The US Food and Drug Administration has issued warning letters to 12 firms for selling hydroquinone-based over-the-counter skin whitening treatments.
According to the FDA and US News, the goods are unapproved medications that have been reported to cause significant side effects such as rashes, face swelling, and irreversible skin discoloration.
Because of the hazards, the FDA recommends that people avoid using these items. Instead, individuals should discuss treatment options for some skin disorders, such as dark spots or age spots, with their healthcare professional.
Over-the-counter (OTC) skin whitening creams are not FDA-approved or otherwise legally available. Some manufacturers and distributors have already pulled such products from the market in the United States, and the FDA has threatened to take legal action against companies who continue to promote “possibly hazardous and illegal” goods.
Companies that received warning letters were instructed to address their infractions as soon as possible. They were given 15 days to inform the FDA of their steps to remedy the violations and prevent them from recurring.
The only FDA-approved hydroquinone therapy now on the market is Tri-Luma, a prescription medication. Tri-Luma is licensed for the treatment of dark spots associated with moderate-to-severe melasma (patchy brown discoloration) of the face for a short period of time. According to the FDA, tri-Luma should only be used under the guidance of a licensed health care practitioner.
The FDA asks for reports of issues with over-the-counter skin whitening products from consumers and health care practitioners.