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Vol. 13 No. 6
May 2010
Natural Medicine LawTM
VITAMIN A & E CASE
UNDER CONSIDERATION
Newsletter
CFSAN DIRECTOR
SUDDENLY LEAVES FDA
EFSA ISSUES NEW
BRIEFING DOCUMENT
As of April 8, 2010, the Alliance Public relations staff at FDA had Concerning
for Natural Health US, et al and
the U.S. Government have filed
their motions and cross motions for
the court’s consideration. After the
Plaintiffs’ Motion for Summary
Judgment was filed on December
30, 2009, the Government’s Cross
Motion and Opposition was filed
February 22, 2010 in duplicate.
The next day the Government filed
an Amended Brief because of
typographical errors, counsel
stated, that came to defendants’
attention after filing the original.
Plaintiffs did not oppose the
amendments. On April 8, 2010, the
Plaintiffs’ filed their Memorandum
in Reply and Opposition.
No hearing was scheduled or
requested on the motions at the
time of this update in the first week
of May. NML will follow and
report what the Court decides at a
later update. Here are a few
comments from the last pleadings
in the file.
to refer NML to three people to find
someone who could speak about
the resignation of Steven Sundlof,
DVM, PhD. All they knew at this
time was that Commissioner
Margaret Hamburg and Deputy
Commissioner for Foods, Michael
Taylor,
issued an
“ o p e n
letter,”
describing
the circumstances, but
that letter
was not easily found on
Stephen Sundlof
FDA’s or
HHS’s main media websites.
Sundlof was said, in the “open
letter,” to be taking a two-year
assignment with a collaborative
effort between the VirginiaMaryland Regional College of
Veterinary Medicine, the
University of Minnesota, and the
Ohio State University to develop
and establish a regulatory science
program. This is a masters level
program. Sundlof came to head
CFSAN in January of 2008 after
being director of the Center for
Veterinary Medicine for several
years. He spent 16 years with
FDA.
the evaluation of
Article 13.1, 13.5 and 14 health
claims on request from EFSA,
Question No EFSA-Q-2010-00822
and EFSA-Q-2010-00821, issued
for public consultation on 10 May
2010. A copy may be downloaded
from www.efsa.europa.eu/en/
ndameetings/docs/nda100601Copyrignrt
ax01.pdf.
The new 18-page briefing
document reviews previous
clarifications for stakeholders in
the form of meetings and
frequently asked questions
documents in anticipation of
another stakeholder meeting to be
held on June 1. Following that
meeting this document will be
revised.
The briefing document is a list
of 11 questions with a response
formulated by the NDA Panel
members. These questions are:
See EFSA BRIEFING -- Continued on p. 23...
Plaintiffs say that Defendants
In This Issue:
want the District Court to reverse
Vitamin A & E Case Under Consideration.................1
CFSAN Director Suddenly Leaves FDA....................1
the Circuit Court decision in
EFSA Issues New Briefing Document.......................1
Selenium Case Reaches Surreply.............................2
Pearson I which “is beyond the
New Dietary Ingredients.............................................3
limits of law in our precedentSection 403 Letters....................................................4
Canada Warns About Products.................................5
based system of jurisprudence.”
New Zealand Amends Regulations...........................5
Recent Research.......................................................5
Plaintiffs say the Defendants
Alliance GMP Case Readies for Review.................10
Consumer Claims Fraud Over Walnut Claims........10
arguments are that Plaintiffs’
Current Status of Walnut Health Claims..................12
science lacks credibility, “thus
Selenium NDI Not Posted by FDA..........................13
Lloyd Library Photo Credits.....................................15
Michael
Taylor
was
reemployed
deeming it not evidence, and in an
Trademarks for Atropha belladonna........................22
ultimate twist of logic, non- by FDA in the summer of 2009 to Interesting Meetings & Programs............................24
Health from the Editor...........................24
implement the food safety laws that Harvesting
Special Supplement....................................Centerfold
See VITA MIN A & D -- Cont’d on p. 13..
See FDA -- Cont’d on p. 21...
NIH Alzheimers Consensus Conference
ECJ Rules on Upper Limits of Nutrients
Page 2
SELENIUM CASE REACHES
SURREPLY TO
DEFENDANTS’ REPLY
Closing out the arguments before
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the Court, unless some new issue
is belatedly discovered by one of
the parties, the Plaintiffs have filed
their Surreply, that says, in part,
“Defendants characterize
Plaintiffs’ argument as a
please for special treatment.
It is not, but the point reveals
irony. While Plaintiffs ask
the Court to apply the
controlling
precedent
established in Pearson I and
Whitaker I wherein each
Court applied Cetnral
Hudson (see Pearson I, 164
F.3rd at 659-660; Whitaker I ,
248 F. Supp. 2d at 10, the
Defendants ask the Court to
exempt them from the
strictures of those cases,
reverse the decisions, and
give
the
agency
unprecedented
new
discretion to censor. Who
seeks ‘special treatment?’”
Plaintiffs’ Surreply, p. 6
Continuing, the Plaintiffs state
that “Defendants admit for the first
time in reply that they want this
Court to overrule its previous
decision in Whitaker. Def. Reply at
7). They present the extraordinary
argument on conjecture that
Whitaker I conflicts with Pearson
I. … The argument is volte face,
coming eight years after FDA
stated its unreserved acceptance of
Whitaker I as governing law (never
uttering a peep that it was at odds
with Pearson I) (Def. MSJ at 1415.)”
May 2010
Plaintiffs restate that they have
presented credible scientific
evidence to support each of their
claims, but FDA eschews the
studies on one presumed technical
defect or another instead of
recognizing them as supportive.
Plaintiffs would accept any
reasonable disclaimer in order to
educate the public of the possible
benefits of selenium supplementation.
Also Plaintiffs state that “the
state of the evidence supporting the
selenium/cancer site risk reduction
relationships is indistinguishable
from the science that existed for
every claim at issue in Pearson I.
Pearson I and Whitaker I have
ordered the FDA to end its legacy
of suppression and open the
channels of commerce to
information indispensable to
informed consumer choice….”
Plaintiffs’ claims must be
allowed, they argue, “unless FDA
proves with empirical evidence
that the disclaimers are incapable
of correcting for misleadingness,”
citing the above cited cases. This
will be the last word until the Court
issues a ruling.
The case is Alliance for Natural
Health US, et al v. Sebelius, et al,
Case No. 1:09-cv-01470, U.S
District Court for the District of
Columbia, Ellen S. Huvelle,
presiding.
www.natmedlaw.com
is where you can
research cases
Natural Medicine LawTM
Natural Medicine LawTM
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NEW DIETARY
INGREDIENTS
T he
following New Dietary
Ingredients summaries have not
appeared in NML in the past, so
these will be new information that
allows you to understand how FDA
treated these 75-day notices during
the first few years of DSHEA.
Keep in mind that the DSHEA
language requires FDA to post
these to the public files. FDA is
not doing that regularly, thus
flaunting the law. And besides
flaunting the specific directions of
the law, FDA is entering the data
in a haphazard manner with a very
jumbled order in the two-year old
dockets on www.regulations.gov.
U S Botanicals of Mesa,
Arizona, wrote FDA on October
14, 1997, to give notice that it
would be marketing Sadenosylmethionine (SAM) as a
new dietary ingredient in a daily
dose of 1200 mg. Certain journal
articles were included with relevant
information being circled or
underlined according to the cover
letter. Unfortunately, none of the
submission documents were made
part of the public file. FDA’s James
Tanner, Ph.D., acting director of the
Division of Programs and
Enforcement Policy, Office of
Special Nutritionals, CFSAN,
responded to Dave Brown on
November 14, 1997 with a letter
stating that the information will be
kept confidential until January 20,
1998 and then be placed on display
at the Dockets Management
Branch. Posted on September 28,
2008 on www.regulations.gov
Docket No. FDA-1995-S-00390038. The original FDA Docket
was No. 95S-0163, RPT 19.
May 2010
Malabar Productos Naturales
of Guadalupe, Mexico, wrote to
FDA on January 23, 1998 to give
notice that it would sell five dietary
supplement products – Jointaid,
Pancrease, Gastritease, Menstrualaid, and Laxatease. These
products will contain five new
dietary ingredients — Tecoa
mollis, H.B.K. or T. stans Juss.,
Mexican name Tronadora;
Montanoa tormentosa Cerv.
Mexican name Zoapatle; Tagetes
lucida Cav. or Tagetes florida, SW,
Mexican name Pericon; Loeseloa
Mexicana (Lam.) Brand, Mexican
name Espinosilla; and Cecropia
obstusifolia Bert., Mexican name
Guarumbo. There were 24 articles
mentioned in the letter with at least
four for each new dietary
ingredient supporting their
historical and safety of use. There
were English translations for all of
the articles. Most of the articles
were not part of the public file.
FDA’s James Tanner, Ph.D., acting
director of the Division of
Programs and Enforcement Policy,
Office of Special Nutritionals,
CFSAN, responded on April 10,
1998 to Natalia Garza, export
manager, in a letter that stated that
FDA had carefully considered the
information in the submission and
has significant concerns about the
evidence on which the company
relies to supports its conclusion
that the five new dietary
ingredients will reasonably be
expected to be safe. FDA stated
that there was not an adequate basis
to conclude that Tonadora, Pericon,
Espinosilla and Chancarro, when
used for the conditions suggested,
will reasonably be expected to be
safe. Introduction of such products
into interstate commerce is
prohibited.
Based on the
submission, FDA disagrees that
Page 3
Zoapatle will reasonably be safe.
The information submitted states
that this botanical contains several
terpene compounds that have an
adverse affect on fertility, and other
interferences in pregnancy
including adverse effects
associated with consumption of the
plant, including abortion and death.
Therefore introduction of this
product into interstate commerce
is prohibited. Posted on September
28, 2008 on www.regulations.gov
Docket No. FDA-1995-S-00390039. The original FDA Docket
was No. 95S-0163, RPT 20.
Humanetics Corporation of St.
Louis Park, Minnesota, wrote to
FDA on October 21, 1997 to send
a NDI for the ingredient alpha-D() Ribofuranose (Ribose), a
naturally occurring sugar in all
foods. Enclosed were a safety
profile summary, ten preclinical
pharmacology and toxicology
reference reprints on ribose, 15
clinical trial reference reprints on
ribose, and two general clinical
review reprints on ribose. The
documents indicated that studies in
humans demonstrate the only
safety issue is related to decreased
blood sugar. Therefore, the notice
proposed that use of up to 5 grams
or less than 0.1 gram/kg would be
well tolerated and elicit no chronic
adverse health effects. There were
27 references listed in the notice.
FDA’s James Tanner, Ph.D., acting
director of the Division of
Programs and Enforcement Policy,
Office of Special Nutritionals,
CFSAN, responded to Ronald J.
Zenk on November 17, 1997 with
a letter stating that the information
will be kept confidential until
January 20, 1998 and then be
www.NatMedLaw.com
for
Natural Medicine TiesTM
See NEW INGREDIENTS -- Cont’d on p. 14...
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
Natural Medicine LawTM
Page 4
SECTION 403 LETTERS
NML continues reporting on FDA
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
courtesy letters or letters of
objection concerning structure/
function claims made on dietary
supplement under Section
403(r)(6) of the Dietary
Supplement Health and Education
Act (DSHEA) of 1994. Remember
that you can search for data on the
newsletter website on the Volume
Index and Search Page. Use
ingredient, product name, or
manufacturer claims to find out
what FDA has said about these
forbidden claims.
