Note: Following this article is another draft of the form letter for the
FDA comments period ending August 27. This draft discusses the injunction
against FDA discussed in the article below. Please forward this information
to more people. Anyone can be on the IAHF distribution list by sending
email with "add" in the subject line.
 

June 17, 1998
 

          Judge Rebuffs FDA on Effort to Ban Diet Supplement

          By SHERYL GAY STOLBERG

                 ASHINGTON -- The Food and Drug Administration on Tuesday
lost the first round of its legal battle with the manufacturer of
Cholestin, an herbal remedy that is being marketed as a dietary supplement
to reduce cholesterol but which the agency is trying to declare an illegal
drug.

          In a brief three-page decision, a U.S. judge in Salt Lake City
ordered the agency to permit the manufacturer, Pharmanex Inc., a
small,3-year-old company in Simi Valley, Calif., to continue making
Cholestin while the court case proceeds.

          "Plaintiff's Cholestin product is preliminarily declared to be a
dietary supplement, and not a drug, within the meaning of the Federal Food,
Drug and Cosmetic Act," Judge Dale Kimball of U.S. District Court wrote.

          Kimball added that Pharmanex would "clearly suffer irreparable
injury" if it could not continue to make the herbal remedy.

          The ruling came one day after lawyers for both sides argued the
case before Kimball. It is now up to the judge to make a final decision
about whether Cholestin will be allowed to remain on the market as a
dietary supplement.

          "We are obviously very gratified by the judge's decision,"
William McGlashan Jr., the president of Pharmanex, said in an interview.
"It's an important first step."

          The lawyer who handled the case for the drug agency, Neal Parker,
declined to comment on the ruling. But Lorrie McHugh, the FDA's chief
spokeswoman, said the agency intended to pursue the case despite Tuesday's
setback.

          The case is being watched as a pivotal battle between the food
and drug agency, which is struggling to exert its authority under a 1994
law that left it almost powerless to regulate herbal products, and the
dietary supplement industry, which has been growing at a furious pace since
the law was passed.

          At issue is not whether the product is unsafe; the FDA does not
argue that it is. Rather, the agency asserts that Cholestin is an illegal,
unapproved drug under the Dietary Supplement Health and Education Act of
1994 because it contains a natural form of lovastatin, the key chemical in
Mevacor, a cholesterol-lowering drug made by Merck & Co.

          Cholestin is made from a pulverized strain of rice fermented with
red yeast, which is then ground up into a brick-colored powder and put into
capsules. The rice is imported from China, where it has been used for more
than 2,000 years, as an herbal remedy and a food.

          Officials at Pharmanex say that the lovastatin occurs naturally
in the rice and that, under the law, the FDA cannot take Cholestin off the
market unless it believes the product is unsafe.

          About a year ago, the agency, prompted by complaints from
officials at Merck, began an investigation of Cholestin. While the inquiry
proceeded, the agency impounded 10 tons of the red yeast rice. Then, last
month, agency officials declared Cholestin a drug, and insisted that
the product undergo the same rigorous testing as any pharmaceutical. That
prompted Pharmanex's suit.

          At a hearing on Monday before Kimball, the company asked that the
hold on its red yeast rice be released. The judge complied, ordering the
agency to permit the rice to enter the United States immediately and to
allow Pharmanex to import an additional 6 tons every three months, or
however much the company needed to meet its demand.

URGENT FIRST AMENDMENT ALERT!
COMMENTS DUE AT FDA : AUGUST 27, 1998

Dear Dietary Supplement Consumer:

 The FDA is once again trying to block your access to truthful health
information on the labels of dietary supplements. The FDA has proposed a
new rule that prohibits any reference to a “disease” on the labels, but
they have defined “disease” so broadly that many aspects of normal life are
included, ie: hot flashes during menopause, decreased sexual function
during aging, etc. They won’t even allow information on the label to inform
people who take drugs to try to combat a disease that the dietary
supplement will help relieve the adverse side effects of, ie:
chemotherapy, etc. This rule is far too restrictive. It blurs the
distinction between “disease” and a “health condition.” It will
dramatically narrow the marketing flexability permitted under DSHEA, and it
might also discourage research on dietary supplements by restricting the
use of journal citations that mention a disease.

 Please take a minute to sign the letter below and send it to the FDA. We
need to flood the FDA with letters from people like you who want
unrestricted access to truthful information on the labels of the products
you buy. Also, to learn how the FDA’s proposed rule to limit structure
function claims ties in with a broader international plan to regulate and
restrict access to dietary supplements, visit the IAHF website at
www.iahf.com, email us at jham@iahf.com or call 800-333-2553 for more
information.
----------------------------------------------------------------------------
-----------------------
(Submit written comments to: Dockets Management Branch (HFA-305) FDA 200 C.
St. SW Washington, DC 20204
Re: [Docket No. 98 N-044] RIN 0910-AA59 Regulations on Statements Made for
Dietary Supplements Concerning the Effect of the Product on the Structure
or Function of the Body

To whom it may concern at FDA:
Your proposed rule will have an adverse effect on public health by placing
arbitrary and capricious limits on the allowable health information to be
presented to consumers at the point of sale on dietary supplements, in
complete violation of the first amendment. Your definition of disease is
overly broad. You are clearly over reaching here. Under proposed §
101.93(g)(1) a disease is any deviation from, impairment of, or
interruption of the normal structure or function of any part,organ, or
system (or combination therof) of the body that is manifested by a
characteristic set of one or more signs or symptoms.)

Thus, in your zeal to “insure that dietary supplements don’t act as a
disincentive to new drug development” (the “immortal” words of Gary
Dykstra), you would even disallow structure/function claims relative to
aging: ie, “hot flashes”. (Since when are “aging” or the menopause “disease
states”?)

Judge Dale Kimball just issued an injunction against you forcing you to
lift your ban on cholestin, which he declared was a dietary supplement
under the terms of DSHEA. You tried to ban this safe Chinese red rice yeast
extract which helps lower cholesterol, because its sale angers Merck. We
remind you that dietary supplements were specifically exempted from the
harmonization language in the FDA Reform Bill, and that Congress was
flooded with faxes, email and outraged calls on this issue as recently as
October, 1997. Prior to that, in 1994 Congress received more mail on this
issue than on anything since the Vietnam war. For the sake of the public
health, we strongly urge you to stop blurring the distinction between a
disease, and a health condition. Stop trying to harmonize our laws to EEC
65/65 in the EU, where dietary supplements are regulated as “drugs.”

Signed:__________________________________________________

Address:_________________________________________________

City:___________________________________________State:__________
Zip:___________
(Info provided by International Advocates for Health Freedom 800-333-2553,
www.iahf.com)
 
******************************************
Donations Needed- Need Help to Keep Helper On
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,
jham@iahf.com    http://www.iahf.com
HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868
THE CONSUMER HEALTH FREE SPEECH ACT!!!