Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA confirmed through laboratory analysis that samples of your X RATED HONEY FOR MEN contains the undeclared active pharmaceutical ingredient tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor.
Passage 2Your X RATED HONEY FOR MEN 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(ll) of the FD&C Act.
Passage 3You market X RATED HONEY FOR MEN as a dietary supplement. For example, the product webpage describes the product as a supplement and displays a product label image with “Supplement Facts.” However, this product cannot be dietary supplement because it does not meet the definition of a dietary supplement under section 201(ff) of the FD&C