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.”
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!
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.
the FDA to correct this error and comply with federal law.
personalize and add your own comments if you have time!
Please Issue a Correction in Your 2005 Guidance on Supplements
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]