FDA Proposes removing Supplements subject to published study

[Guest guest]

Is the FDA trying to end-run DSHEA—again?

 

 

 

Today marks the closure of the period of public comment to the FDA,

concerning their highly controversial bid to ban interstate trade of food, food

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

investigation.

What 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!

Having requested comments on this issue, relating to Section 912 of the FDA

Amendments Act of 2007, from July 28, 2008, the FDA is going to have some

difficulty maintaining the stand, particularly as elements of Section 912,

conflict with other legislation already in place, notably the Dietary

Supplement Health and Education Act (DSHEA) (1994).

Find out more in our joint release made with our US affiliate, the

_American Association of Health Freedom._ (http://www.healthfreedom.net/)

.......

_[Click here_

(http://www.anhcampaign.org081125-FDA-LATEST-THREAT-TO-DIETARY-SUPPLEMENT\

S-DEFIES-DSHEA.pdf) for PDF version of press release]

JOINT PRESS RELEASE:

AMERICAN ASSOCIATION FOR HEALTH FREEDOM/

ALLIANCE FOR NATURAL HEALTH

For Immediate Release:

Gretchen DuBeau, ph 800-230-2762

International Contact:

Dr Robert 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,â€

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.â€

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 Robert 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.â€

“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

narrowedâ€, 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.â€

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.