
Ltr. 856, received at Dockets Office Of the reported adverse events, 97%
on February 16, 2006, entered into were minor and did not result in
the Docket on February 16, 2006, discontinuation of therapy, and the
and posted on the FDA Website on only severe events were not attributed
March 6, 2006.
to Cimicifuga treatment. Confirms the
Transdermal Products
International of Bristol,
Pennsylvania, wrote FDA on January
5, 2006 to give notice that it would
use some claims for the product,
Insect Repellant Patch, an external
product, each patch containing 75 mg
of Thiamine (vitamin B1). FDA
responded to William Newbauer by
letter of January 17, 2006 from Susan
J. Walker, M.D, signed by Linda S.
Pellicore, Ph.D. stating that external
use products do not qualify as dietary
supplements under the Act as dietary
safety of specific Cimicifuga extracts,
particularly
isopropanolic
preparations (RemiSure™ black
cohosh), for use in women
experiencing
menopausal
symptoms…”. Docket No. 97S0163, Ltr. 858, received at Dockets
Office on February 162006, entered
into the Docket on February 16,
2006, and posted on the FDA
Website on March 6, 2006.
Beulah Land Corporation of
Oak Park, Illinois, wrote FDA on
January 19, 2006, in seven unsigned
Photo Courtesy of Lloyd Library and Museum
letters, each about a separate
product. These products were
named, Female Age Well,
Menopausal
Support,
EnhanceMENt Plus, Paracid-BGone, De-Yeast Plus, Pro-Cartilage
and Lipid Balance. All were stated
to be dietary supplements on the
labels. The ingredients were listed
for each product on the letter and/or
label of the product attached to the
letter. FDA responded to the
president on January 26, 2006 from
Susan J. Walker, M.D. stating that
the following statements were of
concern: for Female Age Well
Menstrual Support, “[M]ay help
with … chronic fatigue;” for
EnhanceMENt Plus, “Natural
alternative to Viagra…;” for
Paracit-B-Gone, “[A]ssist in
conditions such as parasite
infections, intestinal dysbiosis for
De-Yeast Plus, “[H]elpful for
conditions such as Candida
Albicans, intestinal dysbiosis;”
stomach flu and irritable bowel
syndrome;” for Pro-Cartilage,
“[H]elp with joint injuries…;”
See SECTION 403-- on page 18...
Natural Medicine LawTM
May 2006
Page 5
Natural Medicine Law Around the W
orld
World
Director-General of Health Dr.
Karen Poutasi of New Zealand on
March 1, 2006 warned against taking
two herbal products after government
tests revealed they contained
undeclared prescription medicines for
weight loss and erectile dysfunction.
The
Natural Health Products
Directorate and the Health Products
and Food Branch Inspectorate have
recently developed and implemented
interim measures that will ensure the
The Ministry of Health Medicines continuity of the exportation of
Safety Authority (Medsafe) has Canadian-made natural health
shown that the herbal weight loss products to foreign markets.
product Li Da contains the
Under current legislation, natural
prescription medicine sibutramine,
which is prescribed for overweight health product companies cannot
(obese) patients who have not been hold both a site license and
able to lose weight using a low calorie establishment license. This has been
diet and exercise. Sibutramine can a source of concern for certain
cause increased blood pressure and Canadian exporters of natural health
heart rate and cannot safely be taken products who, until January 1, 2006,
by a range of people, including those held valid establishment licenses, and
with glaucoma, mental illness and based on these, were able to obtain
severe liver or kidney problems. It Certificates of Pharmaceutical
should not be used in combination with Product (CPP). CPPs speak to the
other medicines such as some regulatory status of a product and are
antidepressants and migraine a service offered by Health Canada
treatments, Dr. Poutasi says. Reductil to facilitate the exportation of
is the prescription drug containing Canadian health care products.
sibutramine that is approved in New
Health Canada’s initial solution to
Zealand.
this situation was the development of
See MEDICINES ACT -- Cont’d on p. 11...
a dual licensing system that would
allow Canadian natural health
product companies to hold both
licenses. As reported in the Spring/
Summer issue of the NHPD
Quarterly Report, work on this
initiative began in 2005 and was to
be completed by December 31,
2005 before the coming into force of
the site licensing provisions of the
Natural Health Products Regulations.
Unfortunately, due to the dissolution
of Parliament in late November 2005,
Health Canada was unable to
Big Ben and Parliament in London
See CANADA -- Continued on page 6...
OPERATION BALI STOPS
ILLEGAL SALES OF
MEDICINES
The Medicines and Healthcare
products Regulatory Agency
(MHRA), headquartered in London,
led an operation, on 27 April 2006
at a residential address in
Peterborough. The house is believed
to be connected with an Internet site
which sells and supplies unlicensed
lifestyle medicines called Kamagra,
Tadamax, and Lovegra, which are
sold for the treatment of male erectile
dysfunction. Around 3,000 Kamagra
tablets, 168 Tadamax tablets, 160
Lovegra tablets and 95 sachets of
Kamagra and Apcalis jellies were
seized, worth more than £17,000,
together with computer equipment.
The visit was part of a larger
nationwide operation (known as
“Operation Bali”) that involved
MHRA enforcement and intelligence
officers investigating 27 Internet sites,
all offering illegal medicines. The
MHRA officers visited various private
and business addresses related to
Internet sites supplying unlicensed
medicines claiming to treat obesity,
impotence, herpes and other
ailments. Officers seized unlicensed
medicines, computers, documents
and cash. The police accompanied
the MHRA officers in a number of
cases and arrests were made by the
Sussex Police and Thames Valley
Police in connection with offences
under the Misuse of Drugs Act.
Operations were also conducted in
Reading, Worcestershire, Hayes,
Bedford, Wigan, Hailsham, and
Newhaven.
As a result of these operations, a
See OPERATION BALI -- on page 6...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
CANADA INTERIM
MEASURES FOR
EXPORTATION OF
NATURAL HEALTH
PRODUCTS
HERBS CONTAIN
RX DRUGS
Page 6
CANADA-- Continued from page 5...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
complete this project before the end
of the calendar year. With the site
licensing provisions now in force since
January 1, 2006, the establishment
licenses that certain natural health
product companies once held are no
longer valid and these companies can
no longer obtain CPPs for
exportation.
The Department is aware of the
pressing need to find a long-term
solution to this dilemma and continues
to explore and consider options. In
the meantime, interim measures have
been adopted that will allow natural
health product companies to continue
to obtain CPPs, provided that the
following four conditions are met: 1)
the company must hold a valid site
license; 2) the company must have
held a valid establishment license in
the 2005 calendar year; 3) the
company must have had an
inspection by the Inspectorate and
within the last 3 calendar years
(2003-2005) and found to be
compliant with drug GMPs, 4) and
the product for which the CPP is
requested must have a valid DIN,
DIN-HM or NPN.
May 2006
in effect for a period of ten months,
starting March 1, 2006 and ending
on December 31, 2006. Though only
temporary, the interim measures will
ensure that the export operations of
many Canadian natural health product
companies can continue unhindered
for the remaining calendar year, until
a more permanent solution can be
identified.
CANADA ADVISES
DO NOT USE
“NPN PENDING”
ON LABELS
Natural Medicine LawTM
product will be authorized for sale by
Health Canada when in fact it may
not, should the NHPD’s assessment
conclude that there is insufficient
evidence to support the product’s
safety and efficacy.
The designation “NPN” should only
appear on the labels of natural health
products that have been authorized
for sale by Health Canada.
OPERATION BALI -- Cont’d from page 5...
number of internet sites have been
closed down. “The MHRA has
a coordinated operation
Natural Health Products officials in conducted
against the sale and supply of illegal
Canada have advised companies and unlicensed medicines over the
currently awaiting a product license internet. There is an increased risk to
NOT to label their products with the the public from obtaining medicines
statement “NPN Pending.” Those through unregulated websites.
companies that have already labeled Patients are advised to obtain
their products in this manner should medicines following a consultation
not include this statement on future with a qualified doctor and through a
shipments, lots and batches of their properly licensed and regulated
pharmacy.” Mick Deats, Head of
products.
Though not explicitly written in the
Natural Health Products Regulations,
including the statement “NPN
Pending” on the label is a direct
violation of Part 1, Section 9 of the
Food and Drugs Act which clearly
prohibits individuals and companies
from labeling, packaging, treating,
processing, selling or advertising any
drug or natural health product in a
manner that is false, misleading or
deceptive or is likely to create an
erroneous impression regarding its
character, value, quantity,
composition, merit or safety.
Only those natural health product
companies meeting all four conditions
will be eligible for a CCP under the
interim measures. Natural health
product companies will not be
inspected and will not be issued an
establishment license or a certificate
of compliance for their natural health
products. Companies holding both
an establishment license and a site
license and that have natural health
products that have received DINs, Individuals and companies labeling
can also obtain a CPP for their natural their products with the statement
health products during this interim “NPN Pending” should cease this
practice immediately. Including this
period.
statement on the label gives the false
The interim measures will remain impression to consumers that the
Intelligence and Enforcement at the
MHRA.
The MHRA release said it is the
government agency responsible for
ensuring that medicines and medical
devices work, and are acceptably safe. No
product is risk-free. Underpinning all its
work lie robust and fact-based
judgements to ensure that the benefits to
patients and the public justify the risks.
MHRA keeps watch over medicines and
devices, and takes any necessary action
to protect the public promptly if there is a
problem.
If an individual is convicted of offenses
under the Medicines Act 1968, they can
be sentenced to a maximum of two years
imprisonment and/or an unlimited fine.
Where appropriate the MHRA will use the
Proceeds of Crime Act 2002 to determine
whether or not benefits were accrued
through criminal activity and will recoup
illicit earnings if the individual is found
guilty. Press Office 020 7084 3535/
3564 or [email protected]
Out-of-hours 07770 446 189
DIETARY INGRED. -- Cont’d from p. 3...
