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Date: Thu, 11 Jun 1998 15:43:56 -0400
From: John Hammell <>

IAHF Distribution List USA: WE ARE UNDER ATTACK!!! At the end of this front
page NY Times article I have enclosed a form letter for use in deluging the
FDA during their comments period on the proposed rule which would seriously
limit structure function claims, as well as attack product names that imply
a therapeutic use. ***TO DO: Download this NY Times article and my letter
to your word processor and print them out. Deliver copies to all the health
food stores in your area with instructions for them to bagstuff them. ***We
MUST bury FDA with comments by the end of the deadline on August 27!
Forward this to more people. Anyone can be on the iahf email list by
sending email with the word "add" in the subject line.

June 10, 1998, Wednesday  FRONT PAGE: NEW YORK TIMES
Section: National Desk



          Here at the base of the Rocky Mountains, in a region that is the
heart of the nation's herbal and vitamin industry, a stainless steel
contraption was hard at work on a recent morning, spitting out clear
plastic capsules at the rate of 90,000 an hour. Each contained precisely
600 milligrams of a fine, brick-colored powder that Federal health
officials are trying to ban.

          The powder, a pulverized strain of rice fermented with red yeast,
is imported from China, where it has been consumed for 2,000 years, as an
herbal remedy (it is thought to improve blood flow) and a food (it spices
up tofu and makes a tasty marinade for duck and pork.) Then five
years ago, William McGlashan Jr., a young California venture capitalist,
learned that scientists in Beijing were studying red yeast rice for another
reason: it seemed to lower cholesterol.

          Today, Pharmanex, Mr. McGlashan's company, sells the encapsulated
red powder under the trade name Cholestin in 37,000 American stores,from
health food outlets to the giant Wal-Mart chain. Mr. McGlashan calls
Cholestin a dietary supplement. Officials at the Food and Drug
Administration call it something else: an illegal, unapproved drug.

          On June 15, in the gray stone Federal courthouse in Salt Lake
City, United States District Judge Dale A. Kimball will be asked to
determine who is correct. The case is being watched as a pivotal battle
between the agency, which is chafing at a 1994 law that left it almost
powerless to regulate vitamins and herbal products, and the dietary
supplement industry, which has been growing wildly since the law was passed.

          At issue is not whether Cholestin is dangerous; no one argues
that it is. Rather, the agency contends that Cholestin has crossed the
increasingly murky boundary that separates dietary supplements from drugs,
because it contains an ingredient, lovastatin, that is the key component of
a cholesterol-lowering drug. Pharmanex says the lovastatin occurs naturally
in the rice and that Cholestin is more akin to a food than to a drug.

          The outcome of the case could be reflected in the medicine and
kitchen cabinets of millions of American consumers, including many doctors
and scientists, who have come to believe that ginkgo, echinacea and St.
John's wort, among other natural remedies, are as important to good
health as aspirin and antibiotics.

          Aside from the turf battle between the supplement industry and
regulators, the dispute raises crucial questions: Is there a distinction
between these herbal products, which may contain naturally occurring
chemicals as potent as those in any drug, and the drugs themselves? Must
products like Cholestin be subjected to the rigorous testing that drugs

          ''You see more and more dietary supplements sold right next to
over-the-counter drugs,'' said William B. Schultz, the F.D.A.'s deputy
commissioner for policy. ''There is a risk that the line will blur.

          Indeed, it is already blurry. ''Foods are medicines; medicines
are foods,'' said Loren Israelson, executive director of the Utah Natural
Products Alliance, a trade group based in Salt Lake City that represents 10
of the nation's biggest supplement manufacturers. ''If you drink coffee in
the morning, why are you drinking coffee? You're looking for the caffeine,
a stimulant. That same caffeine is sold over the counter as NoDoz. That's a
drug when it's in a pill form, and it's a food when it's in coffee. Why is

          The Food and Drug Administration struggled with such questions
for decades. But with the passage of the 1994 Dietary Supplement Health and
Education Act, the law under which the Cholestin case will be decided, the
agency's task grew even more vexing.

          The new law moved dietary supplements out of the underground and
into the mainstream, giving manufacturers like Pharmanex the long-sought
right to advertise the potential benefits of herbs, even if the evidence
for those benefits was sketchy. Unless the F.D.A. can prove the product is
unsafe, companies can say what they wish, so long as they do not claim
their products can prevent, treat or cure disease.
  Thus, Mr. McGlashan can advertise that Cholestin ''promotes healthy
cholesterol,'' but not that it ''prevents heart attack or stroke.''

          ''For the first time,'' he said, ''we can educate the American
consumer about what the product does. We don't have to rely on a person in
a health food store to explain it.''

          Since the law was passed, the agency has received about 2,300
notifications from manufacturers intending to make claims about their
products, and has objected to about 150 of them. It has also proposed a
rule that would restrict, but not eliminate, the manufacturer's ability to
use the herbal stimulant ephedra, which has been linked to more than a
dozen deaths nationwide. It has banned one ephedra-based product and it is
now trying to ban Cholestin.

