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The FDA hit Amazon with a on December 20 for distributing energy supplements for men that contain potentially harmful pharmaceutical ingredients.

These products, according to the letter, "are labeled as energy enhancing supplements or food, but laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients." The FDA held Amazon responsible for introducing misbranded, unapproved new drugs and a prohibited food into interstate commerce.

Products that the FDA lab tested included "MANNERS Energy Boost," "Round 2," "Genergy," and "X Max Triple Shot Energy Honey," which contained tadalafil (Cialis); and "WeFun," "Big Guys Male Energy Supplement," and "Mens Maximum Energy Supplement," which contained sildenafil (Viagra).

Marketing such products as dietary supplements, the FDA noted, is prohibited if they contain an "approved new drug," unless the active ingredient was marketed as a supplement before approval. This was not the case for tadalafil and sildenafil.

Because the products are technically drugs, the FDA wrote, "examples of claims observed on the labeling, including the outer packaging, that establish the intended use of these products as drugs" included statements such as, "The Power to Go Again! Strength * Energy * Endurance," "Extreme Power," and product names like "Male Energy Supplement."

The products are misbranded because the labeling "fails to reveal facts material in light of such representations," like the inclusion of PDE-5 inhibitors tadalafil and sildenafil, according to the letter. This class of drugs, the agency wrote, "may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates."

Unwitting consumers with these medical conditions could take them "without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking."

The products are also prescription drugs, and "can be used safely only at the direction and under the supervision of a licensed practitioner," the FDA noted. "Therefore, it is impossible to write 'adequate directions for use' for [the products] such that a layperson can use these drugs safely for their intended uses."

There are no warnings on the products against unsafe dosage or duration of administration that would be needed to protect users, the agency stated, adding to the risk of serious harm.

The warning letter asks Amazon to respond within 15 days to explain how they will address the violations, including "steps you will take to ensure that Amazon will no longer introduce or deliver for introduction into interstate commerce unapproved new drugs and/or misbranded products with undeclared drug ingredients." The agency noted that failure to do so could result in legal action.

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