FDA Sends Warning Letters to CVS, Walgreens, and Other Companies Over Unapproved Eye Products
The US Food and Drug Administration (FDA) has sent warning letters to eight companies, including major retailers CVS and Walgreens, for manufacturing and marketing unapproved eye products. The agency has cited concerns that these products could pose a risk to people who use them.
The FDA states that these eye products are being illegally marketed to treat conditions such as conjunctivitis (pink eye), glaucoma, and cataracts. The agency also notes that some of these products have sterility issues. The warning letters were sent to CVS Health, Walgreens Boots Alliance Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA, and TRP Company Inc. Some of these companies have also been placed on import alert to prevent their products from entering the United States.
The FDA is particularly concerned about the risks these unapproved ophthalmic drug products pose to users due to the fact that drugs applied to the eyes bypass some of the body’s natural defenses. Some of the products contain silver, which can cause areas of the skin or eye to permanently turn gray or blue-gray. Additionally, individuals may delay or stop safe and effective medical treatments while using these unapproved drugs.
The FDA advises individuals who have used the products mentioned in the warning letters to consult with a healthcare provider. Adverse events can be reported to the agency’s MedWatch program.
Jill Furman, the director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, emphasized the agency’s commitment to ensuring harmful eye products stay off store shelves. She stated that the FDA will continue to investigate potential hazards and take action to protect consumers.
The companies that received warning letters have 15 days to respond and outline how they will correct the violations. Failure to make corrections could result in legal action, according to the FDA.
CNN reached out to the companies for their responses. CVS confirmed that it had stopped selling CVS Health Brand Pink Eye Relief Eye Drops and offered full refunds to customers who purchased the product. Walgreens announced that it was pulling the products off shelves as a precautionary measure and providing full refunds to customers. TRP Company stated that no health concerns or adverse events have been reported regarding its ophthalmic products and asserted that their homeopathic drug products are not being illegally marketed. Boiron USA is currently formulating a response to the FDA, and Similasan is analyzing the situation and reaching out to partners.
The FDA’s actions highlight the importance of ensuring the safety and efficacy of healthcare products, particularly those that affect sensitive areas like the eyes. Consumers are encouraged to be cautious and informed when purchasing these types of products and to report any adverse events to the FDA for investigation.