The www.regulations.gov files
that contain a second “LET xx”
designation within Docket FDA1997-S-0039 appear to be files that
were originally filed in FDA
Docket No. 97S-0162. These were
notices that FDA did not have any
question about. NML mentions this
in case you are searching
www.regulations.gov using only
the “LET xx” designation. Be sure
to read the name of the company
to match the letters.
ERRATA – Please note that in the
previous issue (March 2010) the
www.regulations.gov Docket is
FDA-1997-S-0006-xxxx and not
FDA-1996-S-0006-xxxx. A
corrected copy of the Section 403
Letters for March 2010 can be
obtained on www.natmedlaw.com
either as a separate article or as part
of the March 2010 newsletter.
Here are more summaries of files
containing courtesy letters or
letters of objection.
George Eby Research of
Austin, Texas, sent a notice to FDA
by Fax on February 6, 1996
May 2010
concerning its product Fast Dry™
Zinc Lozenges stating that it would
use the claim: “Fast Dry™ Zinc
Lozenges release zinc ions. In vitro
zinc ions are antirhinoviral agents.
T-Cell lymphocyte nutrients,
interferon inducers, and antiinflammatory and drying aides.”
The letter asks John Gordon, Ph.D.
at the Office of Special
Nutritionals, CFSAN, if this claim
meets the criteria of DSHEA.
Gordon also included his book,
Handbook for Curing the Common
Cold – The Zinc Lozenge Story, and
two articles from 1995 concerning
the use of zinc. The book and
articles are not in the public file.
The Gordon letter states that he is
seeking a major pharmaceutical
manufacturer to license his patent
no. 5,409,905 and that this
company would be filing a New
Drug Application for the product.
The Gordon states: “Since the
product contains no drugs and can
be considered a dietary supplement
with drug properties of
considerable importance, I want to
make the product available to the
public now, while we wait for an
NDA.” FDA’s John Gordon, Ph.D.
responded by letter of March 6,
1996 stating that the proposed
claim indicates the product is to
treat or prevent a specific disease
or class of diseases. The labeling
suggests that the product is for
other than food use and references
state that the lozenges may be used
to treat common colds. This means
the product is intended for drug use
and you should contact FDA’s
Center for Drug Evaluation and
Research. The notice letter and
FDA response was received in
FDA’s Dockets Office on August
12, 1997 and was placed in Docket
No. 97S-0163, LET 44 and in
www.regulations.gov Docket No.
Natural Medicine LawTM
Digitalis
Photo Courtesy of Lloyd Library and Museum
FDA-1997-S-0006-334 posted
September 8, 2008. There is also
another LET 44 in FDA-1997-S0006-0163 posted October 14,
2008.
Optimum Lifestyle, Inc. of
Sausalito, California, wrote FDA
on March 14, 1997 to give notice
that it would use the claim:
“Antioxidant
Advantage™
combines a powerful array of
vitamins, minerals, proanthocyanidins, and herbal extracts that
have the ability to help protect our
bodies against destructive
molecules called free radicals.
Many scientists believe that free
radicals play a significant role in
the development of many diseases
and have a profound negative
effect on the aging process.” The
product name is Lite Bites
Antioxidant Ad-vantage™. FDA’s
James Tanner, Ph.D. acting
director of the Division of
Programs and Enforcement Policy,
Office of Special Nutritionals,
See SECTION 403 -- Continued on page 17...
Natural Medicine LawTM
May 2010
Page 5
Natural Medicine Law Around the W
orld
World
NEW ZEALAND AMENDS
REGULATIONS
Three times in March, Health On March 31, 2010 the Dietary
Canada warned Canadians about
dangerously adulterated products.
On March 8, the product was
POWER-MAX imported by Cha
Health Food. The product contains
sildenafil,
a
prescription
medication used to treat erectile
dysfunction but should not be used
by individuals taking any kind of
nitrate drug (e.g. nitroglycerine) as
it can cause potentially lifethreatening low blood pressure.
Individuals with heart problems are
at increased risk of cardiovascular
side-effects such as heart attack,
stroke, chest pain, high blood
pressure and abnormal heart beat.
Other side-effects include
headache, facial flushing,
indigestion, dizziness, abnormal
vision, and hearing loss. This
product was found in Ontario. Its
label says it contains Epimedium
macranthum, Polygonum multifonum, Ligatum lucidum,
Curcuglio orchiodies, and Panax
ginseng. The prescription drug was
See CANADA WARNS -- Cont’s on page 11...
Big Ben and Parliament in London
Supplement Regulations were
amended
by
Regulations
2010(SR1010/5) to introduce a
number of changes. The new
regulations provide:
RECENT RESEARCH
Swedish doctors find that use of
multivitamins by women
increases risk of breast cancer.
What went wrong, NML asks?
They prospectively examined the
association between multivitamin
use and the incidence of invasive
1) A new definition of dietary breast cancer in the Swedish
supplement. This change Mammography Cohort. In 1997,
has the effect of narrowing 35,329 cancer-free women
the scope of the DSR so completed a self-administered
they now cover only questionnaire that solicited
therapeutic-type products. information on multivitamin use as
The food-type supplements well as other breast cancer risk
previously also regulated factors. Relative risks (RRs) and
under the DSR are now 95% CIs were calculated by using
regulated as Supplemented Cox proportional hazard models
Foods under a new and adjusted for breast cancer risk
standard (the New Zealand factors.
Food (Supplemented
Over a mean period of 9.5 years,
Food) Standard 2010
974
of these women were
issued under the Food Act
1981 and administered by diagnosed with breast cancer. The
the New Zealand Food researchers found that the
Safety Authority (NZFSA). multivariable RR of women who
reported the use of multivitamins
2) A permission for a was 1.19 (95% CI: 1.04, 1.37). The
supplement to contain association did not differ
more than a maximum significantly by hormone receptor
daily dose of 300mcg of status of the breast tumor.
folic acid (but not more
NML contacted Susanna C
than a maximum daily dose
of 500mcg) if the Director- Larsson at the Karolinska
General of Health has Institutet, in Stockholm, to ask
confirmed that the what the ingredients of the
supplement has been multivitamins may have included.
prepared in a way that Dr. Larsson responded that
accords with the New multivitamins in Sweden contain
Zealand Code of Good vitamins and minerals. She quoted
Manufacturing Practice for the text of the article which states:
Manufacture and Distri- “Because participants were not
bution of Therapeutic asked about multivitamin brand
Goods (New Zealand Code names, information on nutrient
composition of multivitamins was
of GMP).
See NEW ZEALAND -- Cont’d on p. 8...
See RECENT RESEARCH -- Cont’d on p. 6...
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
CANADA WARNS ABOUT
PRODUCTS
Page 6
RECENT RESEARCH -- Cont’d from p. 5...
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
not available. However, the
number of multivitamin brands on
the Swedish market is limited.
Multivitamins in Sweden generally
contain doses of vitamins and
minerals
close
to
the
recommended daily allowances of
vitamin A (0.9mg), vitamin C (60
mg), vitamin D (5 μg), vitamin E
(9 mg), thiamine (1.2 mg),
riboflavin (1.4 mg), vitamin B-6
(2.1 mg), vitamin B-12 (3μg), and
folic acid (300-400 μg). The
minerals usually included are iron
(10 mg), zinc (12 mg), copper (2
mg), chromium (50 μg), selenium
(40μg), and iodine (150 μg).”
May 2010
diabetes and a clinical diagnosis of
nephropathy who took daily a
single tablet of B vitamins
containing folic acid (2.5 mg/d),
vitamin B6 (25 mg/d), and vitamin
B12 (1 mg/d), or matching placebo
during the study. While the study
took place from May 2001 to July
2007, the report did not say how
long the B vitamins were taken.
Since the patients were recruited
from five medical centers, the
outcome was measured by the
change in radionuclide glomerular
filtration rate (GFR) between
baseline and 36 months. Secondary
outcomes were dialysis and a
composite
of
myocardial
infarction,
stroke,
revascularThe researchers were Susanna C
Larsson, Agneta Åkesson, Leif ization, and all-cause mortality.
Bergkvist and Alicja Wolk from Plasma total homocysteine was also
the Division of Nutritional measured.
Epidemiology, The National
The study concluded that among
Institute of Environmental
Medicine, Karolinska Institutet, patients with diabetic nephropathy,
Stockholm, Sweden (SCL, AÅ, high doses of B vitamins compared
and AW), and the Department of with placebo resulted in a greater
Surgery and Centre for Clinical decrease in GFR and an increase
Research, Central Hospital, in vascular events.
Västerås, Sweden (LB). The
This was a randomized
research was supported by research controlled study conducted by
grants from the Swedish Cancer Andrew A. House, MD; Misha
Foundation and the Swedish Eliasziw, PhD; Daniel C. Cattran,
Research
Council
for MD; David N. Churchill, MD;
Infrastructure. More information Matthew J. Oliver, MD; Adrian
can be obtained from SC Larsson, Fine, MD; George K. Dresser, MD;
Division
of
Nutritional J. David Spence, MD. Their
Epidemiology, National Institute affiliations were: Division of
of Environmental Medicine, Nephrology (Dr House), Division
Karolinska Institutet, Box 210, SE- of Clinical Pharmacology (Drs
17177 Stockholm, Sweden. E- Dresser and Spence), and Robarts
mail: [email protected]
Research Institute (Dr Spence),
Natural Medicine LawTM
Division
of
Nephrology,
University of Toronto, Toronto,
Ontario (Drs Cattran and Oliver);
Division of Nephrology, McMaster
University, Hamilton, Ontario (Dr
Churchill); and Division of
Nephrology, University of
Manitoba, Winnipeg, Manitoba
(Dr Fine), Canada.
The article above is published in
JAMA. 2010;303(16):1603-1609.
Researchers compared the
efficacy and safety of pyronaridineartesunate with that of artemetherlumefantrine for treatment of
uncomplicated Plasmodium
falciparum malaria. Intervention
tablets contained 180 mg
pyronaridine and 60 mg artesunate;
control tablets contained 20 mg
artemether and 120 mg
lumefantrine. Both treatments
were given according to
bodyweight. The primary efficacy
outcome was PCR-corrected
adequate
clinical
and
parasitological response (ACPR)
rate at day 28 in the per-protocol
population. Non-inferiority was
shown if the lower limit of the twosided 95% CI for the difference
between groups was greater than
-5%.
When finished the
interpretation of the study resulted
in the conclusions that the efficacy
of pyronaridine-artesunate was
non-inferior to that of artemetherlumefantrine for treatment of
uncomplicated falciparum malaria.
Pyronaridine-artesunate should be
considered for inclusion in malaria
treatment programs.
University of Western Ontario,
The above article will be London, Ontario; Department of
These medications are derived
published in Am J Clin Nutr 91: Community Health Sciences, from relatives of Artemesia annua,
1268-1272, 2010 (May 2010)
Clinical Neurosciences, and a common weed in many places,
Canadian researchers monitored Oncology, University of Calgary, that was discovered to contain
238 patients with type 1 or 2 Calgary, Alberta (Dr Eliasziw); See RECENT RESEARCH -- Cont’d on p. 7...
RECENT RESEARCH -- Continued from p.6...
compounds effective against
malaria. See Natural Medicine
Law™ Newsletter issue of March
2006.
The 3:1 ratio product is being
investigated for the treatment of P.
falciparum and P. vivax malaria to
see if it is non-inferior to
artemether/lumefantrine
combination that is considered a
“gold standard.” The researchers
concluded that the “study shows
that the efficacy of pyronaridineartesunate is non-inferior to that of
artemether-lumefantrine for
treatment of uncomplicated P
falciparum malaria in children and
adults, measured by PCR-corrected
ACPR rate at day 28. Both
treatments were highly
efficacious with cure rates of
more than 99% and no early
clinical failures. Our results accord
with the high activity reported for
pyronaridine-artesunate against
African P falciparum isolates and
100% cure rates shown in the
previous clinical study of
pyronaridine-artesunate. The
efficacy
of
artemetherlumefantrine was consistent with
recent reports from other studies in
the African and southeast Asian
countries included in our trial.”
