FDA WARNING_LETTER - Empire Distributors, Inc. - April 23, 2019

The FDA issued a Warning Letter to Empire Distributors, Inc., regarding their product "Rhino Black 5K Plus," sold via their website and Amazon.com storefront. An FDA lab analysis confirmed the product contains undeclared sildenafil and tadalafil, active ingredients in prescription ED drugs Viagra and Cialis, respectively.

The product is deemed an unapproved new drug under sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act, as sildenafil and tadalafil were approved as drugs before being marketed as dietary supplements. It is also a misbranded drug under section 502 and sold in violation of section 301(a) because it lacks adequate directions for use, its labeling is false/misleading by not declaring the active ingredients, and it lacks adequate warnings. These undeclared ingredients pose serious health risks, especially for individuals taking nitrates, potentially causing dangerous blood pressure drops.

The FDA also noted other products sold by Empire Distributors, Inc., such as "BLACK MAMBA PREMIUM" and "RHINO 7," which have been found to contain undeclared active pharmaceutical ingredients by other distributors.

Empire Distributors, Inc. must take prompt action to correct these violations and respond in writing within fifteen working days, detailing corrective actions, steps to prevent recurrence, and a timetable for any remaining corrections. Failure to comply may result in legal action, including seizure, injunction, and/or