Press Release: For Immediate Release

7 August 2009

Just days after filing a suit against the US Food & Drug Administration (FDA) over its suppression of freedom of speech about selenium health benefits, the Alliance for Natural Health’s US-based arm, Alliance for Natural Health US (ANH-US), has today filed a second suit. The suit aims ultimately to reverse the disproportionate burden of the FDA’s new cGMP (current Good Manufacturing Practice) rule which may otherwise lead to mass closure of smaller dietary supplement manufacturers, reduced consumer choice as well as significant price hikes for products remaining on the market.

As with the previous suit, plaintiffs in the suit include dietary supplement formulators Durk Pearson and Sandy Shaw, and the Coalition to End FDA and FTC Censorship. The suit was filed in the US District Court for the District of Columbia against the Food and Drug Administration (FDA).

More specifically, the suit seeks declaratory and injunctive relief on the grounds that the FDA violated the Administrative Procedure Act’s prohibition on arbitrary and capricious action when it adopted a rule that subjects dietary supplement manufacturers to the same criminal penalties for minor paperwork violations as for selling contaminated (adulterated) product.

ANH-US (see below) is a membership-based organization that protects the rights of practitioners and consumers of alternative medicine.  ANH-US’ professional and industry members suffer the most from the financial burdens imposed by the new cGMP rule. The rule declares that when a company fails to keep adequate records, a product is automatically deemed to be adulterated without requiring the FDA to prove that the product itself presents a risk of illness or injury. The rule conflicts with the Dietary Supplement and Education Act of 1994, which requires a risk of harm before a product can be declared adulterated and removed from the market.

According to ANH-US, the rule results in significant financial burdens on supplement manufacturers, some of whom may not be able to absorb the cost. FDA has estimated that the rule’s implementation would eliminate 12 percent of the dietary supplement market.

Regarding the suit, ANH-US Executive Director Gretchen DuBeau said, “The FDA cannot be allowed to implement such a blatant attack on the dietary supplement industry, an industry millions of consumers depend on for valuable, affordable access to vitamins necessary to sustain health.” FDA estimates that enforcement of the GMPs will reduce the variety of dietary supplements on the market and increase the cost of dietary supplements.

DuBeau continued, “We take this action today to stop the FDA, which is becoming nothing more than a tool used by Big Pharma to cut off consumer access to natural substances, from continuing its campaign against natural health.”  

ANH-US is represented in this matter by Emord & Associates, P.C.

Ends

CONTACT

Sophie Middleton

Alliance for Natural Health

The Atrium

Curtis Road

Dorking

Surrey 

RH4 1XA

United Kingdom

Tel: +44 (0)1306 646 600

ww.anhcampaign.org 

EDITORS NOTES:

About the Alliance for Natural Health US: 

American Association for Health Freedom (AAHF) is in the process of merging with the international organization Alliance for Natural Health and is already operating as Alliance for Natural Health US.

AAHF is a 501(c)4 nonprofit organization that protects Americans’ right to access integrative medicine and dietary supplements. AAHF defends the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.  More information is available at www.healthfreedom.net.