01.05.24
In late December, the U.S. Food and Drug Administration (FDA) issued a warning letter to Amazon, following an investigation in which the agency bought numerous products marketed as dietary supplements from the retailer and found that they contained drugs commonly used for erectile dysfunction.
According to FDA, the products were marketed as “energy enhancing” supplements, but contained undeclared pharmaceutical ingredients, namely sildenafil (generic Viagra) and tadalafil (generic Cialis).
“Your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs,” the letter, addressed to Amazon CEO Andy Jassy, stated.
FDA purchased “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” “Mens Maximum Energy Supplement,” and “X Max Triple Shot Energy Honey.”
“MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” were shown through laboratory analyses to contain tadalafil, while all other products mentioned contained sildenafil, the agency reported.
Information on the labels of six of the seven products indicates that they were marketed as dietary supplements, while “X Max Triple Shot Energy Honey” was marketed as a food, according to FDA.
Additionally, the products contained several claims which FDA said defined the products as misbranded drugs, due to being related to the diagnosis, cure, mitigation, treatment, or prevention of disease. Many of the claims referenced “strength,” “energy,” “endurance,” and “power,” among other terms.
“The undeclared PDE-5 inhibitors in these products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors 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,” the agency wrote.
As is commonplace with warning letters issued by the agency, FDA requested a written response from Amazon within 15 working days from the date of receipt to outline steps being taken to address the alleged violation, or to submit reasoning and supporting information in the event that Amazon believes the products are not in violation of the Federal Food, Drug, and Cosmetic Act.
According to FDA, the products were marketed as “energy enhancing” supplements, but contained undeclared pharmaceutical ingredients, namely sildenafil (generic Viagra) and tadalafil (generic Cialis).
“Your firm is responsible for introducing or delivering for introduction into interstate commerce products that are unapproved new drugs,” the letter, addressed to Amazon CEO Andy Jassy, stated.
FDA purchased “MANNERS Energy Boost,” “Round 2,” “WeFun,” “Genergy,” “Big Guys Male Energy Supplement,” “Mens Maximum Energy Supplement,” and “X Max Triple Shot Energy Honey.”
“MANNERS Energy Boost,” “Round 2,” “Genergy,” and “X Max Triple Shot Energy Honey” were shown through laboratory analyses to contain tadalafil, while all other products mentioned contained sildenafil, the agency reported.
Information on the labels of six of the seven products indicates that they were marketed as dietary supplements, while “X Max Triple Shot Energy Honey” was marketed as a food, according to FDA.
Additionally, the products contained several claims which FDA said defined the products as misbranded drugs, due to being related to the diagnosis, cure, mitigation, treatment, or prevention of disease. Many of the claims referenced “strength,” “energy,” “endurance,” and “power,” among other terms.
“The undeclared PDE-5 inhibitors in these products may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors 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,” the agency wrote.
As is commonplace with warning letters issued by the agency, FDA requested a written response from Amazon within 15 working days from the date of receipt to outline steps being taken to address the alleged violation, or to submit reasoning and supporting information in the event that Amazon believes the products are not in violation of the Federal Food, Drug, and Cosmetic Act.
