S. 3002 Must Be Overhauled or Scrapped - Act Now!
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, according to the bill preamble, to “more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”
The bill follows a surge of anti-doping initiatives and announcements dating back to September 29, 2009 (when the U.S. Senate Judiciary Subcommittee on Crime and Drugs heard the testimony of the U.S. Anti-Doping Agency, or USADA), and to a December 2nd, 2009 USADA press conference. If passed, the proposed bill would dramatically harm consumers, cripple the nutritional products industry, and do absolutely nothing to stem the tide of laboratory-concocted, performance-enhancing drug hybrids masquerading as dietary supplements.
It is important to recognize that Senator McCain is a true American patriot known for his independence and Senator Dorgan has shown leadership in the area of net neutrality, which is critical to the free flow of health information for consumers.
However there are a host of problems in the bill serious enough to make it a completely irreparable and untenable piece of legislation. These include:
(1) The creation of completely outrageous European Food Supplements Directive (EFSD)/Health Canada-esque facility registration requirements for all brands, products and ingredients, despite the fact that food facilities are already required to be registered;
(2) The effective removal of the "generally recognized as safe" (GRAS) status for most major dietary supplement/herbal ingredients, thereby deeming most supplements as "adulterated" unless they are included on the FDA's "Accepted Dietary Ingredients" list;
(3) The creation and maintenance of voluminous safety dossiers on every dietary supplement and ingredient;
(4) The requirement that “all adverse events” (not just serious adverse events) relating to supplements be reported, including non-serious, trivial and unsubstantiated reports; and
(5) The codification of 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 bill’s 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 its own borders - that it sees fit to battle against internationally?
In addition, the proposed provision that would require “all” 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 commonality (signal events) in a garbage heap of useless information.
Once this bill is shelved, Citizens for Health will be happy to work with Senators McCain and Dorgan to come up with solutions directed at increasing and improving U.S. Food and Drug Administration (FDA) enforcement against labs-for-hire that spike food products with steroids and other banned drugs.
But the priority now is to ensure this bill never sees a vote in the Senate. Send a letter to your Senators now, urging them to reject S. 3002, the Dietary Supplement Safety Act of 2010.
Arizona and North Dakota residents: Since your Senators are the sponsors, you will be sending them a letter urging them to withdraw the bill from consideration. In addition, Arizona residents in one of the districts represented by Congressmen Jeff Flake, Trent Franks and John B. Shadegg will also be sending them a letter asking them to reach out to Senator McCain, urging him to withdraw the bill.