Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You market “Black Indian Salve” as a dietary supplement with directions for both topical application and for ingestion. However, “Black Indian Salve” does not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act. Only products that are intended solely for ingestion may be lawfully marketed as dietary supplements. See section 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(2)(A)(i). Topical products and products intended to enter the body through the skin or mucosal tissues are not dietary supplements. Therefore, your “Black Indian Salve” is not a dietary supplement.