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.Please take action immediately and send the following letter to Senators. Tell your senators NOT to co- sponsor the detrimental legislation and to do everything in their power to defeat it. Then forward this to your friends and family and ask them to do the same!
Here is a sample letter to send to your Senators:
Do Not Co-sponsor Senator McCain's Attack on Dietary Supplements
Dear [Senator],Please do not co-sponsor Senator McCain's Dietary Supplement Safety Act (DSSA). Please instead oppose it!
DSSA would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.
If this bill passes, the FDA would have full discretion and power to compile a discreet list of supplements allowed to remain on the market. Supplements drawn entirely from food and long established supplements or supplement potencies could be arbitrarily banned.
McCain's Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.
The problem here is of course one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?
The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power; we should instead demand that the FDA do its job.
Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements?
One possible explanation is that the bill's sponsor buys into the often heard argument that supplements and drugs should be treated identically, that both should be brought through the FDA's drug approval process in the same way. This is a completely false argument. The FDA drug approval process costs as much as a billion dollars. It is not economically feasible to spend such vast sums on substances that are not protected by patent, and natural substances cannot legally be patented.
This is the great "Catch 22" of American medicine. The FDA is unfriendly to supplements because they do not come through the drug approval process. But the drug approval process only makes sense for patentable substances that will sell at very high prices. This leaves the FDA, which is supposed to guard and promote our health, hostile to the kind of natural medicine--based on diet, supplements, and exercise--that represents the real future of healthcare.
If McCain's bill passes, we can look to Europe for a snapshot of what we may be in for: EFSA, the European Food Safety Authority, has sharply reduced the list of available supplements and is in process of reducing potencies to ridiculous levels, such as less beta carotene than can be found in half of a large carrot.
Please refuse to co-sponsor and otherwise oppose the Dietary Supplement Safety Act!
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