FDA issues CDER safety alert and warning letters after severe injuries from unapproved chemical peel products sold online

Leah Herity described DPV’s evaluation of serious skin injuries linked to unapproved, non‑prescription chemical peel products purchased online and self‑applied without professional supervision.

The signal centered on concentrated acids — for example, trichloroacetic acid (TCA), glycolic, salicylic and lactic acids — that are typically used by health professionals but were being marketed directly to consumers. DPV reviewed FAERS and published literature and supplemented that evidence with consumer product reviews on Amazon.com; some reviews included photographs documenting injuries.

One literature example cited by presenters involved a 38‑year‑old man who purchased a 50% TCA product, self‑applied it for acne, developed stinging and worsening skin discoloration, and was diagnosed with a chemical burn and hyperpigmentation after biopsy. The division’s dermatologist assessed case severity across reports and determined regulatory action and public communication were warranted.

CDER issued a CDER safety alert warning consumers against purchasing and using non‑prescription chemical peel products without professional supervision, published findings in peer‑reviewed literature to reach clinicians and consumers, and issued warning letters to six companies selling implicated products. The presenters said these actions were taken to reduce preventable severe skin injuries from high‑concentration products marketed as consumer cosmetics.

DPV’s use of consumer reviews as nontraditional data underscored the expanding sources the agency uses to identify harms beyond traditional reporting systems.