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 a sample of your Royal Honey for Him contains the undeclared active pharmaceutical ingredient sildenafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor.
Passage 2Your Royal Honey for Him product is a food to which sildenafil 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.