Amazon Receives Warning Letter from FDA

The U.S. Food and Drug Administration (FDA) issued a warning letter dated August 4, 2022, to Amazon.com, Inc.

In the letter sent to Amazon CEO Andy Jassy, the FDA writes that it purchased mole and skin tag remover products on amazon.com. These products "were introduced or delivered for introduction into interstate commerce by Amazon via [the] Fulfillment by Amazon service." However, these products were not evaluated by the FDA for safety, effectiveness or quality, and require FDA approval.

FDA Consumer Update and Press Announcement

In the warning letter, the FDA points out that "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. Moles should be evaluated by a health care practitioner; self-diagnosis and treatment of moles could lead to delayed cancer diagnosis and even cancer progression."

In a consumer update, the FDA goes on to say that "there are potentially dangerous products being sold".

In an FDA press announcement, Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, is cited as follows: “It is the FDA's duty to protect public health from harmful products not approved for the U.S. marketplace. The agency’s rigorous surveillance works to identify threats to public health and stop these products from reaching our communities. This includes where online retailers like Amazon are involved in the interstate sale of unapproved drug products. We will continue to work diligently to ensure that online retailers do not sell products that violate federal law.” 

FDA expects Amazon to take Action

In the warning letter, the FDA makes clear that it is Amazon's responsibility to ensure that it complies with all requirements of federal law, including FDA regulations. The FDA expects that Amazon will no longer introduce, deliver, or cause the introduction or delivery into interstate commerce of such products.

Amazon has 15 working days to respond and explain the specific steps that were taken to address the violations and prevent their recurrence. Failure to adequately address the points mentioned may result in legal action.

For further information, please see the warning letter on the FDA homepage.