Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your product is an unapproved new drug in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Passage 2Your product is also an unlicensed biological product in violation of section 351(a)(1) of the Public Health Service Act (PHS Act), 42 U.S.C. § 262(a)(1).
Passage 3your product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or conditions in humans and/or is intended to affect the structure or function of the body. For example, your brochure states, “With Allerdent you can experience allergy immunotherapy while simply brushing your teeth every day. This is known as oral mucosal immunotherapy, or OMIT”.
Passage 4a biological product as defined in section 351(i) of the PHS Act, 42 U.S.C. § 262(i).