Natural Medicine Law - Dietary Supplement Regulation, Herbal ...

Vol. 10, No. 6 May 2007
Natural Medicine Law TM Newsletter
GMP REGULATIONS
STILL AT OMB
OMB still has the Dietary
Supplement Good Manufacturing
Practice regulations and has not
sent them to FDA as reported in
other news articles you may have
read. FDA spokesperson Linda
Kahl in College Park, Maryland,
where the new headquarters of the
Center for Food Safety and Applied
Nutrition is located, told NML on
April 30 that the White House
Office of Management and Budget
has not signed off on the
regulations.
The regulations were first
requested in October 1994 when
DSHEA was passed, but the FDA
did not submit a draft until
February 1997. After getting
comments and revising the
proposal, the FDA published a new
version in March of 2003 in the
Federal Register. Now, four years
later, there is nothing much
happening.
The Federal government has set
up a new website to keep track of
regulatory processes. You can go
to: www.reginfo.gov then to the
Department of Health and Human
Services to find what is pending,
including GMPs. There we are told
there is “no” legal deadline or
timetable for adopting GMPs for
dietary supplements. HHS
classifies the regulations as
“major” and says they will have a
“significant economic impact.”
HHS (apparently on FDA’s best
EPHEDRA APPEAL
Statutory interpretation is what the
case is all about. FDA and the 10 th
Circuit read the law one way;
Nutraceutical International
Corporation and its attorneys read
the FDC Act another way. A
Petition for Certiorari has been
filed with the Supreme Court of the
United States by Nutraceutical.
The Natural Products Association
has filed an Amicus Curiae petition
in support of accepting certiorari.
The Justices will read the petitions
and determine if they want to hear
the case or not. [See next column.]
If the Petition is denied, the 10 th
Circuit opinion and orders will be
the law of the land, and the 10 mg
of ephedra alkaloids in capsules are
prohibited from sale in the United
States, while the same and higher
doses are still permitted in food and
traditional Asian tea formulations.
The Court denies most Petitions for
Certiorari. According to U.S.
District Judge Peter Messitte of
Maryland, “The justices operate by
what is known as the ‘Rule of
See DS GMPs -- Cont’d on p. 22.. See EPHEDRA APPEAL- Cont’d on p. 10...
SOLICITOR WINS FOR FDA
The Supreme Court was persuaded
by the Solicitor General to
not take up the Petition for Certiorari
on Epheda filed by
Nutraceutical International. The
Court announced its decision on
May 14 in its regular Orders without
comment.
Paul D. Clement is the Solicitor
General who was Counsel of
Record for the U.S. government.
He said that review by the Supreme
Court is not warranted because the
Circuit Court decision is correct
and does not conflict with any other
Circuits’ decision.
The government said the use of
“or” between “significant” and
“unreasonable” meant that the statute
contains two independent
stardards of risk.
Clement argued FDA has affirmed
that the agency has the duty
to do risk-benefit analyses. This is
the first time and the Supreme
Court should leave it alone.
In This Issue:
GMP Regulation Still at OMB.......................1
Ephedra Appeal in Supreme Court...............1
Solicitor Wins for FDA..................................1
Rules & Guiadance for Manufacturers.........2
New Dietary Ingredients...............................3
Section 403 Letters......................................4
Health Product Licensing Strategy...............5
Antioxidant Study Ignores Science...............5
Effect of Cocoa and Tea on Blood Pressure.5
EU Herbal Monographs................................8
Horse Chestnut Recommended ..................8
Natural Products Association Amicus ........10
Lloyd Library Photo Credits........................15
Canada Adopts New Regulations...............18
Canada Approves Ashwaganda................19
Herbal Product Makers Say Drop It............20
Trademarks for Horse Chestnut.................21
Danger in Products Containing Quinine.....23
IHarvesting Health from the Editor.............24

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RULES AND GUIDANCE
FOR
MANUFACTURERS AND
DISTRIBUTORS
For the first time, the United
Kingdom’s Crown Printer has
allowed the Royal Pharmaceutical
Society of Great Britain to take over
the publication of documents that
were always before published only by
the government printer. The Crown
still owns the copyright. Rules and
Guidance for Pharmaceutical
Manufacturers and Distributors is a
paper or computer loadable program
that interacts with the latest
information on the web from the U.K.
government.
NML is telling readers about this
because some of you are interested in
the regulation and manufacture of
herbal medicines in the U.K. and the
E.C. And those readers of NML who
sell or prescribe herbal medicines
need to know what the governments
in Europe are asking be done. Since
1971 this publication has been known
as the “Orange Guide.” Now it has
become digital for the first time.
When you download the disk to
your computer and open it up, you get
documents that were compiled by the
Inspection and Standards Division,
Medicines and Healthcare products
Regulatory Agency (MHRA),
London, UK. The contents are listed
as:
I MEDICINES AND HEALTHCARE
PRODUCTS REGULATORY
AGENCY (MHRA)
1 MHRA: Licensing, Inspection and
Enforcement for Human Medicines
II GUIDANCE ON GOOD
MANUFACTURING PRACTICE
(GMP)
The MHRA Index to the EU Guide to
GMP
2 EU Guidance on Good
Manufacturing Practice
3 UK Guidance on Manufacture
III LEGISLATION ON
MANUFACTURE
4 EU Legislation on Manufacture
5 UK Legislation on Manufacture
IV GUIDANCE ON WHOLESALE
DISTRIBUTION PRACTICE
6 EU Guidance on Wholesale
Distribution Practice
7 UK Guidance on Wholesale
Distribution Practice
V LEGISLATION ON WHOLESALE
DISTRIBUTION
8 EU Legislation on Wholesale
Distribution
9 UK Legislation on Wholesale
Distribution
VI GLOSSARY OF LEGISLATION
Glossary of Legislation
In these six sections and nine
chapters, you get some common sense
information that needs to be said to
clear the air. And the program
provides a search engine to find such
items as “Herbal Medicine” that is
covered in Annex 7A where it states,
for example, under Premises:
“Storage areas
“1 Crude (i.e. unprocessed) plants
should be stored in separate areas. The
storage area should be well ventilated
and be equipped in such a way as to
give protection against the entry of
insects or other animals, especially
rodents. Effective measures should be
taken to prevent the spread of any
such animals and micro-organisms
brought in with the crude plant and
to prevent cross-contamination.
Containers should be located in such
a way as to allow free air circulation.
“2 Special attention should be paid
to the cleanliness and good
See U.K. RULES -- Continued on page 17...
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Natural Medicine Law TM
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Natural Medicine Law TM May 2007 Page 3
NEW DIETARY
INGREDIENTS
The summaries that NML prints
here are condensations of the
notices filed for new dietary
ingredients (NDIs) by
manufacturers and distributors.
Each manufacturer and distributor
that wants to legally market a NDI
must make a separate submission.
The regulations do not allow for
piggybacking on other company’s
notices. Since the DSHEA was
signed in 1994, and Docket No.
95S-0316 was opened in 1995,
FDA finally cleared up the process
for filing Section 413(a) notices
only ten years later. There are still
less than 400 FDA reports reviewed
and filed in this public dockets at
FDA. The agency granted two
NDIs, one for ADM’s BeneFlax
Flax Lignan Extract and the other
for the NDI of Iwade Research for
Freeze-Dried Extract of Agaricus
blazei Murrill.
SEPPIC, INC. of Fairfield,
New Jersey filed a notice of a New
Dietary Ingredient (NDI) by letter
on June 8, 2006, amending its
earlier notice letter of April 28,
2006, for EXTRAMEL ® ,
containing Cantalope melon
(cucumis Melo L – Carl Linneaus)
extract rich in antioxidants.
EXTRAME ® L is recommended for
use as 10 mg daily dose, equivalent
to 142 I.U. of antioxidant enzymes
and 1.8 ì g of other antioxidants as
vitamins A, E, C, carotenoids. This
dose contains less than the ordinary
daily serving of cantaloupe and
may be considered entirely safe,
says the notice. In EXTRAMEL ®
the extract is coated with 80% of
hydrogenated palm oil to protect
the antioxidants. The extract is
concentrated from crushed
cantalope melon, centrifuged and
filtered, then concentrated. The
result is freeze dried and coated
with palm oil as a protective
excipient. Rinds, seeds and pulp
are not included. No chemicals or
catalysts are added. One oral
toxicity test in rats was included.
FDA responded by letter, dated
July 20, 2006, from Linda S.
Pellicore, Ph.D., stating that the
agency had concerns about the
evidence provided because the
extraction process was only
described in very general terms and
did not provide manufacturing
details. Also, the notice did not
provide a history of use, whole
cantalope, including the rind,
establishing that when used as
suggested will reasonably be
expected to be safe. For these
reasons, the information provided
does not provide an adequate basis
to conclude that EXTRAMEL ®
will reasonably be expected to be
safe. Therefore, the product may
be adulterated and introduction of
the product in interstate commerce
is prohibited. Docket No. 1995S-
0316, RPT 353, received at the
Dockets Office on August 18,
2006, filed August 18, 2006, and
posted to the FDA Website on
November 20, 2006 by kk.
Natural ASA of Lysaker,
Norway, filed an NDI notice, dated
May 15, 2006, for its product
Omega-3 Phospholipids, containing
in each gram 105 to 135 mg
of EPA and 50 to 75 mg of DHA,
and 155 to 210 mg combined
EPA+DHA, with a DPA:DHA
ration of approximately 2:1. The
recommended use is the
consumption of up to 4 g per day.
An attachment concerning safety
was provided that included
sections on regulatory status,
background exposure from diet,
metabolism, animal studies,
clinical studies, and a summary.
This attachment was 83 pages of
information, some parts of which
were redacted. FDA took until
August 4, 2006 to respond by letter
to Egil Nilsen from Linda S.
Pellicore, Ph.D. stating that the
agency was concerned about the
evidence upon which the company
relies to conclude that the product
will reasonably be expected to be
safe. FDA did not know how many
drops, milliliters, teaspoons or
similar units of liquid measure will
be used to measure the 4 g daily
serving. And FDA said the 83
pages did not include the safety of
the components of the product or
the entire mixture. Therefore, FDA
said it is unclear how the
interesterfied components are
qualitatively or quantitatively
similar to the substances described
in the safety information in the
notification or how that
information is relevant to the
product. For these reasons, FDA
said the product may be adulterated
under the Act and introduction of
such a product into interstate
commerce is prohibited. Docket
No. 1995S-0316, RPT 354,
received at the Dockets Office on
October 6, 2006, filed October 6,
2006, and posted to the FDA
Website on November 20, 2006 by
kk.
Arthur Daniels Midland
Company of Decatur, Illinois sent
a NDI notice dated June 6, 2006 to
See NEW INGREDIENTS -- Cont’d on p. 7...
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Page 4 May 2007 Natural Medicine Law TM
SECTION 403 LETTERS
More “Courtesy Letters” or
“Letters of Rejection” are being
filed by FDA staff in response to
notices of structure/function claims
or statements of health claims for
dietary supplements. Fewer than
one in twenty notices to FDA gets
such a response, but FDA has
reviewed nearly 20,000 notices so
far. Here are the latest Section 403
letters.
Enzymatic Therapy, Inc. of
Green Bay, Wisconsin, filed a
notice, dated November 8 and 10,
2006 to the FDA for the products
Liquid Calcium Magnesium with
Botanicals and ITI Mega Multi
Vitamin Drink Mix. The Liquid
with Botanicals product contains
Vitamin D, calcium carbonate,
magnesium oxide and boron oxide,
and the amounts are not disclosed
in the filing. The are six claims:
“Provides synergistic boneenhancing
nutrients,” “Bone
health is built on calcium … and
more!,” “Liquid Calcium
Magnesium with Botanicals
maintains optimum bone health
and may reduce the risk of
osteoporosis,” “ Vitamin D and
boron promote absorption of
calcium,” “Giving you bones what
they need has never been easier …
or more delicious!,” and
“Features a highly concentrated
and bioavailable form of calcium
plus magnesium.” For the Drink
Mix product there are a long list of
vitamins, minerals, amino acids,
and botanicals. The single claim
being made is: “Combined with
additional ingredients, including
natural fruit extract antioxidants
and amino acids, they can provide
nutritional assistance for optimal
energy and healthy stress
management.” FDA’s Vasilios H.
Frankos, Ph.D. responded to
Michael P. Devereaux by letter of
November 28, 2006 stating that the
claim concerning risk of
osteoporosis is one that is subject
to 21 CFR 101.72 and failure to
make a claim in accordance with
that regulation subjects the product
to regulation as a drug. Also, the
FDA letter said that a Drink Mix is
not a “dietary supplement” under
the Act, but is a conventional food
that must meet the food
regulations. Ingredients in food
must be GRAS or approved food
additives or the product is
adulterated and cannot be marketed
legally in the U.S. Docket No.
97S-0163, Ltr 911, received at
Dockets on December 18, 2006,
entered the Docket on December
22, 2006 and posted on the FDA
Website on January 10, 2007.
Flora, Inc. of Lynden,
Washington, wrote FDA two letters
on November 3, 2006 to give
notice that it was filing certain
claims for the products Vegetarian
DHA Flax Oil Dietary Supplement
and Udo’s DHA Oil Blend
Dietary Supplement. Ingredients
of both products were omitted from
the letters. The claims for the Flax
Oil product were: “Supports
cognitive function, heart health,
and eye health,” “DHA is an
omega-3 fatty acid that is essential
for the proper functioning of our
brains as adults, and for the
development of our nervous system
and visual abilities during the first
six months of life,” and
“Supportive but not conclusive
research shows that consumption
of EPA and DHA omega-3 fatty
acids may help reduce the risk of
coronary heart disease.” For the
DHA Blend product, the claims
Digitalis
Photo Courtesy of Lloyd Library and Museum
were the same. FDA responded to
Nancy Blake, on November 28,
2006, by letter from Vasilios H.
Frankos, Ph.D. stating that the
claim that the products will reduce
the risk of heart disease is a disease
claim that they will treat coronary
heart disease and if these claims
are used, these products will be
regulated as drug products under
the Act. FDA added that failure to
make claims that are not in
accordance with certain
enforcement letters with respect to
claims about reduced risk of
coronary heart disease at
www.cfdan.fda.gov/~dms/labqhc.html
would misbrand the
dietary supplement and make the
product subject to regulation as a
drug under the Act. Docket No.
97S-0163, Ltr. 912, received at
Dockets December 18, 2006,
entered into the Docket on
December 22, 2006, and posted to
the FDA Website on January 10,
2007.
See SECTION 403 -- Continued on page 14...

