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 Last July the FDA issued a Draft Guidance for New Dietary Ingredients (NDI) -- seventeen years late.
Unfortunately, this draft guidance is a disaster, and poses a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.
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promised not to enforce the draft guidance until they issued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.
is declaring that certain supplements are “adulterated” because they
synthetic botanicals, which the FDA argues are not dietary ingredients. However, the claim that a synthetic botanical is
dietary ingredient is nowhere to be found in the law governing
new distinction comes exclusively from the NDI draft guidance, and it is
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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