Judge Rebuffs FDA on Effort to Ban Diet
Supplement
By Sheryl Gay Stolberg
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 New York Times
Washington -- 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, i.e.: 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 flexibility 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 form letter 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.
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