Amazon viagra pills

By Amrita Khalidone of the authors of audio industry newsletter Hot Pod.

Amazon has been threatened with legal action by the US Food and Drug Administration FDA after the agency found undeclared Viagra and Cialis in several male energy supplements sold on the site. All seven products contained tadalafil or sildenafil, more commonly known as the erectile dysfunction treatments Cialis and Viagra. The FDA first published its findings in August. In its December letter, the agency warned Amazon that it had violated several federal laws set out by the Federal Food, Drug, and Cosmetic Act. FDA approval of both Viagra and Cialis is restricted to use under the supervision of a licensed healthcare professional and requires a prescription.

Amazon viagra pills

The FDA hit Amazon with a warning letter 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. 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! 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.

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Amazon viagra pills

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All seven products contained tadalafil or sildenafil, more commonly known as the erectile dysfunction treatments Cialis and Viagra. US Markets Loading The misbranding "may pose serious health risks because consumers with underlying medical issues may take the products without knowing," the regulator warned, adding that six of the seven products were "unapproved new drugs" that should have been cleared. 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. 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! Copy Link. It symobilizes a website link url. This can be dangerous or even fatal to people with heart problems. Opens in a new tab or window. The agency had identified the products individually throughout the year. If you buy something from a Verge link, Vox Media may earn a commission. Amazon was told it had 15 days to respond to the warning with an explanation of how it would prevent future violations or it would face legal action. 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. This was not the case for tadalafil and sildenafil. 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.

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The products, which were marketed as harmless dietary supplements, should have been defined as drugs as they contain ingredients intended for use in treating and preventing erectile dysfunction, the FDA cautioned. Sign up. Amazon has been threatened with legal action by the US Food and Drug Administration FDA after the agency found undeclared Viagra and Cialis in several male energy supplements sold on the site. Email Twitter icon A stylized bird with an open mouth, tweeting. 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. Share on LinkedIn. Share Facebook Icon The letter F. Amazon did not immediately respond to BI's request for comment, made outside normal working hours. The Verge homepage. Email address. Copy Link.