FDA issues warning letters to firms marketing unapproved eye products

Sept. 14, 2023

The U.S. Food and Drug Administration has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.

Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility. 

The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray, which is called “argyria.” Additionally, unapproved drugs that claim to cure, treat or prevent serious conditions may cause consumers to delay or stop medical treatments that have been found safe and effective through the FDA review process.

“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”  

The agency issued warning letters to the following companies:

Consumers currently using eye products included in these warning letters should speak to their health care professional. The FDA encourages consumers and health care professionals to report any adverse reaction to the agency’s MedWatch program.

The FDA has asked the companies to respond within 15 days of receipt of the letters, stating how they will correct the violations. Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product. Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers. 

The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted. 

FDA has the press release.

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