FDA WARNING_LETTER - 1am usa incorporated - July 12, 2022

On July 1, 2022, the FDA issued a Warning Letter to Mr. Lawson regarding his product, X RATED HONEY FOR MEN, sold on www.pleasureproductsusa.com. The FDA's laboratory analysis confirmed the product contains undeclared tadalafil, an active ingredient in the prescription drug Cialis, used for erectile dysfunction.

This constitutes a prohibited act under Section 301(ll) of the FD&C Act [21 U.S.C. 331(ll)], as tadalafil is an approved drug added to a food product. Tadalafil can dangerously lower blood pressure, especially in individuals taking nitrates for conditions like diabetes, high blood pressure, or heart disease.

Furthermore, the product is marketed as a dietary supplement, but it does not meet the definition under section 201(ff) of the FD&C Act [21 U.S.C. 321(ff)]. Tadalafil is excluded from the dietary supplement definition because it is an active ingredient in an FDA-approved drug, and there is no evidence it was marketed as a dietary supplement or conventional food before new drug investigations were authorized.

The letter requires a written response within fifteen working days detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to address these violations may result in legal action, including seizure and injunction. The FDA also noted that this is not an exhaustive list