Natural Medicine Law TM May 2007 Page 5
NATURAL HEALTH
PRODUCT
LICENSING STRATEGY
Health Canada announced April
10, 2007 that it wants clarify the
product licensing application
process (i.e. the process for
obtaining a NPN) for those natural
health products (NHPs) currently
holding Drug Identification
Numbers (DIN) issued prior to
January 1, 2004. Specifically, this
document clarifies that the
application process for NHPs with
DINs consists of a regular Product
License Application without the
safety and efficacy information
required in section 5(g), as
authorized under Sections 108 and
109 of the Natural Health Products
Regulations.
As outlined in the transition
provisions of the Natural Health
Products Regulations, all NHPs
with DINs must obtain a valid
product license and Natural
Product Number (NPN) no later
than December 31, 2009.
Applicants are encouraged to apply
as early as possible to transition
their DINs to NPNs. This will
Big Ben and Parliament in London
Natural Medicine Law Around the World
See STRATEGY -- Continued on page 6...
ANTIOXIDANT STUDY
IGNORES SCIENTIFIC
EVIDENCE
A meta-analysis undermining the
benefits of antioxidant supplements
in a new study published in the
February 28, 2007 issue of the
Journal of the American Medical
Association ignores the large body
of scientific evidence supporting the
benefits of antioxidants, says the
Canadian Health Food Association,
a national trade association
representing Canada’s natural
products industry.
“A growing number of evidencebased
studies continue to show the
health benefits of antioxidants and
cannot be discounted. They need to
be considered when drawing
conclusions from this metaanalysis,”
says Anne Wilkie, Vice-
President and Head of Regulatory
Affairs, Canadian Health Food
Association (CHFA.)
“The study only serves to confuse
healthy consumers who may take
antioxidants,” she says. The
researchers themselves
acknowledge their analysis of
previous studies has several
limitations, including combining
studies where participants were
vastly different from each other
(healthy versus diseased
populations); where dosages used
varied significantly; where the
length of time of taking the
supplements and the follow-up
differed among the trials, and the use
of varying definitions of “all-cause”
mortality in the trials. Meta analyses
are valuable tools when the included
studies are similar in design and
study populations.
See CHFA -- Continued on page 18...
EFFECT OF
COCOA AND TEA
ON BLOOD PRESSURE
This abstract is from the Arch
Intern Med. 2007;167:626-634,
April 9, 2007 by authors Dirk
Taubert, MD, PhD; Renate Roesen,
PhD; and Edgar Schömig, MD, all
of the Department of
Pharmacology, University Hospital
of Cologne, Cologne, Germany.
This was a meta-analysis of
randomized controlled trials to
determine changes in systolic and
diastolic blood pressure due to the
intake of cocoa products or black
and green tea. Studies from
MEDLINE, EMBASE, SCOPUS,
Science Citation Index, and the
Cochrane Controlled Trials
Register were searched from 1966
until October 2006. The authors
found studies in parallel group or
crossover design involving 10 or
more adults in whom blood
pressure was assessed before and
after receiving cocoa products or
black or green tea for at least 7
days.
There were five cocoa studies
and five teas studies. Five
randomized controlled studies of
cocoa administration involving a
total of 173 subjects with a median
duration of 2 weeks were included.
After the cocoa diets, the pooled
mean systolic and diastolic blood
pressure were –4.7 mm Hg (95%
confidence interval [CI], –7.6 to –
1.8 mm Hg; P = .002) and –2.8 mm
Hg (95% CI, –4.8 to –0.8 mm Hg;
P = .006) lower, respectively,
compared with the cocoa-free
controls. Five studies of tea
consumption involving a total of
See COCOA IN HBP -- Cont’d on page 8...
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Page 6 May 2007 Natural Medicine Law TM
STRATEGY -- Continued from page 5...
provide the Natural Health
Products Directorate (NHPD) with
adequate time to review the
application and will avoid any
interruption in the sale of their
products.
Section 109 of the Natural
Health Products Regulations
creates an exemption from the
safety and efficacy requirements in
Section 5(g) for products
previously assessed and licensed
by the Therapeutic Products
Directorate (TPD) under the Food
and Drug Regulations (i.e., natural
health products previously granted
market authorization pursuant to a
DIN).
NHPs with DINs must receive a
NPN by December 31, 2009.
Companies may seek an NPN for
their NHPs with DINs by
submitting a Transitional DIN
Product Application to the NHPD
for assessment. The NHPD will
review these transitional
applications to ensure that the
products comply with the Natural
Health Products Regulations.
During assessment, the NHPD
will focus on the elements required
by the Natural Health Products
Regulations once the exemption in
Section 109 is applied to these
applications. These elements
include source material, nonmedicinal
ingredients (NMIs) and
finished product specifications.
Information on the label, where the
Natural Health Products
Regulations requirements differ
from the requirements under the
Food and Drug Regulations, will
also be addressed to ensure
compliance with the labeling
requirements for NHPs.
Applicants will only be able to
file a Transitional DIN Product
Application if the product and
associated claims are identical to
what was approved by the TPD.
Any changes to the product and/or
associated claims will result in the
removal of the submission from
this process / refusal of the
submission. Note the only
exceptions: addition of risk
information to the product (e.g. risk
statements from NHPD
monographs) and changes to nonmedicinal
ingredients.
Prior to the issuance of a Product
License and NPN for NHPs with
DINs, the NHPD requires all
products to meet the requirements
of the Natural Health Products
Regulations. Applicants are
encouraged to include new risk
information from published NHPD
monographs when filing a
Transitional DIN Product
Application. This additional
information allows the consumer to
make a more informed decision
about a product.
Transitional DIN Product
Applications must include all the
information listed further below
(Transitional DIN Application
Requirements). The NHPD will
conduct a review of the application
to ensure that all application
requirements have been met. A
Product Licence and NPN will be
issued in which the recommended
conditions of use (i.e. claims, dose,
duration of use, dosage form, and
risk information) are listed.
Should an applicant wish to
submit amendments not previously
approved by the TPD with their
application, the application will be
assessed in the applicable Non-
Transitional DIN queue.
Transitional DIN Application
Requirements
As of May 1, 2007, all
Transitional DIN Product
Applications received by the
NHPD must include the
information listed below or the
application may be refused. For
transitional applications currently
in queue at the NHPD that do not
meet the requirements listed below,
the applicants will be contacted by
the NHPD and given the
opportunity to amend their
applications accordingly.
1. Cover Letter including
the following attestations:
o
o
o
o
the DIN is valid at
the time of filing;
the product and
label are in
compliance with
the terms of
marketing
authorization
issued by the TPD
under the Food &
Drug Regulations;
the product and
associated claims
are identical to
what was
previously
approved by the
TPD; and
the NMIs are listed
on the NHPD’s List
of Acceptable
NMIs, otherwise
the cover letter
must note those not
on the list;
See STRATEGY -- Continued on page 11...

