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# Empire Distributors Selling Unapproved New Drug: FDA
- URL: https://www.fdaweb.com/empire-distributors-selling-unapproved-new-drug-fda/
- Published: 2019-04-24T12:00:00.000Z
- Updated: 2026-09-15T01:22:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143946

FDA says that Empire Distributors is selling an unapproved new drug, Rhino Black 5K Plus, from its Web site and Amazon.com storefront. A 4/10 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm636099.htm?ref=fdaweb.com) says laboratory analysis confirmed that the product contains undeclared active pharmaceutical ingredients sildenafil and tadalafil, used in the branded drugs Viagra and Cialis to treat erectile dysfunction. The letter says the company is marketing Rhino Black as a dietary supplement but legally a dietary supplement may not include an article that is approved as a new drug unless the supplement was marketed before the drug was approved, which is not the case in this instance.

FDA also warns that Rhino Black is misbranded in that its labeling fails to bear adequate directions for use and lacks adequate warnings for the protection of users.

The letter says the company is selling other products that laboratory tests have found in the past to contain undeclared ingredients, including sildenafil and tadalafil or substances similar in structure to those active ingredients. “While the agency has not tested and sampled these products from your inventory to date,” the letter says, “this letter is to express our serious concern about the safety of this product and emphasize that it is your legal responsibility under federal law to ensure that it does not contain any undeclared and potentially harmful ingredients.”

Empire was told to respond with a report on the current status of its corrective actions and the specific steps it has taken to correct the noted violations, with related documentation and a timetable for completion.