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Posted January 03, 2024

FDA Warns Amazon for Selling Men’s Supplements Containing Prescription Drugs

On December 20, 2023, the FDA issued a Warning Letter to, Inc. after FDA analysis found men’s energy supplements sold on the site, including MANNERS Energy Boost, Round 2, WeFun, Genergy, Big Guys Male Energy Supplement, Mens Maximum Energy Supplement, and X Max Triple Shot Energy Honey, to contain undeclared prescription drugs, sildenafil and tadalafil.

Sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in Cialis) are prescribed for erectile dysfunction and are not permitted in dietary supplements. 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.

In addition, the FDA found many of the products to be unapproved new drugs because products were intended to prevent, treat, or cure disease and/or affect the structure or function of the body. For example, Round 2 products were promoted with statements on the product label such as, “THE POWER TO GO AGAIN! STRENGTH * ENERGY * ENDURANCE.”

The FDA also found MANNERS Energy Boost, Round 2, WeFun, Genergy, Big Guys Male Energy Supplement, and Mens Maximum Energy Supplement products to be misbranded because product labeling failed to bear adequate directions for their intended use and lacked proper warnings of the presence of tadalafil or sildenafil for the protection of consumers.

In August 2023, the FDA warned consumers not to use Big Guys Male Energy Supplement after it was found to contain sildenafil, and in September 2023, WEFUN was recalled., Inc. must respond to the agency within 15 days of receipt of the warning explaining the specific steps taken to address any violations.

Consumers and healthcare providers can report any adverse reactions to the FDA’s MedWatch Voluntary Reporting Program.

See ConsumerLab’s Review of Sexual Enhancement Supplements for tests of related products.

Also see: Where to Safely Buy Real Vitamins and Supplements Online, Not Fakes or Counterfeits

For more information, use the link below.

Warning:, Inc.

See related recalls and warnings:

Total Body Nutrition, TBN Labs, and Loud Muscle Science Banned from Selling Adulterated and Misbranded Dietary Supplements

Pain Relief Tea Recalled, Found to Contain Prescription Drugs

Original The Rock Capsules Recalled Due to Undeclared Sildenafil

WEFUN Capsules Recalled Due to Undeclared Sildenafil

FDA Warns Consumers Not to Use Big Guys Male Energy Supplement