May 2006
product was similar to another
formulation reviewed under the NDI
process, namely, Nutratech, Inc.’s
product Diosmin Complex, a 90%/
10% formulation. The product is
made into tablets of 600 mg and
recommended at one tablet per day
with a maximum duration of use of
three months, but not recommended
for use by children or pregnant or
nursing women. The cover letter
stated that the data is “virtually all of
the same information” submitted by
Nutratech. FDA responded by letter
of September 6, 2005 to Mr. Rubin
from Susan J. Walker, M.D. stating
that the agency would complete its
evaluation to determine whether the
product is a dietary supplement within
the meaning of 21 USC 321(ff) and
send you a notice explaining FDA’s
decision. FDA said that the lack of
response to a notice does not
constitute a finding that the ingredient
is safe or is not adulterated. Docket
No., 95S-0316, RPT 293, received
at the Dockets Office September 30,
2005, entered into the docket
October 3, 2005, and posted on a
web page created October 26, 2005.
[There is no follow-up letter stating
this product is a dietary supplement
on the FDA website as of April 28,
2006.—Ed.]
the most substantial daily meal or 3.0
g … between meals…. The ingredient
is intended for use by persons who
wish to increase their satiety feeling,
and as a result reduce their food
intake.” FDA responded by letter
of September 1, 2005 from Susan J.
Walker, M.D., signed by Linda
Pellicore, Ph.D. stating the agency
was concerned about the evidence
submitted. FDA said the notice fails
to adequately identify the new
ingredient since the manufacturing
process is not clearly described. And
FDA said the composition of the
ingredient is described in a semiquantitative way. The evidence
discusses the consumption of nuts and
the use in food of nuts, but there was
no evidence of the use in food of fatty
acids derived from nuts. Other
information submitted did not
relate how it was similar to the new
ingredient. And there was no safety
evaluation of the material used in the
two week, 18-person clinical study.
For these and other reasons, FDA
advised that the product may not be
reasonably be expected to be safe
when used as recommended and may
be adulterated under the law.
Introduction of such a product into
interstate commerce is prohibited.
Docket No. 95S-0316, RPT 292,
Leonard Lee of Cathedral City,
received at the Dockets Office
September 30, 2005, entered into the California, sent FDA by letter of June
docket September 30, 2005, and 15, 2005, notice of two new
posted on a web page create d ingredients – Toona Sinensus, and
Heracleum Lanatum. These
October 18, 2005.
ingredients were each given a Docket
Stragen Pharma of Geneva, number by FDA. Toona Sinensus or
Switzerland, through Paul D. Rubin, Chinese cedar is a deciduous tree
Esq. of Patton Boggs LLP, in whose shoots and leaves have been
Washington, D.C., wrote to give eaten in China. Submitted with basic
FDA an NDI by letter of June 22, descriptive information was a
2005 concerning the new ingredient, Cytotoxic Activity in Human Lung
Diosmin (95/5) Complex, containing Cancer Cells report by several
95% diosmin and 5% hesperidin. The persons at the Tajen Institute of
cover letter pointed out that this Technology in Taiwan which
Page 7
concluded that both an aqueous
crude extract of leaves and a MeOH
extract of leaves possess an
antiproliferative effect on all three cell
types of NSCLC (non-small-cell lung
cancer). The only form or use
mentioned was “content 70% of the
tablet, in powdered form.” There
was not much more information
included in the public file. FDA
responded by letter of September 1,
2005 from Susan J. Walker, M.D.,
signed by Linda Pellicore, Ph.D.,
stating that the notice does not
comply with 21 CFR 190.6 and is
incomplete. Not included in the
notice were: 1) an original and two
copies; 2) a description of the dietary
supplement(s) that contain the new
ingredient; 3) the level of the new
ingredient in the dietary supplement;
and 4) the conditions of use
recommended in the labeling of the
dietary supplement. The information
submitted describes the parts of the
tree, fruit, and leaves, but does not
provide information about the
product that is to be marketed. In
addition, the reference articles relied
upon for safety are citations or
abstracts and there were no reprints
or copies. And there was no
documented history of use of the
ingredient in the food supply. The
information about use in Chinese
medicine does not provide a history
of use as a food. Based on the
information in the notice, FDA cannot
make an evaluation of the safety of
Toona Sinensis. Therefore, because
insufficient information was provided
for FDA to make a determination that
the product when used as
recommended is reasonably
expected to be safe, under the law it
is considered adulterated and may not
be entered into interstate commerce.
Further, FDA said the information
See DIETARY INGRED. -- Cont’d on p. 8...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
Natural Medicine LawTM
Page 8
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
Photo Courtesy of Lloyd Library and Museum
DIETARY INGRED. -- Cont’d from page 7...
indicates that the ingredient is
intended to treat a medical condition
and it may be subject to regulation as
a drug under the Act. Docket No.
95S-0316, RPT 294, received at the
Dockets Office September 30, 2005,
entered into the docket October 3,
2005, and posted on a web page
created October 26, 2005.
Leonard Lee of Cathedral City,
California, sent FDA by letter of June
15, 2005, notice of two new
ingredients – Toona Sinensus, and
Heracleum Lanatum. These
ingredients were each given a Docket
number by FDA. Heracleum
Lanatum (Michx.) or American Cow
Parsnip is a perennial growing 2 to 4
meters tall and hardy in zone 5. It
has been eaten and used as a medicinal
plant widely for many diagnoses in
Chinese medicine and by the
American Indians. There was some
information about furarocoumarins
(psoralen) and their photosensitizing
properties. The only form or use
May 2006
mentioned was “content of tablet
30%, in powdered form.” There was
not much more information included
in the public file. FDA responded by
letter of September 1, 2005 from
Susan J. Walker, M.D., signed by
Linda Pellicore, Ph.D., stating that the
notice does not comply with 21 CFR
190.6 and is incomplete. Not
included in the notice were: 1) an
original and two copies; 2) a
description of the dietary
supplement(s) that contain the new
ingredient; 3) the level of the new
ingredient in the dietary supplement;
and 4) the conditions of use
recommended in the labeling of the
dietary supplement. The information
submitted describes the physical
characteristics and edible uses, but
does not provide information about
the product that is to be marketed.
In addition, the reference articles
relied upon for safety are citations or
abstracts and there were no reprints
or copies. And there was no
documented history of use of the
ingredient in the food supply. The
information about use in Chinese
medicine does not provide a history
of use as a food. Based on the
information in the notice, FDA cannot
make an evaluation of the safety of
Heracleum Lantatum. Therefore,
because insufficient information was
provided for FDA to make a
determination that the product when
used as recommended is reasonably
expected to be safe, under the law it
is considered adulterated and may not
be entered into interstate commerce.
Further, FDA said the information
indicates that the ingredient is
intended to treat a medical condition
and it may be subject to regulation as
a drug under the Act. Docket No.
95S-0316, RPT 295, received at the
Dockets Office September 30, 2005,
entered into the docket October 3,
2005, and posted on a web page
Natural Medicine LawTM
created October 26, 2005.
Global Cancer Strategies Ltd. of
Vancouver, Canada, advised FDA by
letter of June 23, 2005 of a new
dietary supplement, ProhibitRx,
containing six botanical ingredients:
Vietnamese Sophora (Sophora
tonkinensis Gapnep), bistort
(Polygonum bistota), heal all
(Prunella vulgaris L.), perennial
sowthistle (Sonchus brachyotus),
dense fruit dittany (Dictamnus
dasycarpus Turcz), and air potato
(Dioscorea bulbifera). The
supplement is also described as
ACAPHA. The dietary supplement
will contain 600 mg of ProhibitRx in
a film coated tablet with a suggested
dose of 1.8 g per tablet to be taken
three times a day. The product is
designed for distribution in the United
States. The product has been
approved by the Chinese State Food
and Drug Administration for treatment
of esophageal dysplasia and stomach
problems.
The product is
manufactured by Central
Pharmaceutical Co. Ltd., Tianjin,
China.
The contents and
manufacturing method is didacted
from the public record. The
recommended use of the product is
by healthy adult males and females
seeking to support health of their
epithelial tissues in the oropharyngeal
and respiratory tissues, as support for
normal respiratory function in a
smoke-rich environment, for those
exposed to second-hand smoking,
and support ability of the body to
cope with a polluted environment, and
help minimize the risks to long-term
health posed by exposure to
environmental toxins. A history of use
in Chinese medicine was described.
Evidence of safety and toxicology was
didacted as confidential. FDA
See NEW DIETARY INGRED -- Cont’d p. 9.
NEW DIETARY INGRED -- Cont’d from p. 8...
responded by letter of September 9,
2005 from Susan J. Walker, M.D. to
Dr. T. P. Chiang, stating that the
agency has concerns about the
information upon which the
conclusion is supported that the
dietary supplement will reasonably be
expected to be safe. FDA said the
notice fails to adequately describe
ACAPHA as there is no mention of
the herb ratio to solvent in the
manufacturing process. The degree
of concentration cannot be
determined. In addition, the
standardization of the content of the
alkaloid, matrine, present on one of
the six ingredients is not stated. Thus
it is unclear to what extent matrine
contributes to the components. There
was no information about the history
of use of these ingredients as food.
The relationship of the materials used
in animal safety studies to the final
product was not clear. For these
reasons, the notice does not provide
an adequate basis to conclude that
ACAPHA when use under the
conditions recommended will
reasonably be expected to be safe.
Therefore, the product may be
adulterated and may not be
introduced into interstate commerce.
Docket No. 95S-0316, RPT. 296,
entered into the docket on October
3, 2005, and posted to the FDA web
site on October 26, 2005.
Vigonic (International) Ltd. of
Kowloon, Hong Kong, through
Robert DeWitty, Esq. of Baltimore,
on August 11, 2005 submitted a
notification of New Dietary
Ingredients, contained in a dietary
supplement known under the
trademark, VI-28. The new
Natural Medicine TiesTM
www.natmedlaw.com
May 2006
ingredients are radix ginseng, cornu
cervi pantotrichum, fructus cnidi,
semen cuscutae, and kaempferiae
rhizome. The notifier admitted that
none of the ingredients were
marketed in the U.S. prior to October
15, 1994, and that it is believed radix
ginseng was marketed before that
date, but does not possess conclusive
proof of this latter fact. The notice
claims these ingredients are “other
botanicals” as defined in DSHEA.