[footnotes omitted]
The researchers were Antoinette
K Tshefu MD a, Oumar Gaye MD
b, Kassoum Kayentao MD c,
Ricardo Thompson PhD d, Kirana
M Bhatt MMED e, Sanie SS Sesay
MD f, Dorina G Bustos MD g,
Emiliana Tjitra MD h, George
Bedu-Addo MD i, Dr Isabelle
Borghini-Fuhrer PhD j , Stephan
Duparc MD j, Chang Sik Shin PhD
k, Lawrence Fleckenstein PharmD
l, the Pyronaridine-artesunate
May 2010
Study Team‡ from the following
facilities: a Ecole de Santé
Publique, Faculté de Médecine,
Université de Kinshasa, Kinshasa,
Democratic Republic of the
Congo; b Service de Parasitologie,
Faculté de Médecine, Université
Cheikh Anta Diop, Dakar, Senegal;
c Malaria Research and Training
Centre, Faculté de Médecine de
Pharmacie
et
d’OdontoStomatologie, Bamako, Mali; d
Chokwé Health Research and
Training Centre, National Institute
of Health, Chokwé, Mozambique;
e UNITID College of Health
Sciences University of Nairobi,
Nairobi, Kenya; f Farafenni Field
Station, Medical Research Council
Laboratories, Fajara, The Gambia;
g Research Institute for Tropical
Medicine, Manila, Philippines; h
National Institute of Health
Research and Development,
Ministry of Health, Jakarta,
Indonesia; i Komfo Anokye
Teaching Hospital, Kumasi,
Ghana; j Medicines for Malaria
Venture, Geneva, Switzerland; k
Shin Poong Pharmaceutical, Seoul,
South Korea; l University of Iowa,
Iowa
City,
IA,
USA;
Correspondence to: Dr Isabelle
Borghini-Fuhrer, Medicines for
Malaria Venture, International
Center Cointrin, Route de Pré-Bois
20, PO Box 1826, CH-1215
Geneva 15, Switzerland
Page 7
supplements in patients when they
are diagnosed with APOE
genotype disclosure done by direct
to consumer (DTC) testing
companies.
Overall, 16% of all participants
reported a change in dietary
supplement use after AD risk
assessment. Participants who
learned that they had at least one
copy of the risk-increasing e4 allele
(e4+) had 4.75 times the odds of
reporting a change in dietary
supplement use than did their
counterparts who had an absence
of the risk-increasing e4 allele (e4–
) (95% CI: 2.23, 10.10; P < 0.0001)
after adjustment for age, sex, race,
baseline supplement use,
randomization
arm,
and
educational level. There were no
significant differences between
APOE e4+ and e4– participants in
changes in overall diet, exercise,
or medications.
In this sample of 272 unaffected
first-degree relatives of persons
with AD, and who received genetic
susceptibility testing for AD, an
APOE e4+ genotype status was
positively associated with dietary
supplement use after risk
disclosure. Use of dietary
supplements occurred despite the
absence of evidence that
supplement use reduces the risk of
AD. Given the expansion of DTC
The Lancet, Volume 375, Issue genetic tests, this study highlights
9724, Pages 1457 - 1467, 24 April the need for future studies in
2010. Elsevier Ltd, the publisher disease risk communication.
of The Lancet has made the above
article available without charge as
The study authors were
a public service. To obtain a copy Jacqueline A Vernarelli, J Scott
of the complete article, go to Roberts, Susan Hiraki, Clara A
www.thelancet.com.
Chen, L Adrienne Cupples and
Robert C Green from the
Alzheimers researchers check
See RECENT RESEARCH -- Cont’d on p.8...
what happens with dietary
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
Natural Medicine LawTM
Page 8
May 2010
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
in (free text) what supplements
they were taking and how often,
but were not required to put brand
names or dosage. Our interest in
this manuscript was the behavioral
outcome of supplement use. I hope
this helps.”
Theobroma cacao, L.
Photo Courtesy of Ministry of
Agriculture, Kerala State, India
RECENT RESEARCH -- Cont’d from page 7...
Departments of Neurology (JAV
SHRCG) Medicine (Genetics
Program)
(RCG)
Boston
University School of Medicine
Boston, MA; the Department of
Health Behavior Health Education
University of Michigan School of
Public Health (JCR) Ann Arbor,
MI; the Data Coordinating Center
(CAC)
Departments
of
Epidemiology
(LACRCG)
Biostatistics (LCA) Boston
University School of Public Health
Boston, MA.
Natural Medicine LawTM
to note, however, that this risk is
only relative. Most individuals
with ApoE e4 will never develop
AD and there are many AD patients
who are e4 negative”.
ApoE testing was not
recommended by this study for
Apolipoprotein (Apo) E testing relatives of persons with
is done to determine the amount of Alzheimers Disease (AD). So why
ApoE e4 that can be found. To are relatives of AD patients getting
explain this further, take a look at this test done? The National
the
website
at: Institutes of Health had a
w w w . l a b t e s t s o n l i n e . o r g / consensus conference in April on
understanding/analytes/apoe/ AD. See a brief report in the special
sample.html, where is states, “This supplement in this issue.
test looks at a person’s DNA to
determine what combination of
ApoE forms (genotype) is present.
The ApoE gene exists in three NEW ZEALAND -- Cont’d from page. 6...
different forms (alleles) – e2, e3,
3) A transfer of responsibility
and e4 – with e3 being the most
for administration of the
common allele, found in 60% of
DSR from the NZFSA to
the general population. Everyone
the Ministry of Health
inherits a pair of ApoE genes that
(Medsafe).
is some combination of these
three.”
The DSR and the Dietary
“ApoE e3/e3 is the most Supplements Amendment Regcommon genotype. ApoE e4 (e4/ ulations 2010 are available from
e4 and e4/e3) is found in 25% of www.legislation.govt.nz.
The above study is published in
Am J Clin Nutr 91: 1402-1407,
May 2010.
the population and is associated
with an increased risk of
atherosclerosis. People with these
genotypes could be predisposed to
an exaggerated elevation of LDLC (“bad cholesterol”) and
triglycerides when their diet is high
in saturated fat.”
[NML asked Dr. Green if he
could identify the dietary
supplements and amounts that
people started taking after testing.
Dr. Vernarelli replied, “The
supplement information was
gathered from survey data,
therefore we do not know any exact
formulations for the supplements.
Participants were allowed to write
“ApoE e4 has also been
associated with an increased risk
of late onset Alzheimer’s disease
(AD) – AD that develops after the
age of 65. This effect is additive in Dietary Supplements containing
that one copy of e4 (e2/e4 or e3/ more than 300mcg of Folic Acid
It is only lawful for a dietary
e4) carries some increased risk and
two copies of e4 (e4/e4) are supplement to contain more than a
associated with an even greater risk
See NEW ZEALAND -- Continued on p. 9...
of developing AD. It is important .
Guidance on whether a product
is a dietary supplement
The categorization of a product
is determined by its ingredients, its
purpose for use and the manner in
which it is presented in the market.
The Medsafe guideline Is my
product regulated under the
Medicines Act or the Food Act can
be used to determine whether a
product is a dietary supplement.
May 2010
New Zealand Regulatory
maximum daily dose of 300mcg
Guidelines for Medicines.
(but not more than a maximum AND
daily dose of 500mcg) if the
ii. Where
the
dietary
Director-General of Health has
supplement is presented as
confirmed that the dietary
a tablet or capsule, the
supplement has been prepared in a
finished
product
way that accords with the New
specification for the
Zealand Code of Good
dietary supplement must
Manufacturing Practice (GMP).
include a dissolution test
for folic acid that either:
Confirmation of compliance with
· meets the requirements of
GMP is not required for dietary
the USP monograph for
supplements containing up to a
folic acid tablets
maximum daily dose of 300mcg OR
folic acid. It is not permissible to
· meets the requirements for
supply a product containing more
products containing folic
than a maximum daily dose of
acid specified in TG078
500mcg folic acid as a dietary
http://www.tga.gov.au/
supplement.
legis/tgo/tgo78.htm
The completed application form
To obtain confirmation from the and supporting documentation
Director-General that a dietary should be sent to:
supplement has been prepared in a Manager, Compliance Manageway that accords with the New ment
Zealand Code of GMP, a Medsafe
prospective supplier must make an P O Box 5013
application to Medsafe using the WELLINGTON 6145
form provided (Microsoft Word
document 50kb). The application
Following receipt of a completed
must be accompanied by copies of: application form and supporting
i. Good manufacturing documentation, Medsafe will
practice certification check the information supplied.
relating to the manufacture When Medsafe is able to confirm
of the dietary supplement, the acceptability of the
which may be any of the manufacturing arrangements, a
signed statement to that effect will
following:
be added to the form and the form
· a Licence to Manufacture
will be returned to the prospective
Medicines issued by
supplier. This document should be
Medsafe
retained by the supplier as evidence
· a Licence to Manufacture
that supply of the supplement
Therapeutic Goods issued
described on the form is lawful.
by the Australian TheraThe product cannot lawfully be
peutic Goods Adminsupplied as a dietary supplement in
istration
New Zealand until the Medsafe
· a GMP Certificate issued
confirmation has been received.
Na
by Medsafe or by any of the
If not satisfied Medsafe will
recognised regulators listed
contact the supplier to discuss the
in Part D Section 5 of the
NEW ZEALAND -- Continued from p. 8...
Page 9
reason(s) the documentation
supplied is inadequate.
A prospective supplier who does
not hold acceptable GMP
certification should contact
Medsafe’s Compliance Management Branch if they wish to arrange
a GMP audit. A fee for service will
apply to such audits in order to
recover the time and travel costs
associated with the audit.
For further information, contact
the Compliance Management
Branch on 04 819 6800.
Export certification
Export certification in the form
of a Statement to Foreign
Governments that explains the
regulatory setting for dietary
supplements can be obtained on
request and on payment of a fee for
Service of $120 (GST exclusive).
Requests should be addressed to
the Manager Product Regulation,
Medsafe, P. O. Box 5013,
Wellington.
Exporters should note that, due
to the nature of dietary supplement
regulation, it is not possible to
attest to the safety or quality of
products or their compliance with
New Zealand law. Export
certificates will therefore include
the following statement:
Under New Zealand law, dietary
supplements are not assessed by a
Government agency. This
statement cannot therefore provide
any assurance that the product(s)
listed meet any quality or safety
standards, are of New Zealand
origin, or meet the regulatory
See NEW ZEALAND -- Cont’d on p. 10...
