FDA warning letter · Drugs

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Issued · Posted by FDA

FDA published a close-out letter on Feb 13, 2026. The passages below are from the original warning letter.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA 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 2

Your 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.