The notice states: “As CORNU
CERVI PANTOTRICHUM is used
to increase the total dietary intake and
is not classified as a botanical, the
Latin binomial and author are not
required to be included.” The notice
then states that the information upon
which Vigonic has concluded the
supplement is reasonably to be
expected to be safe is attached which
overcomes the initial state of
adulteration. Arguing that FDA has
not promulgated any regulation setting
standards for the information to be
provided, it is bound by the Act. The
information provided was relied upon
by the manufacturer to conclude the
supplement is reasonably expected to
be safe. The file contains another
notice and explanatory letter dated
August 29, 2005 which defined
FDA’s request for information about
cornu cervi pantotrichum as one that
concerned whether the Chinese
characters following the Englishlanguage terminology was a
translation of the English-language
terminology. The explanatory letter
asserted that this was the case, giving
as an example that the term “horn
glue” was translated to “lujiao jiao,”
being a Chinese translation of the
English. Also in the public file were
documents identifying “Provided
Information” for cornu cervi
pantotrichum, another describing
“Provided Information” for Radix
Ginseng, and a third describing
Page 9
“adulteration” under DSHEA, the
conditions of use of the dietary
supplement, and the amount per
serving size. The later document also
contains an argument that a
determination by FDA based on
inadequate information must be
addressed to the conditions of use
indicated by the manufacturer and that
a failure to supply information
directed to these conditions of use will
make the determination arbitrary and
capricious. FDA responded by letter
to Robert DeWitty, dated October
13, 2005, from Susan J, Walker,
M.D., signed by Linda Pellicore,
Ph.D., stating that the agency has
concerns about the evidence on which
Vigonic relies to support the
conclusion that VI-28 will reasonably
be expected to be safe. FDA stated
it was unable to identify any of the
new ingredients used to make VI-28.
The information provide about cornu
cervi pantotrichum is that it is “pilose
antler,” “deer antler,” and “deer
velvet.” The notice did not specify
which species within the genus
Cervus , FDA commented, and said
that some material refers variously to
spotted deer, red deer, North
American elk and Cervus elaphus
nelsoni, but it is unclear if any, all or
none of these species will be the
source of cornu cervi pantotrichum
used in the product. There were other
areas of lack of clarity in the notice.
FDA concluded that it could not
identify the ingredients, how the
ingredients relate to the evidence of
safety, or how that information was
used in evaluating the safe use of the
dietary supplement under the
conditions of use. Finally, FDA said
there was no description of the
manufacturing process used to
combine the five new ingredients or
of the VI-28 product. For these
reasons, FDA concluded the
DIETARY INGRED. Cont’d on p. 10...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
Natural Medicine LawTM
May 2006
Natural Medicine LawTM
Burningham, Esq. from Susan J. Walker, M.D., signed
NEW DIETARY INGREDIENTS -- Continued from page 9...
submission did not provide an adequate basis to conclude by Linda Pellicore, Ph.D., stating that the agency had
that VI-28 will reasonably be expected to be safe when concerns because the agency was unable to determine
used under conditions recommended. Therefore, the the identity of the new ingredient. The description of the
product may be adulterated and may not be introduced specification and physical attributes were inadequate to
into interstate commerce. Docket No. 95S-0316, RPT describe the identity. There was no chemical description
297, received in Dockets Office on November 22, 2005, or manufacturing information from which FDA might have
entered into Docket on November 22, 2005, and posted determine the identity. The dosage form was not described
and the products that will contain the ingredient were not
on a Web page updated December 7, 2005.
described. FDA said that because the identity of the
One more letter was in the public file from Lyle Jaffe, new ingredient was unclear, it is unclear how the ingredient
Division of Dockets Management, advising Robert M. is similar to the substances described in the safety data.
DeWitty that his petition requesting FDA to take FDA says the toxicity study in “six rats” that found 100%
administrative action to clarify the FDA letter received in mortality at the highest doses does not appear to provide
response to a pre-market notification for VI-28, was a basis to support a determination that chronic
received and assigned Docket No. 2005P-0495/CP1 consumption of the ingredient will reasonably be expected
to be safe. For these reasons, FDA said the new
and filed on December 21, 2005.
ingredient notice provides inadequate information to
Albion Laboratories, Inc. of Clearfield, Utah, sent provide reasonable assurance that the ingredient does
FDA a 75-day pre-market notification of an new dietary not present a significant or unreasonable risk of illness or
ingredient by letter of August 24, 2005 concerning its injury. Introduction of such a product into interstate
product, Manganese Glucosamine™, containing 100 mg commerce is prohibited. Docket No. 95S-0316, RPT.
of Manganese Glucosamine™, delivering the RDA dose 298, received in Dockets Office on December 13, 2005,
of 5 mg of manganese and a dose of 43 mg of entered into Docket on December 1, 2005, and posted
glucosamine. The conditions of use were described as: on a Web page updated January 4, 2006.
“oral supplementation in typical dosage forms as a
Natural ASA of Industrivelen, Norway, sent FDA a
supplement to other sources of manganese and
glucosamine in the diet. When administered in the Daily September 1, 2005 letter giving notice of its new dietary
Dosage stated above, consistent with manganese RDA, ingredient, Omega-3 PL, containing a mixture of
additional glucosamine dosage level to levels more typical phospholipids and triglycerides with a small amount of
for glucosamine supplementation. Alternatively, ethyl esters and free fatty acids. Didacted from the public
Manganese Glucosamine™ can be dosed at levels record were part of the name of the ingredient, the
targeting the adult DRI upper limit of 11 mg manganese. manufacturing process, the description of the dietary
A daily dose of 220 mg of Manganese Glucosamine™ supplement containing the ingredient, the history of use,
delivers the adult DRI upper limit of 11 mg of manganese and the assessment of safety. FDA responded by letter
and 95 mg of glucosamine, thus reducing the amount of of November 18, 2005 to Egil Nilsen, business
additional gluscoamine supplementation required from development manager, from Susan J. Walker, M.D.,
other sources.” The history of use section of the notice signed by Linda Pellicore, Ph.D., stating that FDA had
claimed that the safe use of the constituents of Manganese concerns about the evidence submitted as a basis for the
Glucosamine™ was well documented and it listed the Natural ASA conclusion that new ingredient would
references and provided copies. The notice claimed that reasonably be expected to be safe when used as
Manganese Glucosamine™ was a dietary ingredient recommended. FDA states, but NML cannot confirm
because it was a combination of a mineral and another because of the many redactions, that the product will be
dietary substance. The composition of the product was used by consuming 3 g or 1 capsule 3 times daily with
confidential as are the product specifications and MSDS meals. FDA says the ingredient may also be used in
for the starting materials. The safety data disclosure nutrition bars and liquid formations providing a similar
indicated the product was tested in “six animals” at 2000 dose. But FDA goes on to say it is unclear whether
mg/Kg with survival in good health (until necropsy) and these bars and liquid formulations will be marketed as
in “three female animals” at 5000 mg/Kg who all died
within 24 hours. FDA responded by letter to Brent
See NEW DIETARY INGREDIENTS --Continued on page 11...
Page 10
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
Natural Medicine LawTM
May 2006
Page 11
“It is illegal to sell or supply prescription medicines without
dietary supplements or conventional foods. And FDA the purchaser having a prescription from a registered
says it was unable to determine the identity of Omega-3 medical practitioner. Distributors, importers and sellers
Phospholipids, primarily because “the source of the are responsible for ensuring the products they import or
concentrated fish oil and the identity of the triglyceride sell do not contain any undeclared prescription
carrier (marine or vegetable) used to produce your medicines,” Dr. Poutasi says. “It is also illegal for an
ingredient are not described. Furthermore, the products individual to possess personal supplies of a prescription
of the various inter-esterification reactions are not medicine without first having obtained a medical
identified or described. The notification addresses the practitioner’s prescription for them.”
safety of DHA and EPA, but not the other components.
There is no history of use of the material called Omega“Consumers need to be cautious as there may be other
3 Phospholipids, and there is no way to evaluate the safety herbal products at risk of containing prescription
information provided as applied to the Omega-3 medicines or toxic substances. There are many examples
Phospholipids. For these reasons, the notice does not in the international literature where ‘herbal’ products for
provide an adequate basis to conclude the product will the treatment of impotence or for weight loss have been
reasonably be expected to be safe. Therefore, the found to contain prescription medicines.”
products using the ingredients may be adulterated and
the products are prohibited from interstate commerce. Further information is available on the Medsafe website:
Docket No. 96S-0316, RPT. 299, received at the http://www.medsafe.govt.nz/hot.htm New Zealand and
Dockets Office, December 13, 2005, entered into the
Docket on December 14, 2005, and posted on FDA’s
website updated page on January 4, 2006.
MEDICINES ACT -- Continued from page 5...
A second herbal product Nasutra, has been found to
contain the prescription medicine Sildenafil, which is
prescribed for the treatment of erectile dysfunction.
Sildenafil is known to interfere with some heart medication
and could be fatal to some individuals. “Consumers should
immediately stop taking these two products,” Dr. Poutasi
Nasutra
Li Da
says. Sildenafil is also known as Viagra.
Australia are linked in enforcement efforts concerning these
kinds of illegal medicinces.
“People who have taken Li Da or Nasutra should seek
medical advice from their doctor if they are: taking other
medicines; have felt unwell when taking the products; or
DYNAMIC HEALTH OF FLORIDA
if they have become unwell after they stopped taking the
SETTLES FTC CHARGES
products.” The two products were discovered following
routine testing, surveillance activities and through Marketers of Pedia Loss, a purported children’s weightinformation received by Medsafe.
loss product, and Fabulously Feminine, a supposed female
libido enhancement product, have agreed to settle Federal
Action is being taken with respect to the distributors of Trade Commission charges that they made false and
these products and further investigations by Medsafe are misleading claims about their products. FTC announced
underway into the importation and supply of the products. the settlement April 6, 2006.
www.natmedlaw.com
FTC’s complaint alleged that the defendants could not
support claims that Pedia Loss causes weight loss in
overweight or obese children ages six and over, and that
See DYNAMIC HEALTH -- Continued on page 19...
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
NEW DIETARY INGREDIENTS -- Continued from page 10...
Page 12
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
Photo Courtesy of Lloyd Library and Museum
PHARMACISTS -- Continued from p. 2...
