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# 12 Warning Letters Sent to Skin Bleaching Marketers
- URL: https://www.fdaweb.com/12-warning-letters-sent-to-skin-bleaching-marketers/
- Published: 2022-04-19T12:00:00.000Z
- Updated: 2026-09-14T17:41:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151625

FDA has sent [Warning Letters](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters?ref=fdaweb.com) to 12 companies for selling unapproved over-the-counter (OTC) products intended to bleach or lighten the skin. The letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are also not generally recognized as safe and effective.

The group enforcement action is based on reports FDA received about serious side effects, including skin rashes, facial swelling, and ochronosis (discoloration of skin), according to an [agency notice](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDAsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA0MTkuNTY2NDUxMTEiLCJ1cmwiOiJodHRwczovL2NvbnRlbnQuZ292ZGVsaXZlcnkuY29tL2FjY291bnRzL1VTRkRBL2J1bGxldGlucy8zMTQxOWI2In0.brurFRS2w4RxPaRScVKXN6aphLdvRWO6FZHxZ-UQldg/s/1255720147/br/130019624037-l?ref=fdaweb.com). It notes that Tri-Luma is the only FDA-approved drug containing hydroquinone. It is approved for the short-term treatment of dark spots associated with moderate-to-severe melasma of the face, and it should only be used under the supervision of a licensed health care professional.