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Posted February 28, 2015

Drugs Found in Male Enhancement Supplements

On December 11, 2014, the FDA issued a warning letter to Biogenix USA, LLC, following a facility inspection which found the company's sexual enhancement products, HAM, CE6 and SARMZ to contain undeclared drugs, as well as drugs which were listed on the label but are not permitted in dietary supplements.

HAM was found to contain undeclared tadalafil and vardenafil. Tadalafil, the active ingredient in the prescription drug Cialis, and vardenafil, the active ingredient in the prescription drug Levitra, are typically prescribed for erectile dysfunction. These drugs can cause symptoms like headache and flushing, and can interact with medications containing nitrates such as nitroglycerine, resulting in dangerously low blood pressure

CE6 and SARMZ were labeled as containing ostarine, a selective androgen receptor modulator that may have effects similar to anabolic steroids.

In addition, company's HAM, CE6 and SARMZ to be adulterated because they were prepared, packed, or held under conditions that violate Current Good Manufacturing Practices for dietary supplements.

These violations include failure to establish specifications for dietary supplement labels, and failure to make and keep written procedures for the responsibility of quality control operations, as required by federal regulations.

Statements on product labels such as "Androgenic Modulator" and "Take 1 capsule... prior to sexual activity." were found to be drug claims.

See ConsumerLab.com's Review of Sexual Enhancer Supplements for tests of related products.

See Related Warnings:

Seller of Antioxidant Water, Energy Drops Warned for Manufacturing Violations and Drug Claims

Seller of "Natural" Cough Syrup Warned for Manufacturing Violations, Drug Claims

Seller of Aloe, Sexual Enhancement Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Aloe, Weight Loss Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of Omega-3 "Syrup" Warned for Manufacturing Violations and Drug Claims

Seller of Diabetes, Prostate Supplements and More Warned for Manufacturing Violations, Drug Claims

Seller of "Cleanse," Allergy Supplements and More Warned for Manufacturing Violations, Drug Claims

Maker of Herbal Supplements Warned for Manufacturing Violations and Drug Claims

Seller of Mineral and Joint Supplements Warned for Manufacturing Violations and Drug Claims

Vita Springs Health Warned for Manufacturing Violations and Drug Claims

Seller of Flaxseed, Ginkgo and More Warned for Manufacturing Violations and Drug Claims

Seller of Aloe, Thyroid and Other Supplements Warned for Manufacturing Violations and Drug Claims

Herbal Supplement Company Warned For Drug Claims, Manufacturing Violations

Maker of Digestive Health Supplement Warned For Manufacturing Violations, Drug Claims

To read the FDA's warning, use the link below.