Used for years as an “unapproved” drug for lightening of skin color, the FDA issued warning letters to twelve firms selling the drug, telling them that hydroquinone is not generally recognized as safe and effective.

On August 29, 2006, the FDA issued a Notice of Proposed Rulemaking that would establish that over-the-counter (OTC) skin-bleaching drug products are not generally recognized as safe and effective (GRASE) and are misbranded.  That Proposed Rulemaking also withdrew the Tentative Final Monograph (TFM) of 1982 that permitted the OTC marketing of hydroquinone, the only ingredient found to be possibly effective for skin bleaching at that time.  The Agency reconsidered its TFM after additional information, showing some serious adverse events, became available.

Fast forward to 2022 and the FDA has finally put the hammer down on these products, sending warning letters to twelve firms, telling them that continued OTC marketing of the products, which are now considered new drugs by the Agency, is not permitted.  You can find the warning letters here and the history of OTC rulemaking for Skin-Bleaching Drug Products here.  The FDA says, “FDA is alerting consumers there are no FDA-approved or otherwise legally marketed OTC skin lightening products.  Some manufacturers and distributors have already removed their OTC skin lightening products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products.”

Don’t hold your breath any longer; the time has finally come for this product class.