Amazon Receives FDA Warning Letter for Selling Energy Supplements Containing Harmful Ingredients
The FDA issued a warning letter to Amazon on December 20 regarding the distribution of energy supplements for men that contain potentially dangerous pharmaceutical ingredients.
According to the letter, these products were labeled as energy-enhancing supplements or food, but laboratory tests confirmed the presence of undisclosed and potentially harmful active pharmaceutical ingredients. The FDA held Amazon accountable for introducing misbranded, unapproved new drugs, as well as prohibited food, into interstate commerce.
Among the products tested by the FDA were “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).
The FDA emphasized that marketing such products as dietary supplements is prohibited if they contain an “approved new drug,” unless the active ingredient was marketed as a supplement prior to approval. In the case of tadalafil and sildenafil, this requirement was not met.
The FDA pointed out that the labeling of these products included claims and statements that establish their intended use as drugs. Examples of such claims included statements like “The Power to Go Again! Strength * Energy * Endurance” and product names like “Male Energy Supplement.”
The agency stated that the products are misbranded because their labeling fails to disclose important information, such as the inclusion of PDE-5 inhibitors tadalafil and sildenafil. These drugs can interact with nitrates found in certain prescription medications, leading to potentially dangerous drops in blood pressure. Consumers with diabetes, high blood pressure, or heart disease often take nitrates, making them particularly vulnerable to harm.
The FDA also noted that these products are prescription drugs and can only be used safely under the supervision of a licensed practitioner. Therefore, it is impossible to provide “adequate directions for use” that would allow laypeople to use these drugs safely for their intended purposes.
Furthermore, the products lack warnings regarding unsafe dosage or duration of administration, further increasing the risk of serious harm.
In the warning letter, the FDA requested that Amazon respond within 15 days to explain how they plan to address these violations. Specifically, the agency asked for details on the steps Amazon will take to ensure that unapproved new drugs and misbranded products with undeclared drug ingredients are no longer introduced or delivered into interstate commerce. Failure to comply may result in legal action.
Source: MedPage Today – Sophie Putka