Dr. Shapiro said the American
Heart Association recommended fish
high in omega-3 oils twice a week
when no cardiovascular heart disease
is present and when CHD is present,
at least one gram per day of omega3 oils in supplement form. The
National Cholesterol Education
Program (NCEP) Expert Panel on
Detection, Evaluation, and Treatment
of High Blood Cholesterol in Adults
(Adult Treatment Panel III)
recommends fish oils as an alternative
treatment for lowering triglycerides.
1 to 4 g or more daily will decrease
triglycerides by 25% to 50%. Fish
oils are also being used for cancer
prevention, CSA-induced toxicities,
bipolar disorder and depression, dry
eye syndrome and other conditions.
Oats are recommended at one cup
per day to decrease LDL 5 mg/dl.
Psyllium 10 to 12 g per day, divided
can decrease LDL by 5% to 15%.
Soy 25 g per day can decrease LDL
by 10%. Plant sterols taken 1 to 8
g, divided in 2 or 3 doses per day,
can decrease LDL 10% to 15%.
May 2006
Natural Medicine LawTM
Policosanol 5 mg twice a day will Castañeda, Pharm.D., Marialice S.
lower LDL 11% to 27% and increase Bennett, R.Ph., Esperanza J.
HDL 11% to 25%.
Carchaced de Blanco, Ph.D. and
Laura Hall, Pharm. D. Assistant
Multivitamins are popular and Clinical Professor at Ohio State
worthwhile, according to Shapiro, University College of Pharmacy and
and combination products containing Columbus Neighborhood Health
Vitamin A (beta –carotene 14,320 Centers, Inc. The study confirms a
IU), Vitamin C (ascorbic acid 226 fairly simple message: patients are not
mg.), Vitamin E (dl-alpha tocopherol being asked by health care
acetate 200 IU), Zinc oxide 34.8 mg, professionals about herbal/natural
and Cupric oxide 0.8 mg were used products; patients are treating
in the National Eye Institute age- respiratory, central nervous system
related study that showed a slowed and gastrointestinal symptoms with
progression of macular degeneration. herbs; and a system to document
Arch. Ophthalmology 2001; 119: herbal/natural product use is needed.
1436. Lutein may also improve
macular degeneration at 10 mg per
The poster was displayed at the
day. JAMA 1994; 272: 1413-20.
San Francisco meeting among rows
and rows of other posters. Many
Gingko use at 120 mg to 240 mg subjects were covered. Some
daily, divided into 2 doses, in a concerned therapy management. To
product containing 24% flavone just identify the topics of each poster
glycosides can support modest would have taken several hours. To
memory improvement, Shapiro said, study them all to an understanding of
and may reduce the concentration what was being done and concluded,
needed of omeprazole and possibly would have taken days. But since
other drugs. Huperzine A is derived March, the study has proceeded, and
from a Chinese herb Huperzia NML contacted the authors for more
serrata and used for Alzheimers. information. Dr. Castañeda
[The National Institute on Aging is responded recently with more data.
recruit for a 150 person study at this
time. Study No. NCT00083590. – The five health centers have 18,037
Ed.] 100 to 200 mcg per day is used patients, 66% of whom are uninsured,
to obtain modest delay in symptom 62.% women and 78.5% over 18.
progression.
They are primarily indigent and
homeless in the Columbus, Ohio area.
Shapiro mentioned the weight loss The study goals remained the same
products Dexatrim ® Natural from the beginning. In March the
Ephedrine Free Formula and researchers reported 85 people in the
Hydroxycut ®Advanced Weight Loss study, now they report 130, closer
Formula – Ephedra Free as products to the goal of 200. None of the 130
to consider. Also products containing patients had been asked about herbal/
bitter orange peel. St. John’s Wort, natural products in the past 12
given 300 mg three times daily for months. A minority of whites and
mild to moderate depression may be African Americans use herbals.
obtained, but there are minor side Though much smaller numbers of
effects and many interactions.
people, the Hispanic, Asians and
A poster was by Daniela V.
See PHARMACISTS --Cont’d on p.13...
PHARMACISTS-- Cont’d from p. 12...
May 2006
clarifying the FDA implementation of
American Indians use herbals in higher DSHEA, plus a complete list of all
numbers than do not.
special regulations applicable to
natural health products. The talk also
Among the 130 persons, 45 used describes the billions in costs to the
herbals. The reasons they use herbals American public from the failure of
are varied, including family traditions, Federal agencies to promote the use
more effective than Rx, no doctor visit of vitamins, minerals, and others
is required, safer than Rx, someone natural substances for a list of
recommended, and they improve conditions. The talk is available as a
health. The recommendations to use Powerpoint presentation on
herbals came primarily from family, www.natmedlaw.com. Go to the List
and only a few from health care of Articles page and scroll to the
providers. Almost half the 45 users bottom. The List of Articles page is
were occasional or always users located under “Products and
before going to a health care Services.” There is no charge to look
provider. 61.5% of the users and learn. Copy the list of regulations
obtained symptom relief from herbal that apply to dietary supplements.
use and only 33% told the doctor Review these when considering
they had treated the symptoms.
whether to market or file notices of
claims. Share this with your friends.
The researchers realize their
questionnaire is not validated, the
sample size is small and does not
SUPPLEMENTARY
represent the clinic population. In the
GUIDANCE ON
future, they hope to identify and target
TRANSITION
commonly treated symptoms, identify
the safety of commonly used T raditional herbal medicinal
products, and identify and avoid products (Directive 2004/24/EC,
possible drug interactions.
amending Directive 2001/83/EC)
requires supplementary guidance that
For more information, contact: has been developed in response to a
Daniela Castañeda, Pharm.D., number of queries received by the
Ambulatory/Community Care MHRA about the end of transitional
Resident, The Ohio State University, protection under the Directive on
College of Pharmacy, 500 West 12th traditional herbal medicinal products.
Ave., Columbus, OH 43210, Tele: Please note that this guidance
(915)276-4608,
Email at: represents MHRA’s view and cannot
[email protected]
be taken to be a definitive statement
of the law. This can only be given by
The final talk on natural products at the courts. Where you have any
the pharmacists’ annual meeting was doubts about your obligations, you
by NML’s editor to a meeting should always consult your own
cosponsored by the American professional advisors. Any enquiries
Society for Pharmacy Law. The title relating to the transitional
of the talk was “Health and Legal arrangements or this note should be
Problems Arising From Failure to addressed
to
Implement DSHEA.” This talk [email protected].
documents the delays in proposing
regulations, holding meetings and
Page 13
Relevant provisions of the Directive
on Traditional Herbal Medicinal
Products
Regulation 4(1) of the Medicines
(Traditional Herbal Medicinal
Products for Human Use) Regulations
2005 (“the Herbals Regulations”) of
the regulations states that: • No
traditional herbal medicinal product
shall be (a) placed on the market, or
(b) distributed by way of wholesale
dealing, unless a traditional herbal
registration has been granted by the
licensing authority (which is in force,
and which has been granted in
accordance with the Community
provisions).
Provisions made under Schedule 6
mean that: • Where a product has
been placed on the market, lawfully,
under section 12(2) on or before 30th
April 2004 regulation 4(1) would not
apply until 30th April 2011 to
products which were on the market
under section 12(2) on 30th April
2004.
Q & A on the end of Transitional
Arrangements and how this will
operate
Q: Can a product continue to benefit
from transitional protection after April
2011 if the company has made an
application by 30th April 2011?
A: No. Starting from 30th April, no
product may be placed on the market,
or distributed by way of wholesale
dealing, unless a registration has been
granted. It is not enough that an
application has been made - it must
have been granted.
Q: What are the timetable
requirements for MHRA in
See TRANSITION -- Continued on page 21...
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Natural Medicine LawTM
Page 14
May 2006
EMAX -- Continued from page 1...
time, FDA exempted from the rule ephedrine alkaloidcontaining conventional foods (such as ephedra tea),
regardless of the quantify of naturally occurring ephedrine
alkaloids within a daily serving.
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
FDA then issued an import alert on July 13, 2004
asking Customs to not permit the importation of any
ephedrine containing herb whether in completed dietary
supplement or bulk form. The alert says release of the
products may be expressly conditioned on the importer’s
ability to provide documentary evidence that the products
do not contain ephedrine alkaloids.
Natural Medicine LawTM
Neutraceutical v. Crawford requires FDA to conduct a
dose dependent determination of adulteration and prove
by the preponderance of evidence that a dietary
supplement containing 10 mg or less of ephedrine alkaloids
per daily dose were adulterated. The Import Alert states
that a shipment may be permitted entry if lab tests show it
contains no ephedrine. The Import Alert has no provision
for the lawful entry of products containing 10 mg or less
or ephedrine alkaloids. The invalidation of the Final Rule
renders invalid the Import Alert. FDA has not offered
any other reason for the detention and FDA has said that
there would be no labeling that would permit a lawful entry
of any bulk ephedra shipment. This is contrary to
Neutraceutical v. Crawford.
On April 5, 2005, U.S. District Judge Tina Campbell
in the District of Utah ruled that FDA’s Final Rule was
Second, FDA exceeds its authority and violates the
invalid for two reasons. Neutraceutical v. Crawford, adulteration provisions under Neutraceutical v.
364 F.Supp. 2d at 1319-1321.
Crawford by adhering to the provisions of the invalid Final
Rule and invalid Import Alert.
In violation of that order and without seeking a stay
from Judge Campbell or the Tenth Circuit Court of Third, FDA’s actions are contrary to the Administrative
Appeals, where FDA had appealed, FDA has continued Procedure Act (APA) because FDA has acted in an
to enforce the Final Rule and the Import Alert. One arbitrary and capricious way without a stay of the court
instance of this illegal activity was cited in the complaint, order and the plain requirements of 21 USC § 342(f)(1).
namely, a shipment sent to the Salt Lake City Airport on FDA’s refusal is also a violation of the proof requirements
February 22, 2006 containing some ephedrine-alkaloid of the Act and is in violation of the APA.
containing dietary supplements that were labeled that the
maximum daily dose shall not exceed 10 mg of ephedrine Emax asked the Court to hold the Final Rule and Import
alkaloids. The next day, FDA decided to place a “Hold” Alert as unenforceable as to plaintiffs, to declare the refusal
on the shipment and take samples for testing. On March in excess of FDA’s authority, to declare the actions of
21, 2006, FDA said it would discontinue the testing and FDA arbitrary and capricious, to enjoin the defendants
hold the shipment. The Notice of Detention designated from enforcing the Import Alert against Emax and to enjoin
April 10, 2006 for the time for taking testimony to the defendants from enforcing it against Emax as grounds
establish the admissibility of the shipment.
for prohibiting any future shipment. Emax also asked for
attorney fees and costs.
