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Regulatory News | 25 February 2015 | By Alexander Gaffney, RAC
For one dietary supplement company warned by the US Food and Drug Administration (FDA) this week, regulatory compliance has something in common with what the company claims its "male enhancement" product will do to users: It's hard.
The Warning Letter—among the very few we've ever read to include explicit language—calls out Biogenix USA, a Mississippi- and Georgia-based company inspected by FDA in 2013. During the inspection, FDA said it collected "product labels and samples" of the company's products.
Subsequent laboratory testing by FDA confirmed the products contained active pharmaceutical ingredients, including tadalafil and verdenafil—both active ingredients in the FDA-approved erectile dysfunction medications Cialis and Levitra.
The inclusion of FDA-approved drugs in a supplement causes them to become drugs under the Federal Food, Drug and Cosmetic Act (FD&C Act), FDA noted.
"According to section 201(ff)(3)(B)(ii) of the FDCA [21 U.S.C. § 321 (ff)(3)(B)(ii)], a dietary supplement also may not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, unless the article was marketed as a dietary supplement or food before its authorization as a new drug," the agency wrote in its letter, which was posted to FDA's website on 24 February 2015.
Regulators' concerns about the company extend beyond its ingredients, however. FDA found the company's labels included statements that the products would make users "hard as a mother**cker" and should be taken "prior to sexual activity."
Even if the products didn't contain prescription drug ingredients, these claims alone would have caused the supplements to become drugs because they are intended for conditions requiring licensed medical supervision, FDA said.
The company also failed to exercise proper oversight of its manufacturing operations, FDA claimed in the Warning Letter.
FDA Warning Letter to Biogenix USA
Tags: Warning Letter, Compliance