April 20, 2022 -- The FDA issued warning letters to 12 companies selling over-the-counter skin lightening products that contain a compound that can cause serious side effects and don't meet the requirements to be sold legally over-the-counter.

The 12 products that contain the compound hydroquinone are unapproved drugs and are not generally recognized as safe and effective, the FDA said in the April 13 letters.

Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration, also known as ochronosis. The discoloration can be permanent, the FDA says.

The lighteners are marketed for use on age or dark spots on the skin associated with melasma. Melasma, sometimes called the ''mask of pregnancy," because it often happens then, is marked by light brown, dark brown or blue-gray patches on the skin.

The only FDA-approved product that contains hydroquinone is Tri-Luma, a prescription drug for the treatment of moderate to severe melasma of the face. It is meant to be used under the supervision of a health care professional.

The FDA letters come after reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the way in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.

The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The FDA asked the companies to respond with 15 days saying what they have done to correct the violations.

The 12 companies include:

  • AMBI Enterprises
  • Clinical Formula LLC
  • Elements Brands Inc.
  • Genomma Lab USA
  • Intilight/Dr. Thomas Balshi
  • M&M Beauty and Wellness
  • Neoteric Cosmetics/Scott's Liquid Gold
  • Skin Authority LLC
  • Skin Pro
  • Skin PS Brands
  • True Earth Health Products
  • Ultimark Products

Tri-Luma cream, the approved prescription cream, contains 4% hydroquinone and is for use for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products often contain less hydroquinone. For example, AMBI's cream has 2%, as does M&M Beauty and Wellness' and Genomma's products.

Health care professionals and consumers can report side effects from these products to the FDA’s MedWatch Adverse Event Reporting program.

Show Sources

FDA: "FDA Issues Warning Letters for OTC Skin Lightening Products."

Tri-Luma.com

Cleveland Clinic: "Melasma."

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