FDA OVERSIGHT HEARINGS NEEDED

The Honorable Orrin G. Hatch .......................................... _________1998
United States Senate
Washington, DC 20510
Hatch's FAX #202-224-9102 (Please use only from 7pm to 7am)

Dear Senator Hatch: ....... Attn: Trish Knight or Bruce Artim

THANK YOU for the Dietary Supplement Health and Education Act (DSHEA) of 1994!!!

We need your help again. The U.S. Food and Drug Administration (FDA) is working to discredit and dismantle DSHEA. FDA oversight hearings by the U.S. Senate are urgently needed.

"Dr. David A. Kessler, the former Commissioner of Food and Drugs, who waged a bitter, unsuccessful battle against the 1994 law [DSHEA] claims [falsely] the agency [FDA] is powerless." (See New York Times 6/10/98 for all quotes). You've heard that wailing before!

Ignoring the clear intent of Congress in DSHEA, FDA is vigorously prosecuting Pharmanex, a new California dietary supplement company for marketing "...a pulverized strain of rice fermented with red yeast...under the trade name Cholestin." Cholestin is encapsulated in Utah. "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 [naturally] contains an [active] ingredient, lovastatin, that is the key component of a cholesterol-lowering drug."

FDA is excessively influenced by the drug industry and at war with the dietary supplement industry. Foods and herbs do not become drugs if they naturally contain active ingredients.

Last year Pharmanex "...received a visit from FDA investigators. The agency had received complaints that Cholestin contained lovastatin, both from a pharmacist and from Merck and Company, which makes Mevacor, the [synthetic] cholestorol-lowering drug, known generically as lovastatin. Shortly thereafter, Federal authorities impounded ten tons of red yeast rice. Then on May 20, 1998, the FDA notified Pharmanex that it considered Cholestin illegal..."
FDA OVERSIGHT HEARINGS ARE URGENTLY NEEDED BY THE U.S. SENATE!!!

Sincerely yours,

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Prepared by Clinton Ray Miller, Health Freedom Legislative Advocate, 139 Northmont Dr., Statesville, NC 28625;
(704) 924-8615; FAX: 704-928-8616 ............................................................................................................... (tom-2) (98-5)

(This form letter is not authored or sponsored by Pharmanex or any other company)