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
Natural Medicine LawTM
Page 10
May 2010
Natural Medicine LawTM
before June 8, 2010. The parties must also file a Rule
26(f) Report by June 22, 2010 abd meet for an initial
In April 2010, the Administrative Record, in the form case management conference on June 29, 2010.
of a 52-page index of FDA Docket No. FDA-1996The causes of action are: “Unlawful” Business
N-0028 (formerly Docket No. 1996N-0417) was filed
Practices in Violation of The Unfair Competition Law,
with the Court. The first date in the FDA docket is
Bus. & Prof. Code 17200, et seq,; “Unfair” Business
Christopher Grell’s comments that reached FDA on
Practices in Violation of The Unfair Competition Law,
November 20, 1996. The last item in the docket is a
Bus. & Prof. Code 17200, et seq,; “Fraudulent”
Memo from the FDA Regulations Policy and
Business Practices in Violation of The Unfair
Management Staff to Dockets Management re OMB
Competition Law, Bus. & Prof. Code 17200, et seq,;
Review, Executive Order 12866, July 30, 2007,
False Advertising in Violation of California Bus. &
demonstrating the almost 10-year period of time it
Prof. Code 17500, et seq.; Violation of the Consumers
took for the Good Manufacturing Practices
Legal Remedies Act, Calif. Civ; Code 1750, et seq.;
regulations to be formulated. There are three-plus
and Restitution Based On Quasi-Contract/Unjust
pages of Tab A’s and Tab B’s attached to this Memo.
Enrichment.
ALLIANCE GMP CASE
READIES FOR REVIEW
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
The actual documents are certified to be in the
In the opening paragraphs of the complaint Elliot
possession of the Food and Drug Administration by
Zeisel claims that since March 19, 2006, he has
Philip C. Spiller, the Interim Director of the Division
purchased Diamond Foods walnuts in packages
of Dietary Supplement Programs, CFSAN, FDA.
bearing claims that are false and misleading. Zeisel
says that Diamond Foods has used express and
The 17,000 pages of the Administrative Record was
implied statements about positive effects of omega-3
filed on two compact disks and not filed in the District
fatty acid consumption on health to entice consumers
Court’s electronic filing system due to its size.
to purchase its Shelled Walnut products. The phrase
“Omega-3 2.5 g per serving” is displayed adjacent to
A Motion for Summary Judgment, Opposition,
heart symbols, “thereby implying that consumption
Cross-Motions for Summary Judgment, and Replies
… of walnuts is linked to heart health.” Zeisel also
from both sides are to be filed sequentially, under an
claims that the packing bears a statement that: “The
Order of the Court filed on October 8, 2009, on or
omega-3 in walnuts can help you get the proper
before October 1, 2010.
balance of fatty acids your body needs for promoting
heart health. In fact, according to the Food and Drug
The case is Alliance for Natural Health US, et al v.
Administration, supportive but not conclusive
Sebelius, et al, Case No. 1:09-cv-01523, U.S. District
research shows that eating 1.5 oz. of walnuts per day,
Court for the District of Columbia, Colleen Kollaras part of a low-saturated and low cholesterol diet,
Kotelly, presiding.
and not resulting in increased caloric intake, may
reduce the risk of coronary heart disease.”
Then Zeisel claims that FDA advised Diamond
Foods in February 2010 there is not sufficient
With two attorneys representing him in a class action evidence to identify a biologically active substance
lawsuit, Elliot Zeisel of New York, New York is suing in walnuts that reduces the risk of coronary heart
Diamond Foods, Inc., makers of Diamond of
California Shelled Walnuts, for damages, equitable,
See WALNUT CLAIMS FRAUD -- Continued on page 12...
declaratory and injunctive relief in the United States
District Court for Northern California. The complaint
was filed March 22 and contains six causes of action.
www.natmedlaw.com
CONSUMER CLAIMS FRAUD
OVER WALNUT LABEL CLAIMS
Now set for Alternative Dispute Resolution by
United States Magistrate Judge Elizabeth D. LaPorte
Natural Medicine LawTM
May 2010
Page 11
ounces of water or other fluid. The risk to Canadians
includes choking and/or blockage of the throat,
requirements of the importing country.
esophagus or intestine. These products should NOT
If the product(s) listed comply with the requirements be taken immediately before going to bed.
of the New Zealand Dietary Supplements Regulations
Health Canada is working with the Canadian
(and any other applicable legislation) the product(s)
Boarder Services Agency to stop importation of the
are legally able to be sold in New Zealand.
product into Canada.
Any requests for certification that attests to aspects
On March 31, Health Canada announced it had
of regulation administered by the NZFSA (such as
the Animal Products Act 1999 or the Food Hygiene found an unauthorized health product, “West Pharm
Regulations 1974) should continue to be sent to the Therma Lean Fat Burner Energizer” was found on
the Canadian market. West Pharm Therma Lean Fat
NZFSA.
Burner Energizer contains ephedrine and caffeine,
Please e-mail general inquiries to Medsafe at which combined together, may cause serious and
possibly fatal adverse effects. Canadians suffering
[email protected].
from heart conditions, high blood pressure and
diabetes are among those particularly at risk. The
product was distributed across Canada via the internet
CANADA WARNS -- Continued from page 5...
by Nutrition First (www.nutritionfirst.ca), a company
located in Nova Scotia.
not included in the list of ingredients.
On March 25, Health Canada warned about
HERBAL DIET NATURAL that contains an
undeclared pharmaceutical ingredient similar to the
prescription drug sibutramine, used for obesity
treatment. The use of sibutramine may cause serious
side-effects, including cardiovascular reactions, such
as increased blood pressure, chest pain, and stroke,
in addition to dry mouth, difficulty sleeping and
constipation. Sibutramine should only be used under
the supervision of a healthcare practitioner.
Sibutramine should not be taken by people who have
had a heart attack, coronary artery disease, heartrelated chest pain, irregular heart beats, congestive
heart failure, a stroke or symptoms of a stroke, in
individuals with unstable or poorly controlled high
blood pressure, or in patients who have clinically
diagnosed depression or have a psychiatric illness.
Sibutramine is not recommended for women who are
pregnant, breastfeeding or planning to become
pregnant.
Ephedrine taken in combination with caffeine can
cause symptoms ranging from dizziness, tremors,
headaches and irregularities in heart rate to seizures,
psychosis, heart attacks and stroke. Consumers who
have purchased “West Pharm Therma Lean Fat Burner
Energizer” are advised to consult with a medical
professional if they have used the product or have
concerns about their health.
The use of products containing ephedrine is not
recommended in people with heart problems,
hypertension, thyroid disease, diabetes, enlarged
prostate, anxiety and restlessness, glaucoma (serious
eye disorder) and pheochromocytoma (serious gland
disorder) because Ephedra/ephedrine aggravates these
conditions.
In all three cases, once the makers or distributors
were notified of violations, the products were recalled
and taken off the market. Consumers requiring more
information about this advisory can contact Health
According to the product label, Herbal Diet Natural Canada’s public inquiries line at (613) 957-2991, or
also contains glucomannan used for the treatment of toll free at 1-866-225-0709.
weight loss. In January 2010, Health Canada advised
Canadians that natural health products containing the
ingredient glucomannan in tablet, capsule or powder
WWW.NATMEDLAW.COM
form, which are currently on the Canadian market,
have a potential for harm if taken without at least 8
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
NEW ZEALAND -- Continued from page 9...
Page 12
May 2010
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
Los Angeles (310) 392-8801 and
Michael D. Braun of the Braun
Law Group, P.C. in Los Angeles
(310) 836-6000. The case is Zeisel
v. Diamond Foods, Inc. Case No.
3:10-cv-01192-EDL in the United
District Court for the Northern
District of California. Watch for
more information in the July issue
of NML.
CURRENT STATUS OF
WALNUT HEALTH CLAIMS
FDA
Photo Courtesy of Lloyd Library and Museum
WALNUT CLAIMS FRAUD -- From p.10...
has granted and not yet
revoked a qualified health claim
petition for walnuts and heart
disease by issuing a letter of
discretion that is summarized on
FDA’s website at: www.fda.gov/
Food/LabelingNutrition/
L a b e l C l a i m s /
QualifiedHealthClaims/
ucm073992.htm#walnuts, where it
stated:
“Walnuts & Heart Disease
Docket
No.
02P-0292
03/09/2004 enforcement discretion
letter”
disease (“CHD”) or to support the
statement that the omega-3 fatty
acids found in walnuts promote
heart health or reduce the risk of
CHD. Continuing, “Defendant’s
health claims are therefore
unauthorized under federal law and
misleading to consumers. As the
FDA specifically found in February
2010, Defendant’s Shelled Walnuts “Claim Statement
products are ‘in violation of the
• (1) Supportive but not
Federal Food, Drug, and Cosmetic
conclusive research shows
Act and applicable regulations …
that eating 1.5 ounces per
and are misbranded … in that
day of walnuts, as part of a
[Diamond’s] products bear health
low saturated fat and low
claims are not authorized by the
cholesterol diet and not
FDA.’”
resulting in increased
caloric intake, may reduce
The six causes of action are based
the risk of coronary heart
on the health claims on the
disease. See nutrition
packaging of Diamond Foods
information for fat [and
Shelled Walnuts.
calorie] content.
Diamond Foods is a Delaware
Corporation doing business in San
Francisco. Attorneys for Zeisel are
Janet Lindner Speilberg, Esq, of
o
Note:
The
bracketed phrase
“and calorie” is
optional in that
FDA does not
Natural Medicine LawTM
intend for the
presence
or
absence of such
phrase to be a
factor in whether it
c o n s i d e r s
enforcement
discretion for the
use of the qualified
health claim. FDA
considered this
additional
information might
be beneficial to
consumers
to
heighten
their
awareness of the
c a l o r i c
contribution from
walnuts
and
encourages
companies
to
include it in
product labeling.”
“Eligible Foods
Whole or chopped walnuts”
“Factors
The claim meets the general
requirements for health claims in
21 CFR 101.14, except for the
requirement that: (1) the evidence
for the claim meet the significant
scientific agreement standard; (2)
the claim be made in accordance
with an authorizing regulation; (3)
the food not exceed the
disqualifying level for total fat; and
(4) the food provide at least 10
percent of the Daily Value of
vitamin A, vitamin C, iron,
calcium, protein, or dietary fiber
per reference amount customarily
consumed.”
“The disclosure statement about
total fat content (i.e., See nutrition
information for fat content) is
See CURRENT STATUS -- Cont’d on p. 13...
Natural Medicine LawTM
May 2010
Page 13
The enforcement discretion letter
demonstrating consumer deception
existent.” FDA believes outright as a condition precedent to claim was issued March 9, 2004 to the
California Walnut Commission’s
censorship is permitted by Pearson suppression.
legal counsel, Sarah E. Taylor, J.D.,
I because the agency views the
R.D., M.P.H., Covington &
In
Plaintiffs’
Motion
for
Plaintiffs’ science as unconvincing.
FDA believes this because it Summary Judgment they had Burling, in Washington, D.C. and
believes the speech suppression is requested the Court rule on all the letter is several pages long and
not reviewable under the First causes of action contained in their can be obtained at: www.fda.gov/
Amendment standard of Pearson complaint. These causes included F o o d / L a b e l i n g N u t r i t i o n /
I but under the deferential standard a declaration that FDA’s Final L a b e l C l a i m s /
of the Administrative Procedure Order in Docket No, FDA-2008- Q u a l i f i e d H e a l t h C l a i m s /
Q-0299-0014 violates Plaintiffs’ ucm072910.htm.
Act.
First Amendment rights and the
Plaintiffs argue that Defendants constitutional mandates of the U.S.
request to reverse the Court of Court of Appeals in Pearson v.
NDI NOT POSTED BY FDA
rd
Appeals and three other decisions Shalala, 163 F.3 650 (“Pearson
of the District Court, after years of I”), and the U.S. District Court in In the January issue of NML, we
refusal to abide by the Whitaker v. Thompson, 248 F. reported on a news release on the
constitutional mandate in Pearson Supp. 2d 1 (D.D.C. 2002), appeal web site of Sabinsa Corporation
dismissed, 2003 U.S. App. LEXIS who announced that FDA had
I, is contumacious.
