Class Action Alleges CVS Pink Eye Drops Are Misbranded, Require FDA Approval

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CVS Pharmacy has been hit with a proposed class action after it received an FDA warning letter about its over-the-counter CVS Health Pink Eye Relief Drops, which the agency said are labeled in a manner that requires regulatory approval. 

Have you bought eye drops from any of the companies that received an FDA warning letter? Let us know here.

The 15-page lawsuit contends that certain efficacy claims on the packaging of CVS’ Pink Eye Drops lead consumers to believe that the product is a drug “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.” As such, the FDA warned CVS—and seven other companies who sell similar products—that its Pink Eye Drops are essentially an unapproved new drug not generally recognized as safe and effective for its promoted uses or evaluated by qualified experts, the case states. 

In particular, the complaint challenges the label claims that the Pink Eye Drops have “a homeopathic formula that stimulates the body’s ability to relieve redness, burning, watery discharge, and sensations of grittiness.” As the case tells it, the eye drops are misbranded given that they are unable to “relieve the identified symptoms.” 

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“The FDA emphasized that ‘Homeopathic drug products are subject to the same statutory requirements as other drugs,’ and are prohibited from being adulterated, misbranded, and marketed to the public without approval,” the suit summarizes. “The Product is misbranded because it is marketed to consumers as if it were safe and effective for the identified conditions, even though its use poses a public health risk.” 

The filing stresses that an ophthalmic product administered into the eyes poses a heightened risk of harm given that route of administration “bypasses some of the body’s natural defenses.” The FDA raises alarm in particular about the inclusion of the preservative silver sulfate in the eye drops, the long-term use of which may cause irreversible skin and eye discoloration,” among other issues, the lawsuit relays. 

On September 12, 2023, the Food and Drug Administration announced that it issued warning letters to eight companies—Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens—regarding their marketing of what the agency called “unapproved ophthalmic drugs.” The agency argued that the companies’ eye drops were illegally marketed as able to treat conjunctivitis (pink eye), cataracts, glaucoma and other conditions and that the products “pose a heightened risk of harm to users” given that the apparent drugs are meant to be administered through the eye. 

Additionally, the FDA highlighted that some of the products at issue contain silver sulfate, or argentum.

“Consumers currently using eye products included in these warning letters should speak to their health care professional,” the FDA said in its press release, urging users to report any adverse reactions from the products to its MedWatch program. 

The lawsuit looks to cover consumers in New York who bought CVS Pink Eye Drops during the applicable statute of limitations period.

Have you bought eye drops from any of the companies that received an FDA warning letter? Let us know here