Return-Path: jham@concentric.net Errors-To: Date: Mon, 10 Nov 1997 16:05:16 -0500 (EST) X-Sender: jham@pop3.concentric.net (Unverified) To: cafmr@pnc.com.au From: John Hammell Subject: Dietary Supplements Exempted from Harmonization Language in S.830 Until I see the complete Conference Report, I will reserve final judgement of the extent of our victory, but I'd like to thank all of you who called, sent email, and faxes in an effort to remove or amend the harmonization language in the FDA Reform Bill (S.830), because we have won at least a partial victory. Both the House and Senate passed the Conference Report yesterday, Sunday, 11/10. The complete Conference Report will be available on the Thomas database in a few days, and will also be available from the Senate document room by calling them via 800-972-3524.A copy is being overnighted to me, and I will be discussing it with someone this evening. I will put out an additional message to supplement this one after further analysis of what passed. The Senate Labor Committee has just faxed me pp.202-203 from the Conference Report which covers section 410 Mutual Recognition Agreements and Global Harmonization I will quote this whole section on pp.202-203 so that the exemption language on p.203, lines 18-19, can be seen in the proper context. I'll put the exemption language in CAPS so you can spot it quickly (scroll down to lines 18-19 on p.23) The exemption refers you to section 201(ff) of the Food, Drug, and Cosmetic Act, which is the part of the Act that defines dietary supplements. I'll include that for you at the end so you can see what it says. Congressman Ron Paul has just introduced a new bill, HR 2868 the "Consumer Health Free Speech Act" In an upcoming email message I will provide you with a copy, as well as commentary on its importance. Among other important things, the bill exempts foods from the current definition of "drug", and in so doing, exempts dietary supplements. The value of this is that it will stop FDA from blocking the making of therapeutic claims on dietary supplements when they exceed the current "structure-function" claims that are presently allowed under DSHEA. Please start calling your Congressmen and Senators to ask them to cosponsor HR 2868- The Consumer Health Free Speech Act, which was just introduced by Congressman Paul. What follows is from the Conference Report on the FDA Reform Bill (S.830) (page 22) 1 SEC 410 MUTUAL RECOGNITION AGREEMENTS AND GLOBAL 2 HARMONIZATION 3 (a) GOOD MANUFACTURING PRACTICE REQUIRE- 4 MENTS- Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) 5 is amended-- 6 (1)in clause (i), by striking ", and" at the end 7 and inserting a semicolon; 8 (2) in clause (ii), by striking the period and insert- 9 ing "; and"; and 10 (3) by inserting after clause (ii) the following: 11 (iii) ensure that such regulation conforms, to 12 the extent practicable, with internationally recog- 13 nized standards defining quality systems, or parts of 14 the standards, for medical devices." 15 (b) HARMONIZATION EFFORTS.--Section 803 (21 16 U.S.C. 383) is amended by adding at the end the follow- 17 ing: 18 "(c)(1)The Secretary shall support the Office of the 19 United States Trade Representative, in consultation with 20 the Secretary of Commerce, in meetings with representa- 21 tives of other countries to discuss methods and approaches 22 to reduce the burden of regulation and harmonize regu- 23 latory requirements if the Secretary determines that such 24 harmonization continues consumer protections consistent 25 with the purposes of this Act. (Page 203: 1 "(2) The Secretary shall support the Office of the 2 United States Trade Representative, in consultation with 3 the Secretary of Commerce, in efforts to move toward the 4 acceptence of mutual recognition agreements relating to 5 the regulation of drugs, biological products, devices, foods, 6 food additives, and color additives, and the regulation of 7 good manufacturing practices, between the European 8 Union and the United States. 9 "(3) The Secretary shall regularly participate in 10 meetings with representatives of other foreign govern- 11 ments to discuss and reach agreement on methods and 12 approaches to harmonize regulatory requirements. 13 "(4)The Secretary shall, not later than 180 days 14 after the date of the enactment of the Food and Drug Admin- 15 instration Modernization Act of 1997, make public a plan 16 that establishes a framework for achieving mutual recogni- 17 tion of good manufacturing practices inspections. 18 "(5) PARAGRAPHS (1) THROUGH (4) SHALL NOT APPLY WITH 19 RESPECT TO PRODUCTS DEFINED IN SECTION 201(ff)." -------------------------------------------------------------- FROM THE FOOD, DRUG, AND COSMETIC ACT- SECTION 201(ff) defines "dietary supplement": (Section 201(ff)The term "dietary supplement"-- (1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin (B) a mineral (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E); (2) means a product that- (A)(i)is intended for ingestion in a form described in section 411(c)(1)(B)(i) or (ii)complies with section 411(c)(1)(B)(ii); (B)is not represented for use as a conventional food or as a sole item of a meal or the diet; and (C)is labeled as a dietary supplement; and (definition goes on- to see the whole definition get a copy of the Food, Drug, and Cosmetic Act from the Government Printing Office) ****************************************** Donations Needed- Am One Person Working Alone International Advocates for Health Freedom John C. Hammell, Legislative Advocate 2411 Monroe St.#2 Hollywood, FL 33020 USA 800-333-2553, 954-929-2905, FAX 954-929-0507, FAX ON DEMAND 954-927-8795,jham@concentric.net http://www.pnc.com.au/~cafmr/hammell/index.html