18288 (D.C. Cir. 2003). Another accepted its New Dietary
notice
for
Plaintiff say that for FDA to meet cause was for an injunction Ingredient
blocking
FDA
from
taking
any
SelenoForce®,
a
“seleniumits heavy burden and to censor the
garlic
product
claims, the agency must establish action to prevent their use of the enriched
health
claims
specified
herein
with
manufactured by a patent pending
that the Plaintiffs’ science is false,
reasonable,
“sort,
succinct,
and
soilless culture process. Garlic
or disproved, and that empirical
evidence proves the disclaimers accurate” disclaimers prescribed bulbs are naturally enriched with a
incapable of curing potential by the agency. In Plaintiffs’ unique composition of organic
compounds
for
deceptiveness. FDA has never proposed order, there are six claims selenium
set
forth
that
appear
in
Natural
nutritional supplementation, using
attempted to do so and does not do
Medicine
Law™
Newsletter,
a proprietary hydroponics method.
so in its opposition arguments.
September 2009, at page 14. The selenium enriched bulbs are
Plaintiffs set forth seven pages of (Readers can view this on the web dried, powdered and standardized,
to yield SelenoForce® containing
argument why the Administrative at www.natmedlaw.com.)
1000 ppm selenium, in
Procedures Act does not apply, and
This
case
is
Alliance
for
Natural
bioavailable organic form, in a base
28-pages of argument why FDA’s
censorship of Plaintiffs’ qualified Health US, et al v. Kathleen of natural garlic powder.”
health claims violate the First Sebelius, et al, Case No. 1:09-cvThe news release states that
Amendment. Saying that the First 01546-RJL, U.S. District Court for
the
District
of
Columbia.
“Low selenium status has been
Amendment Standard applies to
linked with the occurrence of
Qualified Health Claims, that
decreased immunity to diseases
Plaintiffs’ proposed health claims
and the prevalence of various
are supported by credible peerforms of cancer.”
reviewed scientific evidence, that CURRENT STATUS -- Cont’d from p. 12...
FDA must draft reasonable, “sort,
At the time, late December or
succinct,
and
accurate” placed immediately following the
disclaimers, and that Pearson I and claim, with no intervening early January, the FDA had not
Whitaker I established a Per se material, in the same size, typeface, placed this acceptance on the FDA
requirement of empirical evidence and contrast as the claim itself.”
See SELENIUM NDI -- Continued on p. 14....
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
VITAMIN A & D -- Cont’d from p.1...
Page 14
May 2010
Natural Medicine LawTM
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
SELENIUM NDI GRANTED -- Continued from page 13 ...
NEW INGREDIENTS -- Continued from page 3...
portion of the www.regulations.gov website as
required by law. The statute requires that any
accepted new dietary ingredient be placed on file for
public view. Apparently the “new” FDA does not
consider the website a necessary part of the public
view. Prior to 2008, when the FDA Dockets office
received the documents from reviewers, the
documents would go into the docket with a file
number, and shortly thereafter the documents would
be placed on the FDA website.
placed on display at the Dockets Management Branch.
Posted
on
September
30,
2008
on
www.regulations.gov Docket No. FDA-1995-S-00390042. The original FDA Docket was No. 95S-0163,
RPT 21.
[FDA still has not placed notice of this acceptance
on its web site, since discontinuing the Docket No.
95S-0316 in 2008. The new www.regulations.gov
Docket No. FDA-1995-S-0039 is not up to date and
therefore this company’s claims about acceptance
cannot be verified until one or the other of these
Federal agencies get around to updating the public
files. Normally, NML does not report on the same
product twice, but in this case, NML is monitoring
FDA’s performance in adhering to the statutory
requirements to place the acceptance on public
display. Readers will be able to see why when you
read the remainder of this summary. – Ed.]
NML is now able to confirm that the NDI was
accepted because of FDA’s response to a Freedom
of Information request, No. F-10-252. The NDI states
the product is manufactured in India by Sami Labs
Limited in Banglalore. The submission was made
September 2, 2009. The draft label contains a
warning that states: “Warning: SelenoForce is
standardized for Selenium which is toxic in high
doses. A daily maximum recommended does of 200
microgram, for adults, of Selenium from dietary
supplements should not be exceeded. Selenium intake
from all sources should not exceed 400 microgram
per day.” The product is being sold in bulk for adding
to other products. The intended use of the product
is explained in six bulleted statements on page 13 of
a 74 page submission. Among these six statements
are: “Selenium-enriched garlic contains selenium
species that are reported to be more beneficial to
health as compared to other forms of selenium
supplementation. Selenium is an essential trace
mineral nutrient with multiple roles in health
maintenance as an antioxidant. Ideally, selenium
See SELENIUM NDI GRANTED -- Continued on page 20...
Technical Sourcing International, Inc. of Sandy,
Utah, wrote FDA on November 19, 1997 as a trade
secret: confidential and proprietary information notice
for the new dietary ingredients, Isopropoxy isoflavone.
Included was a 52 week oral toxicity study on 32
beagle dogs. Also in the file is a letter dated October
9, 2003 from Perrigo of Allergan, Michigan,
submitting a notice for Ostivone® containing 100 mg
of Isopropoxy Isoflavone, 100 IU Vitamin D and 250
mg calcium per caplet. Suggested use will be for adult
women, two tablets per day. With this notice was a
safety profile and Technical Sourcing International,
Inc’s 75-day notificiation. The 2003 submission
contained summaries of a number of human studies
and three pharmacokinetic and metabolic modeling
studies, plus a list of 19 reference papers. FDA’s James
Tanner, Ph.D., acting director of the Division of
Programs and Enforcement Policy, Office of Special
Nutritionals, CFSAN, responded to Steve Lee on an
unknown date with a letter stating that the information
will be kept confidential until February 22, 1998 and
then be placed on display at the Dockets Management
Branch. Posted on September 28, 2008 on
www.regulations.gov Docket No. FDA-1995-S-00390041. The original FDA Docket was No. 95S-0163,
RPT 22 after being received in the FDA Dockets
Management Branch on October 22, 2003.
General Nutrition Corporation, Inc. of Pittsburgh,
Pennsylvania, wrote FDA on February 19, 1998, to
give notice of an NDI for methyltetrahydrofolate (5MTHF) the active form of folate. The supplement
containing the 5-MTHF will consist of 400 mcg of 5MTHF in a tablet or capsule suggested to be taken
one time per day. Included were chemical
pharmaceutical data, toxicology studies and clinical
studies, all in summary form. FDA’s James Tanner,
Ph.D., acting director of the Division of Programs and
Enforcement Policy, Office of Special Nutritionals,
CFSAN, responded to Dr. John Troup on April 6, 1998
with a letter stating that the information will be kept
NEW INGREDIENTS -- Continued on page 15....
Natural Medicine LawTM
May 2010
Page 15
serious health risks for oral use of GBL that precludes
confidential until May 27, 1998 and then be placed a determination that GBL will reasonably be expected
on display at the Dockets Management Branch. to be safe as a dietary ingredient. Tanner stated that
Posted on September 30, 2008 on the references to presence in food cannot be compared
www.regulations.gov Docket No. FDA-1995-S-0039- to the proposed exposures to GBL and the differences
0043. The original FDA Docket was No. 95S-0163, in bioavailability and absorption of GBL from foods
RPT 23 after being received in the FDA Dockets and encapsulated products were not considered.
Further FDA disagrees that the two human studies
Management Branch on April 9, 1998.
show the safety of long-term exposure to GBL. FDA
Unique Products Company of Brentwood, cited other safety evidence that was not considered
Tennessee, wrote to FDA on February 11, 1998 to in the notice. FDA determined that the product would
give notice it would sell a new dietary ingredient, 4- be adulterated a new dietary ingredient for which there
butyrolactone also known as gamma-butyrolactone. is inadequate evidence to assure that the ingredient
The letter was marked as contaiing trade secret and/ does not present a significant or unreasonable risk of
or confidential commercial information. This illness or injury. Introduction of such a product into
ingredient is found in numerous foods, References interstate commerce is prohibited. Posted on
to this statement were provided. The product will be September 30, 2008 on www.regulations.gov Docket
sealed capsules of 325 to 500 mg in a sealed single No. FDA-1995-S-0039-0044. The original FDA
pouch of 4 to 5 capsules packaged in cartons five to Docket was No. 95S-0163, RPT 25 after being
thirty pouches. The product is intended to support received in the FDA Dockets Management Branch
relaxation, normal sleep and the release of growth on May 5, 1998. There is no RPT 24 in the
hormone in the body. The maximum dose www.regulations.gov at this time.
recommended is five capsules and smaller amounts
General Nutrition Corporation, Inc. of
for smaller individuals. There will be a warning that
the product is not to be used with alcohol or central Pittsburgh, Pennsylvania, wrote FDA on March 2,
nervous system depressants. Consumers will be 1998, to give notice of an NDI for Ademetionine, in
warned not to use prior to driving or operating a 500 mg capsule or tablet. Included in the notice were
machinery. A warning will be listed for persons under chemical pharmaceutical data, toxicology data, and
age 18, pregnant or lactating women, persons with clinical studies. This was a 469 page submission.
epilepsy, convulsions, seizures, bradycardia, high Ademetionine is the initiator of two important
blood pressure or cardiovascular disease, Cushing’s metabolic pathways in humans – transmethylation and
syndrome or hyperprolactinemia. A WHO
See NEW INGREDIENTS --Continued on page 16...
Monograph and two clinical studies were referred to
in summary form. FDA’s James Tanner, Ph.D., acting
director of the Division of Programs and Enforcement PHOTOGRAPHS FROM LLOYD LIBRARY AND MUSEUM
Policy, Office of Special Nutritionals, CFSAN,
responded to Jay L. Caplan on April 29, 1998 with a Back Cover -- Podophyllum (Podophyllum Peltatum) from AMERIfive-page letter stating that the information had been CAN MEDICINAL PLANTS by Charles F. Millspaugh, M.D, 1887
reviewed carefully and the agency had significant Back Cover --Goldenseal (Hydrastis Canadensis) from AMERICAN
concerns. Tanner stated that FDA believes the MEDICINAL PLANTS by Charles F. Millspaugh, M.D, 1887
company did not consider significant limitations of
Page 4 - Foxglove (Digitalis purpurea) from MEDICAL BOTANY
the evidence cited and the serious, unresolved, health by John Stephenson, M.D. and James Morss Churchill, F.L.S.
risks associated with GBL and the submission ignores 1828
unequivocal evidence in the scientific literature of Page 12 - Ginseng (Panax quinquefolium) from THE FAMILY FLORA
AND MATERIA MEDICA BOTANICA by Peter P. Good 1845-47
Page 16 - Olive Tree (Olea Europæa) from FLORA GRÆCA by
Johannes Sibthorp. M.D. & Jacobus Edvardus Smith, M.D., 1806
www.natmedlaw.com
Page 22 -- Cone Flower (Echinacea Intermedia) from PAXTON’S
MAGAZINE OF BOTANY, 15th Vol. 1849
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
NEW INGREDIENTS-- Continued from page 14...
Page 16
NEW INGREDIENTS -- Cont’d from p.15 ...
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
transsulfuration. FDA’s Robert J.
Moore, Ph.D., Senior Regulatory
Scientist, Office of Special
Nutritionals, responded to John
Troup, Ph.D. by letter of March 13,
1998 stating that the notice was
received and that introduction of
any dietary supplement containing
Ademethionine or katsuobushi
oligopeptide into interstate
commerce shall not be done until
after 75 days. Posted on September
30, 2008 on www.regulations.gov
Docket No. FDA-1995-S-00390045. The original FDA Docket
was No. 95S-0163, RPT 26 after
being received in the FDA Dockets
Management Branch on April 9,
1998.