Natural Medicine Law TM May 2007 Page 7
NEW INGREDIENTS -- Continued from p. 3...
FDA for the product BeneFlax
Flax Lignan Extract. The notice
was a new revision of a notice
previously sent on December 2,
2005. The letter accompanying the
notice said the company had a
telephone conference with Linda
Pellicore, Ph.D. and Vicky Lutwak
in February 2006 and it believed
that this notice “clearly establish
(es) that BeneFlax Flax Lignan
Extract will reasonably be
expected to be safe….” Attached
to the letter was a package of
documents bearing page numbers
stamped on that indicated more
than 400 pages were submitted.
The initial page was marked
“Confidential” and indicates it was
compiled by James S. How, Ph.D.
and that Luis S. Mejia, Ph.D.
was to be contacted. A large
number of pages were redacted;
however, within the package was
information stating that ADM
would manufacture tablets or
capsules of doses ranging from 30
to 300 mg of SDG
(secoisolariciresinol diglucoside)
as the active ingredient which will
be provided by approximately 86
to 860 mg of BeneFlax Flax
Lignan Extract. Also, the
suggested daily dose was 86 to
1720 mg of BeneFlax Flax
Lignan Extract. Depending on the
tablet or capsule size the suggested
daily use will be “Take 1 to 4
tablets or capsules a day.” SDG is
the active and major lignan
component. The chemical name is
â-D-Glucopyranoside, 2,3-bis[(4-
hydroxy-3-methoxyphenyl methyl]-1,4-butanediyl
bis-,[R-)R*,
R*)]. The information stated that
the documents contained a literature
review summary of 44 key
human and animal studies in an appendix,
and this is in the public
record as an attachment to a letter
from ADM dated June 23, 2006.
FDA’s newest response to ADM
was addressed to Luis J. Mejier,
Ph.D. from Linda S. Pellicore,
Ph.D. and dated August 18, 2006.
In this letter FDA had no further
questions and the agency said
“FDA reviews this information to
determine whether it provides an
adequate basis for such a conclusion
[that the evidence indicates the
product when used as suggested
will reasonably be expected to be
safe]. Under 21 USC 350b(a)(2),
there must be a history of use or
other evidence of safety establishing
that the new dietary ingredient,
when used under the conditions
recommended or suggested in the
labeling of the dietary supplement,
will reasonably be expected to be
safe. If this requirement is not met,
the dietary supplement is considered
to be adulterated under 21
USC 342(f)(1)(B) because there is
inadequate information to provide
a reasonable assurance that the new
dietary ingredient does not present
a significant or unreasonable risk
of illness or injury. This letter is to
alert you within the 75-day notification
period that FDA intends to
complete its evaluation within a
few weeks and send you a response
to your notification. Please note
that a lack of a response to a notification
within the 75-day
timeframe does not constitute a
finding by the agency that the ingredient
or a product that contains
the ingredient is safe or is not adulterated
under 21 USC 342, See 21
CFR 190.6(f).” [Because there is
no other entry in this docket, and
that multiple exchanges of information
had taken place between
ADM and FDA before these documents
were placed in the public
file, it is presumed that this NDI
was approved. Nevertheless,
FDA’s preferred legalese in handling
responses to these filings
leaves matters confusing and unclear.
– Ed.] Docket No. 1995S-
0316, RPT 355, received at the
Dockets Office on October 6,
2006, filed October 6, 2006, and
posted to the FDA Website on November
20, 2006 by kk.
IWADE RESEARCH
INSTITUTE OF MYCOLOGY
CO., LTD, of Mie, Japan, sent
FDA a NDI notice, dated June 21,
2006, for its product Freeze-Dried
Extract of Agaricus blazei Murrill
(ABM-FD), which had been
submitted in 1999 (RPT 49) and
2000 (RPT 76). The cover letter
points out that a very similar NDI
was submitted by Japan Applied
Microbiology Research Institute
Ltd as RPT 276. The product is
made from Himematsutake. It is
to be used by dissolving the extract
in water in a marked bottle,
shaking, and drinking on an empty
stomach prior to a meal. Each
bottle contains 3.0 grams of ABM-
FD. Adults (non-pregnant and
non-lactating) are instructed to
consume one bottle per day. The
product is sold in boxes containing
10 bottles. There were seven tabs
of materials attached to the letter
and the manufacturing information
was marked “confidential.” FDA
responded to Toshimitsu Sumiya
by letter dated September 11, 2006
from Linda S. Pellicore, Ph.D.,
signed by Vasilois H. Frankos,
Ph.D. stating: “FDA reviews this
information to determine whether
it provides an adequate basis for
such a conclusion [that the
evidence indicates the product
when used as suggested will
See NEW INGREDIENTS -- Cont’d on p. 9...
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Page 8 May 2007 Natural Medicine Law TM
Theobroma cacao, L.
Photo Courtesy of Ministry of
Agriculture, Kerala State, India
COCOA IN HBP -- Cont’d from page 5...
343 subjects with a median
duration of 4 weeks were selected.
The tea intake had no significant
effects on blood pressure. The
estimated pooled changes were 0.4
mm Hg (95% CI, –1.3 to 2.2 mm
Hg; P = .63) in systolic and –0.6
mm Hg (95% CI, –1.5 to 0.4 mm
Hg; P = .38) in diastolic blood
pressure compared with controls.
The authors conclude that these
randomized dietary studies indicate
that consumption of foods rich in
cocoa may reduce blood pressure,
while tea intake appears to have no
effect.
EU HERBAL MONOGRAPHS
The EU Herbal Monograph
system is moving ahead. On
March 20, 2007, the Committee on
Herbal Medicinal Products
published its list of status levels for
herbs under consideration. The
process starts with assigning a
Rapporteur, then a groups
discusses the information collected
and publishes a draft monograph.
The monograph is given an
assessment and then a final opinion
is adopted. The monograph then
goes up the ladder to other
approvals in the EU system.
Final opinion adopted
Aloe
Frangulae cortex
Lini semen Althaeae radix
Plantaginis ovatae semen
Plantaginis ovatae seminis
tegumentum
Psyllii semen
Sennae folium
Sennae fructus
Valerianae radix
Rapporteur assigned
Absinthii herba
Allii sativi bulbus (new Rapporteur to be
appointed)
Althaeae radix
Avena sativa
Boldi folium
Calendulae flos
Carvi fructus
Centaurii herba
Cimicifugae rhizoma
Curcumae longae rhizome
Cynarae folium
Echinaceae angustifoliae radix
Echinaceae pallidae radix
Echinaceae purpureae radix
Equiseti herba
Hamamelidis cortex
Hamamelidis folium
Hamamelidis folium et cortex,
distillate
Hippocastani semen
Hyperici herba
Lichen islandicus
Meliloti herba
Menthae piperitae folium
Polygalae radix
Polypodii radix
Rhei radix
Ribis nigri folium
Rusci aculeati rhizoma
Salicis cortex
Salviae folium
Sambuci flos
Solidaginis virgaureae herba
Thymi herba
Urticae folium
Urticae radix
Uvae ursi folium
Verbasci flos
Zingiberis rhizome
Assessment close to finalisation
(pre-final)
Anisi fructus
Anisi aetheroleum
Foeniculi amari fructus
Foeniculi amari fructus aetheroleum
Foeniculi dulcis fructus
Draft published
Echinaceae purpureae herba
Passiflorae herba
Primulae flos
Primulae radix
Rhamni purshianae cortex
Draft under discussion
Betulae folium
Eleutherococci radix
Harpagophyti radix
Lupuli flores
Melissae folium
Menthae piperitae aetheroleum
Urticae herba
NML readers who want to know
more can find it at:
www.emea.eu.int/htms/human/
hmpc/mpcmonographsadopt.htm/
HORSE CHESTNUT
RECOMMENDED BY
WELLNESS LETTER ®
The respected Wellness Letter ® ,
published by the School of Public
Health at the University of
California at Berkeley, says horse
chestnut extract might be worth
trying for treatment of hemorrhoids
since most over-the-counter
treatments are of limited value.
.
See WELLNESS -- Cont’d on p. 9...
www.NatMedLaw.com
to search back issues

Natural Medicine Law TM May 2007 Page 9
WELLNESS -- Cont’d from p. 8...
The article in the May 2007 issue
says that Aesculus hippocastanum
has been in Europe for treatment
of various vein disorders of the
legs. In Germany they say the
extract is approved for treatment
of varicose veins and hemorrhoids.
You can read the complete article
at: www.wellnessletter.com/html/
wl/wlAskExperts.html/
In the 1998 First Edition of The
Complete German E Commission
Monographs/Therapeutic Guide to
Herbal Medicines by Blumenthal,
Busse, Goldberg, Gruenwald, Hall,
Klein, Riggins & Rister, the plant
is also described as Hippocastani
cortex/ -flos and its parts, the bark
and flower are used as well as
preparations thereof.
Horse chestnut is combined with
a large number of other herbs in
these preparations. Commission E
says there are no known risks, but
since effectiveness is not
documented, “a therapeutic
application cannot be
recommended.” p. 394. However,
in the Approved Herbs section of
the Commission E book there is
listed Horse Chestnut seed which
is a dry extract prepared from the
seeds that is adjusted to 16 to 20
percent triterpene glycodies
(calculated as anhydrous aescin).
Under the Approved Herb
section clinical studies in humans
are mentioned without citations of
publications stating that with a
placebo as reference, “a significant
Natural Medicine Ties TM
www.natmedlaw.com
reduction of transcapillary
filtration has been demonstrated in
pharmacological studies involving
human subjects, and a significant
improvement shown in the
symptoms of chronic venious
insufficiency (sensation of
tiredness, heaviness and tension,
pruritus, pain and swelling in the
legs) in various randomized
double-blind studies and/or
crossover studies.”
The Approved Herbal monograph
also states there are no known
contraindications, special caution
for use, or interaction with other
drugs.
It is important to remember that
the German Commission E system
which started in 1978 is be
superceded by the European Union
Adopted Community Monographs
in a system that will require each
member state to adopt the EU
labeling over a period of time. At
the present the only adopted EU
monographs are for aloe, frangulae
cortex, linum semen, plantaginis
ovatae semen, plantaginis ovatae
semen tegumentum, psyllii semen,
senna fructus, senna folium, and
valerianae radix. In plainer
English these are aloe, frangula
bark, linseed, plantago seed,
plantago husk, psyllium seed,
senna pods, senna leaf, and
valerian root.
As of March 20, 2007
hippocastani semen has a
“Rapporteur” assigned to the
monograph process, which is the
first stage of collecting data in the
UE review system. See the
complete list of in-process herbal
drugs in the article on page 8. More
information is at: www.emea.eu.int/
pdfs/human/hmpc.
NEW INGREDIENTS -- Con’d from p. 7...
evidence indicates the product
when used as suggested will reasonably
be expected to be safe].
Under 21 USC 350b(a)(2), there
must be a history of use or other
evidence of safety establishing that
the new dietary ingredient, when
used under the conditions recommended
or suggested in the labeling
of the dietary supplement, will
reasonably be expected to be safe.
If this requirement is not met, the
dietary supplement is considered to
be adulterated under 21 USC
342(f)(1)(B) because there is inadequate
information to provide a
reasonable assurance that the new
dietary ingredient does not present
a significant or unreasonable risk
of illness or injury. This letter is to
alert you within the 75-day notification
period that FDA intends to
complete its evaluation within a
few weeks and send you a response
to your notification. Please note
that a lack of a response to a notification
within the 75-day
timeframe does not constitute a
finding by the agency that the ingredient
or a product that contains
the ingredient is safe or is not adulterated
under 21 USC 342, See 21
CFR 190.6(f).” [Because there is
no other entry in this docket, and
that multiple exchanges of information
had taken place between
Iwade and FDA before these documents
were placed in the public
file, it is presumed that this NDI
was approved. Nevertheless,
FDA’s preferred legalese in handling
responses to these filings
leaves matters confusing and unclear.
– Ed.] Docket No. 1995S-
0316, RPT 356, received at the
Dockets Office on October 6, 2006,
filed October 6, 2006, and posted
See NEW INGREDIENTS -- Cont’d on p. 22...
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Page 10 May 2007 Natural Medicine Law TM
EPHEDRA APPEAL -- Continued from page 1...
Four’; that is, cert will be granted if a minimum of
four of the nine justices favor the grant. This is not a
written rule, but rather a long-standing tradition.
Accordingly, cert has been denied even when as many
as three justices have favored it. The philosophy is
that if a ‘substantial minority’ feels the case should
be heard and decided (not necessarily that it should
be decided a certain way), the Court should consider
the merits and decide the case.” 1 From 1980 to 2003
thousands of Petitions are filed each year, but fewer
than 100 are accepted. See chart from Judge
Messitte’s article reproduced on page 1.
Judge Messitte also says “Much can be said about
what makes a petition worthy of a grant of cert or
‘certworthy,’ as lawyers say. Perhaps the main point
of interest is whether and how much the petitioner
must argue the merits of his case in his petition.
Inevitably, some part of the petition must do this, but,
again, the primary showing must be whether there is
a split of authority over the legal questions posed by
the given case and/or why it is in the public interest
that the questions be decided.” 2
The Neutraceutical Petition, provided courtesy of
its counsel, Emord & Associates, to NML gives
several good arguments and four Justices may want
to send FDA a message about statutory interpretation.
Here are some of the arguments being made by the
Petitioners.
The major statutory construction argument is all
about what “or” means. In setting up the arguments,
the Petition states: “Although FDA refused to permit any
exception to its ban on dietary supplements, it did exclude
from its ban all ephedrine alkaloid containing foods as
well as all traditional OTC Asian medicines (regardless of
ephedrine alkaloid dose). Therefore, it limited its ban to
dietary supplements. See App. 70-73. The FDA decision
thus produced the illogical and irrational result of removing
ephedrine alkaloids at every quantitative amount from the
market when in dietary supplements but of not removing
ephedrine alkaloids in any quantitative amount from the
market when in other foods. The Final Rule thus prohibited
petitioners from selling their raw crushed Ephedra sinica
herb in a gelatin capsule (a dietary supplement form) but
did not prohibit them from selling the very same substance
as a tea (a food form). The FDA decision thus defines
adulteration law in a way that discriminates based on the
form of dietary ingredient rather than on the substance of
the ingredient, such that dietary ingredients sold as foods
or as traditional OTC Asian medicines enjoy a statutorily
protected position
denied dietary
ingredients sold
as dietary
supplements.” 3
“To reach this
odd result, the
FDA had to adopt
a novel standard
for proving
ephedrine
alkaloids harmful,
a standard
applicable to all
d i e t a r y
supplements and
in conflict with the
pre-existing
NPA AMICUS BRIEF
The Natural Products Association
(formerly the National Nutritional
Foods Association)
filed an Amicus Curiae brief
with SCOTUS on April 6, 2007
in the Neutraceutical International
case concerning the ephedra
ban. NPA represents over
10,000 manufacturers, wholesalers,
distributors and retailers
of natural products, including
dietary supplements.
See AMICUS --Continued on page 19...
standard for foods, including dietary supplements. The
standard, adopted for all dietary supplements, not just
EDS, fundamentally alters adulteration law for those
products….”
In FDA’s final rule, the agency declared dietary
supplements adulterated if the contained so much as a
single molecule of ephedrine alkaloids and did not rely on
any evidence of the levels where toxicity occurred. Thus
FDA abandoned the Paraselsian axiom that is the basis
of all toxicology – “[a]ll things are poison and nothing is
without poison. Solely the dose determines that a thing is
not a poison.” This position also abandons the basis
for the law of adulteration, the Petition said.
What FDA did was to adopt a new adulteration
test “articulating a standard for unreasonable risk under
402(f) (1) (A) of the [FDCA] for the first time…. ‘In so
doing it took the interpretive leap of equating the
‘unreasonable risk’ statutorily prescribed for dietary
supplements with the ‘safe and effective’ standard that
the FDCA uses to assess whether new drugs may be
granted approval to enter the market. See FDA, 21 U.S.C.
§ 355(b)(1)(A); see also Guidance for Industry: Premarket
Risk Assessment, 5, n.4 (2005) (associating FDA’s risks
and benefits’ test with statutory requirements that drugs
be safe and effective). Thereafter, without specific statutory
authorization, FDA adopted the following three-step
approach.”
“Step 1. The FDA read the statutory words
‘unreasonable risk’ to permit the FDA to use a generalized
risk/benefit standard to determine whether a dietary
supplement should remain on the market. App. 75, 105-
116.”
“Step 2. The FDA assigned minimal health benefits to
ordinary uses, including important consumer objectives
See EPHEDRA APPEAL -- Continued on page 11...

