Friday, February 26th, 2010
Senator John McCain (R-Arizona) has introduced a new bill called The Dietary Supplement Safety Act (DSSA) of 2010 (S. 3002), that, if enacted, would severely curtail free access to dietary supplements. Cosponsored by Senator Byron Dorgan (D-North Dakota), the bill would essentially give the FDA full control over the supplement industry.
Most of the industrialized world has incredibly restrictive laws governing supplements. People worldwide often purchase supplements from the U.S. because they are freely available at low costs.
All of this could change, however, if DSSA passes. DSSA would change key sections of the Federal Food, Drug, and Cosmetic Act (FD&C), undoing protections in the Dietary Supplement Health and Education Act (DSHEA) of 1994, effectively eliminating free access to supplements.
The importance of DSHEA
The passage of DSHEA resulted from millions of Americans who worked hard to reinforce their freedom to buy and sell supplements. At the time, the Food and Drug Administration (FDA) was alleging that nutrients like CoQ10 and selenium were dangerous and should be pulled from the market.
Though weak in some areas, DSHEA established a foundation upon which free access to dietary supplements would be protected from attacks by drug companies and the FDA.
What prompted DSSA?
McCain’s DSSA bill emerged in response to illegal steroid use among Major League Baseball players. Likely instigated by pharmaceutical interests, the bill is being posited as necessary to prevent supplement adulteration.
The FDA already has the power to pull supplements from the market that are contaminated but it has not been doing its job. DSSA is not only unnecessary, but it would actually reward the FDA for its failures. DSSA would also strip DSHEA and give full control of the supplement industry to the FDA.
DSSA would mandate that all supplement companies register with the Secretary of Health and Human Services (HHS), which oversees the FDA. Any company that refuses to register and comply with HHS would be subject to hefty fines, the classification of its products as “adulterated”, and their removal from the market. The new system would burden manufacturers with significant new costs that would cause supplement prices to increase. A new taxpayer-funded bureaucracy would also be created to conduct inspections and oversee compliance.
DSSA would require all “non-serious adverse events” received by supplement companies to be reported to the government, regardless of whether or not the events are related to the supplements for which they are submitted. Pharmaceutical companies would have access to these reports which they could use to petition the FDA to have supplements removed from the market. The FDA could also arbitrarily pull supplements from the market if it believes it has “reasonable probability” that there may be a problem.
FDA would decide which supplements are legal
Perhaps the most chilling aspect of DSSA is that it would allow the HHS Secretary to establish a list of permitted supplements. Reversing common law, which assumes all is legal unless restricted, DSSA would allow only what is permitted to be legal.
In a nutshell, DSSA would increase supplement costs for consumers, grant incredible new power over the supplement industry to the FDA, and drastically limit the availability of supplements. Drug companies could also use the bill to remove supplements from the market, patent them, and sell them as drugs!
It is absolutely critical to contact your Congressmen and oppose this bill. LifeExtension Magazine has a convenient “Action Alert” page in which to do so.
This article was posted: Friday, February 26, 2010 at 5:03 am