On April 4, 2006, Emax sent an Email to FDA stating
that Neutraceutical v. Crawford rendered the FDA
The defendants have not answered. The Plaintiff states
Final Rule invalid and held FDA lacked the that it will file an amended complaint. The ephedra
preponderance of the evidence to prove the shipment shipment was released. Attorneys for Plaintiff were
labeled not to exceed 10 mg per daily dose of ephedrine Jefferson W. Gross, Esq., Richard D. Burbidge, Esq. and
alkaloids, is adulterated, and the Import Alert was invalid Robert J. Shelby, Esq., of Burbridge & Mitchell in Salt
as well. FDA stood firm saying it was relying on previous Lake City, and Jonathan Walker Emord, Esq. and Andrea
communications. On April 12, 2006, FDA issued a Gallimore Ferrenz, Esq. of Reston, VA. Stephen J.
Notice of Refusal for the shipment requiring it to be Sorensen, Esq., Acting U.S. Attorney in Salt Lake City
destroyed within 90 days.
represented the federal government. The case was
assigned to U.S. District Judge Dale A. Kimball as Case
The lawsuit has three causes of action. First, Emax No. 2:06-cv-334. This same District Court issued the
claims FDA’s determination of adulteration was based decision in Neutraceutical v. Crawford. Then the judge
on an unlawful test requiring supplements to prove a was U.S. District Judge Tina Campbell. Until now FDA
benefit as a condition precedent to lawful sale. insisted that decision only applied to one company.
.
These products claim to be anabolic and problems
associated with anabolic steroids include: liver toxicity,
testicular atrophy and male infertility, masculinization of
women, breast enlargement in males, short stature in
children, adverse effects on blood lipid levels, and a
potential to increase the risk of heart attack and stroke.
“FDA takes its responsibility to protect Americans from
dangerous unapproved drugs seriously. Today’s action
is indicative of our resolve,” said Margaret O’K. Glavin,
FDA’s Associate Commissioner for Regulatory Affairs.
Consumers who have any of the products listed below
should stop taking them and return them to their place of
purchase.
GENISTEIN IS NOT HAZARDOUS
TO HUMANS
An independent panel of 14 scientists convened by the
Center for the Evaluation of Risks to Human Reproduction
(CERHR), of the NIEHS and National Toxicology
Program, reviewed recent scientific data and concluded
exposure to genistein or soy formula is not hazardous to
human development or reproduction. The 2.5 day meeting
on March 15 to 17 resulted in a 264 page report on
genistein.
FDA issued warning letters for the following so-called
The panel consisted of Karl K. Rozman, Ph.D.,
dietary supplement products:
Department of Pharmacology and Toxicology, University
Anabolic Xtreme Superdrol, manufactured for Anabolic
Resources LLC, Gilbert, Arizona, and distributed by See GENISTEIN -- Continued on page 16...
Supplements To Go, Cincinnati, Ohio
Methyl-1-P, manufactured for Legal Gear, Brighton, MI
and distributed by Affordable Supplements, Wichita,
PHOTOGRAPHS FROM LLOYD LIBRARYAND MUSEUM
Kansas
These warning letters are part of FDA’s continued
efforts to protect consumers from dangerous steroid
products. In March 2004, FDA sent warning letters to
23 manufacturers and distributors of products containing
androstenedione.
Warning Letters require specific responses be made
to FDA within time limits. For these letters go to:
www.natmedlaw.com
Page 4 - Foxglove (Digitalis purpurea) from MEDICAL
BOTANY by John Stephenson, M.D. and James Morss Churchill,
F.L.S. 1829
Page 8 - Valerian (Valeriana officinalis) from MEDICAL
BOTANY by John Stephenson, M.D. and James Morss Churchill,
F.L.S. 1829
Page 12 - Ginseng (Panax quinquefolium) from THE FAMILY
FLORA AND MATERIA MEDICA BOTANICA by Peter P. Good
1847
Page 16 - Evening Primrose (Oenothera biennis) from AMERICAN MEDICINAL PLANTS, by Charles F. Millspaugh, M.D.,
1887
Page 22 - Goldenseal (Hydrastis canadensis) from AMERICAN MEDICINAL PLANTS,supra, 1887
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
Natural Medicine LawTM
May 2006
Page 15
ILLEGAL STEROID PRODUCTS
Affordable Supplements
SOLD AS DIETARY SUPPLEMENTS
http://www.fda.gov/foi/warning_letters/g5739d.pdf
FDA on March 9, 2006 warned several manufacturers http://www.fda.gov/foi/warning_letters/g5739d.htm
Anabolic Resources LLC
and distributors of unapproved drugs containing steroids
http://www.fda.gov/foi/warning_letters/g5736d.pdf
that continued distribution and sale of these products
http://www.fda.gov/foi/warning_letters/g5736d.htm
without approval could result in regulatory action including
Legal Gear
seizure and injunction. FDA is concerned that the use of
http://www.fda.gov/foi/warning_letters/g5738d.pdf
these products, which are marketed as dietary
http://www.fda.gov/foi/warning_letters/g5738d.htm
supplements and promoted for building muscle and
Supplementstogo.com, LLC
increasing strength, may cause serious long-term adverse
http://www.fda.gov/foi/warning_letters/g5737d.pdf
health consequences in men, women, and children.
http://www.fda.gov/foi/warning_letters/g5737d.htm
Page 16
May 2006
The general conclusions about human
of Kansas Medical Center, Kansas toxicity were published on page 238
City, KS; James S. Kesner, Ph.D., with only one scientist, Dr. Rauth
National Institute for Occupational Etzel, saying there was reason for
Safety and Health, Cincinnati, OH; concern about soy intake among
Antonia M. Calafat, Ph.D., National humans. The report is titled: “NTPCenter for Environmental Health, CERHE Expert Panel Report on the
Centers for Disease Control and Reproductive and Developmental
Prevention, Atlanta, GA; Elizabeth H. Toxicity of Genistein.” Copies may be
Jeffery, Ph.D., Department of Food obtained at http://cerhr.niehs.nih.gov/
Science and Human Nutrition, chemicals/genistein-soy/genistein/
University of Illinois, Urbana, IL; Genistein_Report_final.pdf .
Martine Culty, Ph.D., Department of
Here is what the report said about
Biochemistry and Molecular Biology,
Georgetown University Medical soy consumption in humans.
Center, Washington, DC; Jatinder
“In a large multigenerational study,
Bhatia, M.B.B.S., Division of
Neonatology, Department of exposure to purified genistein occurred
Pediatrics, Medical College of throughout fetal development as well
Georgia, Augusta, GA; Ruth A. Etzel, as during adulthood. This experimental
M.D., Ph.D., Anchorage Native design made it extremely difficult for
Primary Care Center, Alaska Native the Expert Panel to clearly separate
Medical Center, Anchorage, AK; Sue developmental toxic effects from
Marty, Ph.D., Toxicology Research reproductive toxic effects. The Expert
Laboratory, The Dow Chemical Panel viewed some of these diverse
Company, Midland, MI; Deborah K. endpoints as a continuum from the
Hansen, Ph.D., Division of Genetic maternal exposure (oral) to the effects
and Reproductive Toxicology, observed in multigenerational offspring.
National Center for Toxicological Even though there is a paucity of
Research, Jefferson, AR; Jodi A. available human data on exposure to
Flaws, Ph.D., Department of purified genistein, the Expert Panel
Epidemiology and Preventive expresses negligible concern for
Medicine, University of Maryland reproductive and developmental effects
School of Medicine, Baltimore, MD; from exposure of adults in the general
Christina Chambers, Ph.D., population. The most highly reported
Departments of Pediatrics and Family exposed human population is
and Preventive Medicine, University Japanese adults with ingestion of
of California San Diego Medical approximately 0.43 mg/kg bw/day.
Center, San Diego, CA; John A. However, adverse effects in rodent
Thomas, Ph.D., Department of studies were not observed at levels
Pharmacology and Toxicology, below 35–44 mg/kg bw/day. Therefore,
Indiana University School of the Expert Panel feels that under
Medicine, Indianapolis, IN; Patricia current exposure conditions, adults
B. Hoyer, Ph.D., Department of would be unlikely to consume sufficient
Physiology, University of Arizona, daily levels of genistein to cause
Tucson, AZ; and David Umbach, adverse reproductive and/or
Ph.D., National Institute of developmental effects. The Expert
Environmental Health Sciences, Panel expresses negligible concern6
for adverse effects in neonates and
Research Triangle Park, NC.
Natural Medicine LawTM
GENISTEIN-- Cont’d from p. 15..
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
infants who may consume up to 0.01–
Photo Courtesy of Lloyd Library and Museum
0.08 mg/kg bw/day of genistein
aglycone contained in soy formula (it
is noteworthy that about 1% of total
genistein in soy formula is present as
the aglycone; see Table 6 in the
CERHR Soy Report).”
“ 6 Dr. Ruth Etzel did not concur with
the Expert Panel’s “negligible concern”
for developmental effects in the infant
population. Dr. Etzel concluded that a
higher level of concern, i.e. “concern”,
was justified based on the expectation
that genistein induced body weight
changes could exhibit a linear doseresponse relationship at low exposure
levels, the fact that infants may receive
no other foods than soy infant formula
for up to 6 months, and the fact that
exposure occurs during a critical time
in infancy when any exposure may
have the greatest potential to affect
later neurological status and
reproductive competency.”
Some of the scientists produced
lists of additional research projects to
further determine the effects of
genistein on humans. [These are
GENISTEIN -- Cont’d on page 17...