Natural Medicine Law TM May 2007 Page 11
STRATEGY -- Continued from page 6...
2. Completed Product License Application
Form (PLA-FORM);
3. Copy of the label most recently approved by
the TPD;
• Copy of product information printed from
the TPD Drug Products Data base (DPD).
More information is available at: www.hc-sc.gc.ca/
dhp-mps/prodnatur/bulletins/din_trans_din_e.html
4. Copy of the proposed product label text
meeting the labelsing requirements for NHPs
Sections 93 - 95 of the Natural Health
Products Regulations. Also refer to Chapter 3
of the Labeling Guidance Document).
5.
NOTE: if the only claim on the TPD label is
“For therapeutic use only”, applications for
vitamin and mineral products must include the
health claim(s) indicated on the applicable
NHPD monograph(s) (see: Compendium of
Monographs). Risk statements from
applicable NHPD monographs should be
added to the label;
6. Copy of the finished product specifications
including identity, purity and potency;
NOTE: if it is unclear as to which tests are
used to identify the medicinal ingredients in
the finished product, the raw material
specification for that medicinal ingredient
should be included as well;
7. Completed animal tissue forms, if applicable.
NOTE: Specified risk materials (SRMs) are
prohibited, therefore, if any non-medicinal
ingredients are SRMs they must be removed or
replaced by a non-SRM source material. This must
be done in order to be categorized as a Transitional
DIN Product Application; and Product registration
information:
• Copy of Drug Notification form or Notice
of Compliance
www.natmedlaw.com
EPHEDRA APPEAL -- Continued from page 10...
such as weight loss, enhanced athletic performance,
increased energy levels, easier breathing, and other uses,
finding among them only weight loss sufficient to warrant
critical assessment. FDA then determined that scientific
evidence concerning those effects assessed ‘short term’
rather than ‘long term’ weight loss, and ‘short term’ weight
loss was not a significant health benefit according to FDA.
App. 119-121.
“Step 3. The FDA hired Dr. Mario Inchiosa to evaluate
the scientific literature on the effects of intravenously
injected drugs epinephrine and ephedrine, effects it
claimed would occur in orally ingested EDS. Inchiosa’s
untested assessment, in the form of letters of opinion,
concluded that no clear evidence established that the
drugs epinephrine and ephedrine were safe at any
dosages. Dr. Inchiosa created his own unique unpeerreviewed
and untested hypothetical extrapolation in which
he presumed EDS would affect the body in a manner
chemically indistinguishable from ephedrine and
epinephrine, both potent drugs. He extrapolated from the
studies involving intravenous injection of those drugs, even
though the dietary ingredient is orally ingested. He
assumed comparable effects, despite the fact that the
drugs are very potent inducers of rapid heart contractions
and elevated blood pressure and directly affect parts of
the body that the dietary ingredient does not. He employed
a mathematical model never before used in pharmacology
or toxicology to compare the drugs with the dietary
ingredient. Based on those unconventional and
unprecedented techniques, he concluded that continuous
ingestion of 1.5 mg of ephedrine alkaloids every four hours
would present a risk of injury comparable to the drugs.
Neither Dr. Inchiosa nor anyone else at FDA ever
discussed, let alone evaluated clinically, ingestion of 5 mg
or less of ephedrine alkaloids twice daily at meal times,
the actual dosing in the conditions of use for the petitioners’
product. Dr. Inchiosa’s letters were not peer-reviewed.
His hypothesis was never tested. His conclusions of
toxicity were not based on any clinical testing of the actual
dietary ingredient at any dose level, let alone 10 or fewer
mg. The drug-dietary ingredient comparison model he
invented was not adopted through scientific consensus
and is not a standard method for pharmacological or
toxicological evaluation, yet that comparison acquired
decisional significance in the Final Rule’s assessment of
low dose ephedra. App. 101.”
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See EPHEDRA APPEAL -- Continued on page 12...

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Page 12 May 2007 Natural Medicine Law TM
Photo Courtesy of Lloyd Library and Museum
EPHEDRA APPEAL -- Continued from page 11...
“On the strength of this record, the
FDA concluded that it had carried its
burden of proof that ephedrine
alkaloids posed a risk of illness or
injury at every dose level, including
daily dose amounts of 10 mg or less,
justifying a total ban. In words that
track the statute:
The [FDA] is issuing a final
regulation declaring dietary
supplements containing
ephedrine alkaloids adulterated
under the [FDCA] because
they present an unreasonable
risk of illness or injury
under the conditions of
use recommended or suggested
in labeling, or if no
conditions of use are suggested
or recommended in
labeling, under ordinary conditions
of use.
App. 46.
“As should be apparent from the
FDA’s calculated omission of the word
‘significant’ in the quoted passage,
the FDA did not find that ephedrine
alkaloids posed a ‘significant risk’ of
harm. Its ruling is therefore wholly
consistent with the proposition that
ephedrine alkaloids may present at 10
mg or less per daily dose amounts
only a miniscule risk of harm in their
specified use. Stressing the word ‘or’
as disjunctive in the phrase ‘significant
or unreasonable risk’ (and ignoring
‘significant risk’ entirely), the FDA
concluded solely that the risk,
however small, was unreasonable in
light of the minimal health benefits it
stated the substance provided. FDA
therefore concluded that it was wholly
‘unnecessary’ to ask whether the risk
was significant because the term was
included in the statute as a strict
alternative to the phrase
‘unreasonable risk.’ App. 70 (‘We are
not addressing the issue of whether
these products present a ‘significant’
risk under section 402(f)(1)(A) of the
act’); see also Def. Mem. Supp.
Cross-Mot. Summ. J. at 31 n.14
(‘Because the FDA concluded that
EDS pose an unreasonable risk, it
was not necessary for the agency to
address DSHEA’s significant risk
standard’). In sum, the FDA’s position
is that ephedrine alkaloids present an
insignificant, but unreasonable risk of
illness or injury at 10 mg or less (but
no significant health benefit at any
dose).”
Further along in the Petition,
Nutraceutical says that the 10 th
Circuit held the term
“unreasonable risk” required the
risk-benefit comparison as
prescribed in the New Drugs
section of the FDCA. And the 10 th
Circuit violated the Supreme
Court’s holding that reading
wording in a statute, in this case
“unreasonable risk” in isolation
from all other terms in the statute
to avoid treating the words as
surplusage is unacceptable in when
used to interpret the law contrary
to congressional intent. Scheidler
v. National Organization for
Women, Inc. 126 S. Ct. 1264, 1273
(2006)
The Petition then argues that “But
even under the surplusage canon, the
Tenth Circuit’s decision fails because
it has not satisfied the statutory
requirement that adulteration be
determined based on recommended
or suggested dosages in labeling. The
surplusage canon hardly requires the
FDA to introduce through the back
door a fundamental regime change
whereby dietary supplements are now
evaluated under the standards
reserved for drugs in the FDCA with
the FDA bearing (an attenuated)
burden of proof.”
“The Tenth Circuit has ruled out the
possibility of a simpler reading, one
consistent with the plain language of
the statute and the legislative intent.
‘Unreasonable’ need not beget a
meaning independent of all other
words in the statutory sentence nor
does it require consideration of health
benefit when no reference to a
comparison of risk with benefit exists
in the Adulterated Food section or in
the legislative history pertaining to that
section. ‘Unreasonable’ does not
require abandonment of the central
principle of adulteration law, the
Paracelsian axiom that dose
determines toxicity. Within the
meaning of the statute, a risk
becomes ‘unreasonable’ at a dose
level that causes illness or injury. A
risk becomes ‘significant’ based on
the degree of illness or injury
experienced (e.g., a tumor as
opposed to a headache). The term ‘or’
does not carry a disjunctive meaning,
such that FDA is at liberty to ignore
‘significant’ risk in finding adulteration.
Rather, each term independently
modifies the noun ‘risk’ and must be
interpreted. Harmonized with the food
subparts of Section 342, a ‘significant
or unreasonable risk’ is one that
causes illness or injury at a particular
dose level (and above) that cannot be
mitigated through modification of
labeling but is a characteristic
response experienced by users to the
dose recommended, suggested, or
ordinarily consumed. Moreover,
‘unreasonable’ in the dietary
ingredient subsection of the
Adulterated Food section does not
invite a construction of the FDCA that
supports the bizarre distinction that
defines a food containing 15 to 30 mg
See EPHEDRA APPEAL --Cont’d on p.13...