General Nutrition Corporation,
Inc. of Pittsburgh, Pennsylvania,
wrote FDA on March 4, 1998, to
give notice of an NDI for
Katsuobushi Oligopeptide, a
peptide obtained from thermolysin
digested Katsuobushi (dreid
bonito), in a tablet or powder form
that will provide I gm per serving.
Suggested use will be three times
per day. Included in the notice were
product specification and process
manufacturing, summary of safety,
stability and clinical reports,
scientific study describing
physiological effect and dosing,
cute toxicity and references.
FDA’s Robert J. Moore, Ph.D.,
Senior Regulatory Scientist, Office
of Special Nutritionals, responded
to John Troup, Ph.D. by letter of
March 13, 1998 stating that the
notice was received and that
introduction of any dietary
supplement containing Ademethionine or katsuobushi oligopeptide
into interstate commerce shall not
be done until after 75 days. Posted
on September 30, 2008 on
May 2010
Natural Medicine LawTM
www.regulations.gov Docket No.
FDA-1995-S-0039-0046. The
original FDA Docket was No. 95S0163, RPT 27 after being received
in the FDA Dockets Management
Branch on April 9, 1998.
SKW Trostberg AG of
Trostberg, Germany, through
Robert B. Nicholas, Esq. of
McDermott, Will & Emery of
Washington, D.C. on March 27,
1998 filed a NDI notice for creatine
pyruvate, containing pure pyruvic
acid molecularly bonded to pure
creatine, in a 40 to 60 percent ratio.
The recommended condition for
use is 5 to 10 grams per day, taken
in two equal doses, mixed with a
beverage. Eight documents were
listed in the letter as the basis for
the company’s expectation that the
ingredient will reasonably be
expected to be safe under the
conditions of use. Copies were
appended to the notice letter.
However, these documents were
not in the public file. FDA’s Robert
J. Moore, Ph.D., Senior Regulatory
Scientist, Office of Special
Nutritionals, responded to Robert
B. Nicholas, Esq. by letter of April
6, 1998 stating that the notice was
received on March 31, 1998 and
that the submission will be kept
confidential for 90 days and not
placed on public display until after
June 28, 1998. Commercial and
confidential information in the
notification will not be made
available to the public. Posted on
October
6,
2008
on
www.regulations.gov Docket No.
FDA-1995-S-0039-0051. The
original FDA Docket was No. 95S0163, RPT 28 after being received
in the FDA Dockets Management
Branch on April 9, 1998.
Olive Tree (Olea Europæa) 1806
Photo Courtesy of Lloyd Library and Museum
General Nutrition Corporation, Inc. of Pittsburgh,
Pennsylvania, wrote FDA on April
20, 1998, to give notice of an NDI
for Seaprose-S (Semi-Alkaline
Proteinase), a homogeneous
crystealline proteinase originated
from Aspergillus Melleus. The
supplement which contains
Seaprose-S will consist of fifteen
(15) mg of Seaprose-S in a tablet
or powder form that will be
suggested for use two times per
day. Included in the notice were
Development and manufacturing
chemistry, toxicity studies, product
stability data and physiological
studies. FDA’s Robert J. Moore,
Ph.D., Senior Regulatory Scientist,
Office of Special Nutritionals,
responded to John Troup, Ph.D. by
letter of April 29, 1998 stating that
the notice was received on April
29, 1998 and that the submission
will be kept confidential for 90 day
until after July 11, 1998 placed on
public display. Posted on October
See NEW INGREDIENTS -- Cont’d p 17...
NEW INGREDIENTS -- Cont’d from p.16 ...
6, 2008 on www.regulations.gov
Docket No. FDA-1995-S-00390065. The original FDA Docket
was No. 95S-0163, RPT 29 after
being received in the FDA Dockets
Management Branch on April 30,
1998.
Malabar Productos Naturales
of Guadalupe, Mexico, wrote to
FDA on May 1, 1998 to give notice
that it would sell five dietary
supplement products – Jointaid,
Pancrease, Gastritease, Menstrualaid, and Digestaid. These
products will contain the same five
new ingredients mentioned in the
company letter of January 23, 1998
(See the letter posted on September
28, 2008 on www.regulations.gov
Docket No. FDA-1995-S-00390039. The original FDA Docket
was No. 95S-0163, RPT 20). The
Digestaid contains Loeselia
Mexicana (Lam.) Brand. 5%. plus
Aloe vera, senna, cassia
augustifolia, cascara, and Rhamnus
purshiana. . FDA’s James Tanner,
Ph.D., acting director of the
Division of Programs and
Enforcement Policy, Office of
Special Nutritionals, CFSAN,
responded on July 15, 1998 to
Natalia Garza, export manager, in
a letter that stated that FDA
considered the information and
concludes that “it appears to meet
the standard in 21 U.S.C.
350b(a)(2) for the new dietary
ingredients Tronadora, Pericon,
Espinosilla, and Chancarro. The
date received, May 15, 1998, is the
filing date for the notification and
therefore, the products may not be
distributed until July 29, 1998, 75
days after the filing date. Tanner
then stated that the submission
does not provide an adequate basis
May 2010
to conclude that Montanoa
tormentosa, when used under the
conditions suggested in the
labeling, will reasonably be
expected to be safe. For the
reasons in FDA’s earlier response
the product is adulterated because
it contains an ingredient for which
there is inadequate information to
provide reasonable assurance that
the ingredient does not present a
significant or unreasonable risk of
illness or injury. The May 1
submission contains further
information confirming the
uterotonic effects and induced
cervical dilatation and uterine
bleeding. Introduction of such a
product into interstate commerce
is prohibited. Posted on October
6, 2008 on www.regulations.gov
Docket No. FDA-1995-S-00390054. The original FDA Docket
was No. 95S-0163, RPT 30 after
being received in the FDA Dockets
Management Branch on July 20,
1998.
SECTION 403 -- Continued from p. 4...
CFSAN, wrote to Cheryl Radetsky
on May 5, 1997 to state that these
claim statements are interpreted to
mean the product is intended to
treat diseases and the product is a
drug subject to regulation as a drug
under the drug provisions of the
Act. The notice letter and FDA
response was received in FDA’s
Dockets Office on August 12,
1997 and was placed in Docket
No. 97S-0163, LET 45 and in
www.regulations.gov Docket No.
FDA-1997-S-0006-0335 posted
September 8, 2008.
Herbs for Kids, Inc. of
Bozeman, Montana, wrote to FDA
on February 5, 1997 to give notice
Page 17
of statements of claims for 35
different products by enclosing
labels. FDA’s James Tanner,
Ph.D., acting director of the
Division of Programs and
Enforcement Policy, Office of
Special Nutritionals, CFSAN, on
April 15, 1997, wrote to Steve
Guettermann stating that two of the
products had claims that did not
meet the requirements of Section
403(r)(6) because they were claims
that the products treat disease. The
products and claims were: 1)
Echinacea/Golden
Root™
Immune
Support
Blend
(Blackberry Flavor and Orange
Flavor), “This blend contains herbs
which support the body’s ability to
resist the onset of infection;” and
2) Vi Blend™ Immune Support
Blend, “This blend contains herbs
which support the body’s antiviral
capabilities.” The FDA letter of
April 15, 1997 said that if those
claims were used the products
would be regulated as drugs under
the Act. The notice letter and FDA
response was received in FDA’s
Dockets Office on August 12, 1997
and was placed in Docket No. 97S0163, LET 46 and in
www.regulations.gov Docket No.
FDA-1997-S-0006-336 posted
September 8, 2008. There is also
a LET 46 for a different product at
FDA-1997-S-0039-0164 posted on
October 14, 2008.
The Health Connection,
Limited of Copiague, New York,
wrote FDA on March 14, 1997
through Emord & Associates,
P.C. of Washington, D.C. to give
notice that the company would be
using three statements of
nutritional support for its product,
SPV-30, containing Extract of the
See SECTION 403 - Cont’d p. 18...
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Natural Medicine LawTM
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May 2010
SECTION 403 -- Continued from page 17...
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
Boxwood Evergreen Tree. The statements of support
are: “SPV-3- provides nutritional support for the
body’s immune system;” “SPV-3- provides nutritional
support for the body’s natural defense;” and “SPV30 enhances immune system function by increasing
CD4 and CD8 counts.” FDA’s James Tanner, Ph.D.,
acting director of the Division of Programs and
Enforcement Policy, Office of Special Nutritionals,
CFSAN, on April 4, 1997, wrote to Jonathan Emord,
Esq. and Claudia A. Lewis, Esq. to state that the claim:
“SPV-30 enhances immune system function by
increasing CD4 and CD8 counts” is not a Section
403(r)(6) claim, but a claim to treat immune deficiency
diseases and therefore it will be regulated as a drug
under the Act if used. The notice letter and FDA
response was received in FDA’s Dockets Office on
August 12, 1997 and was placed in Docket No. 97S0163, LET 47 and in www.regulations.gov Docket
No. FDA-1997-S-0006-337 posted September 8,
2008. There is also a LET 47 for a different product
at FDA-1997-S-0039-0165 posted on October 14,
2008.
Natural Medicine LawTM
notice of claims it was to make for its product, Soy
Life, a soy protein isolate. The claims were: “As a
result of numerous studies, evidence is mounting that
soybeans may inhibit tumor growth. Genistein, an
Isoflavone found chiefly in soybeans, has been
identified as an angiogensis blocker. Angiogensis is
the process by which new blood vessels grow and
nourish malignant tumors. Bu blocking angiogenesis
(sic), isoflavones may inhibit tumors.” Elizabeth A.
Yetley, Ph.D., R.D., Director of the Office of Special
Nutritionals at CFSAN, on December 29, 1995, wrote
to Ernest Fleming to state that the claims are that the
product is intended to prohibit tumor growth and
block the growth of malignant tumors. These are not
Section 403(r)(6) claims and if the claims are used
the product will be regulated as a drug under the Act.
The notice letter and FDA response was received in
FDA’s Dockets Office on August 12, 1997 and was
placed in Docket No. 97S-0163, LET 49 and in
www.regulations.gov Docket No. FDA-1997-S-0006339 posted September 8, 2008.
Wakunaga of America Co., Ltd. of Mission Viejo,
California, wrote FDA on April 2, 1997 to give notice
that labeling for the product, PROBIATA™,
containing Lactobacillus acidophilus, would contain
the claims: “Replenishes healthy intestinal flora,
avoiding disorders such as diarrhea, constipation and
yeast discomfort caused by antibiotic usage.” James
Tanner, Ph.D., acting director of the Division of
Programs and Enforcement Policy, Office of Special
Nutritionals, CFSAN, on May 22, 2997 wrote to
Mitsuru Takiura at the same address as the company
to state that the claims to “ avoiding disorders such
as diarrhea, constipation and yeast discomfort caused
by antibiotic usage” are not Section 403(r)(6) claims,
but rather are claims to treat a special class of diseases.
The claims make the product subject to regulation as
a drug under the Act. The notice letter and FDA
response was received in FDA’s Dockets Office on
August 12, 1997 and was placed in Docket No. 97S0163, LET 50 and in www.regulations.gov Docket
No. FDA-1997-S-0006-340 posted September 8,
2008.
