Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your Vital Honey product is a food to which tadalafil has been added. Therefore, the introduction or delivery for introduction into interstate commerce of this product is a prohibited act under section 301(II) of the FD&C Act.
Passage 2Your Vital Honey is not generally recognized as safe and effective for the above-referenced uses and, therefore, the product is a “new drug” under section 201(p) of the FD&C Act [21 U.S.C. § 321(p)]. With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)].
Passage 3Your product Vital Honey is intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for its intended purposes. Accordingly, Vital Honey fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].