May 2006
GENISTEIN-- Cont’d from p.16...
findings of a long-term feeding study
listed in the report and should be on aspartame conducted in rats.
considered by marketers desiring to Scientists from ERF concluded from
make health claims for soy products. their study that aspartame causes
cancer and that current uses and
-- Ed.]
consumption of the sweetener should
The report data states that be re-evaluated.
exposure to genistein continues to rise
EFSA’s review of ERF’s study
in the United States with estimated
concluded,
among other things, that
soy sales in 2003 approaching $4
billion. A form of genistein is a primary, on the basis of all evidence currently
naturally occurring estrogen in available to EFSA:
soybeans (estrogenic chemicals in
❁ ERF’s conclusion that
plants are called phytoestrogens) and
aspartame is a carcinogen is
can mimic the effects of estrogen in
not supported by the data;
the body. Genistein can be found in
and
foods containing soy such as soybased infant formulas, tofu, soy milk,
❁ EFSA sees no need to
soy flour, textured soy protein,
further review its earlier
tempeh, and miso, as well as overscientific opinion on the safety
the-counter dietary supplements.
of aspartame or to revise the
Soy-infant formulas are widely used.
Acceptable Daily Intake.
It is estimated that 10-20 percent of
Upon learning of the ERF study
infants in the United States are fed
soy formula. It is often administered results, FDA requested the study
to infants as a supplement or data from ERF to evaluate the
replacement for maternal breast milk findings. On February 28, 2006, the
agency received a portion of the data
or cow’s milk.
requested. We are actively reviewing
the data provided by ERF and will
complete our review of those data as
soon as possible. When FDA
FDA STATEMENT
completes its review of the ERF study
ON EUROPEAN
data, it will announce its conclusion.
ASPARTAME STUDY
FDA issued this statement on May
8, 2006 in response to the European
Food Safety Authority (EFSA) press
release on its review of the long-term
carcinogenicity study of aspartame
conducted by the European
Ramazzini Foundation (ERF).
Since it was first approved for use
in the United States, the safety of
aspartame has been questioned by
some. To date, however, the agency
has not been presented with scientific
information that would support a
change in our conclusions about the
safety of aspartame. Those
conclusions are based on a detailed
review of a large body of information,
including more than 100 toxicological
and clinical studies regarding the
sweetener’s safety.
Aspartame, a low-calorie
sweetener, is composed primarily of
two common amino acids, aspartic
acid and phenylalanine. Each of these
is also a building block for
conventional foods such as protein http://www.fda.gov/bbs/topics/
NEWS/2006/NEW01369.html
and natural flavor molecules.
In 2005, ERF published new
Page 17
“NATURAL” BEVERAGES
The Sugar Association has filed a
citizen petition with FDA to define
what is meant by the term “natural”
when applied to beverages. The
petition asks FDA for consistency
across Federal agencies based on the
definition adopted by USDA in its
Food Standards and Labeling
Book.
In the case of meat and poultry, the
term “natural” may be used as long
as the applicant demonstrates: (1) the
product does contain any artificial
flavor or flavoring, coloring ingredient,
or chemical preservative (as defined
in 21 CFR 101.22), or any other
artificial or synthetic ingredient; and
(2) the product and its ingredient are
not more than minimally processed.
Natural claims should be
accompanied by a brief statement of
what is meant by the term natural.
This statement should appear directly
beneath or beside the “natural” claim.
The Sugar Associations asked that
foods and beverages represented as
“natural” that do not meet the
regulatory criteria be deemed
misbranded. The petition said the
current situation is ambiguous. FDA
currently allows 3,000 approved
food additives and by contrast the
European Union only allows 311,
while New Zealand and Australia
allows only 299.
Using a definition of “natural” and
“minimally processed” together will
achieve a level of specificity that will
negate the current ambiguity
associated with the term “natural.”
The petition points out that the
Canadian Food Inspection Agency
See NATURAL -- Cont’d on p.24...
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Natural Medicine LawTM
Page 18
May 2006
SECTION 403 LETTERS-- Continued from page 4...
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
“[H]elp to relieve pain and arthritis symptoms...;”
“[R]educe pain and accelerate the inflammatory
healing response for painful joint conditions, sports
injury…;” and [M]ay help rebuild cartilage and
alleviate pain in joint injury and other painful joint
conditions.” FDA also stated that the statements made
about Lipid Balance required an additional statement
about it being intended to affect blood cholesterol that is
already in the normal range. Therefore, FDA concluded
that the italicized statements were drug claims and the
products would be regulated as drugs if the statements
were used. FDA also stated that since the content of the
notices were not certified as true and not misleading and
were not signed, they were not acceptable as notices.
The failure to submit a valid notice may subject the
products to further regulation. Docket No. 97S-0163,
Ltr. 859, received at Dockets Office on February 16,
2006, entered into the Docket on February 16, 2006,
and posted on the FDA Website on March 6, 2006.
Brownwood Acres Foods, Inc. whose legal counsel,
Neal D. Fortin, Esq., of Okemos, Michigan, wrote FDA
on January 24, 2006 to give notice that he would use
certain claims for the product Concord Grape Juice
Concentrate, namely, “Helps maintain healthy blood
pressure levels,” and “Resveratol … to lower
cholesterol.” FDA’s Susan J. Walker, M.D. responded
by letter of February 10, 2006 stating that based on
reasoning in the January 6, 2000 final rule on structure/
function claims, a claim about maintenance of cholesterol
levels and blood pressure must also have statements about
them being intended to affect cholesterol levels and blood
pressure levels that are already in the normal range, or
they are disease claims. The claims presented are drug
claims and the products will be regulated under the drug
provisions of the Act. Docket No. 97S-0163, Ltr. 860,
received at Dockets Office on February 16, 2006, entered
into the Docket on February 16, 2006, and posted on
the FDA Website on March 6, 2006.
Beulah Land Corporation of Oak Park, Illinois,
wrote FDA on February 1, 2006, to give notice that it
would use certain claims for the product Beulah’s Bone
Plus Pack, namely, “may help promote bone health.”
The product contains Vitamin D3 1000 IU, Vitamin K 1
mg, Folic Acid 800 mcg, Magnesium 400 mg, Selenium
200 mcg, Copper 1 mg, Manganese 10 mg, Molybdenum
150 mcg, Ipraflavone 600 mg, Strontium Citrate 1000
mg, Montmorillonite 150 mg, Boron 5 mg. The label
Natural Medicine LawTM
suggests use of 2 packets per day. FDA responded by
letter dated February 10, 2006 from Susan J. Walker,
M.D., to President saying the notices are not compliant
with the regulations because they are not signed and
certified as to the truth and non-misleading nature of the
contents. FDA did not comment further. [Notice this
product does not contain calcium, so FDA could not
comment on meeting the health claims for the relationship
of calcium and bones. – Ed.] Docket No. 97S-0163,
Ltr., 861, received at Dockets Office on February 16,
2006, entered into the Docket on February 16, 2006,
and posted on the FDA Website on March 6, 2006.
Atlas Productions, Inc. of Pompano Beach, FL wrote
to FDA on January 16, 2006 to give notice that it would
use certain claims for its products: Nutra/MD™ High
Blood Pressure Essential Nutrients Supplement,
“[D]esigned for consumers and doctors who know
that many blood pressure lowering medicines can
hinder or deplete essential nutrients…;” Nutra/MD™
High Cholesterol Essential Nutrients Supplement,
“[D]esigned for consumers and doctors who know
that many cholesterol lowering medicines can hinder
or deplete essential nutrients…;” Nutra/MD™
Diabetes Essential Nutrients Supplement, “[D]esigned
for consumers and doctors who know that many
diabetes medications can hinder or deplete essential
nutrients…;” and Nutra/MD™ Arthritis Essential
Nutrients Supplement, “[D]esigned for consumers and
doctors who know that many medications given to
treat arthritic pain can hinder or deplete essential
nutrients….” FDA responded by letter to Don Ford,
M.D., P.A., from Susan J. Walker, M.D. stating that the
January 6, 2000 final rule on structure/function claims
(65 FR 1029) says that “a claim that a product is useful
because it counterbalances the effect of a drug in
depleting a nutrient of interfering with the metabolism of
a nutrient would be acceptable as a structure/function
claim” if the claim does not suggest that treatment of an
adverse reaction that meets the definition of disease.
However, the final rule also states, “if the claim expressly
or impliedly suggests that the supplement is intended to
augment a specific drug, d rug action, or therapy for a
disease, then the statement may be considered a disease
claim.” In addition, FDA said there were other statements
in the labeling of these products, such as the one for Nutra/
MD™ High Blood Pressure Essential Nutrients
Supplement, which states, “to aid in the prevention of
cardiovascular disease risk factors.” FDA said these
See SECTION 403 LETTERS -- Continued on page 19...
Natural Medicine LawTM
May 2006
Page 19
subject to public comment, was 5-0. The FTC will publish
claims “go beyond representing the products as intended an announcement regarding the agreement in the Federal
to replace nutrients lost as a consequence of the use of a Register. The agreement will be subject to public comment
specific therapy. Rather, they expressly are represented for 30 days, beginning today and ending on May 5, 2006.
to treat the underlying diseases for which the consumer Staff contacts are: Janet Evans or Sydney Knight, Bureau
would be consuming a drug.” These, FDA said, are disease
of Consumer Protection at telephone numbers:
claims. The claims taken together do not represent section
202-326-2125 or 202-326-2162 and for details at the
403(r)(6) claims, but they are disease claims. If these
claims are used, the products will be regulated as drugs. FTC website at: www.ftc.gov/opa/2006/04/
Docket No. 97S-0163, Ltr. 862, received at Dockets dynamichealth.htm.
Office on February 16, 2006, entered into the Docket on
February 16, 2006, and posted on the FDA Website on
March 6, 2006.
GUAIACUM TRADEMARKS
This word is not in the indexes of the U. S. Patent and
DYNAMIC HEALTH -- Continued from page 11...
when taken by overweight or obese children, Pedia Loss
suppresses appetite, increases fat burning, and slows
carbohydrate absorption. The FTC also alleged that the
defendants could not support claims that Fabulously
Feminine will increase a woman’s libido, sexual desire,
and sexual satisfaction. The FTC further alleged the
defendants falsely claimed that clinical testing proves
Fabulously Feminine enhances a women’s satisfaction with
her sex life and level of sexual desire.
