FDA WARNING_LETTER - Amazon.com, Inc. - April 29, 2025

On April 17, 2025, the FDA issued a Warning Letter to Amazon concerning the distribution of unapproved new drugs and misbranded drugs via its website, www.amazon.com, specifically through its Fulfillment by Amazon (FBA) service. The FDA purchased several external analgesic drug products, including "Painless Tattoo: Tattoo Numbing Cream," "Ink Scribd: Numbing Cream," and "TKTX 40%," intended for use prior to sensitive cosmetic procedures like tattooing and piercing.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). The violations stem from the products' active ingredient concentrations (e.g., Lidocaine 5%, exceeding the 0.5%-4% permitted range), unauthorized combinations of active ingredients (e.g., Lidocaine, Prilocaine, Epinephrine), and unapproved indications (e.g., for tattooing and piercing), all of which do not conform to the Over-the-Counter Monograph M017: External Analgesic Drug Products for Over-the-Counter Human Use. The FDA expressed safety concerns regarding increased absorption of active ingredients when applied to large or broken