- The Food and Drug Administration sent warning letters to several companies for manufacturing or marketing unapproved eye products.
- The products are marketed to treat conjunctivitis (“pink eye”), cataracts, glaucoma and other conditions.
- Consumers using any of these products should talk to a health care professional, the FDA said.
The Food and Drug Administration (FDA) sent
Some of the warning letters also cite quality issues related to the sterility of the products.
The FDA issued warning letters to: Boiron Inc.; CVS Health; DR Vitamin Solutions; Natural Ophthalmics, Inc.; OcluMed LLC; Similasan AG/Similasan USA; TRP Company, Inc.; and Walgreens Boots Alliance, Inc.
The agency also placed some of these companies on import alert to help keep their products from entering the United States.
“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,” the agency said in its release.
“Some of these illegally marketed, unapproved products have silver compounds which can cause discoloration of the eye, skin and other tissues, causing them to turn gray or blue-gray,” said Dr. Brian Boxer Wachler, ophthalmologist and medical reviewer at All About Vision.
People using these unapproved eye products may also delay or stop safe and effective medical treatments, the FDA said.
“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,” Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA has asked the companies to respond within 15 days of receiving the warning letter, indicating how they will correct the violations.
Failure to make corrections may result in legal action, the agency said, including seizure of the products or a court order requiring the company to stop manufacturing or distributing the unapproved eye product.
Wachler recommends that consumers who have been using an eye product search the
“If consumers have been using a product [covered by a warning letter], they should immediately stop and consider seeing their eye doctor to assess if there has been any issues from its use,” he told Healthline.
Dr. William Hogue, an optometrist at Vitreous Retina Macula Consultants of New York (VRMNY), said people using eye products should watch for symptoms such as eye redness, discharge, blurred vision and eye pain. These may indicate an infection.
If you experience a new onset of any of these symptoms after using an eye product, go see your eye doctor, he said.
Consumers and health providers can also report adverse reactions to a product to the FDA’s
“Careful consideration should be given when navigating the eye drop market,” he told Healthline. “It is best to seek an eye care professional for advice on which brand of eye drops are reputable and effective for each individual’s condition.”
But Hogue warned that with over-the-counter products, the advertising on the labels is not always backed up by science. So “it is great to see the FDA cracking down on the unfounded claims that naturopathic drops make,” he said.
Healthline reached out to the companies that received warning letters from the FDA.
In an email, Walgreens said it was pulling these products off the shelves, “out of an abundance of caution.”
“Customers who have purchased these products can return the item to their nearest Walgreens for a full refund,” Walgreens said.
Likewise, CVS said in an email that it has stopped selling CVS Health Brand Pink Eye Relief Eye Drops in its stores and online.
“Customers who purchased this product can return it to CVS Pharmacy for a full refund,” the company said. “We’re committed to ensuring the products we offer are safe, work as intended and satisfy customers.”
Similasan said in a statement that to its knowledge, there have been “zero cases of adverse events linked to the use of Silver Sulfate [used in its products] as a preservative.”
“We are engaging with [the FDA] to better understand the issues raised and provide updated documentation around our manufacturing processes,” the company said. “We are cooperating with the FDA and hope to have this matter resolved quickly.”
Boiron Laboratories USA pointed out that the FDA did not cite specific safety issues with the company’s “Optique 1 Eye Drops” product.
The company said it is preparing a response to FDA. “There is no reason for consumers to be concerned about past use of Optique 1,” it added.
The other companies had not replied to Healthline by the time of publication.
CVS, Walgreens and several other companies received warning letters from the Food and Drug Administration for manufacturing or marketing potentially harmful unapproved eye products.
The products claim to treat eye conditions such as conjunctivitis (“pink eye”), cataracts and glaucoma. Some of the letters mention quality issues related to product sterility.
Consumers who are using any of these products should talk to their doctor. Suspected adverse effects from use of a product can be reported to the FDA’s MedWatch program.