Trademark Office as spelled. But if you use the asterisk
(*) in searching, you can find a live mark for MADE
FROM GREEN GUAIACOL. This mark is owned by
the Rhodia Corporation in France as Serial No. 78/
708595, filed September 7, 2005 in International Class
001 for chemicals, namely, compounds containing
guaiacol for use in the perfume, food aromas, food
manufacturing, cosmetics industries and in the manufacture
of pharmaceuticals. It was first used March 31, 2003
and has been approved for publication.
Defendants under the proposed agreement, Vineet K.
Chhabra (also known as Vincent K. Chhabra) and his
companies, Dynamic Health of Florida, LLC, and
Chhabra Group, LLC, are based in Weston, Florida. The
other two defendants named in the FTC’s complaint,
Jonathan Barash and DBS Laboratories, LLC, previously
settled the charges against them.
There is also a live mark for GUAIAFAGE, Registration
No. 2272069, in International Class 005, for antitussive,
expectorant, descongestant (sic) in the form of liquid,
tablets, capsule and injectable. This was first used May
15, 1998 by Alberto S. Bartolomea, of Puerto Rico. The
registration date is August 24, 1999.
The proposed agreement requires that the defendants
rely on competent and reliable scientific evidence to
substantiate weight loss, appetite suppression, fat burning,
or carbohydrate absorption claims for Pedia Loss or any
other dietary supplement, food, or drug. The defendants
must have competent and reliable scientific evidence to
substantiate claims that Fabulously Feminine or any other
dietary supplement, food, or drug will increase a woman’s
libido, sexual desire, or sexual satisfaction. The proposed
order also prohibits the defendants from making
unsubstantiated benefits, performance, or efficacy claims
for any dietary supplement, food, or drug, and prohibits
the defendants from misrepresenting any test or study.
Finally, it contains recordkeeping provisions to assist the
FTC in monitoring compliance.
The Commission vote to accept the consent agreement,
1
From 1905 to 1988, McKesson & Robbins, a
partnership in New York City, held a trademark for
GUAIAQUIN, Registration No. 0052729, in
International Class 001, for chemical preparations for the
treatment of malarial fevers and diseases characterized
by intestinal fermentation and in anemias and cachexiae.
The mark was first used October 5, 1896 and has now
expired.
Back in 1989 FDA was revising the Over-the-Counter
Drug Monographs and had originally classified
See GUAIACUM -- Continued on page 20...
www.NatMedLaw.com
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SECTION 403 LETTERS-- Continued from page 18...
Page 20
May 2006
Natural Medicine LawTM
GUAIACUM -- Continued from page 19...
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
Phytopharm licensed the global patent rights for the
extract of Hoodia gordonii, a cactus plant indigenous to
guaifenesin, a synthetic compound made to similate
South Africa, for incorporation into weight loss products
guaiacol, as a Class III OTC ingredient. But the agency from the South African Council for Scientific and Industrial
relented and allowed it to use a claim “helps loosen phlegm Research (CSIR) in 1997.
(sputum) and thin bronchial secretions to make coughs
more productive” based on the Vercelli study. 54 FR at
[Perhaps this will mean that some Hoodia products
8499 (Feb. 28, 2989)
now on the market will be required to cease and desist
when Unilever focuses its intellectual property attorneys
As late as July 2005, FDA was concerned about on infringers. We will watch for you. – Ed.]
combination products with guaifenesin and ephedrine. 70
FR 40233 (July 13, 2005)
Guaiacol did not make it into the Botanical Safety
Handbook, McGuffin et al, CRC 1997. But Guaiacum
Resin is featured in the British Herbal Compendia, Vol.
1, 1992.
FTC STAFF ADVISES FDA
ON QUALIFIED HEALTH CLAIMS
The FDA held a public meeting on November 17, 2005,
to present recent research on consumer perceptions of
The Arco Chemical, 3801 W. Chester Pike, Newtown qualified and unqualified health claims for conventional
Square, PA. is selling a guaifenesin made by new process foods and dietary supplements. In the meeting
announcement, the agency sought comments on available
recently.
research and the implications of the research for further
If you are thinking about using this mark, you need to consumer studies, and other approaches that might
effectively convey to consumers the strength of supporting
study how to use it with some expert guidance.
health claims.
UNILEVER SPENDS ON HOODIA
Phytopharm plc of Cambridgeshire, U.K. announced
April 10 that it has successfully completed the first stage
of the Joint Development Agreement for Hoodia gordonii
extract with Unilever and will now progress to the second
stage which includes clinical safety studies.
In its January 20, 2006 comment, the FTC staff focused
on facilitating additional useful consumer research in this
area. Specifically, the comment states that the staff’s
review of the research presented at the November 17
meeting suggests the following findings: 1) the current FDA
language for qualified and unqualified claims does not
communicate the four intended levels (A through D) of
scientific certainty to consumers; 2) consumers do not
perceive the current FDA unqualified significant scientific
agreement (SSA) claim to convey strong scientific
certainty; 3) the results of the FTC’s copy tests indicate
that it is possible to craft language that differentiates
clearly among differing levels of scientific certainty; 4) a
“report card” format performed consistently well in the
ranking tests; and 5) consumer interpretation of qualifying
language tends to vary widely. The comment also
discusses certain implications that the findings noted above
may have on future qualified health claims research.
Under the terms of the agreement, Phytopharm and
Unilever are collaborating on a five-stage research and
development program of safety and efficacy studies with
a view to bringing new weight management products to
market. As part of the agreement announced in December
2004, Unilever committed to initial payments of
approximately £6.5 million for the first stage and for the
second stage have now committed to a further £3.5
million out of a potential total of £21 million in payments
to Phytopharm. In addition, Phytopharm will receive an
undisclosed royalty on sales of all products containing
The Commission vote authorizing the staff to file the
the extract. Unilever is also managing a separate comments, which can be found on the FTC’s Web site
agronomy program and supporting the international patent
www.ftc.gov, was 5-0. (FTC File No. V060005; the
program for the products.
staff contacts are Dennis Murphy and Pauline Ippolito,
See FTC STAFF ADVISES FDA -- Continued on page 21...
May 2006
FTC STAFF ADVISES FDA -- Continued from page 20...
Page 21
CHINA SELLS STEVIA
Bureau of Economics, 202-326-3524 or 202-326- Worldwide demand for healthy sweeteners is rising, and
3477; see related press release dated January 29, 2004.) Sunwin International Neutraceuticals, Inc. of Qufu,
Shandong, China estimates that the demand for stevioside
Copies of the documents mentioned in this release are in recent years is increasing at a rate of 15% to 20%
available from the FTC’s Web site at www.ftc.gov and every year. The company’s aim is to get stevioside into
also from the FTC’s Consumer Response Center, Room grocery stores and making it known to the general public.
130, 600 Pennsylvania Avenue, N.W., Washington, DC
20580. Call toll-free: 1-877-FTC-HELP.
According to the China Stevioside Sugar Association
[Readers should watch for changes in FDA’s focus on
qualified and unqualified health claims for dietary
supplements. FTC has been working on claims longer
than FDA staff who may find FTC comments helpful, –
Ed.]
TRANSITION -- Contiuned from page 13...
(CSSA), in 2002, worldwide demand for stevioside
exceeded 1,200 tons and China supplied more than 1,000
tons, accounting for 80% of worldwide consumption of
stevioside. Steadily increasing production, Sunwin
stevioside production reached 150 tons in the year prior
to April 24, 2004, which according to the CSSA,
accounted for approximately 8.3% of the global
production. Sunwin plans to manufacture and resell
approximately 300 tons of Stevia in the fiscal year of
2006.
processing applications for traditional herbal registrations?
A: Under article 17 of Directive 2001/83/EC, Member
States must take all appropriate measures to ensure that
the procedure for granting a marketing authorization is
completed within 210 days after the submission of a valid
application. This provision also applies to traditional
herbal registrations. In certain situations there is provision
for “clock stops” in
the timetable.
Sunwin is engaged in the areas of essential traditional
Chinese medicine, 100% organic herbal medicine,
neutraceutical products, natural sweetener, and animal
medicine prepared from 100% organic herbal ingredients.
As an industry leader in agricultural processing, Sunwin
has built an integrated global firm with the sourcing and
production capabilities to meet the needs of consumers
throughout the world. Sunwin makes and sells over 120
Chinese herbs.
Q: What is the position of transitionally protected
Stevoside is estimated to be approximately 200 to 300
products legally placed on the market as at 30th April times sweeter than general sucrose, but it has only 1/300
2011?
of the calories and it is often referred to as the third
generation of natural low calorie sweeteners. The Stevia
A: Regulation 4 of the Herbals Regulations applies not rebaudiana plant, which originally grew in Paraguay and
just to placing on the market, but also wholesale dealing. Brazil, was successfully introduced to China in 1970’s.
Therefore, a wholesale dealer cannot distribute a product China is presently the largest domestic producer of Stevia
after 30th April 2011 where that product does not have rebaudiana, and the primary producer and exporter of
a registration, even if it had been placed on the market stevioside worldwide.
by its manufacturer before 30th April in accordance with
the transitional provision.
Sunwin announced April 18, 2006, that its wholly
owned subsidiary, Sunwin Stevia International Corp., has
However, the product could be sold if, for example, a engaged Blue Chip Marketing and Communications to
product was placed on the market by sale direct to a assist the company in marketing its Stevia to North
retailer (i.e. not a wholesale dealer) on 29th April 2011, American consumers. Blue Chip, based in Northbrook,
that retailer could sell the product after 30th April 2011 Illinois, and established in 1982, is a full-service marketing
even if a registration had not been granted. Guidance agency which represents several Fortune 500 U.S. and
issued May 2006 at www.mhra.gov.uk
global brands.
See STEVIA -- Continued on page 22...
Copyright 2006 by Muscatatuck Publishers, Inc. For Information on photocopying, see Inside Cover
Natural Medicine LawTM
Page 22
STEVIA -- Continued from page 21...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
The company claims that since the
passage of the Dietary Supplement
Health and Education Act of 1994,
Stevia can be sold legally in the United
States as a dietary supplement. Even
so, it can be found in many forms in
most health-food stores, and is also
incorporated into drinks, teas and
other items all labeled as dietary
supplements. Currently the FDA
requires Stevia to be labeled as a
dietary supplement for sale in the
U.S., the company information
stated.