Natural Medicine Law TM May 2007 Page 13
EPHEDRA APPEAL -- Continued from p. 12...
or more of a dietary ingredient exempt
from the holding of adulteration but
declares a dietary supplement
containing 10 mg or less of the same
dietary ingredient adulterated and
banned from the market. Congress
intended that the dietary ingredient
subsection be harmonized with the
pre-existing statute, S. Rep. No. 103-
410 at 21, not interpreted to create a
separate regime in conflict with the
old. The FDA’s view upheld by the
Tenth Circuit is clearly incorrect
because it exempts all ephedrine
alkaloid-containing foods, including
ephedra tea (having ephedrine
alkaloids per serving in concentrations
greater by far than the 10 mg per daily
dose in the petitioners’ dietary
supplements). Indeed, the herb used
in ephedra tea is precisely the same
as the herb used in Petitioners’ dietary
supplement (raw crushed ephedra
sinica), differing only in the amount of
ephedrine alkaloids delivered (15 to
30 mg or more from the tea per
serving compared to 10 mg or less
mg from the capsule per daily dose).
DSHEA contains no intimation that
Congress has authorized an absurd
reading of the Adulterated Food
section, one that construes a single,
uniform statutory section to yield an
internally inconsistent result, against
the statutory construction
requirements of this Court. See FDA
v. Brown & Williamson Tobacco Corp.,
529 U.S. 120, 133 (2000).”
The Petition next says FDA has
fundamentally altered food
adulteration law without
authorization from Congress and
the 10 th Circuit has condoned this
usurpation of legislative power.
FDA relied on a non sequitur: “that
the absence of evidence proving
safety is the same as the presence
of evidence proving harm. Quite
simply, FDA has smuggled a
finding of significant risk into its
unbalanced risk-benefit analysis.”
And finally, the Petition
summarizes: “In sum, if the FDA is
allowed to conduct future analyses of
dietary supplements under the
skewed test that it has adopted and
the Tenth Circuit has upheld, then the
congressional compromise that
defines separate regimes for foods
and drugs no longer holds true in the
food adulteration context. Rather, the
FDA may henceforth draw inferences
about the risks of dietary supplements
at any dose level whatsoever, in the
face of the statutory requirement that
it run its evaluation at the
recommended or suggested levels of
use. It may henceforth evade its
burden of proof by relying on unpeerreviewed,
solicited opinion letters that
present untested models that
extrapolate from results of tests
conducted on different substances
(drugs) intravenously injected and
presume those results the same for
dietary ingredients orally ingested.
Under the Tenth Circuit’s decision,
FDA may now insist that infinitesimal
risks are unreasonable, magnifying
them beyond the record evidence, as
it has done in Nutraceutical’s case,
and then conduct a statutorily
unauthorized benefit comparison that
ignores all non-health benefits and
subjectively deems virtually all health
benefits insufficiently weighty to
counterbalance perceived risks.
Indeed, significant and clinically
proven health benefits, presumably
the kind that might be viewed by FDA
as sufficiently weighty, cannot be
demonstrated because intent to
produce therapeutic benefits defines
a drug and is impermissible for
supplements.”
“In short, the FDA has nullified the
bedrock of adulteration law, that dose
determines toxicity. It has negated the
fundamental requirement that FDA
prove a dietary ingredient itself, rather
than a surrogate substance, i.e., a
drug, a significant risk before banning
the ingredient from the market.
Without statutory authorization and
against the plain and intended
meaning of Congress, FDA has
superimposed on the Adulterated
Food section a drug risk-benefit
standard, eliminating the essential
divide between foods and drugs
created by the FDCA and rendering
the critically important Adulterated
Food section internally inconsistent
and irrational. That rewrite of the law
is causing instability in food and
supplement markets. Lawless
behavior by agencies in defiance of
their enabling statutes should never
be tolerated when the means are at
hand to correct that behavior.”
Imagine reading several
thousands of these petitions and
trying to sift out fewer than 100 to
ask counsel for more briefs and
argument. The job will take
concentration and maybe some
enthusiasm, but issues about
government agencies writing their
own laws have always been of
interest to Supreme Court Justices.
If the Court ignores such rogue
government overreaching as
happened in this case, then
Congress is likely to react.
The Petition for Certiorari is 29
pages and the Court’s rule limits it to
30 pages. There is an appendix of 137
pages. Richard A. Epstein, Esq., who
is the James Parker Hall
Distinguished Service Professor of
Law, Faculty Director for Curriculum,
and Director, Law and Economics
Program at the University of Chicago,
(773) 702-9563) is on the Petition
with Jonathan W. Emord, Esq. of
Reston, Virginia, (202) 466-6937)
who is the Counsel of Record.
(Footnotes)
1 eJournal USA: Issues of Democracy,
April 2005, http://usinfo.state.gov/
journals/itdhr/0405/ijde/messitte.htm
2 Ibid.
3 All additional quotations are from the
Petition for Certiorari.
Nutraceutical Corporation; Solaray, Inc.
v. Andrew Von Eschenbach,
Commissioner, et al., United States
Supreme Court, No. 06-922.
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Page 14 May 2007 Natural Medicine Law TM
SECTION 403 LETTERS - Continued from page 4...
Holistic Therapies of Boca Raton, Florida, wrote
FDA on November 8, 2006 stating that it was a
distributor for the product MegaBone, made by
Orthomolecular Products of Stevens Point,
Wisconsin. MegaBone contains Vitamins D3, K,
Folic Acid, Calcium, Phosphorus, Magnesium,
Selenium, Copper, Manganese, Molybdenum,
Ipriflavone, Strontium Citrate, Montmorillionite,
Boron, Cranberry Juice Concentrate and Tumeric
Root Extract. There were no claims and the letter
was unsigned over the words “[Your name here}.”
There was one other notice letter included, also
unsigned, but this time with a copy of the label for
the product ThyroMega, containing Iodine, L-
Thyrosine USP, Ashwaganda Root Extract,
Bladderwrack Leaf and again no claims. FDA’s
Vasilios H. Frankos, Ph.D. responded to the
“President” at the company address by letter dated
November 28, 2006 and stated that since the notices
submitted were not signed they do not meet the
requirements of 21 CFR 101.93(a)(3) and as such do
not comply with the Act. Docket No. 97S-0163, Ltr
913, received at the Dockets Office on December 18,
2006, entered into the Docket on December 22, 2006,
and posted to the FDA Website on January 10, 2007.
Tronex Company of Parsippany, New Jersey,
wrote FDA on October 31, 2006 to give notice that it
represented Wellslife Corporation of Taiwan as its
authorized U.S. Agent and Principal Distributor for
products named Eydeal, Soligen, Beauty Sleep,
Trimnastics and Trimnastics Tea, CD – Cup D’Jour,
Celline, and Hair 3 System. However, FDA included
in the public file information pages on only two of
the eight products. [NML has requested FDA to post
to the website the other eight pages. – Ed] The page
on Trimnastics Tea indicates it contains Rose, Flower
Bud of Seville orange, Jasmine, Chunxiong Rhizome,
and Lotus Leaf. Trimnastics Tea is to be used one
teach a time and two times a day in hot water to steep
2 to 4 minutes. There are 60 tea bags in a box. The
claim statement offered is: “Trimnastics Tea is the
safe and natural companion to Trimnastic. It
compliments the daily regime by reminding you to
take a weight-reduction tea break. Trimnastics and
the “TEA” are made from all natural herbal
ingredients.” Beautysleep is recommended for use
by taking one packet per day with warm water one
hour before bedtime. There are 30 packets in a box.
The contents of a packet are Zizphus 800 mg, Oyster
shell 600 mg, Rehmanniae 600 mg, Spica Pruneellae
500 mg, and White Peony Root 500 mg. The claim
statement for Beautysleep is: “Beauty Sleep(sic) helps
you enjoy good sleep naturally without taking the risk
of prescription drugs dependency. Beauty Sleep(sic)
is based on a Traditional Chinese Medicine formula,
and made from all natural herbal ingredients. It is
absolutely safe and effective.” FDA responded to
Peter Sewell by letter of November 28, 2006 signed
by Vasilios H. Frankos, Ph.D. to these two notices.
Frankos wrote that Trimnastics Tea, as a drink, is a
conventional food and must comply with nutrition
labeling defined at 21 CFR 101.9. Any ingredient in
food must be GRAS or an approved food additive or
the food is adulterated and cannot be legally marketed
under the Act. FDA wrote that the claims for
Beautysleep “Helps you fall asleep if you have
difficulty falling asleep” and “helps to reduce difficulty
falling asleep” are disease claims. [Neither of these
claims are in the documents FDA placed in the public
file. – Ed.] Also, FDA stated that the January 6, 2000
rule on structure/function claims does not permit a
dietary supplement manufacturer to state that it has
fewer side effects than a drug. Because of these claims
Beautysleep will be regulated as a drug if the claims
are used. Docket No. 97S-0163, Ltr 914, received at
the Dockets Office on December 18, 2006, entered
into the Docket on December 22, 2006, and posted to
the FDA Website on January 10, 2007.
Alert Nutrition, LLC of Wayzata, Minnesota wrote
FDA on November 11, 2006 to give three notices that
it would use certain “label revision” statements of
claim on its products, Immune Alert R Children’s
Formula – Cherry Flavor Chewable Tablets, Immune
Alert R Adult’s Formula – Orange Flavor Chewable
Tablets, and Immune Alert R Adult’s Formula –
Capsules. Each letter was accompanied by a product
label and a copy of the cover of a pull out Spanish
label and cap sticker. For Immune Alert R Children’s
Formula – Cherry Flavor Chewable Tablets contain
BetaRight R of beta 1,3/1,6 glucan extracted from foodgrade
Baker’s yeast (Saccharomuyces cerevisiae), a
FDA-approved ingredient (21 CFR 170.30) and the
claim was “Germs, virus, bacteria … kids pass them
back and forth and bring them home to you. Taken
daily, Immune Alertwith Beta 1,3/1,6 Glucan (an all
See SECTION 403 LETTERS -- Continued on page 15... .

Natural Medicine Law TM May 2007 Page 15
SECTION 403 LETTERS -- Continued from page 14...
natural complex carbohydrate extracted from baker’s
yeast) puts your children’s natural defenses on high
alert to fight off these invaders.” FDA’s December
8, 2006 letter from Vasilios H. Frankos, Ph.D. to
Jerome Licari, Ph.D. stated that this claim was a
disease claim, namely diseases caused by pathological
organisms. For Immune Alert R Adult’s Formula –
Orange Flavor Chewable Tablets, and Immune Alert R
Adult’s Formula – Capsules, containing the same
ingredients, the claims also were the same, namely,
“Each day your body fights off billions of diseasecausing
micro-organisms. Taken daily, Immune
Alertwith Beta 1,3/1,6 Glucan (an all natural complex
carbohydrate extracted from baker’s yeast) puts your
children’s natural defenses on high alert to fight off
these invaders – stopping them before they stop you.”
FDA’s letter also stated that these claims were disease
claims and if Alert Nutrition intends to make these
claims, the products are subject to regulation as drugs
under the Act. Docket No. 97S-0163, Ltr 915,
received at the Dockets Office on December 18, 2006,
entered into the Docket on December 22, 2006, and
posted to the FDA Website on January 10, 2007.
Enzymatic Therapy, Inc. of Green Bay, Wisconsin,
filed a notice, dated November 10, 2006 to the FDA
for the product LeveLife Synergy Drink containing
taurine, Benco Synergy 1, whey protein,
Glucomannan Extract, Chromium picolinate, Malic
Acid, Hersperidin Complex 50%, Vitamin C, L-
Tyrosine, Glycine, Roboflavin, and Inositol. The
amounts are not disclosed in the filing. There are
thirteen claims made for the product. FDA’s Vasilios
H. Frankos, Ph.D. responded to Michael P. Devereaux
by letter of December 8, 2006 stating that a drink is a
conventional food and not a dietary supplement.
Therefore the product should be labeled with nutrition
labeling and all ingredients must be GRAS or
approved food additives or the product is adulterated
and may not be marketed in the United States. Docket
No. 97S-0163, Ltr 916, received at the Dockets Office
on December 18, 2006, entered into the Docket on
December 22, 2006, and posted to the FDA Website
on January 10, 2007.
Calgenex Corporation of Tampa, Florida, filed a
notice, dated November 29, 2006 for its product
Omeganol, containing fish oil concentrate, d-alpha
tocotrienol, d-beta tocotrienol, d-gamma tocotrienol,
d-delta tocotrienol and d-alpha tocopherol. The
ingredient amounts were not indicated. The claims
were: “Manage your cholesterol and triglycerides.
A natural solution to help maintain blood lipid
balance. Helps protect your heart.” FDA’s Vasilios
H. Frankos, Ph.D. responded to Grant Carlson by
letter of December 13, 2007, stating that the preamble
to the final rule on structure/function claims, January
6, 2000, explained that claims about maintenance of
normal cholesterol levels do not necessarily constitute
implied disease claims, but the claims would have to
clarify that the product is only for maintenance of
cholesterol levels that are already within the normal
range. Without such an addition, the claims being
made are disease claims making the product subject
to regulation as a drug under the Act. Docket No.
97S-0163, Ltr 917, received at the Dockets Office on
December 18, 2006, entered into the Docket on
December 22, 2006, and posted to the FDA Website
on January 10, 2007.
World Nutrition, Inc. of Scottsdale, Arizona,
wrote FDA on December 11, 2006 to give notice that
See SECTION 403 LETTERS -- Continued on page 16...
PHOTOGRAPHS FROM LLOYD LIBRARY AND MUSEUM
Cover -- Common Horse Chestnut (æsculus hippocanstnum) from
MEDICAL BOTANY by John Stephenson and James Morss Churchill,
M.D. 1829.
Cover -- Podophyllum (Podophyllum Peltatum) from AMERICAN
MEDICINAL PLANTS by Charles F. Millspaugh, M.D, 1887
Cover --Goldenseal (Hydrastis Canadensis) from AMERICAN ME-
DICINAL PLANTS by Charles F. Millspaugh, M.D, 1887
Page 4 - Foxglove (Digitalis purpurea) from MEDICAL BOTANY
by John Stephenson, M.D. and James Morss Churchill, F.L.S.
1828
Page 12 - Ginseng (Panax quinquefolium) from THE FAMILY FLORA
AND MATERIA MEDICA BOTANICA by Peter P. Good 1847
Copyright 2007 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
www.natmedlaw.com
Page 16 - Olive Tree (Olea Europæa) from FLORA GRÆCA by
Johannes Sibthorp. M.D. & Jacobus Edvardus Smith, M.D., 1806
Page 22 -- Cone Flower (Echinacea Intermedia) from PAXTON’S
MAGAZINE OF BOTANY, 15th Vol. 1849