          Agency officials say the 1994 law, restrictive though it is,
gives them the authority to take Cholestin off the market, because it bars
companies from bringing dietary supplements to market if they contain the
same active ingredients as previously approved drugs. In passing the
Dietary Supplement Health and Education Act, Mr. Schultz says, Congress did
not intend for companies to skirt the drug-approval process by selling
medicines under the guise of dietary supplements.

          Lawyers for Pharmanex, however, contend that Cholestin falls
squarely within the intent of the 1994 law.

          ''This product was specifically developed to be a dietary
supplement,'' said Daniel Kracov, a company lawyer. ''What the F.D.A.
objects to is the fact that this product has a drug substance in it, in
their view. You may object to that, but our response is: If you don't have
a safety issue,don't go after these products.''

          Whatever the outcome, Dr. David A. Kessler, the former
Commissioner of Food and Drugs, says the agency's action will hardly make a
dent in the rampant proliferation of herbal remedies that he says are
ineffective at best and unsafe at worst.

          ''Just walk into your pharmacy; it's out of control,'' said Dr.
Kessler, who waged a bitter, unsuccessful battle against the 1994 law as
commissioner. ''Efficacy is now defined as what sells off the shelves. The
agency is powerless.''

          While the law was a disaster for regulators, it was a windfall
for makers of dietary supplements and vitamins. After the act was adopted,
annual sales of dietary supplements in the United States skyrocketed,
jumping to nearly $12 billion last year from more than $8 billion in
1994,according to the Nutrition Business Journal, a trade publication.

          So furious has the growth been that one analyst, Matthew Patsky
of the Boston-based investment banking firm of Adams, Harkness & Hill,said
some of the biggest pharmaceutical companies were planning to sell their
own herbal products.

          That worries Mr. Schultz, the F.D.A. deputy commissioner for
policy. ''If companies that would have tested their products and sold them
as drugs are now going to not test them and sell them as dietary
supplements,'' he said, ''then we have lost information about the safety and
efficacy of those products.''

          Among the law's beneficiaries was Mr. McGlashan, a 34-year-old
Stanford University business school graduate who studied Chinese
history.With the aging of baby boomers, Mr. McGlashan saw a growing demand
for natural medicines the Chinese have used for centuries.

          Mr. McGlashan says he had a vision for his business; he wanted to
apply ''pharmaceutical rigors'' to the dietary supplement industry, using
research to persuade consumers that Eastern therapies worked. In early
1994, he met Michael Chang, a former pharmaceutical industry
researcher who had set up a plant to produce herbal medicines in Huzhou,
China, near Shanghai.

          Dr. Chang scoured Chinese research for promising herbal products,
identifying 5,000; the list was narrowed to 30. By early 1995, Pharmanex
was born, with headquarters in Simi Valley, Calif. Red yeast rice, called
hong qu, was one its most promising projects.

          ''We know hong qu has been used for centuries, but we don't know
why it lowers cholesterol,'' Dr. Chang said. ''We need to find out.''

          The 1994 law, Mr. McGlashan said, made it worth investing in
science. The company introduced Cholestin at the end of 1996, after nearly
three years of study. Most recently, Pharmanex enlisted Dr. David Heber,
director of the Center for Human Nutrition at the University of
California at Los Angeles, to study the effects of Cholestin in adults with
moderately elevated cholesterol.

          The study, financed by Pharmanex, compared the cholesterol levels
of 42 adults who took 2.5 grams of Cholestin every day for three months
with the levels in 41 adults who were given placebos. Dr. Heber said the
total cholesterol counts of those who took the supplement dropped,
on average, from 250 to 210.

          Dr. Heber dismisses the contention that red yeast rice is a drug;
instead he calls it ''a functional food.'' The same cholesterol-lowering
ingredient in lovastatin, he notes, occurs in even higher concentrations in
oyster mushrooms, commonly used in Asian cooking. And nobody, he said, is
trying to ban mushrooms.

          However, Dr. Richard A. Friedman, director of psychopharmacology
at New York Hospital-Cornell Medical Center, contends the current
distinction between dietary supplements and drugs is based on semantics,
not biology, and that both should be carefully regulated.

          ''If there is a biologically active component in the supplement,
to say it is not a drug is illogical because it will have a similar
effect,'' he said.Companies like Pharmanex, he added, ''want to be able to
implant the idea in the public that the drug is medically beneficial''
without the rigorous research.

          That kind of science, Mr. McGlashan admits, would cost far too
much for a small company like his. Yet with a decent body of research
behind Cholestin, he said, he at one time envisioned himself becoming the
F.D.A.'s model for good behavior.

          Instead, he received a visit from F.D.A. investigators last year;
the agency had received complaints that Cholestin contained lovastatin,
both from a pharmacist and from Merck and Company, which makes Mevacor, the
cholestorol-lowering drug, known generically as lovastatin.

          Shortly thereafter, Federal authorities impounded ten tons of red
yeast rice. Then on May 20, the F.D.A. notified Mr. McGlashan that it
considered Cholestin illegal, a move that led the company to ask for a
hearing before Judge Kimball.

