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November 10, 1997
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:
(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)
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