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This rule, if finalized, would provide by regulation that a specific ingredient is not excluded from the dietary supplement definition in the Federal Food, Drug, and Cosmetic Act (FD&C Act). Accordingly, products containing this ingredient could be lawfully marketed as dietary supplements, provided they otherwise meet the definition of "dietary supplement" under section 201(ff) of the FD&C Act and are not otherwise in violation of the FD&C Act. Section 201(ff) of the FD&C Act authorizes FDA, in its discretion, to issue a rule after notice and comment, finding that the article would be "lawful" under the FD&C Act. This rule would also provide that the addition of this ingredient to a dietary supplement is not a prohibited act under section 301(ll) of the FD&C Act.