FDA Warns Companies Selling OTC Skin Lighteners

Kathleen Doheny

April 19, 2022

The US Food and Drug Administration (FDA) issued warning letters to 12 companies selling over-the-counter (OTC) skin lightening products, the agency announced today. All the products contain hydroquinone as the active ingredient, and don't meet the requirements to be sold legally over-the-counter. The letters were dated April 13.

The 12 products with hydroquinone are "unapproved drugs and are not generally recognized as safe and effective" (abbreviated as GRASE), the FDA says.

Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or 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.

Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a healthcare professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription and meant to be used under a doctor's supervision, dermatologists said.)

"Hydroquinone is a very effective medication, and that's exactly what it is, a medication," said Lily Talakoub, MD, a dermatologist in McLean, Virginia, who supports the FDA action. "It's very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems." Those problems often occur, she said, when there is no healthcare professional overseeing the use of the OTC products, and when people use them over the long term.

The FDA action to ban the OTC products is "very appropriate," said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University in Washington, DC. "We know patients pick this up [an OTC product] and use it without physician oversight." When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.

The action follows 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 method 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 agency asked the companies to take prompt action and respond with 15 days, stating 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

The OTC products often contain a lower concentration of hydroquinone; for example, AMBI's cream has 2%, as does M&M Beauty and Wellness' and Genomma's products.

Healthcare professionals and consumers can report adverse reactions associated with these products to the FDA's MedWatch Adverse Event Reporting program.

Editor's Note // April 20, 2022: This story has been updated with an additional comment from Dr Pooja Sodha of George Washington University. 

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