Paracelsian, Inc. of Ithaca, New York, wrote FDA
on February 11, 1997, through Anthony L. Young,
Esq. of Piper & Marbury, LLP, in Washington, D.C.
concerning a statement of nutritional support for its
product, AndroVir™-DS containing the extract of
Andrographis paniculata. The statement was: “Helps
to support normal immune function.” FDA’s James
Tanner, Ph.D., acting director of the Division of
Programs and Enforcement Policy, Office of Special
Nutritionals, CFSAN, on April 4, 1997, wrote to
Anthony Young, Esq. to stated that the statement is
not a Section 403(r)(6) claim, but a claim to teat HIVpositive persons and therefore it will be regulated as
a drug under the Act if used. The FDA letter also
mentions the product, Androcar being marketed to
persons with cancer, but there is no such letter in this
Docket file. The notice letter and FDA response was
received in FDA’s Dockets Office on August 12, 1997
and was placed in Docket No. 97S-0163, LET 48 and
in www.regulations.gov Docket No. FDA-1997-S0006-338 posted September 8, 2008. There is also a
Institute for Nutritional Science Limited of San
LET 47 for a different product at FDA-1997-S-0039Diego,
California, wrote to FDA on December 3, 1996
0166 posted on October 14, 2008.
to give notice that it would use certain claims on three
Global Marketing International of Richardson,
See SECTION 403 -- Continued on page 19...
Texas, wrote to FDA on September 11, 1995 to give
May 2010
Page 19
SECTION 403 LETTERS -- Continued from page 18...A
and Research. FDA also declined to have a meeting
of its products, Sugar-Eze, ProFlow, and BioCalcium. since there is no information in the submission that
An attachment to the letter provided product labels would lead FDA to change its position in the matter.
with a list of ingredients and the claim information. Also in the file was a letter from Paul Hyman, Esq. of
For Sugar-Eze, the claim was: “contains chromium Hyman, Phelps & McNamara, P.C. of Washington,
and vanadium which have been shown to be essential D.C. commenting on a telephone conversation about
for normal glucose metabolism.” For ProFlow the the May 22 letter being addressed personally to
claim was: “Contains Saw Palmetto and Pygeum Mitsuru Takiura instead to the same person in his
Africanum which have been shown to reduce prostate official capacity as president. Hyman asked for a
inflammation.” For BioCalcium the claim was: revised letter, but it does not appear in this docket
“Contains the minerals magnesium, manganese, zinc, file. The notice letter and FDA response was received
boron, and copper which have been shown to improve in FDA’s Dockets Office on August 12, 1997 and was
the uptake of calcium by the bone.” FDA’s James placed in Docket No. 97S-0163, LET 52 and in
Tanner, Ph.D., acting director of the Division of www.regulations.gov Docket No. FDA-1997-S-0006Programs and Enforcement Policy, Office of Special 342, posted September 8, 2008. There is also a LET
Nutritionals, CFSAN, on January 6, 1997 wrote to 52 for a different product at FDA-1997-S-0039-0170
Dr. Steven E. Whiting, that the claim used on ProFlow posted on October 14, 2008.
was not a proper Section 403(r)(6) claim, but a claim
to treat a class of diseases – symptoms of Benign
Prostatis Hypertrophy or Prostatitis. This claim is
subject to regulation under the drug provisions of the
Act. The notice letter and FDA response was received
in FDA’s Dockets Office on August 12, 1997 and was
placed in Docket No. 97S-0163, LET 51 and in
www.regulations.gov Docket No. FDA-1997-S-0006341, posted September 8, 2008. There is also a LET
51 for a different product at FDA-1997-S-0039-0169
posted on October 14, 2008.
Wakunaga of America Co., Ltd. of Mission
Viejo, California, wrote FDA on June 6, 1997
concerning the letter to Mr. Mitsuru Takiura, dated
May 22, 1997 to state that the company was making
a change in the claim to: “Replenishes healthy
intestinal flora, avoiding disorders such as diarrhea,
constipation and yeast discomfort caused by antibiotic
usage.” The June 6 letter insisted that the product
was intended to help maintain normal body function,
that diarrhea and other conditions associated with
antibiotics are not diseases, and that the product only
affects the structure and function of the digestive tract
and is a Section 403(r)(6) claim. FDA’s Robert J.
Moore, Ph.D., Senior Regulatory Scientist, Office of
Special Nutritionals, CFSAN, wrote to Harunobu
Amagase, Ph.D., on June 18, 2007 that the May 22,
1997 letter contains statements that the product is
intended to treat, prevent or mitigate a drug-induced
disease. If the company intends to make such claims,
it should contact the FDA Center for Drug Evaluation
Pacific BioLogic of Orinda, California, wrote to
FDA on November 11, 1996, to give notice to FDA
that it would make revisions in certain product
descriptions in light of concerns of Robert Moore of
FDA. The letter explained the meaning of the words
“heat” and “clear” or “clearing” as applied to a
Chinese concept of spiritual balancing. The products
RESIST, RESIST 2, PRE COLD PLUS and Cold
Free 1 Plus each have lengthy statements made about
them and sources of additional information, closing
by stating that these changes will sufficiently address
your concerns while still communicating the proper
use of our products. FDA’s James Tanner, Ph.D. wrote
to Randall Wisegarver on January 14, 1997 stating
that FDA had no further comment on the claims for
RESIST 2 and COLD FREE 1 PLUS. However, for
the products RESIST and PRE COLD PLUS, the FDA
letter explained again why the claims were making
claims to treat diseases and the company should
contact the FDA Center for Drug Evaluation and
Research if they intended to use the claims. For the
product RESIST, the November 15, 1996 letter claims
were: Application: To supplement the diet when
following a total dietary and lifestyle program which
is intended to strengthen and support the body’s own
See SECTION 403 LETTERS -- Continued on page 20...
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Natural Medicine LawTM
Page 20
May 2010
SECTION 403 LETTERS -- Continued from page 19...
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
defense mechanisms” and “Recommendation: Resist
is best used in conjunction with Resist 2 in daily
rotation. Reduce or discontinue use of Resist during
flare-ups of symptoms or during illnesses such as
colds and flus.” For the product PRE COLD PLUS,
the November 15, 1996 letter claims were a similar
Applications statement followed by: “Pre Cold Plus
is a unique design which is considered to be a mild
tonic but also contains significant clearing
components (as defined by TCM). It is intended to
be used to supplement the diet when following total
dietary and lifestyle programs which are intended to
build the body’s own defense mechanisms when the
seasons are changing or during the winter months.
Proper nutrition is a key component of insuring the
best immune function. The body is best able to combat
the woes of the cold and flu season when immune
function is optimal. Highly concentrated.” The
statement then gives suggested use schedules. FDA
says these claims suggest treatment, prevention or
mitigation of the symptoms of cold and flu. If these
claims are used the company should contact the FDA
Center for Drug Evaluation and Research. The notice
letter and FDA response was received in FDA’s
Dockets Office on August 12, 1997 and was placed
in Docket No. 97S-0163, LET 53 and in
www.regulations.gov Docket No. FDA-1997-S-0006343, posted September 8, 2008.
SELENIUM NDI -- Continued from page. 14...
should be supplemented in the form or forms in which
it occurs in foods. Garlic grown in selenium rich
soil naturally contains organic selenium compounds”
and “Selenium may reduce the risk of certain cancers.
Some scientific evidence suggests that consumption
of selenium may reduce the risk of certain forms of
cancer. However, FDA had determined that this
evidence is limited and not conclusive. (Qualified
Health Claim, CFSAN, 2003).” Numerous safety
studies were summarized in the notification, but no
copies of these were provided in response to the FoI
request. All parts of the file should have been supplied
under the request. The only history of use information
supplied was contained in the final summary in the
notification where it is stated: “There is a long history
of traditional food use for garlic, and at the
Natural Medicine LawTM
recommended levels 50- 200 mcg of SelenoForce™
would be the dose consumed per day, supplying 50200 mcg of supplemental selenium per day.” Also
the summary contains the statement: “The organic
selenium species in SelenoForce™ have been
previously marketed as dietary ingredients in the
United States. L-Seleonomethionine was marketed
as a dietary supplement prior to 1994 (ã-glutamyl-LSeleonomethionine is broken down to yield LSeleonomethionine in the gastrointestinal tract); SeMethyl-L-selenocysteine was notified as a new
ingredient by the manufacturer in 1999 (ã-glutamylL-Seleonomethionine is converted to Se-Methyl-Lselenocysteine in the gastrointestinal tract).” Thirty
one pages were redacted from the public file. FDA
responded by letter dated November 30, 2009 to Dr.
Lakshmi Prakash from Dan D. Levy, Ph.D.,
Microbiologist, Supervisor, New Dietary Ingredient
Review Team, Division of Dietary Supplement
Programs, CFSAN stating that this notification is a
procedural matter and does not constitute an FDA
finding that the ingredient is safe or not adulterated.
Also, the letter states FDA is not precluded from
taking action in the future if it or any product in which
it is placed is found to be unsafe, adulterated or
misbranded. No docket numbers are provided on the
papers disclosed by the FDA in response to the FoI
Request as the 90 days from November 30, 2009 have
not been reached.
As of May 7, 2010, the place where FDA is
supposed to place the information is in the Dockets
Management Branch Office, where data is obtained
to fulfill FoI Requests, and from which the data is
forwarded to the www.regulations.gov staff. Since
there was no docket number for the information in
the Dockets Office files or in the www.regulations.gov
files, and since what was provided under the FoI
Request was not complete, it cannot be verified
whether the Sabinsa advertising claims in the news
release were approved or accepted by FDA. This
incompleteness is not fair to Sabinsa or the consumers
of the United States. If all of the file were disclosed
under the FoI Request there may be a basis for
determining whether the advertising is misleading or
whether FDA has complied with the law of the land
by its actions. Right now the answers are in a dark
hole at FDA. Accountability is not possible at FDA
under these circumstances.
Natural Medicine LawTM
May 2010
Page 21
2008, FDA inspected 153 foreign food facilities out
Congress was working on at that time. S. 510 was of an estimated 189,000 such facilities registered with
reported out of the Senate on March 3, 2009, but has FDA; in 2007, FDA inspected 95 facilities. FDA
not gone anywhere since, except to have some estimated that it would conduct 200 inspections in
members suggest amendments are needed. The bill 2009 and 600 in 2010. In addition, FDA opened
was placed on the General Calendar in the Senate on offices in China, Costa Rica, and India and expects
December 19, 2009. In the House, H.R. 1332 has to open offices in Mexico and Chile and to post staff
gone nowhere since April 2009. A subcommittee of at European Union agencies.”
the Agriculture Committee requested comments from
HHS and USDA.
“Furthermore, FDA’s testing of a new computer
screening system—the Predictive Risk-Based
With slow progress on the food safety bill, and a Evaluation for Dynamic Import Compliance Targeting
new Deputy Commissioner inserted into the (PREDICT)—indicates that the system could enhance
organization chart ahead of you, and closer to the FDA’s risk-based screening efforts at ports of entry,
Commissioner, what was Sundlof expected to do, but but the system is not yet fully operational. PREDICT
to look around. Sundlof made the choice to develop is to generate a numerical risk score for all FDAprograms that will educate people who are needed at regulated products by analyzing importers’ shipment
FDA and USDA. That is a wise choice it seems to information using sets of FDA-developed risk criteria
NML. FDA does not have the brain power that is and to target for inspection products that have a high
needed, nor does it have the numbers of staff that are risk score.”
needed. FDA cannot hire them if they are not
available. So Sundlof is attempting to help solve a
“GAO previously identified several gaps in
big problem by leaving now. Or is he?
enforcement that could allow food products that
violate safety laws to enter U.S. commerce. For
Maybe the Congress knew that “sticker shock” was example, FDA has limited authority to assess penalties
coming on the cost of new food safety programs or on importers who introduce such food products, and
was waiting on the new Obama Administration to the lack of a unique identifier for firms exporting food
figure out what it would support. But in the meantime products may allow contaminated food to evade
the Congress asked the General Accountability Office FDA’s review. In addition, FDA’s and CBP’s
to do a study. The Subcommittee on Oversight and [Customs and Border Protection] computer systems
Investigations, Committee on Energy and Commerce, do not share information. FDA does not always share
House of Representatives heard testimony from GAO certain distribution-related information, such as a
on May 6, 2010 that put the food inspection program recalling firm’s product distribution lists with states,
in perspective. See GAO 10-699T testimony report which impedes states’ efforts to quickly remove
that is available at www.gao.gov.
contaminated products from grocery stores and
warehouses.”