Mr. Stanton Kawer, Chairman
and CEO of Blue Chip stated “As
America is faced with finding
solutions to our alarming growth rates
of obesity and diabetes, Sunwin
Stevia is positioned perfectly as the
best choice for today’s consumers.
Additionally, research indicates that
the traditional grocery has recognized
over $25 billion in health and natural
purchases are going to outside
channels. Sunwin is committed to
educating those consumers that
Stevia can be purchased at their
neighborhood grocery, making it
easier to incorporate healthy products
as part of their regular shopping
regiment.”
Mr. Laiwang Zhang, Chairman and
President of Sunwin International
commented “Blue Chip represents
many major U.S. brands. With
assistance from Blue Chip, we believe
Sunwin is well suited to accomplish
its goal of becoming the number one
seller of Stevia in the U.S. Sunwin
believes Blue Chips unique blend of
expertise in the food and
pharmaceutical industries is a prefect
fit for our company. Blue Chip has a
long and successful history of
providing similar services with some
of the largest companies in the United
States.”
May 2006
Natural Medicine LawTM
Mr. Zhang concluded, “Our
ambitious goal is to establish our
Stevia brand as the preeminent
alternative sweetener in the North
American sweetener market. Entering
the United States consumer market
will be a significant challenge for our
organization. Upon a review of the
many accomplishments of Blue Chip,
we believe we have assembled the
right group to assist our company in
working towards this goal.”
On April 26, Sunwin announced
that the company’s Stevia production
at their newly constructed facility has
reached 22 to 25 tons per month or
260 to 300 tons per year following a
major renovation effort commenced
in 2005. In the first three months of
2006, the company has received
purchase orders in excess of 125 tons
of Stevia, a 100% increase
compared to same period in 2005,
or 80% of Sunwin’s Stevia
production for the entire 2005 fiscal
year. Mr. Zhang concluded, “Our
goal is to increase Stevia production
to 800 to 1,000 tons per year by the
end of 2007. Furthermore we plan
to move forward with our marketing
campaign to access the U.S.
consumer market. Lastly we will
continue our M&A strategy as we are
presently reviewing several Stevia
production facilities for acquisition.”
Sunwin’s Stevia division alone
could achieve approximately $12 to
$15 million in annual sales in the
coming fiscal year, prior to any
potential acquisitions, and the
potential Stevia sales in North
America.
Japan, known worldwide as
having healthy dietary habits with a
population of over 127 million people,
utilizes Stevia for 30% to 40% of their
entire sweetener consumption
including sugar. Stevia is used as a
Photo courtesy of Lloyd Library & Museum
sweetener by some of the largest
North American food and beverage
manufacturers in their Japanese
production facilities. The population
of countries that currently use Stevia
as a sweetener exceeds two billion
worldwide.
This article was prepared from
press materials available at
www.sunwin.biz.
[Readers are invited to watch for a
number of legal problems to arise
with increased use of stevia. For
example, an FDA Import Alert, #4506 was revised on October 27, 2005
whose subject is “Automatic
Detention of Stevia Leaves, Extract
of Stevia Leaves, and Food
Containing Stevia.” This Import
Alert states that: “unless explicitly
labeled as a dietary supplement, or
for use solely as a dietary ingredient
in the manufacture of a dietary
supplement” Districts may detain
without examination all products
identified on the attachment to this
See STEVIA-- Continued on page 23...
Natural Medicine LawTM
qualified advice.”
The NIMH, one of the world’s
oldest professional bodies
representing qualified herbalists.
Established in 1864, NIMH is the
UK’s leading authority on herbal
health matters. To find out more about
Herbal Medicine Awareness Week,
please contact the NIMH head office
at Elm House, 54 Mary Arches
Street, Exeter, EX4 3BA or email
[email protected].
The Institute’s web site can be found
at www.nimh.org.uk.
-- Ed.
According to the website of GBW
the Members of the program must pay
a fee to use the Seal® and must sign
an agreement that they will use only
CHINA NOW SELLS
Wisconsin Ginseng products on
WISCONSIN GINSENG
packages labeled with the Seal.® The
Once a nice cash crop in Wiscon- GBW reserves the right to test the
product to assure program complisin, the ginseng business has
ance and periodically randomly seplummetted according to Jane
lects products to be tested. These
Zhang’s article March 8, 2006 Wall
tests determine the purity of the prodStreet Journal.
uct and assure that it is true Wisconsin Ginseng.
Wisconsin ginseng was known to
be superior, especially in Marathon
It also claims “Wisconsin Ginseng
County, known as the ginseng capiis grown to exacting standards estabtal of the world. In the early 1990s
lished by the U.S. Food and Drug
there were 1,600 growers, now there
Administration.”
are only 200.
STEVIA -- Continued from page 22...
alert.
There was a detention of stevia
extract on February 6, 2006 as
indicated in the data below.
Nan Hua Jia , CN 226014
LOS-DO WRE-0338150-6/26/1
45TF-99 STEVIA EXTRACT
(FOOD ADDITIVE SWEETNER)
06-FEB-2006
UNSAFE ADDITIVE
Stevia is on the NNFA list of
botanicals used before passage of
DSHEA. See www.fda.gov/ohrms/
dockets/dockets/05p0305/05p0305-cr00001-03-NNFA-Listvol1.pdf.
There is no New Dietary Ingredient
notice filed for stevia in Docket No.
95S-0316, but there is one that cited
some stevia research. See RPT 57
on Lo Han Kuo. FDA’s import
detention memo mentions to Districts
that some research is going on to
support a future food additive
petition. A number of products
containing stevia are included in
Docket No. 97S-0162 that
represents the FDA file for
“approved” structure/function claims.
Page 23
Canada purchased Wisconsin
seeds in the early 1990s and then sold
surplus seeds to China. By 1994 the
price of ginseng dropped to 50% of
previous prices.
Some growers must have known
they had a problem as they established the Ginseng Board of Wisconsin in 1986. The GBW is the administrator for the Wisconsin Ginseng
Seal® Program. This program was
developed in 1991 to protect the integrity of Wisconsin Ginseng products.
The Wisconsin Ginseng Seal®
program provides consumers with a
simple, convenient method of identifying authentic Wisconsin Ginseng at
the point of purchase. Packaged
products bearing the official Wisconsin Ginseng Seal® must contain 100
percent pure Wisconsin Ginseng,
grown and harvested in Wisconsin.
Interestingly, the GBW has producer members in Illinois, New York
and California, as well as Wisconsin.
The Ginseng Board is located at:
555 N. 72nd Ave Ste 2,
Wausau,
WI
54401
Phone:
715-845-7300
Fax:
715-845-7300
[email protected]
NATURAL -- Continued from page 17...
has deemed only food or food
ingredients who processing has not
significantly altered the original
physical, chemical or biological state
can be described as “natural.”
Processes such as hydrolysis or
enzymolysis where the raw material
is fundamentally altered to the extent
that these processes manipulate the
molecules of one substance to create
another would preclude the “natural”
claim. Other altering processes
would include: hydrogenation of oils,
starch-based break down processes
using things like maltodextrin and
modified food starch, and flour treated
with agents such as potassium
bromate or chlorine dioxide to boost
ingredient performance.
See NATURAL -- Continued on page 24...
Copyright, 2006 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Inside Cover
AWARENESS-- Cont’d from p. 1...
May 2006
NATURAL -- Continued from page 23...
The USDA lists many other at Docket No., 2006P-0094, docket
processes considered rather severe entered on March 21, 2006, and
processes, but allows case by case Web page created on May 3, 2006.
exceptions for the use of the term
The Center for Science in the
“natural.”
Public Interested filed a letter dated
The mere existence in nature should March 13, 2006 in support of the
not be a factor for a qualifying “natural” petition. CSPI stated it had
“natural” claim. The Petition is filed spoken to three companies that make
deceptive claims and while one has
said it will make changes, others have
refused. CSPI said it was preparing
a lawsuit to address the misuse of
“Natural.” This letter was signed by
Stephen Gardner, Director of
Litigation for CSPI.
ingredients and no directions for use
going to buy such products, if FDA
lets them through the regulatory
maze.
FDA. This particular complaint that
FDA is wrong about turning down
your NDI for inadequate information,
caused FDA to open up a Citizens
Petition docket and put resolution of
the issue on a new regulatory tract
that will be busy for a few more
years.
HARVESTING HEALTH
A recent phenomenon in new dietary
ingredient notifications is the attempt
by filers to protect as confidential
information the ingredient amounts,
conditions of use, methods of
manufacturer, and other information.
Considering that these products have
to be labeled for the consumer, the
rationale for attempting to not disclose
the ingredient amounts and conditions
of use are baffling. The method of
manufacture may be worth protecting
from competitors combing the FDA
files for product ideas, but the product
will have to disclose ingredient
amounts and conditions of use or
servings on the label. Consumers
would be foolish to buy any product
whose ingredient contents and serving
size are not on the label. FDA is
unlikely allow this.
So what are these submitters
thinking or trying to prove by asking
for confidentiality? And why is FDA
granting it preliminarily? Won’t the
makers have to spend a lot of money
to market a product with confidential
Back when some of companies
were complaining about FDA’s turn
down rate for new dietary ingredient
notices, they were saying it is not nice
to be told your product is
“adulterated,” but on the whole not
all of them have learned from the
November 2004 open meeting on new
dietary supplements. Or, could it be
the industry and FDA have not made
it clear yet what is expected?
One notifier told FDA last year that
the agency had not yet promulgated
regulations on what kind of
information the agency wants. That
is true. And, this notifier said, as a
result, FDA was stuck with enforcing
the law without regulations, meaning
that FDA had to accept what was
given to FDA in the notices, and this
“giving” shifted the burden to FDA to
prove the product was not safe. That
is an arguable outline for a motion in
court, but it is not working before the
Until a court or Congress looks at
these kinds of problems, FDA has the
upper hand. So, learn from the
mistakes of others. Read Natural
Medicine Law Newsletter and try to
understand how to work with the
agency. NML is proud to say,
paraphrasing former Chrysler
president Lee
Iacoca’s
advertisement
on cars, “If
you find a
b e t t e r
information
source, buy
it.”
William J. Skinner, R.Ph.,
Attorney at Law, Editor