On July 21, 2023, the FDA issued a warning letter to Gadget Island, Inc. after FDA laboratory analysis determined NUX Male Enhancement, DYNAMITE Male Sexual Enhancement, and ProPower Knight Plus 2550mg products, promoted to improve sexual function for men, contained tadalafil and sildenafil.

Sildenafil (the active ingredient in Viagra) and tadalafil (the active ingredient in Cialis) are 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.

In addition, the FDA found statements on the company’s website and social media to be drug claims because products were intended to prevent, treat, or cure disease and/or affect the structure or function or the body. For example, NUX Male Enhancement products were promoted with statements such as, “SIZE increase in thickness and in length.”

The FDA also found 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.

Gadget Island, Inc. must respond to the agency within 15 days of receipt of the warning explaining 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: Gadget Island, Inc.

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