Up­dat­ed: FDA slaps Ama­zon with a warn­ing let­ter for sell­ing OTC mole re­moval prod­ucts

The FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search on Tues­day re­leased a warn­ing let­ter sent last week to Ama­zon CEO Andy Jassy in Seat­tle for sell­ing mole re­moval prod­ucts over-the-counter, or, as the FDA ex­plains, “in­tro­duc­ing, de­liv­er­ing, or caus­ing the in­tro­duc­tion or de­liv­ery in­to in­ter­state com­merce of prod­ucts that are un­ap­proved new drugs.”

“There are no over-the-counter (OTC) drugs that can be legal­ly sold for mole or skin tag re­moval, and FDA has safe­ty con­cerns about drugs mar­ket­ed OTC di­rect­ly to con­sumers for these us­es,” the agency said in its Aug. 4 warn­ing.

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