Bill 3156 - FDA Wants Power to Remove Supplements
June 30, 2005 - Representatives Susan Davis, John Dingell and Henry Waxman have introduced H. R. 3156, also called the "Dietary Supplement Access and Awareness Act". The bill requires notification of new supplements put on the market and close monitoring of any untoward effects.
The stricter rules are directed at supplements that contain herbs and herbal extracts as well as any other substances that are not strictly vitamins and minerals. In an apparent attempt to pre-empt a recent court ruling that held ephedra may be sold as long as the dose is lower than 10 mg, the bill authorizes the Secretary of Health and Human Services to require reports of adverse events and to determine the fate of any supplement by assessing the risks against the benefits.
Even a small risk may lead to removal of a supplement from the market, as it would be up to the Secretary to assess whether there is sufficient benefit. In a sane world, this would be acceptable, but the trouble is that the FDA usually acts to remove a whole class of supplements, regardless of dose, source of the ingredient or combination with other ingredients. This happened with ephedra, leading to a de-facto complete ban of any supplement containing the herb. Except, of course, prescription and over-the-counter medicines that contain the extract, and that, in my book, is an unjustifiable double standard. The Secretary is also directed by the bill and given funding to promote the reporting of side effects.
Now if supplements are to be evaluated, controlled and taken off the market at the first hint of trouble, I would like to see the same treatment be reserved to food additives, such as aspartame, the toxic sweetener and to pharmaceutical drugs that have been shown to kill people by the thousands routinely and to any other things we routinely ingest, be they foods, drinks or meds.
While it is quite reasonable to demand supplements be safe, why not demand that food additives and medicines be just as safe? Perhaps the Davis-Dingell-Waxmann bill should be extended to cover not only supplements but all the substances we routinely ingest!
According to the statistics compiled by Ron Law, risk analysis expert and policy analyst from New Zealand, supplements are the absolutely safest category of products in existence. I would certainly welcome all other ingestable products be brought to the same level of safety.
Here is a call for action issued by the Weston A. Price Foundation, forwarded by Chris Gupta of "Share the Wealth":
- - -
WESTON A. PRICE FOUNDATION
ACTION ALERT
July 25, 2005
TAKE ACTION TO DEFEAT HR 3156, LIMITING AVAILABILITY OF DIETARY SUPPLEMENTS
We need your help to put the brakes on a bad bill in the U.S. House of Representatives. H.R. 3156, otherwise known as the Dietary Supplement Access and Awareness Act, would give the FDA authority to ban virtually any herb or specialty product from the market if it failed to pass an arbitrary risk/benefit analysis.
H.R. 3156 threatens to fundamentally alter DSHEA (the Dietary Supplement Health & Education Act.) DSHEA allows you to purchase dietary supplements while giving the Food and Drug Administration authority to remove unsafe products from the market.
H.R. 3156 would hold dietary supplements to a higher standard than riskier food additives and over-the-counter drugs. It proposes onerous and unnecessary reporting requirements that will increase the cost of your medicinal herbs without providing a safer product. It also establishes a troubling risk analysis process that could remove any dietary supplement even if there is no proof of actual harm.
According to the language of H.R. 3156, an herb should be removed from the market if there is any chance of a so-called risk unless "sufficient" health benefits are proved to the FDA's satisfaction. This approach ignores the bio-individuality of individuals and is an impossible standard for most supplement manufacturers to meet; the science in this area receives less than 1% of U.S. research funding.
This bill is unacceptable and if allowed to progress will severely undermine your health rights. Take action today! And tell your friends. Together, we can put the brakes on this bill that is bad for health, bad for you, and bad for the nation's pocketbook.
Please go to this link to ask your Congressperson to vote NO on this bill:
Thank you.
*********************************************************
Bill Sanda
Executive Director
Weston A. Price Foundation
bsanda@westonaprice.org
Our postal address is
PMB #106-380
4200 Wisconsin Avenue, NW
Washington, District of Columbia 20016
United States