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Posted January 11, 2023

Male Sexual Enhancement Supplement Found to Contain Prescription Drug

On January 9, 2022, the FDA issued a warning letter to Distributor RFR, LLC after laboratory analysis of the company’s SANGTER Natural Male Energy Supplement found the product to contain undeclared sildenafil, a prescription medication. The company has previously recalled other products due to sildenafil contamination.

Sildenafil (the active ingredient in Viagra) is prescribed for erectile dysfunction. This drug 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 statements made on the product’s label and the company’s website to be drug claims. For example, the company claimed its product could be used to treat erectile dysfunction and general weakness. Distributor RFR, LLC received a warning letter in 2022 for the same product.

The FDA also found SANGTER Natural Male Energy Supplement products to be misbranded because product labeling fails to bear adequate directions for its intended use and lacks proper warnings of the presence of sildenafil for the protection of consumers.

The company has 15 days to respond to the FDA in writing to explain the specific steps taken to address any violations.

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

For more information, use the link below.

Warning: Distributor RFR, LLC

See related recalls and warnings:

FDA Warns Consumers Not to Use Male Enhancement Supplement

FDA Warns Sellers of Tainted Honey-Based Sexual Enhancement Products

Honey-Based Enhancement Supplement Recalled

FDA Finds Unapproved Drugs in Many Weight Loss and Sexual Enhancement Products Sold Online

FDA Warns Consumers Not to Use Certain Sexual Enhancement Supplements