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Page 16 May 2007 Natural Medicine Law TM
SECTION 403 -- Contintued from p. 15..
it would use a certain claim for its
product, Wang’s Juemingjing Herb
Extract, containing Flatstem,
Milkvetch Seed, Chinese Wild
Yam, Safflower, Milkvetch root,
Cape Jasmine fruit, Kudzu vine
root, Licorice Root, Korean
ginseng. The amounts of
ingredients are not disclosed. FDA
wrote Tom Miano on December 13,
2006 that the notice must be
certified by a responsible
individual that the notice is
complete and accurate and that the
notifying firm has substantiation
that the statement is truthful and not
misleading. FDA’s letter signed by
Vasilios H. Frankos, Ph.D. did not
comment further. Docket No. 97S-
0163, Ltr 918, received at the
Dockets Office on December 18,
2006, entered into the Docket on
December 22, 2006, and posted to
the FDA Website on January 10,
2007.
Alltech Biotechnology Center
of Nicholasville, Kentucky, sent
FDA a letter on December 5, 2006
to give notice that it would make
statements of nutritional support
for its product SEL-PLEX –
mineral supplement – capsule. The
ingredients of the product are
selenium yeast, magnesium state an
gelatin. The claims were:
“Mineral supplement to maintain
health. 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 has
determined that this evidence is
limited and not conclusive.
Selenium may produce
anticarcinogenic effects in the
body. Some scientific evidence
suggests that the consumption of
selenium may produce
anticarcinogenic effects in the
body. However, FDA has
determined that this evidence is
limited and not conclusive.” FDA
responded to Pearce Lyons, Ph.D.
by letter, dated December 22, 2006
from Vasilios H. Frankos, Ph.D.
stating that this claim is not a
structure/function claim, but a
claim under 21 USC 343(r)(1)(B)
because it represents the product
will reduce the risk of a disease.
FDA explained that it had
previously agreed to exercise
enforcement discretion for
selenium products and claims for
selenium at www.cfsan.fda.gov/
~dms/ds-ltr35.htm and failure to
make a claim in accordance with
the enforcement discretion would
cause the product to be
misbranded. FDA added that using
the proposed claim would result in
the product being regulated as a
drug because it claims the product
is used to treat cancer, a disease.
Docket No. 97S-0163, Ltr 919,
March 1, 2007, entered into the
Docket on February (sic) 1, 2007,
and posted to the FDA Website on
March 29, 2007.
New Chapter, Inc. of
Brattleboro, Vermont, wrote FDA
on December 13, 2006 to give
notice that it would use certain
claims for its products
Rhodiolaforce 100 and
Rhodiolaforce 300. The product
contains Rhodiola rosea. The
claims were the same for these
products, and were: (1) Thriving in
high altitudes and in nature’s most
challenging climates, this most
resilient herbal is intensively
studied for calming stress,
increasing energy, metabolism of
fat, enhancing memory, and
boosting the body’s immune
Olive Tree (Olea Europæa) 1806
Photo Courtesy of Lloyd Library and Museum
defenses. 2) Rhodiola also protects
the heart in several ways, including
boosting the energy available to
heart muscles, thereby preventing
the kind of damage that can lead
to heart attacks or heart failure. 3)
And its unique group of antioxidant
compounds also helps to protect
cells and DNA from being
damaged by unstable oxygen
compounds.” FDA responded to
Ashley Chapin by letter of January
3, 2007 from Vasilios H. Frankos,
Ph.D. stating that the claim
“Rhodiola also protects the heart
… preventing the kind of damage
that can lead to heart attacks or
heart failure” was a disease claim
for treating heart disease and stated
that if this claim is used, the
products are subject to regulation
as a drug under the Act. Docket
No. 97S-0163, Ltr 920, received at
the Dockets Office on March 1,
2007, entered into the Docket on
February (sic) 1, 2007, and posted
See SECTION 403 LETTERS -- Cont’d p. 17...

Natural Medicine Law TM May 2007 Page 17
SECTION 403 -- Continued from p.16 ...
to the FDA Website on March 29,
2007.
Global Pharmatech, Inc. of
Gaithersburg, Maryland wrote
FDA on December 13, 2006 to give
notice of its intent to distribute the
product Vigor Supplier ® Tablet,
containing Echinacea purpurea
extract 0.4 g and American ginseng
extract 0.1 g, made by Jilin
Bencaotang Pharmceutical Co.,
Ltd of China. The company also
apparently wrote on December 12,
2006 to submit a notice for the
product Radish Seed Tablets,
containing 1.4 g of Radish seed
extract. FDA’s letter in response,
dated January 16, 2007, signed by
Vasilios H. Frankos, Ph.D. to Tom
Du, M.D., Ph.D. states that the
label for Vigor Supplier ® Tablet
bears the statement “Echinacea
has been used for the enhancement
of human health for centuries.
Anti-fatigue activity of American
ginseng is well recognized in
American and Asian community
(Integr Cancer Ther. 2003 Sep:
2(3):247.” The label for Radish
Seed Tablets bears the statement
“Chinese scientist observed that
Radish seed extract is helpful to
maintain human blood pressure in
normal range. Pakistan scientists
found that extract of Radish Seeds
was able to decrease blood
pressure in experimental animals
(Fundam Clin Pharmacol 2006
Feb; 20(1)57,” and “Chinese
herbalists also showed that Radish
seed extract reduced blood lipid
levels in 38 Chinese human
subjects (Zhejian Zhongyi J. 1995.
30(1):494.” FDA’s letter states
that the preamble to the January 6,
2000 final rule on structure/
function claims gave FDA’s
position on using citations to
scientific references on the product
label or packaging should be
considered a disease claim because
of the unusual and unnecessary
prominence of such placement.
Since the word “cancer” appears in
the citation on the label of the Vigor
Supplier ® Tablet and the claims on
the Radish Seed Tablets includes
disease claims, the articles
expressly or impliedly describe
effects of the ingredients on
diseases. FDA says, since these
claims suggest use as drugs for
treatment, if the claims are used,
the products are subject to
regulation as drugs under the Act.
Docket No. 97S-0163, Ltr 920,
received at the Dockets Office on
March 1, 2007, entered into the
Docket on February (sic) 1, 2007,
and posted to the FDA Website on
March 29, 2007. [NML has marked
the February 1, 2007 dates with
(sic) in the last three summaries
because it seems impossible that the
documents were entered into the files
before they were received. – Ed.]
U.K . RULES -- Continued from page 2...
maintenance of the storage areas
particularly when dust is generated.
“3 Storage of plants, extracts,
tinctures and other preparations may
require special conditions of
humidity, temperature or light
protection; these conditions should be
provided and monitored.
“Production area
“4 Specific provisions should be
taken during sampling, weighing,
mixing and processing operations of
crude plants whenever dust is
generated, to facilitate cleaning and
to avoid cross-contamination, as for
example, dust extraction, dedicated
premises, etc.”
This new publication is the first
thing NML recommends that you
study if you are going to start selling
herbal remedies in the U.K. or
European Community. You can get
more information about this and other
publications of similar nature from
www.medicinescomplete.com where
you will find details about other
publications such as the AHFS Drug
Information publication from the
American Society for Health-System
Pharmacists, the book Herbal
Medicines, the British National
Formulary, Martindale: The
Complete Drug Reference, and
Dietary Supplements that are relied
upon in the U.K. For pricing
information go to:
www.pharmpress.com/shop/
default.asp , the web for the
Pharmaceutical Press.
ONE QUININE PRODUCT
FDA told manufacturers to stop
marketing unapproved drug products
containing quinine because of serious
safety concerns. While quinine has
traditionally been used as a treatment
for malaria, many patients use these
products to treat leg cramps and
similar conditions, a use which is not
approved by FDA.
FDA has received 665 reports of
serious adverse events associated with
quinine use since 1969, including 93
deaths. Among the side effects of
quinine are cardiac arrhythmias,
thrombocytopenia, and severe
hypersensitivity reactions.
Because of the side effects, and
because the toxic dose for quinine is
only slightly higher than the
therapeutic dose, patients should be
warned against treating their leg
cramps with quinine products.
At the present time, Qualaquin,
See QUININE -- Continued on page 18...
Copyright, 2007 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside

Copyright 2007 by Muscatatuck Publishers, Inc. For Information on photocopying, see Page 2 Inside
Page 18 May 2007 Natural Medicine Law TM
CINCHONA -- Photo courtesy of M L Wee
and The Australian National University.
manufactured
by Mutual
Pharmaceutical
Company, is
the only
quinine product
approved
by the FDA.
Qualaquin is
indicated for
the treatment
of malaria,
and its labeling specifically warns that the product is
not indicated for treating leg cramps. FDA Medwatch
Safety Alert for Quinine products. For more see:
www.fda.gov/medwatch/safety/2006/
safety06.htm#Quinine
CHFA -- continued from page 5...
QUININE -- Cont;d
from page 17...
“Healthy consumers should continue to rely on
antioxidant supplements for the benefits they confer,”
says Wilkie. “This meta analysis does not provide
convincing scientific evidence that antioxidant
supplements do not provide potential health benefits.”
The CHFA reminds consumers that Health Canada
has established monographs with dose information and
indications for the antioxidants beta-carotene, vitamin
A, and vitamin C and has not reported any risks in the
use of these supplements. In fact, the federal government
introduced the Natural Health Products Regulations in
2004 to ensure natural health products, such as vitamins,
sold in Canada were safe, had evidence to support their
claims and contained what was on the label.
For further information, contact Natalie Cajic,
Communications Coordinator, at 416-497-6939 ext.
234, 1-800-661-4510 or ncajic@chfa.ca.
The Canadian Health Food Association (CHFA) is
Canada’s largest national trade association
representing the organic and natural products industry.
Its members include over 85 per cent of the subsectors
such as vitamin and mineral supplements,
herbals, homeopathics, sports nutrition products,
natural foods and organic products. CHFA members’
products support Canadians seeking optimal health
and quality of life.
CANADA ADOPTS NEW REGULATIONS
In the monthly update of information concerning
natural health products, the Canadian government has
announced that is has adopted the nutrient content
claims now exiting in the Nutrient Content Claims
listed in sections B.01.500 to B.01.513 and the Table
that follows B.01.513 of the Food and Drug
Regulations. This information can be accessed from
the Department of Justice Canada Website
(www.justice.gc.ca).
The announcement said that after careful
consideration, for the assessment of “absence of” and
“addition of” claims, the NHPD has decided to adopt
these criterion. The Table following B.01.513 in
particular provides definitions of 47 common
“absence of” and “addition of” claims and outlines
specific guidelines and limitations for their use. These
criteria will in turn be used by the NHPD during
product assessments to determine if a specific claim
with respect to the absence or addition of medicinal
or non-medicinal ingredients is true, false or
misleading.
Example:
Based on the Table following section
B.01.513 of the Food and Drug Regulations
For a natural health product to make the claim
“fat-free”, the product must meet the following
criteria:
• less than 0.5 g of fat per reference amount
and serving of stated size; or
• less than 0.5 g of fat per serving of stated
size, if the product is a pre-packaged meal.
If the applicant provides the necessary evidence
demonstrating that the product meets one of the
following criteria listed above, then the following
“absence of” claims would be acceptable: “fat-free”,
“free of fat”, “no fat”, “0 fat”, “zero fat”, “without
fat”, “contains no fat” or “non-fat”
The NHPD will also be developing additional
criteria for “absence of “and “addition of” claims
currently not found in the Table following section
B.01.513. and will deal with these on a case-by-case
basis in the interim.
Also in the new information Health Canada
announced that Revisions have recently been made
See REVISIONS -- Continued on page 19...

