I just received a copy of a letter by Norman Farnsworth to the FDA in
defense of Cholestin. Farnsworth is a man I honestly never thought I'd see
actually defending a dietary supplement company given that he was on the
Commission on Dietary Supplement Labels, an entity which I had no respect
for. I'm also still inclined to be distrustful of Farnsworth because he is
running a WHO Collaborating Centre on Traditional Medicine at University of
Illinois, but I'll give credit where credit is due.

In his letter of December 15, 1997 to FDA Lead Deputy Commissioner Michael
Friedman, MD,Farnsworth defended Cholestin stating that "it does not
contain a prescription or a regulated drug. It contains mevinolin, which is
chemically distinct from Lovastatin (Mevacor), (which is a prescription
drug.)"

Farnsworth goes on to say that "This fact, in combination with the
knowledge that the fermented red rice product has been used as a dietary
supplement both in China and in the United States for many years, in my
opinion makes the product a dietary supplement as defined by DSHEA."
Farnsworth also stated that claims of reducing mild to moderate elevated
cholesterol levels are true and not misleading and do not constitute "drug"
claims. Farnsworth told Friedman that if the CDSL efforts over a two year
period of open debate, discussion and analysis are to mean anything, FDA
must be open enough to make judgements that are in support of what Congress
and the people intended."

Farnsworth went on to laud Pharmanex as one of the few dietary supplement
companies to base their claims on sound science and original research and
said "My fear is that should FDA force Cholestin from the market place,
there will be a dramatic negative effect on other [dietary supplement]
firms to put money and resources into providing dietary supplements that
are desired by the American consumer and mandated by Congress. Should this
happen, the industry will revert to "business as usual" in providing
consumers with unsupported and outlandish claims to an extent that the
American public will not be best served from a health or safety."

I called Pharmanex to see if they had any press releases defending
Cholestin, and am still waiting to hear back from their PR Firm which I
called at 310-444-1341. Their court hearing will be on June 15th.

Even though Farnsworth came to our assistance this time, he STILL shouldn't
be trusted: he's running a WHO Collaborating Centre on Traditional
Medicines at University of Illinois, and more than likely hobnobs with
people like Simon Mills of ESCOP which has as its mission statement the
intention of forcing the global harmonization of laws pertaining to the
sale of herbal products.

I will relay anthing I get from Pharmanex's PR firm, and will keep you
posted on whatever happens in court with this on June 15, but in the
meantime, it is ESSENTIAL that we keep flooding FDA with comments on their
proposed rule for structure function claims.
******************************************
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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,
jham@iahf.com    http://www.iahf.com
HERBS ARE _NOT_ DRUGS! HELP PASS HR 2868
THE CONSUMER HEALTH FREE SPEECH ACT!!!