Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a Specialist1am USA Incorporated marketed X RATED HONEY FOR MEN, a food product containing the undeclared pharmaceutical ingredient tadalafil (the active ingredient in prescription drug Cialis), which violated Section 301(ll) of the Federal Food, Drug, and Cosmetic Act. FDA laboratory analysis confirmed the presence of tadalafil, a phosphodiesterase type-5 inhibitor used to treat erectile dysfunction that poses serious safety risks including dangerous blood pressure drops when combined with nitrates found in common prescription medications. The company's website marketing of this product as a food with an added FDA-approved drug constituted a prohibited act under federal law.