Natural Medicine Law TM May 2007 Page 19
REVISIONS -- Continued from page 18...
to the monographs for Black Cohosh, Ginger, and
Valerian. The revised monographs are currently
available online in the Compendium of Monographs.
From the NHPD Monthly Communiqué, Vol. 2,
Issue 6 - April 2007 found at www.hc-sc.gc.ca/dhpmps/prodnatur/bulletins/communiques/
communique_april07_e.html#1_2
CANADA APPROVES
ASHWAGANDA MONOGRAPH
Health Canada approved a monograph for withania
somniferai on April 18, 2007 for traditional uses in
Ayurveda medicine as a rejuvenative tonic,
convalescence in old age, sleep aid, to balance
aggravated Vata or nervine or tonic, and for memory
enhancement. The dose recommended is 2 to 6 Grams
per day of the dried roots by mouth. The plant is also
known as Ashvagandha, Asgandh and Winter Cherry.
See the full monograph at: www.hc-sc.gc.ca/dhp-mps/
prodnatur/applications/licen-prod/monograph/
mono_ashwagandha_e.html.
The Natural Health Products office also modified
the monographs for Blessed Thistle and Heal-All, but
said the changes did not require any action by current
licensees. For details go to: Blessed Thistle at
www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/
licen-prod/monograph/mono_blessedthistlechardonbeni_e.html
and for Heal-All go to: www.hcsc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/
monograph/mono_healall-prunvul_f.html.
AMICUS -- Continued from page 10...
A summary of the argument was presented in the
introduction of the 17 page brief as:
“This case presents an exceptionally important
issue of administrative and statutory law: may
the FDA ignore the clear distinction Congress
has drawn between drugs and dietary
supplements, which are classified as foods,
and thereby greatly expand its authority to
declare a dietary supplement ‘adulterated’
Congress has given the FDA ample powers to
protect public health and safety from
adulterated foods, including dietary
supplements. But in banning ephedrine
alkaloids in dietary supplements, the FDA
chose not to rely on its lawful powers. Instead,
it took the opportunity to re-write the DSHEA,
a statute the FDA strenuously, and
unsuccessfully, opposed.
“The FDA concluded that ephedrine
alkaloids in dietary supplements pose an
‘unreasonable’ risk to health, and are thus
adulterated and should be banned. Amicus
takes no position on whether, under the proper
definition of “unreasonable,” the FDA’s
decision was correct. The FDA relied,
however, on an unauthorized “risk-benefit”
analysis for dietary supplements, essentially
requiring that dietary supplements provide
significant health benefits, proved in rigorous
clinical studies, sufficient to overcome any
risks associated with the product. This is the
standard that governs FDA pre-marketing
approval of drugs; foods, including dietary
supplements, are not subject to any such
standard. The FDA’s test, moreover, affords
the agency an exceptionally large degree of
discretion to ban dietary supplements as
“adulterated.’ Indeed, in applying the standard
in this case, the FDA discounted the
significance of most non-‘health’ benefits
provided by dietary supplements — which are
important to millions of consumers and are
recognized expressly in the DSHEA — and
concluded that those benefits would
henceforth be insufficient to overcome even
a small risk of harm. The District Court held
that this expansive interpretation of the
agency’s powers violated the statute, but the
Tenth Circuit reversed. The FDA’s rule, and
the Tenth Circuit’s decision, cannot be
reconciled with the DSHEA, and a writ of
certiorari is warranted to bring the agency’s
rule in line with Congress’s commands.
See AMICUS -- Continued on page 20...
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AMICUS -- Continued from page 19 ...
“Unless this Court grants the petition for a
writ of certiorari, the dietary supplement
industry will suffer severe harm. A significant
percentage of the principal makers of dietary
supplements are located within the Tenth
Circuit, and are therefore subject to its
erroneous decision. If that decision is allowed
to stand, the distinction between dietary
supplements and drugs will effectively
evaporate, the makers of supplements will be
forced to conduct the types of rigorous clinical
tests that Congress declined to require, and
consumer choice in fulfilling their dietary
needs (protected under the DSHEA) will be
curtailed. Amicus urges the Court to grant the
petition.”
The Amicus goes on to say that “The FDA’s
consideration of this issue could, upon application of
a proper standard, result in the banning of EDS”
[ephedra dietary supplements] and broadly covered
the regulatory differences between drugs using a riskbenefit
analysis and foods, particularly DSHEA that
places dietary supplements in the food category. The
“significant or unreasonable” requirement of §
342(f)(1)(A)(i) as interpreted by FDA and the 10 th
Circuit, where more than 150 companies or 20 per
cent of the industry is located in Utah alone, has no
support in the statute or legislative history. The brief
said that “By classifying dietary supplements as foods
…, Congress did not tie the permissibility of selling
supplements to any showing or evidence that they
improve health. Moreover, in permitting the makers
of dietary supplements to make certain types of healthrelated
claims, Congress required only that such
claims be ‘substantiated,’ not clinically proven.”
The Amicus argues that dietary fiber and fish oil,
which are used widely and beneficially, have not been
subjected to the clinical testing that FDA’s new found
risk-benefit standard would require, implying these
would disappear from the market as banned under
the new 10 th Circuit standards. And Amicus told the
Court that the significant problems posed for the
industry by the 10 th Circuit decision will “effectively
unravel the DSHEA.” The Amicus also said that the
10 th Circuit got it wrong when it defined “significant
risk” as a great danger. Under DSHEA “substantial”
and “unreasonable” define two different categories
of harm in the context of dietary supplements. Amicus
challenged the Court to allow it to help “prove, on
the merits, that the FDA has overreached and
exceeded the bounds of Congress’ statutory scheme.”
Joseph R. Guerra, Esq. is Counsel of Record, with
I. Scott Bass, Esq. and Robert A. Parker, Esq. of Sidley
Austin LLP of Washington, D.C. (202) 736-8000 on
this Amicus Curiae brief.
HERBAL PRODUCT MAKERS
SAY DROP THE GUIDANCE
In the March 2007 issue of Natural Medicine Law
Newsletter the FDA’s Guidance on Complementary
and Alternative Medicine Products and Their
Regulation by the Food and Drug Administration was
summarized, but not explored. The FDA first
proposed the Guidance on February 27. Now the
American Herbal Products Association (AHPA) of
Silver Spring, Maryland has filed comments telling
FDA to drop the whole idea. It looks like the FDA
Office of Policy and Planning came up with an
unnecessary document. AHPA wants the document
to go away.
In fairly pointed and direct remarks, the comments
of AHPA on the Guidance said that the group “has
observed that, since publication of the draft guidance,
confusion has mounted and continues to grow. This
confusion extends to the content of the draft, as well
as to FDA’s purpose in developing the draft. The result
is that publication of the draft guidance has had
exactly the opposite effect as the agency’s expressed
intention to address confusion concerning the
regulatory status of products used by practitioners of
complementary and alternative medicine. AHPA
strongly encourages the agency to discontinue any
further substantive work on this topic. Rather, FDA
should simply inform the public that the draft
guidance has been withdrawn.”
This was predictable to NML since most people
selling products that interface with complementary
and alternative medicine have never studied food and
drug law. Also some health care professionals have
become enraged at the FDA’s attempt to control and
See CAM GUIDANCE -- Continued on page 21...

