FIRST AMENDMENT ALERT! COMMENTS DUE AT FDA

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 This info provided courtesy John C. Hammell, legislative advocate, IAHF, 800-333-2553, www.iahf.com, jham@iahf.com

To Whom it May Concern at FDA:

Your proposed rule to limit manufacturers ability to properly inform the American public on the health benefits of dietary supplements flies in the face of sound public health policy, and constitutes nothing more than a crass and despicable effort to protect the interests of multinational pharmaceutical giants whose profits you protect at the expense of the American public.

Your bias against the use of dietary supplements is glaringly apparent in the case of FDA v Pharmanex, manufacturers of a product called Cholestin, an extract of red rice yeast, which you (and Merck) falsely maintain contains the prescription drug "lovastatin" which is sold by Merck under the trade name "Mevacor".

Norman Farnsworth, Ph.D. is a Research Professor in Pharmacognosy and Senior University Scholar at University of Illinois. He is a former member of the Presidentially Appointed Commission on Dietary Supplement Labels. On December 15, 1997 he sent a letter to Michael A. Friedman, MD, Lead Deputy Commissioner of the FDA to inform you thusly: "Cholestin does not contain a prescription or regulated drug. It contains mevolin, which is chemically distinct from Lovastatin (Mevacor), the latter being a prescription drug. This fact, in combination with a knowledge that the fermented red rice product has been used as a food or dietary supplement both in China and the United States for many years, in my opinion makes the product a "dietary supplement" as defined in DSHEA. Further, DSHEA was enacted by Congress "....following public debate concerning the importance of dietary supplements in leading a healthier life, the need for consumers to have current and accurate information about supplements and controversy over the FDA's regulatory approach to dietary supplements...." (CDSL Report p.v) Farnsworth goes on to state: "The FDA Final Rules on labeling statements, in my opinion, were not helpful to industry as to how to craft truthful and non misleading health claims. For this reason, the CDSL stated on p.37 of their Report "....it is possible to craft a statement of nutritional support and not a health claim or drug claim." Farnsworth went on to say "It seems to me that having a mild to moderately elevated cholesterol level being lowered is a clear structure function claim as opposed to a statement that lowering cholesterol may prevent atherosclerosis."

CDSL took two years to study this matter, yet it is painfully evident that in your zeal to "harmonize" American food and drug laws to EEC 65/65 (An EU directive which turns all dietary supplements into "drugs") that you choose to utterly IGNORE this Presidentially Appointed Commission, and further waste our tax dollars attacking Pharmanex due to the revolving door between the FDA and such pharmaceutical giants as Merck. The American people have spoken, FDA. We told you to keep your hands off our supplements, and we MEAN it! I am ccing this to my congressman to request that he cosponsor HR 2868 The Consumer Health Free Speech Act, which removes "food" from the current, overly broad statutory definition of "drug" because FOODS are NOT DRUGS!!!!

We are ON to your little shell game, FDA! We have TAKEN NOTICE of the despicable efforts of the EU funded ESCOP at University of Exeter in the UK to attempt to force the global harmonization of laws governing the manufacture and sale of herbal products, just as we are ALSO enraged by the German Codex Proposal to restrict our access to only RDA levels of vitamins & minerals! IAHF has exposed the whole scam at www.iahf.com, especially the ANPR in the July 7, 1997 Federal Register (Vol. 62, #129, pp. 36243-36248) in which you vow to "harm-onize" your regs to emerging Codex (and ESCOP) full ISO pharmaceutical standards! BACK OFF, FDA, OBEY THE LAW, & LISTEN TO FARNSWORTH!

(cc to my Senators & Congressman)

Name ________________________________________________ Date_____________________

Address________________________________________________________________________

City __________________________________________________State___________Zip____________