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 e-mail, 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 e-mail 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: