FDA Warns – OTC Skin Lightening Products Can Cause Potentially Harmful and Irreversible Side Effects

mdi like to provide updates on various FDA situations showing how the FDA follows up with sending out multiple warning letters on a specific situation. Here is a recent case of 12 companies promoting the same product.

FDA issued warning letters to 12 companies for selling over-the-counter (OTC) skin lightening products containing hydroquinone that do not meet the requirements to be legally sold as OTC drugs. The warning letters explain that these OTC skin lightening products containing the active drug ingredient hydroquinone are unapproved drugs and are not generally recognized as safe and effective (not GRASE).

FDA has received reports of serious side effects including skin rashes, facial swelling, and ochronosis (discoloration of skin) from the use of skin lightening products containing hydroquinone. FDA advises consumers not to use these products due to the potential harm they may cause, including ochronosis, which may be permanent. Consumers should talk to their health care professional about treatment options for certain skin conditions including aged or dark spots.

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 products from the marketplace, and FDA plans to take action against those continuing to market these potentially harmful and illegal OTC products.

Questions?

For more information on the FDA follow up and the issuance of warning letters or on this specific warning on these products, please email us at: [email protected] and ref:. OTC Skin Lightening Products.