Citizens for Health

www.citizens.org

FOR IMMEDIATE RELEASE

February 8, 2010

CONTACT: Glenn Turner, 917-817-3396 or Shayna Samuels, 718-541-4785

McCain / Dorgan “Dietary Supplement Safety Act” Would Cripple Nutritional Products Industry While Doing Nothing to Protect Consumers from Dangerous Performance Enhancing Drugs, Says Nonprofit Consumer Group

Interviews Available with Jim Turner, Chair of Citizens for Health
& Leading Expert on Consumer Access to Dietary Supplements

On Thursday, Feb. 4, 2010, Senators John McCain (R-AZ) and Byron Dorgan (D-ND) introduced The Dietary Supplement Safety Act (DSSA) of 2010. This bill would amend the Dietary Supplement Health and Education Act (DSHEA), undermining, if not entirely eliminating, consumer access to valuable dietary supplements, according to Jim Turner, Citizens for Health Board Chair.

The bill would reverse supplements’ 100 year long status as foods, create onerous requirements for supplements not applied to other foods or even to prescription drugs, and wipe out significant numbers of small supplement manufacturers and sellers.

“This bill, typical of Washington’s destroy the economy, wipe out consumer rights, and undermine individual health mentality, thoughtlessly reinforces the costly, unresponsive, dangerous policies that have created an unsafe and depleted food supply and a bankrupt health care system” says Turner.

James S. Turner is a partner in the Washington, DC, law firm of Swankin & Turner, formed in 1973, and Board Chair of Citizens for Health, the consumer voice of the natural health community. In 1994, he worked with the newly created Citizens for Health to send over a half million communications to Congress in support of DSHEA, which then passed.

Citizens for Health Analysis of the McCain / Dorgan Bill:

Introduced by Senators John McCain (R-AZ) and Byron Dorgan (D-ND) on February 4th as the “Dietary Supplement Safety Act of 2010,” S. 3002 is designed, says the bill preamble, to “more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”

Following a surge of anti-doping initiatives and announcements dating back to a September 29, 2009 — when the U.S. Senate Judiciary Subcommittee on Crime and Drugs heard the testimony of the U.S. Anti-Doping Agency USADA), and to a December 2nd, 2009 USADA press conference — the proposed bill would dramatically: cripple the nutritional products industry, harm consumers and do absolutely nothing to stem the tide of laboratory-concocted, performance-enhancing drug hybrids masquerading as dietary supplements.

Problems in the bill serious enough to make the bill a completely un-fixable and untenable piece of legislation include:

1. Creating completely outrageous facility registration requirements for all brands, products and ingredients, similar to the unworkable European Food Supplements Directive (EFSD) despite the fact that US food facilities are already required to be registered;
2. Effectively removing the Generally Recognized As Safe (GRAS) status of most major herbs and botanical ingredients, thereby deeming most (if not all) herbals as “adulterated” unless they are included on the FDA’s “Accepted Dietary Ingredients” list;
3. Mandating the creation and maintenance of voluminous safety dossiers on every dietary supplement and ingredient;
4. Requiring that “all adverse events” (not just serious adverse events) relating to supplements be reported, including non-serious, trivial and unsubstantiated reports which will make the effective adverse reporting system supported by Citizen For Health unworkable; and
5. Codifying arbitrary and capricious cease and desist and recall authority based merely on the FDA’s “reasonable probability” that an item is adulterated or misbranded — this action can be taken regardless of whether the manufacturer is properly challenging the order;

This bills’ proposed establishment of an approved list of ingredients (much like EFSD’s approved lists of supplement ingredients and ingredient forms) is something to which the U.S. government (specifically the U.S. Codex delegation) has been adamantly opposed — so why would that same U.S. government endeavor to create “lists” within America’s own borders that it sees fit to battle against internationally?

The proposed provision that would require adverse events to be reported would bog the AER system down with hundreds if not thousands of trivial and product-unrelated reports; this would serve to bury reports noting potential areas of concern (signal events) in a garbage heap of useless information.

We ask all members of the U.S. Senate to NOT sponsor this misdirected, supplement-scapegoating bill that does nothing to fix the performance-enhancement spiking problems endemic within professional sports today. We also ask members of congress to demand that FDA use its existing ample authority to force off the market all products falsely branded as herbal products or dietary supplements particularly those that contain dangerous ingredients that the law already makes illegal.

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