Outreach
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Senator McCain's Proposed Legislation Could Limit Your Access to Supplements
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On February 4, 2010, Senator John McCain introduced a new bill to his peers which would give the FDA unbridled power over the supplement industry, and which could impede consumer access to health-promoting supplements while unnecessarily overburdening supplement companies. McCain’s proposed legislation, The Dietary Supplement Safety Act of 2010 (S.3002), would amend The Federal Food, Drug, and Cosmetic Act so that the FDA would have absolute discretion to decide market availability of, as well as mandatory recall authority over, supplements. On the surface, the bill seems relatively innocuous and consumer-friendly…. And we at HMDI agree that consumer safety is of the utmost importance. The problem with this bill is that its provisions are too broad: they do not specifically target the problems at hand.1 The bill gives the FDA too much power: it would allow the FDA to arbitrarily ban and/or recall supplements from the market, including vital supplements such as coenzyme Q10, and Vitamins D3 and C, to mention a few. We agree that products like weight loss supplements or steroid-enhancing products, which have proven to cause harm, should be regulated. However, FDA regulation of all supplements under MCCain’s bill could potentially strangulate the supplement industry and exhaust small company resources. Such regulation could also ultimately result in loss of consumer access to potentially life-saving products. We don’t mind if McCain protects us against harmful products, but we don’t want to “throw out the baby with the bathwater.”
ANH-USA has taken a stand against Senator McCain’s proposed legislation and has composed a letter for you to send to your state Senators. Read more about S.3002 and send your letter here.
Follow S.3002 here.
We need the FDA to protect consumers against harmful products without smothering an industry that lacks the resources to comply with over-regulation. In addition to implementing a multitude of extra administrative steps supplement companies must take before introducing any product on the market, McCain’s new bill would require supplement companies to now report all non-serious adverse events, on top of “serious adverse events,” associated with product use. Coupled with greater FDA authority to decide which supplements are suitable for market, the new regulations create the potential for pharmaceutical companies to indirectly strong-arm smaller supplement companies out of business.
A more realistic balance between consumer safety and freedom in health care is possible through a more streamlined and carefully structured bill. S.3002 should not be passed as is, and public opposition could set the stage for closer scrutiny of any related supplement regulation.
For information about existing supplement regulation, see:
The Dietary Supplement Health and Education Act of 1994 (DSHEA), which amends the Federal Food, Drug and Cosmetic Act (FD&C Act);
The FDA's Current Good Manufacturing Practices (CGMP's) for Dietary Supplements.
1. In support of S.3002, Senator McCain cited the suspension of six NFL players for taking supplements which contained bumetanide, a diuretic banned by the NFL because it has the potential to mask steroid use. Bumetanide had not been listed on the product labels at issue. McCain also noted that it took the FDA ten years to ban Ephedra, another weight loss supplement. The FDA considers a supplement with an undeclared active pharmaceutical drug to be illegal, and has cited approximately 70 different weight loss supplements for having tainted ingredients.
© 2010 Heart MD Institute, PA
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