FDA WARNING_LETTER - Shopaax.com - July 12, 2022

On July 1, 2022, the FDA issued a Warning Letter to Mr. Mousstaid regarding his product, Royal Honey for Him, purchased from www.shopaax.com. Laboratory analysis confirmed the product contains undeclared sildenafil, a phosphodiesterase type-5 (PDE-5) inhibitor and the active ingredient in the prescription drug Viagra.

This constitutes a prohibited act under Section 301(ll) of the FD&C Act [21 U.S.C. 331(II)], which prohibits introducing into interstate commerce any food to which an approved drug like sildenafil has been added. Sildenafil can dangerously lower blood pressure, especially in individuals taking nitrates for conditions like heart disease.

The letter states this is not an exhaustive list of violations and emphasizes the firm's responsibility to ensure compliance with federal law. The FDA has not conducted a complete inventory review. The firm must respond in writing within fifteen working days, detailing corrective actions, steps to prevent recurrence, and supporting documentation. If unable to complete actions within this timeframe, a reason for delay and a timeline must be provided. Failure to address the matter may result in legal action, including seizure and injunction.