Stop the FDA from Removing Thousands of Nutritional Supplements from the Market

Did you know that the US Food and Drug Administration has begun to enforce its new draft guidelines for dietary supplements? If they succeed, we will lose up to 29,000 nutritional supplements currently on the market, forcing over 100,000 Americans to lose their jobs. Millions of Americans rely on supplements for their health—and their families’ health. Will the supplements your family uses be banned from sale?

The law governing supplements—the landmark Dietary Supplement Health and Education Act (DSHEA), passed by Congress in 1994—mandates that supplement manufacturers notify the FDA whenever they introduce a new dietary ingredient to the market. FDA was supposed to create guidelines for submitting these notifications. Last July the FDA issued a Draft Guidance for New Dietary Ingredients (NDI) -- seventeen years late.

Unfortunately, this draft guidance is a disaster, and poses a significant threat to supplements. The biggest problem is that this guidance will turn what is supposed to be a simple notification system into a pre-approval system—a terrible precedent that will utterly cut off the supply of nutritional supplements. It will also create such huge barriers for supplement manufacturers that it will be much more difficult and expensive to produce them.

We, along with many other organizations and hundreds and thousands of supplement users, submitted formal comments articulating the numerous problems with this guidance. In fact, the original authors of DSHEA, Senators Hatch and Harkin requested that the FDA withdraw the guidance altogether.

The FDA refused to listen to the senators; however, the FDA explicitly promised not to enforce the draft guidance until they issued a final version. But now, through a series of warning letters they sent to supplement manufacturers, the FDA has broken that promise. The FDA is declaring that certain supplements are “adulterated” because they contain synthetic botanicals, which the FDA argues are not dietary ingredients. However, the claim that a synthetic botanical is not a dietary ingredient is nowhere to be found in the law governing supplements! This new distinction comes exclusively from the NDI draft guidance, and it is a perversion of what Congress intended when the law was created.

Ask your member of Congress to support the Rep. Chaffetz amendment that will prohibit FDA from using funds to implement their controversial NDI draft supplement guidance.


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