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On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
The US Food and Drug Administration (FDA) has circulated warning letters to eight companies for manufacturing unapproved ophthalmic drug products in violation of federal law, including CVS Health and Walgreens.1
Announced on September 12, 2023, the companies addressed in the warning letters were indicated to have illegally marketed their eye products to treat conditions including conjunctivitis, cataracts, and glaucoma. Released in accordance with an agency-wide effort to protect citizens from potentially harmful ophthalmic products, many of the FDA letters also cite quality issues related to product sterility.
“The FDA is committed to ensuring the medicines Americans take are safe, effective, and of high quality,” 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 full list of companies and products in the warning letters include:
The agency cited concerns about a potentially raised risk of harm with the use of these illegally marketed, unapproved ophthalmic drug products, as ophthalmic products bypass many of the human body’s natural defenses. Many of the products listed were labeled to contain silver (silver sulfate, silver sulphate, or argentum). The agency reports the long-term use of drugs containing silver has been linked to argyria in various areas of the skin and other body tissues, including the eye.
The release suggests unapproved drugs claiming to cure, treat, or prevent serious medical conditions may result in consumers delaying or stopping safe and effective medical treatments tested in the rigorous FDA review process.
These companies have been asked to respond within 15 days of receipt of the letters, stating how they will correct the violations. The release states a failure to correct the violations could lead to legal action, including product seizure and/or a court order requiring the manufacturing and distribution process of the unapproved product to stop.
Some have been placed on import alert to prevent their products from entering the US and reaching consumers. As the FDA investigation remains ongoing, further regulatory or enforcement actions may be taken, as necessary.
The agency urges consumers using the eye products in these warning letters to contact their healthcare provider and to report any adverse reaction to their MedWatch program.