Lisa Shames, director of Natural Resources and
Environment for GAO testified that FDA could
“GAO identified certain statutory authorities that
strengthen oversight of imported food by improving could help FDA in its oversight of food safety.
enforcement and seeking additional authorities. But Specifically, GAO previously reported that FDA
GAO is independent of the Obama Administration, currently lacks mandatory recall authority for
so this testimony does not necessarily fit with the companies that do not voluntarily recall food products
Administration’s plans, unless it is more spending and identified as unsafe. Limitations in FDA’s food recall
more programs that they want.
See FDA -- Continued on page 22...
FDA has attempted to get money to protect
American citizens, who pay the bills from foreign
foods that are unsafe by inspecting foreign food
sources, but this is a larger problem than most people
understand. From the testimony we learn that “in
www.NatMedLaw.com
to search past issues
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
FDA -- Continued from page 1...
Page 22
May 2010
“atropa,” but “belladonna” is
different. There are eleven marks
authorities heighten the risk that
containing the word “belladonna,”
unsafe food will remain in the food
and five are still alive.
supply. In addition, under current
FDA regulations, companies may
Belladonna is a word mark in
conclude a food ingredient is
International Class 032 for
generally recognized as safe
concentrates, syrups or powders
without FDA’s approval or
used in the preparation of soft
knowledge. GAO recommended
drinks and other beverages. It was
that if FDA determines that it does
first used on June 30, 2005 by Jusnot have the authority to implement
Made, LP of Dallas, Texas and filed
one or more recommendations, the
on May 3, 2010 under Serial No.
agency should seek the authority
85/029088. The application states
from Congress. Finally, GAO
that the English translation of
reported that FDA has identified a
belladonna is pretty woman.
need for explicit authority from
Congress to issue regulations
Belladonna is a word mark in
requiring preventive controls by
International Class 031 for
firms producing foods that have
chocolate syrup; Coffee flavored
been associated with repeated
syrup for making food beverages,
instances of serious health
flavoring syrup as well as tea based
problems or death. FDA already
beverages and as a topping syrup.
has preventive regulations for
It was first used on June 30, 2005
seafood and juice, which require
by Jus-Made, LP of Dallas, Texas
firms to analyze safety hazards and
and filed on May 3, 2010 under
implement plans to address those
Serial No. 85/029077. The
hazards.”
application states that the English
translation of belladonna is pretty
NML contacted Frank Pearsall,
woman.
Director of Development at the
Virginia-Maryland Regional
Intima Belladonna is a word
College of Veterinary Medicine to
mark in International Class 025 for
obtain comments on the new
apparel and accessories, namely
regulatory program. Pearsall just
lingerie, sleepwear, chemises,
took over media relations in
wraps, gowns and other clothing
addition to development at the
items. It was first used October 1,
school. Pearsall had not heard
2001 and is Registration No.
about this new masters program
3731357 since December 29, 2009.
but offered to let NML know what
The Owner is Ray Quinones of
he could find out. At the time this
Gardena, California. The word
issue was printed, coments had not
Intima is disclaimed apart from the
been received.
mark as shown, and the English
meaning is Intimate Beautiful
Woman.
TRADEMARKS FOR
Belladonna, Pocket Full of
ATROPA BELLADONNA
WWW.NATMEDLAW.COM
Posiez
is a word and design mark
Surprise – there are no trademarks
in International Class 016 for
for “atropa belladonna” or
stickers. The mark was first used
Natural Medicine LawTM
FDA -- Continued from p.21...
Copyright 2010 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
CONE FLOWER (E. Intermedia)
Photo Courtesy of Lloyd Library & Museum
on October 1, 2001 and is
Registration No. 2955032 as of
May 24, 2005. The owner is
Patricia M. Gravning of Encino,
California.
Belladonna Entertainment is a
word and design mark in
International Class 009 for prerecorded videotapes and Digital
Video Disks featuring adult
oriented entertainment. The mark
was first used August 29, 2002 and
is Registration No. 2899071 as of
November 2, 2004. The owner is
Belladonna Entertainment, LCC,
LTD of Woodland Hills,
California.
One of the common names,
Deadly Nightshade, is also a
trademark in International Class
003 for cosmetics, hair care
products and fragrances, namely
make-up, lipstick, hair dyes, hair
colors and perfume. This mark was
first used July 1, 1994 and is
Registration No. 2006413 as of
October 8, 1996. The owner is Tish
See TRADEMARKS -- Cont’d p. 23...
.
TRADEMARKS -- Cont’d from p. 22...
& Snooky’s N.Y.C, Inc of Long
Island City, New York. The
Section 15 and Section 8 affidavits
and first renewal were accepted
November 15, 2006.
Nightshade is also a mark in five
other live filings and thirteen other
dead filings, including Nicotiana
Solanaceae Nightshade Extract.
None of those marks are in
International Class 005 that might
be used for dietary supplements.
Proceed with experienced counsel
to register a Belladonna mark
under these circumstances.
EFSA BRIEFING -- Cont’d from p. 1...
1. Overview of main issues
addressed by the NDA Panel in
evaluation of Article 13.1, 13.5
and 14 health claims
2. How does the NDA Panel
decide whether a health claim is
substantiated?
3. What is the totality of the
available scientific data?
4. What are pertinent studies for
substantiation of a health claim?
5. On what basis does the NDA
Panel propose wordings of
health claims?
6. To what extent should a food/
constituent be characterised?
May 2010
Page 23
related to children and disease risk
reduction health claim applications
10. Procedural aspects for (Article 14 health claims) and 22
Article 13.5 and 14 health claims opinions related to health claim
applications based on newly
11. Procedural aspects for Article
developed science and/or
13.1 health claims
proprietary data (Article 13.5 health
Although the notice of the claims). Out of the over 4,600
meeting includes a list of persons general function health claims
who should attend the notice also (Article 13.1 health claims)
states that registration is closed. submitted to EFSA via the Member
The meeting will be held in an States/European Commission, the
auditorium in a public park in NDA Panel has evaluated 937
Parma, Italy from 9:00 AM to 5:00 claims and published them in
PM and there is no charge to attend respective opinions.
if you were invited. For more
information, contact: meeting
On April 30, 2010 European
secretary, Cinzia Percivaldi, Health Product Manufacturers
European Food Safety Authority (EHPM) called on Members of the
(EFSA), Tel. +39 0521 036 689 European Parliament to review
[email protected] what was described as the “devastating impact” of the current apThe NDA Panel (Dietetic proach to regulation of Generic
products, nutrition and allergies) Health Claims on the industry and
has treated all health claims with consumer choice.
the same scientific standards and
this is the main problem faced by
Since the claims have been apsubmitters. Many manufacturers proved in batches, this distorts the
and consultants had not expected competition in the market. Peter
this would be the case and Van Doorn, chairman of the EHPM
therefore were submitting claims called for a stop to the piecemeal
with less stringent proof in some adoption of Article 13 lists and a
cases for products used for years. review of the impact of the legislaSome Panel rejections caused tion.
some manufacturers to withdraw
claims from the approval process
To contact EHPM email
so as not to damage their [email protected]. tele
marketing of well-known products +(32) 2 209 11 45 or visit ehpm.org.
in Europe.
for health claims
Regulation (EC) No 1924/
2006[1] harmonises the provisions
7. How should the claimed effect
that relate to nutrition and health
be shown to be beneficial?
claims and establishes rules
8. What is a risk factor for the governing the Community
development of a human authorisation of health claims
made on foods. Up to now the
disease?
EFSA NDA Panel has adopted and
9. Compliance/eligibility issues published 63 scientific opinions
[1] European Parliament and
Council (2006). Regulation (EC)
No 1924/2006 of the European
Parliament and of the Council of
20 December 2006 on nutrition and
health claims made on foods.
Official Journal of the European
Union OJ L 404, 30.12.2006.
Corrigendum OJ L 12, 18.1.2007,
p. 3–18
Copyright, 2010 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside
Natural Medicine LawTM
Page 24
MEDICINES FROM THE
EARTH June 4 to 7
Blud Ridge Assembly
Black Mountain, NC
Influential Herbal Practitioners
will teach their skills
www.botanicalmedicine.org
Copyright 2010, Muscatatuck Publishers, Inc. For Information on Photocopying see Inside Cover
Society of Economic Botany
Xalapa, Veracruz, Mexico
June 6 - 10, 2010
https://payments.botany.org/
seb2010/
login.php?next_registration
May 2010
AMERICAN SOCIETY OF
PHARMACOGNOSY
Trade Winds Island Resort, St.
December 15-20, 2010 in Hono-
AMERICAN HERBALISTS
GUILD
NEW ENGLAND WOMEN’S
HERBAL CONFERENCE
August 20 - 22, 2010
October 1-3, 2010 at the
Registration limited to 500
Hyatt Regency, Austin, Texas.
Early registration begins May 30
http://americanherbalistsguild.com/
www.womensherbalconference.com
symposium_2009
across Europe are strapped for income and being barraged by tax
nel have taken a back seat to payers for their spending programs.
Obamacare plans in the American
Take Greece, for example, that is
Congress. For more than a year
Congress wanted to respond to having riots in the streets because
amendments to establish better the county has to stop spending
food safety, but the legislation is money it does not have. This conset aside to deal with other issues. tagion may spread to other places
where people are seeking a governThis month, the GAO testified ment paid vacation every year.
that FDA should ask for more auIn the United States, the money
thority, but FDA cannot do more
problems
are tremendous after
with current budgets and staff.
bailing out banking, autos, insurAcross the pond, the EU health ance, and other sectors. This week
claims approval process is tearing the government-backed housing
down businesses with long-time mortgage companies asked for anrecognized health claims on prod- other $20 Billion that the USA does
ucts by applying new and unex- not have coming in. The taxpaypected scientific standards to prod- ers have spent about $145 Billion
bailing out the housing sector.
ucts.
Food safety programs and person-
At the same time, governments
PACIFICHEM 2010
lulu, Hawaii. For registration, hoPetersburg Beach, Florida tel and other information go to:
July 10-14, 2010
www.pacifichem.org. Registration
opens in June.
www.phcog.org/FutureASP.html
HARVESTING HEALTH
The industry is balking at these
actions, seeking modifications.
When the products come off the
market, unemployment will increase.
Natural Medicine LawTM
Unemployment is hovering
around 10% nationwide in the U.S.
and higher in some of the states.
Housing markets are down another
10% or more in some states.
And at the same time, people
seem to want safer food and less
spending, if you believe what some
people are saying.
Liberal government politicians
cannot resist giving people what
they want, knowing that this has
bought them votes for years.
What will we do now? Trust the
farmers? Grow our own? Learn
how to do our own food inspections before we pay our money.
Use common sense and read the
labels. Rely on grocers to do the
inspections
for us?
The U.S. is
not capable
of being the
food safety
inspector for
the world’s
food market.
And many Americans are saying
money does not grow on trees.
Who is correct?
William J. Skinner, R.Ph.,
Attorney at Law, Editor