(US) FW: FDA defies DSHEA in latest threat to dietary supplements

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ANH Press Release: FDA defies DSHEA in latest threat to dietary supplements

Some new language in Section 912 of the FDA's Amendments Act of 2007 could

hand over control of all scientifically-verified dietary supplements to the

pharmaceutical industry. The ANH and its US affiliate, the American

Association for Health Freedom (AAHF) _http://www.healthfreedom.net/_

(http://www.healthfreedom.net/) , submitted its comments to the FDA showing

them they do not

have the legal power to do this.

The FDA*s highly controversial bid to ban interstate trade of food, food

ingredients and-dietary supplements-that have been subject to clinical

investigation is utter madness. The more effort a company spends in trying to

verify

the efficacy and benefit of its product, the more likely that it will not be

able to trade the product between states!

The ANH and AAHF have released the following press release following

submission of comments to the FDA. Please forward widely using the *Forward to

a

Friend* link at the bottom of this eBlast.

JOINT PRESS RELEASE:

AMERICAN ASSOCIATION FOR HEALTH FREEDOM/ ALLIANCE

FOR NATURAL HEALTH

For Immediate Release:

Gretchen DuBeau, ph

International Contact: Dr Verkerk, ph +44-1306-646-600

November 25, 2008

FDA'S LATEST THREAT TO DIETARY SUPPLEMENTS DEFIES THE DIETARY SUPPLEMENT

HEALTH AND EDUCATION ACT

According two leading health freedom groups

Today, the American Association for Health Freedom (AAHF) and its

international affiliate, the Alliance for Natural Health (ANH), jointly

submitted

comments to the US Food and Drug Administration (FDA) in response to its

request

for comments from industry and consumers to help them interpret recent changes

to Section 912 of the Amendments Act of 2007

(FDAAA). The submission was accompanied by comments from 700 concerned

citizens and practitioners exasperated over the latest threat to supplements

from

the FDA. The FDA's unprecedented, controversial, and ambiguous changes to

Section 912, specifically the addition of Section 301 (ll), may mean that all

food products, including dietary supplements, could be barred from being

marketed if they have been the subject of published clinical studies. AAHF and

ANH point out that this provision is so far-reaching that a very large number

of commonly consumed foods could be impacted by the new regulation and hence

barred from interstate trade.

**If the FDA determines that Section 301 applies to dietary supplements,

this would strangle innovation. It would create a *Catch 22* situation in which

supplement producers who undertake scientific research on new supplements

will find that their very research will lead to a ban on the proposed

supplement. This is totally senseless. This is too senseless even for the

FDA,** said

Gretchen DuBeau, AAHF Executive Director.

At the crux of the issue is whether the new Section 301 applies to dietary

supplements, which are already covered by Section 201 (ff) of the Federal

Food, Drug, and Cosmetic Act (FDCA). This means that Section 301 is in direct

conflict with Section 201 of the FDCA that already governs dietary supplements

through the Dietary Supplements Health and Education Act (DSHEA).

DuBeau added: **This conflict-which is supported by influential case law-

gives Section 301 of the FDAAA no legal basis. Congressional language has

already made clear and unambiguous that the FDAAA, currently under

consideration,

shall not affect the regulation of supplements under DSHEA.**

Section 201 currently also prevents the marketing of dietary supplements

which have been subject to published clinical studies-but only when they have

also been the subject of a Investigational New Drug (IND) application.

Dr Verkerk, executive and scientific director of the ANH emphasized:

**Unlike Section 201 of the FDCA, the proposed new Section 301 of the FDA

Amendments Act doesn't just limit the ban to supplements that have been subject

to drug applications, it applies a ban to some of the best researched and

most useful supplements and ingredients on the market today. This is clearly

nonsensical and if enforced, would represent one of the most severe

restrictions

seen in any country at any time.**

**There will be no shortage of big corporations that will exploit this

situation to their benefit unless the scope of Section 301 is both clarified

and

narrowed**, commented Gretchen DuBeau, **one such company is already trying to

use it to ban the natural zero-caloric sweetener stevia, given that stevia

has been subject to scientific research and has been a thorn in the side of

the sugar and artificial sweetener giants for years.**

Since the FDA*s call for comments issued on July 28, 2008, the AAHF sent an

alert to its members, including professional, integrative medicine

organizations, apprising them of the threat posed by the FDAAA*s Section 912.

More

than 700 concerned doctors and citizens emailed comments to AAHF, which

accompanied the AAHF*s joint submission with ANH. Among the prestigious groups

opposing the FDA's erroneous interpretation are the International College of

Integrative Medicine (ICIM), the American College for Advancement in Medicine

(ACAM), The American Holistic Medical Association (AHMA), the Certification

Board

for Nutrition Specialists

(CBNS), and the American College of Nutrition (ACN).

ENDS.

C Alliance for Natural Health, The Atrium, Curtis Road, Dorking, Surrey RH4

1XA, United Kingdom _www.anhcampaign.org_ (http://www.anhcampaign.org)

Alliance for Natural Health, The Atrium, Curtis Road, Dorking, Surrey RH4

1XA, United Kingdom

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Source: CO-CURE