Tell the FDA to Issue a Correction on Dietary Supplements!

Under the Food, Drug, and Cosmetic (FD&C) Act, all dietary supplements must be clearly identified as dietary supplements, so most supplements place the words “Dietary Supplement” on their front label. But according to a guidance issued by the FDA in 2005, the term “Dietary Supplement” by itself “is not appropriately descriptive to be a statement of identity.”

This not only contradicts the language in the FD&C Act, but also the language in the federal code of regulations—which the FDA cites to support its position!

Class action lawsuits are being filed against supplement companies, with plaintiffs’ lawyers citing this erroneous guidance as their basis for the suits. The FDA’s nonsensical guidance also complicated a multi-state investigation of a supplement manufacturer over labeling issues, in which the states accused the company of violating federal guidance.

Ask the FDA to correct this error and comply with federal law.

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Recipients

  • Stephen Ostroff

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Please Issue a Correction in Your 2005 Guidance on Supplements

Dear [Decision Maker],

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]