Drugs

Amazon Selling Unapproved, Misbranded Drugs: FDA

FDA says it purchased from Amazon external analgesic products intended to be used before sensitive cosmetic procedures. A just-released 4/17 Warning Letter says the products are unapproved new drugs that are misbranded.

The letter says the products are marketed as, among other things, external analgesics to be used before, during, and/or after various sensitive cosmetic procedures such as tattooing, piercing, and laser hair removal.

“FDA has safety concerns about external analgesic drug products formulated with active ingredients at concentrations that exceed levels currently permitted for nonprescription external analgesic products because they are intended to be used before or during certain cosmetic procedures in ways that could lead to increased absorption of the drug product through the skin,” the letter says. “FDA is aware that use of these products before and/or during a cosmetic procedure may not be supervised by trained health professionals. Without this supervision, large amounts of topical analgesics may be applied to a person’s skin.”

The letter gives examples of marketing claims that establish that the products are drugs that require FDA approval and the reasons the products are misbranded.

Amazon was reminded that it is responsible if it introduces unapproved and misbranded products into interstate commerce. FDA told it to respond with a list of specific steps it is taking to correct violations and prevent their recurrence, including an explanation of each step being taken to ensure that Amazon will no longer introduce, deliver, or cause the introduction or delivery for introduction into interstate commerce of unapproved external analgesic products intended to be used before sensitive cosmetic procedures, with copies of related documentation.

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