          ''This case is going to determine the extent to which companies
can imitate prescription drugs,'' said Mr. Schultz of the F.D.A., ''and
avoid the approval process.''

          But Mr. McGlashan contends that the dispute is an economic one.
Cholestin, he said, is intended for use by people who are too healthy for
Mevacor. Merck, he contends, is trying to push Cholestin off the shelves --
a charge denied by Jan Weiner, a company spokeswoman.

          While the court case is pending, Mr. McGlashan said, sales of
Cholestin are booming. Even his mother called, he said, asking, ''How am I
supposed to get my Cholestin?''

          For now, Mr. McGlashan has no answer. Standing outside the
low-pressure room where the encapsulating machine was spinning, a lab coat
covering his royal blue shirt and Hermes tie, he looked a little wistful.
The fine red powder being packed into the capsules, he said, was the last
of his supply.
BY AUGUST 27,1998 [Docket No. 98N-0044] RIN 0910-AA59
Regulations on Statements Made for Dietary Supplements Concerning the
Effect of the Product on the Structure or Function of the Body; Proposed

Rule and Dietary Supplements: Comments on Report of the Commission on
Dietary Supplement Labels; Notice

Submit written comments to: Dockets Management Branch (HFA-305) FDA 200 C.
St. SW, Washington DC 20204, 202-205-4697 or send them to LEF Box 229120,
Hollywood, FL 33022 Dept IAHF

To Whom it May Concern at FDA:
A Supreme Court  decision on June 28, 1993 renders your proposed rule to
limit manufacturers ability to properly inform the American public on the
health benefits of dietary supplements utterly and completely illegal. (It
puts Section 403 (r)(6) of the Food, Drug, and Cosmetic Act pertaining to
structure-function claims in question, and it means that the so called
Commission on Dietary Supplement Labels (whose advice you were following
when you drafted your proposed rule) has utterly and completely ignored the
Supreme Court Decision of Daubert v. Merrill Dow. (We hereby put you on
notice that the Supreme Court is the highest court in America, and the
Commission on Dietary Supplement Labels (CDSL), Congress, and the FDA are
required by law to not only be aware of their decisions, but to abide by
them when proposing new regulations such as this.)

Under Daubert, the "General Acceptance Test" (an equivalent phrase to
significant scientific agreement) was replaced by the Federal Rules of
Evidence for admitting scientific testimony at a Federal Trial. As a
Federal Agency FDA ought to formulate its proposed rules in accordance with
this decision, but has failed to.

Given the Daubert decision, rather than find in favor of the so called
"significant scientific agreement" standard, what CDSL should have done as
to define what kinds and combinations of studies validate claims based on
significant scientific evidence. Rather than recommend arbitrary and
capricious limits on health information provided at the point of sale
through labels and labeling of dietary supplements, CDSL should have
recommended the adoption of the "gradation of claims" proposal recommended
in comments to the CDSL by Durk Pearson and Sandy Shaw, Jonathan Emord and
Associates, International Advocates for Health Freedom, and many others.
This proposal allowed for a gradation of claims, depending on the amount of
evidence supporting them, and the consumer can then be in a position to
make their own decisions- but you have no legal right to withhold truthful
information, and your proposal severely BLOCKS our access to information
that we need in order to make better health choices for ourselves and our

In your proposed rule you say that it would be illegal to suggest anything
but drugs to reduce nausea associated with chemotherapy. This is arbitrary
and capricious. What about ginger to reduce nausea? What about co-enzyme
Q-10 and vitamin E to reduce chemotherapy-induced heart muscle damage;
melatonin to reduce chemotherapy-induced immune system damage; and
n-acetyl-cysteine to reduce chemotherapy induced liver damage??
Since you are ruling it "illegal" to use the words "protects against
cancer", you will also consider it "illegal" to use the words "protects
against heart attacks." This means folic acid can be promoted to "lower

homocysteine levels" but it would be "Illegal" to say that folic acid
"protects against heart attacks" even though The New England Journal of
Medicine (April 9, 1998) recommends the use of folic acid to lower heart
attack risk (!!!) Since when did the FDA become the sole repository of truth?

In light of the fact that your proposed rule is of questionable legality in
view of  the Daubert decision, I hereby call for its immediate withdrawal,
and demand that my Congressman address this outrage by cosponsoring HR 2868
The Consumer Health Free Speech Act, which removes food from the current,
overly broad statutory definition of drug. This will allow us to make
therapeutic claims on dietary supplements, something which you have no
legal right to block with this proposed rule. Now that I have appraised you
of the Daubert decision, please let me know precisely how you  intend to
artfully dodge the law by utterly ignoring it?
(cc to my Senators and Congressman)
Signed:________________________________________  Date: _______________

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International Advocates for Health Freedom
John C. Hammell, Legislative Advocate
2411 Monroe St. Hollywood, FL 33020 USA
800-333-2553, 954-929-2905, FAX 954-929-0507,