A nonsensical guidance issued by the FDA in 2005 continues to cause confusion. Action Alert!
Under the Food, Drug, and Cosmetic (FD&C) Act, a supplement is misbranded if it does not announce itself as a supplement. The actual statute says that it is violating the law if “the label or labeling of the dietary supplement fails to identify the product by using the term ‘dietary supplement,’ which term may be modified with the name of such an ingredient.” Most producers place the words “Dietary Supplement” on the front label of their product in order to comply with this requirement.
However, 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 position not only appears to contradict the language in the FD&C Act, but also the language in the federal code of regulations—which the FDA cites in order to support its position!
This regulation reads:
Dietary supplements shall be identified by the term “dietary supplement” as a part of the statement of identity, except that the word “dietary” may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins).
So where is the FDA coming from with their guidance? This is not an obscure technical matter—it’s causing real problems. 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.
Ten years after its first appearance, the FDA has done nothing to address this glaring error. Are supplements actually supplements? The law says they are. The FDA still says they may or may not be.
Action Alert! Urge the FDA to correct this mistake and comply with federal law. Please send your message immediately.
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Lawyers love ambiguous and contradictory laws. It’s what keeps them in business.