FDA Announces New Supplement Recall

By Policy and Advocacy Brief posted 06-05-2019 12:44


The Food and Drug Administration (FDA) announced several supplements promoted for sexual enhancement have been found to contain undeclared active ingredients.  The presence of the undeclared active ingredients renders the products unapproved drugs for which safety and efficacy has not been established and, therefore, subject to recall.

STIFF BOY LLC is voluntarily recalling The Beast because an FDA laboratory analysis found the supplement contains undeclared sildenafil.  Additional FDA laboratory analyses found that Man Fuel Xtreme Edition contains sildenafil, dithiodesmethyl carbodenafil and desmethyl carbodenafil and Man Fuel Shooter contains tadalafil and desmethyl carbodenafil. The FDA has not yet announced a recall for the last two products, but the public is advised not to use them.

Sildenafil is an FDA approved drug for the treatment of male erectile dysfunction and is in a class of drugs called phosphodiesterase (PDE-5) inhibitors. Dithiodesmethyl carbodenafil and desmethyl carbodenafil are structurally similar to sildenafil. Tadalalafil is another FDA approved drug used for the treatment of male erectile dysfunction. While there are no reports of illness associated with these supplements, they could pose a threat to consumers because an undeclared product can interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, and heart disease often take nitrates.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this product. Consumers can report adverse reactions or quality control problems to the FDA’s MedWatch Adverse Event Reporting program as follows:

  • Complete and submit reporting form online; or
  • Mail or fax reporting form. Download form or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-1078.

The AUA strives to notify its members about pertinent FDA alerts and recalls including medical devices, drugs and supplements.  For previous notices, see prior issues of the Policy and Advocacy Brief.