Natural Medicine Law TM May 2007 Page 21
CAM GUIDANCE -- Continued from page 20...
define the practice of their roles, taking regulation
from the states to the FDA. On this issue AHPA said
“AHPA notes that FDA does not regulate the practice
of medicine and does not have jurisdiction over health
care practitioners, whether conventional, allopathic,
complementary or alternative.”
Also FDA failed to state in the Guidance who the
document was meant to control, said AHPA. When
FDA cited reasons for issuing the Guidance, it stated
two: 1.) That FDA “has seen increased confusion as
to whether certain products used in CAM… are
subject to regulation under the Federal Food, Drug,
and Cosmetic Act (‘the Act’) or Public Health Service
Act (‘PHS Act’).” 2.) That the agency has “also seen
an increase in the number of CAM products imported
into the United States.”
But AHPA said it might be that FDA employees are
confused and instead of a Guidance to Industry, there
may be a need to issue a new training manual to FDA
employees. And AHPA added, “if it were
representatives of the media that are confused, for
example, by identifying products used by CAM
practitioners as “unregulated,” FDA could and should
issue specific clarifying statements, but again should
not rely on a guidance for industry to address media
confusion; and that if it is the public that is confused,
FDA could, for example, address this confusion with
one or more articles in FDA Consumer magazine, but
not through guidance for industry.”
AHPA also said that FDA has ignored Executive
Order 13422. On January 18, 2007 President Bush
signed Executive Order 13422, amending Executive
Order 12866 on Regulatory Planning and Review of
September 30, 1993. Of significance to these
comments is that the amendments enacted on January
18, 2007 expanded the scope of this Executive Order
to place restrictions on federal regulatory agencies
not only when they promulgate regulations but also
when they issue guidance documents. Specifically,
the draft guidance document raises ‘novel legal or
policy issues arising out of legal mandates,’ this
triggering requirements under the Executive Order.
These requirements have not been met.”
Finally AHPA said that the announcement was
inconsistent with its dates for comments, saying in
one place that comments must be in within 90 days
of publication and in another stating that the date was
April 30, 2007, a date that was only 62 days after
publication. If 90 days is the operative date, then
May 28, 2007 is the date comments are due. [It
appears that someone at FDA was permitted to issue
the Guidance without knowing how to submit it to
the Federal Register. – Ed.] The full AHPA
comments are available at: www.ahpa.org/Portals/0/
pdfs/07_0427_AHPAComments_FDA_CAM
_Guidance.pdf/.
As of May 14, 2007, the FDA had posted less than
10 of the 55 comments to the public website, including
the AHPA comments, which means that the only
people who know what is going on with this issue are
those who have personal researchers in the FDA
Docket Clerks Office on a daily basis to extract and
copy records. Comment 55 was placed on the FDA
web and updated April 20, 2007.
TRADEMARKS FOR
ÆSCULUS HIPPOCASTANUM
Surprise ! There are no trademarks on the USPTO
web based data base that contain the words
“ÆSCULUS HIPPOCASTANUM,” but as readers of
NLM know well every Latin binomial herb has a
common name. Neither are the words “Common
Horse Chestnut” found in the USPTO trademark files.
When carefully thought about, then searched, one can
find three “dead” marks for “Horse Chestnut,” and
no marks at all for “Common Horse” or “Common
Chestnut.”
Therefore, it may be possible to obtain a trademark
for “Horse Chestnut.” But for what The last three
were for dietary supplements, but they were either
cancelled or abandoned, most likely because the
products did not sell and did not warrant the expense
of registration.
Horse Chestnut Plus was filed March 9, 1999 as a
mark for dietary supplements by Metagenics, Inc. of
San Clemente, California in International Class 005.
The mark was first used January 28, 1999. But the
See TRADEMARKS -- Continued on page 22...
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Page 22 May 2007 Natural Medicine Law TM
TRADEMARKS -- Cont’d from p.21...
application was cancelled under
Section 8 for failure to file an
affidavit of use on January 6, 2007.
See Serial No. 75/660962.
Horse Chestnut Xtra was filed
March 16, 1998 as a mark for
vitamins, minerals, dietary and
nutritional supplements containing
horse chestnut by Rexall Sundown,
Inc. of Boca Raton, Florida in
International Class 005. This mark
was filed as an intent to use mark
and was apparently never used,
since the mark was abandoned
November 19, 1999. See Serial
No. 75/451206.
Horse Chestnut-Power was
filed by Twin Laboratories, Inc. of
American Fork, Utah, on July 29,
1997 for dietary supplements, and
herbs, extracts, concentrates, and
combinations thereof, all for use as
dietary supplements. Twin Labs
assigned the mark to ISI Brands,
Inc. of Grand Rapids, Michigan,
but the mark was cancelled
February 25, 2006 under Section
8, which means no affidavit of use
was filed in the time required. See
Serial No. 75/332373.
What was so magical about this
name in 1997 to 1999 And why
did all three companies drop the
products. NML does not know.
But read the article about Horse
Chestnut in the Wellness Letter and
what NML has added to it. You will
learn that Horse Chestnut is used
widely in Europe for varicose veins
and hemorrhoids. Now remember
your DSHEA. Rubbing Horse
Chestnut on your legs or around
your bottom is not “ingestion” and
therefore these products could not
be dietary supplements under
DSHEA.
Still interested in using this Horse
Chestnut on a product Then do a
“Google” search and one of the
first files that comes up is one
listing thirteen studies that
appeared in the medical literature
from 1979 to 1999 from an article
from Environmental Nutrition
newsletter by Denise Webb, Ph.D.
See www.horsechestnut.com for
the list of articles. Maybe you will
want to get this trademark for an
OTC drug. This might take some
more research.
Another page you can find on the
web is a page from http://
nccam.nih.gov/health/
horsechestnut/ that is on the
National Institutes of Health
website. Here you will again see
recommendations for the use of
products made from Horse
Chestnut for venious insufficiency
and hemorrhoids, but it is not
recommended for anything else.
There are a number of Horse
Chestnut seed extracts on the
market, some standardized to
contain certain amounts of Aescin
or esculin, the ingredient thought
to be the active ingredient.
Keep in mind that words used for
trademarks may be “descriptive”
under the statute and not
immediately registerable. But over
time a descriptive name can
become known in the market place
as the source for the product, in
which case it can become
distinctive and registerable. Talk
to your legal counsel about better
ways to make a trademark
distinctive.
WWW.NATMEDLAW.COM
CONE FLOWER (E. Intermedia)
Photo Courtesy of Lloyd Library and Museum
DS GMPs -- Continued from page 1...
estimate) expected the release of
the GMPs in December 2006.
If you are still worried about what
to do, go to 68 Federal Register
12157 to review the last Notice of
Proposed Rule Making and read
what FDA wants you to do. Then
you will understand why OMB is
taking so long.
NEW INGREDIENTS -- Cont’d from p. 9...
to the FDA Website on November
20, 2006 by kk.
National Center for Tobacco
Research of Sarasota, Florida, sent
FDA an NDI, dated June 21, 2006
for a natural herbal extract,
cytisine, from the Golden Rain
plant (Cytsius labroinu L.) grown
in Italy and other European countries.
The supplier is a Bulgarian
company, Sopharma, that sells a
product named Tabex. Each tablet
contains 1.5 mg of cytisine and it
is used for various indications including
smoking cessation. The
See NEW INGREDIENTS -- Cont’d on p. 23... .

Natural Medicine Law TM May 2007 Page 23
NEW INGREDIENTS -- Conti’d from page 22...
usual dose is one tablet four times
a day. With the letter was an abstract
of a clinical study of 436
consecutive attendees of a smoking
clinic in Warsaw, Poland, that
tested Tabex and the conclusions
were that the results were similar
to that of nicotine replacement
therapy. The article was apparently
not published as no citation was
given. FDA responded by letter
of September 7, 2006 to Kirk G.
Voelker, M.D., from Linda S.
Pellicore, Ph.D., stating that the
notification does not comply with
21 CFR 190.6 and is incomplete
as it did not contain an original and
two copies, it did not provide a
description of the dietary supplement
that contains the new ingredient,
and a history of use or other
evidence of safety was not provided.
FDA said it was unable to
determine on the basis of the one
clinical study that was provided
whether it provides an adequate
basis for a conclusion that the dietary
supplement will reasonably
be expected to be safe because the
information is incomplete. FDA
said if the product is marketed
without an adequate notification it
will be considered adulterated and
introduction of such a product in
interstate commerce is prohibited.
Docket No. 1995S-0316, RPT 357,
received at the Dockets Office on
October 6, 2006, filed October 6,
2006, and posted to the FDA
Website on November 20, 2006 by
kk.
RPT 358 is not on the Public
Website.
SCIENTIFIC WELLNESS of
DOX, LLC of Ann Arbor, Michigan,
filed a NDI, dated June 26, 2007,
for 19-nordehydro-epiandrosterone
made in 100 mg capsules to be
taken three times a day with the
directions “DIRECTIONS FOR
USE: This product is for adults
over the age of 21 only. Do not
exceed recommended dosage.
This product is not intended to diagnose,
treat, cure or prevent any
disease.” KEEP OUT OF REACH
OF CHILDREN. The information
given indicates that DHEA was
marketed before October 15, 1994.
The letter was not signed but had
attached numerous pages discussing
DHEA. FDA responded by
letter of September 19, 2007, from
Linda S. Pellicore, Ph.D. to Dennis
Hayes begins by acknowledging
DHEA, but at the last paragraph
on page one, states that
“Your notification about ‘Nucleic
Acid Supplement Capsules’ does
not comply with the requirements
of 21 CFR 190.6 and is incomplete.”
FDA points out the letter
was not signed and only abstracts
were submitted. FDA indicated it
had requested three copies of all
reference articles and did not receive
them. Because of this, FDA
is unable to proceed with the review.
FDA’s response never made
clear why it started the response
with one NDI and completed it
with another as the subject NDI.
Docket No. 1995S-0316, RPT 359,
received at the Dockets Office on
November 3, 2006, filed November
3 and 12, 2006, and posted to
the FDA Website on February 12,
2007.
AJINOMOTO U.S.A., Inc. of
Washington, D.C. sent a NDI to
FDA, dated July 18, 2006, concerning
a product named
Capsinoids (Extracted Oil of Sweet
Chili Peppers) also called CH-19
Sweet Extract. It is derived from
Capsicum annuum L. chili peppers.
Soft gelatin capsules containing 1
mg will be recommended to take
three 1 mg capsules orally once per
day. [FDA did not post the
company’s Notice. - Ed.] FDA responded
to this notice by letter of
October 2, 2006 stating that it had
“significant concerns” about the
evidence presented. FDA was unable
to determine the identity of the
ingredient because the extraction
process if given only in very general
terms. The notice does not include
methods of analysis, active
or inactive. The notice does not
provide studies with the preparation
that will be marketed. It is
unclear, FDA said, how Capsiate
Natura is similar to peppers and
this unclear how information about
its use is related to the NDI. The
history of use of chili peppers
throughout the world given in the
notice, FDA said, gives estimated
current intakes of capsinoids in the
U.S. per capita. “However, the recommended
intake of the new dietary
ingredient (i.e., 3 mg
capsinoids/day) is about twice the
current daily intake at the 90 th percentile
of intake by chili pepper
eaters. Moreover, it is not possible
to calculate the concentration of
capsinoids present in the proposed
dietary supplement based upon the
information provided.” FDA mentioned
several other reasons and
concluded that the information
does not provide an adequate basis
to conclude that the product will
reasonable be expected to be safe
when used as suggested. FDA said
that introduction of the product into
interstate commerce is prohibited.
Docket No. 1995S-0316, RPT 360,
received at the Dockets Office on
November 3, 2006, filed November
3 and 12, 2006, and posted to the
FDA Website on February 12, 2007.
Copyright, 2007 by Muscatatuck Publishers, Inc. For Information on Photocopying, see Page 2 Inside

PHARMACY LAW
SEMINAR
Developments in Pharmacy Law
Seminar XVIII will be November
8 - 11, 2007 at Loews Coronado
Bay Resort, Coronado, California.
Details are available at the American
Society for Pharmacy Law
website -- www.aspl.org. The program
is cosponsored by the National
Association of Chain Drug
Stores.
MAY IS NATIONAL HIGH
BLOOD PRESSURE
EDUCATION MONTH
The National Center for Complementary
and Alternatiave Medicine
is promoting the month on
http://nccam.nih.gov
Check out the recommendations
about natural medicines. One in 3
Americans has high blood pressure.
The 15th Annual Symposium featuring
20 speakers will be held June
1 to 4 at the Blue Ridge Assembly
in Black Mountain, North Carolina.
Registration information can be
obtained at (800) 252-0688 and
and www.botanicalmedicine.org.
AMERICAN HOLISTIC
MEDICAL ASSOCIATION
AHMA 2007 Clinical & Scientific
Conference, Portland, Oregon,
June 6 - 9, 2007. Details are
www.holisticmedicine.org or The
Center for Mind-Body Medicine,
5225 Connecticut Ave, NW, #414,
Washington, D.C. 20015. All
health professions are invited.
National Pharmacy Law and
Ethics Symposium
Sponsored by the American Society
for Pharmacy Law and the
Duquesne University School of
Pharmacy. June 8-9, 2007
Pittsburgh, PA. Rooms are reserved
at the Marriott Pittsburgh
City Center hotel, one block from
Hanley Hall where the symposium
will be held. For more info go to
www.aspl.org.
HARVESTING HEALTH
Denial of Certiorari in the ephedra
case will increase the use of the
legal ephedra tea for about the next
10 years until another case is decided
differently from that in the
10th Circuit. Then the “de novo”
review provisions in the law that
were not applied by the10th Circuit
might be read the way the Congress
wanted. Or the Congress might
strengthen DSHEA by amending
the review provisions. NML will
watch this issue carefully.
The U. S. Senate passed a bill
giving FDA more responsibility.
See the Special Supplement in this
issue. If the House agrees, will either
body properly fund the new
tasks, or will FDA have to struggle
to figure out its priorities
The new Reagan-Udall Institute
will be faulted in a few years, particularly
after a director is appointed,
and that person testifies a
few times before dozens of committees
of Congress. There will
little time for this new “chief scientist”
to coordinate research activities.
The current FDA Commissioner
will become more like a Chief of
Police in the public mind. That is
what the Editor believes could happen
down the road.
The European Community and
other states are fine tuning their
laws concerning dietary supplements
and herbal medicines.
Developments on most of the
World’s seven continents will continue
in the dietary supplement and
related fields.
This issue marks the end of 10
years for this
newsletter.
Thanks to all
who keep
reading.
need their help.
Let others
know about
us because
you will soon
William J. Skinner, R.Ph.,
Attorney at Law, Editor