FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits / Postmarket Safety

Online Pharmacy Hit with FDA Warning for Using Undeclared Viagra in Supplements

Aug. 18, 2015
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A New York-based online pharmacy received an FDA warning letter for selling dietary supplements that contain Viagra.

R Thomas Marketing, through its websites www.herbviagra.com and www.herbsviagra.com, sold the supplements under the names Black Ant, Herb Viagra, Real Skill and Stree Overlord. All four items contain undeclared sildenafil, the active ingredient in Viagra.

The July 31 warning letter accuses the websites of making claims about sexual performance benefits with the products — claims that qualify them as unapproved new drugs. Further, because sildenafil wasn’t marketed as a dietary supplement before Viagra was approved in March 1998, the products are excluded from the definition of a dietary supplement under the FD&C Act, the FDA says.

The products also are misbranded because they don’t have adequate directions for use.

The FDA documented another 16 products R Thomas Marketing sells in the U.S. that contain undeclared tadalafil, the API in Cialis, sildenafil and noracetildenafil, which is structurally similar to sildenafil. The FDA notes that while it hasn’t tested and sampled these products from the company’s inventory, the agency is responsible for ensuring they don’t contain any undeclared and potentially harmful ingredients.

The agency warned the firm that it faces seizure, injunction and/or prosecution if the violations are not corrected.

R Thomas Marketing did not return a request for comment by press time. To view the warning letter, go to www.fdanews.com/08-12-15-RThomasWarning.pdf. — Kellen Owings