Amazon has been looking to expand into the healthcare industry.
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Amazon has been handed a warning by the FDA over sales of mislabelled and unapproved products.A lab analysis found several male energy supplements contained undisclosed Viagra and Cialis. The warning comes as Amazon has been trying to expand into the healthcare industry.
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.
In a letter sent in December, the agency said it had purchased seven male energy supplement products sold on Amazon including Round 2, Big Guys Male Energy Supplement, and X Max Triple Shot Energy Honey.
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.
“Laboratory analyses confirmed that they contained undeclared and potentially harmful active pharmaceutical ingredients,” the agency said.
FDA approval of both Viagra and Cialis is restricted to use under the supervision of a licensed healthcare professional and requires a prescription.
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.
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.
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.
“Safety is a top priority at Amazon. We require all products offered in our store to comply with applicable laws and regulations,” Samantha Boyd, an Amazon spokesperson, told The Verge.
“Following the FDA’s previous guidance, we removed the products in question earlier this year,” she said.
The company has received several similar warnings over the sale of “unapproved” drugs this year.
In August, the regulator warned that prescription-only drugs used to treat serious skin conditions were being marketed for use by children on Amazon, the FT reported.
The persistent warnings come as the retail giant looks to expand its healthcare offering through services such as video calls with doctors, and a £3.9 billion acquisition of One Medical, a subscription-based healthcare provider.
Amazon did not immediately respond to BI’s request for comment, made outside normal working hours.