The FDA has issued a warning letter to Amazon for selling energy supplements for men that contain potentially harmful pharmaceutical ingredients. The products were labeled as energy-enhancing supplements or food, but laboratory tests confirmed the presence of undeclared and potentially dangerous active pharmaceutical ingredients. The FDA held Amazon accountable for introducing misbranded and unapproved new drugs, as well as prohibited food, into interstate commerce.
The FDA’s lab tests included products such as “MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey,” which were found to contain tadalafil (Cialis). Additionally, “WeFun,” “Big Guys Male Energy Supplement,” and “Mens Maximum Energy Supplement” contained sildenafil (Viagra).
According to the FDA, marketing these products as dietary supplements is prohibited if they contain an approved new drug, unless the active ingredient was marketed as a supplement before approval. In this case, tadalafil and sildenafil were not marketed as supplements prior to approval.
The FDA highlighted that the products are considered drugs, as evidenced by claims on their labeling and packaging that establish their intended use as drugs. Statements like “The Power to Go Again! Strength * Energy * Endurance” and product names such as “Male Energy Supplement” indicate their drug-like nature.
The products are deemed misbranded because their labeling fails to disclose important information, such as the inclusion of PDE-5 inhibitors tadalafil and sildenafil. The FDA emphasized that these drugs may interact with nitrates found in certain prescription drugs, potentially lowering blood pressure to dangerous levels. Individuals with diabetes, high blood pressure, or heart disease often take nitrates, making them particularly vulnerable to harm.
Consumers with these medical conditions may unknowingly take these products without realizing the serious risks or potential interactions with other medications they may be using.
Furthermore, the FDA noted that the products are prescription drugs and can only be used safely under the supervision of a licensed practitioner. It is impossible to provide adequate directions for use that would enable laypeople to safely use these drugs for their intended purposes.
The absence of warnings on the products regarding unsafe dosage or duration of administration further increases the risk of serious harm.
The FDA has requested that Amazon respond within 15 days, outlining how they plan to address these violations. This includes steps to ensure that Amazon no longer introduces or delivers unapproved new drugs or misbranded products with undeclared drug ingredients into interstate commerce. Failure to comply may result in legal action.
Source: Sophie Putka is an enterprise and investigative writer for MedPage Today. Her work has appeared in various publications, including the Wall Street Journal, Discover, Business Insider, Inverse, and Cannabis Wire. She joined MedPage Today in August 2021. Follow Sophie on Twitter.