The US Food and Drug Administration (FDA) has issued warning letters to major retailers CVS Health Corp., Walgreens Boots Alliance, and six other companies, stating that their over-the-counter eye drops are illegally marketed and pose a significant public health concern. The FDA considers these eye drops to be unapproved new drugs, in violation of federal law. These products were manufactured by companies with known quality issues related to product sterility, although the names of these manufacturers were redacted from the warning letters.
Earlier this year, a fatal bacterial outbreak was linked to other eye drop products, which further emphasizes the importance of ensuring the safety and efficacy of these products. As a result, the FDA has increased its surveillance of eye drop products and is taking action to protect consumers from potentially harmful ophthalmic products.
CVS has swiftly responded to the warning letters by halting the sale of the eye drops mentioned and offering refunds to customers who have purchased them. CVS stated that it remains committed to offering safe and effective products that meet customers' expectations.
During a visit to a CVS store in downtown Boston, it was observed that the store-brand pink eye drops, specifically mentioned in the warning letter, were still in stock but were prohibited from being purchased through the store's system. Similar actions were taken against a product from Similasan AG, a Swiss company also included in the warning letters.
Walgreens, on the other hand, has not yet provided a response regarding the warning letters.
Other companies receiving warning letters include Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, and TRP Company, Inc. The FDA emphasizes that these warning letters are part of its ongoing effort to protect Americans from potentially harmful eye care products.
This increased surveillance and action by the FDA follows a deadly bacterial outbreak earlier this year that was linked to contaminated eye drops manufactured in India. This outbreak resulted in several deaths, cases of vision loss, and numerous infections. The FDA has recently issued warnings about two more eye drop brands due to bacterial and fungal contamination.
In August, KC Pharmaceuticals Inc., a contract manufacturer for eye drops based in California, received a warning letter from the FDA for significant violations of good manufacturing practices, including the lack of an effective quality oversight system. KC Pharmaceuticals is one of the largest suppliers of private label eye care products in North America.
The companies that received the warning letters have been given 15 days to respond to the FDA, outlining how they will address and correct the violations. Failure to do so promptly may result in the FDA taking legal action, including product seizure or court orders to cease manufacturing and distributing unapproved products. The FDA has also placed some of these companies on import alert to prevent their products from entering the US. Similasan AG is among the companies on the import alert list.