The US Food and Drug Administration (FDA) has issued warning letters to eight companies manufacturing or marketing unapproved eye products that violate federal law.
The FDA said the warning letters are part of the agency’s ongoing effort to protect Americans from potentially harmful ophthalmic products.
Companies that the FDA sent the letters to include Walgreens, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA and TRP Company Inc.
“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.
Some of the products contain silver, which may appear on labels as silver sulfate, silver sulphate or agentum. These agents can cause areas of the skin or eye to permanently turn gray or blue-gray, a condition called argyria, said the FDA.
The agency added another concern is that people may buy into claims of a product to cure, treat or prevent serious conditions, which could cause consumers to delay or stop medical treatments that are safe and effective as per FDA review processes.
The ophthalmic eye products in question include drugs that claim to treat diseases such as pink eye, glaucoma and cataracts, among others.
The FDA is advising people who are using the illicit products to consult with a healthcare professional. It also said it encourages consumers and healthcare professionals to report any adverse reaction to the agency’s MedWatch program.
The companies have 15 days to respond to the FDA letters, which should include how they plan to correct the violations. The agency said if the companies fail to respond within the given time frame, it may pursue legal action, which could include seizing the products and/or a court order requiring the company to stop manufacturing or sale of the unapproved product.
CVS has been quick to take action, having stopped selling its Pink Eye Relief Eye Drops in stores and online, according to Reuters. It said consumers who had purchased the drops could return it to the company’s pharmacy for a full refund.
Walgreens said it has also pulled the FDA-flagged products off its shelves and is offering a full refund to customers who have purchased them.
According to CNN, other companies like TRP are saying there are no health reports of adverse events linked to its ophthalmic products, adding that “homeopathic drug products are not illegally marketed.” Boiron USA told CNN that it is formulating a response to the FDA while Similasan is assessing the situation and consulting partners.
The FDA said its investigation of eye products is ongoing and may take “additional regulatory or enforcement actions, as warranted.”
The FDA routinely looks out for illicit drugs on the market. Recently, it flagged the sale of unauthorized versions of Novo Nordisk’s obesity drug Wegovy being made by compounding pharmacies.