Eye Drops Lawsuit Investigation: FDA Issues Warning About Unapproved, Potentially Dangerous Products

Attorneys working with ClassAction.org are investigating whether class action lawsuits can be filed on behalf of people who purchased certain eye drop products that the FDA found were illegally marketed and sold without the agency’s approval.

On September 11, 2023, the agency sent warning letters to eight companies that manufacture or market the eye drop products at issue, finding that the eye drops were represented as able to treat medical conditions such as conjunctivitis (pink eye), cataracts and glaucoma even though they hadn’t received FDA approval for that purpose and are not considered safe treatments for those conditions. The FDA also expressed concern about quality issues with some of the companies’ manufacturing processes and warned that consumers’ use of the eye drops at issue could be dangerous to their health.

The attorneys are now looking into whether class action lawsuits can be filed to help consumers get back some of the money they spent on the unapproved eye drop products.

Which Eye Drops Were Mentioned in the FDA Warning Letters?

The eye drop products that were the subject of the FDA warning letters include the following:

What’s the Problem with the Eye Drops in the FDA Warning Letters?

The agency warned that the companies at issue were manufacturing or marketing drugs that had not received FDA approval in violation of the Federal Food, Drug, and Cosmetic Act.

Essentially, products that are marketed as able to diagnose, cure, treat or prevent disease are considered drugs that require FDA approval before they can be legally sold in the U.S. The approval process requires the products to undergo extensive testing to determine whether they are safe and effective for their intended use.

The FDA found that the eye drops at issue were being marketed as able to treat certain health conditions, including conjunctivitis, cataracts and glaucoma, even though they had not received the required approval and were not “Generally Recognized as Safe and Effective” (GRASE). Even products marketed as “homeopathic” could still be considered drugs subject to FDA approval requirements.

The FDA also said it was “particularly concerned” that the eye drop products could be dangerous to users because drugs applied to the eyes “bypass some of the body’s natural defenses.” Moreover, the agency warned that consumers who use unapproved drugs to treat their medical conditions could be misled into delaying or stopping necessary known safe and effective treatments.

Is This a Recall?

The FDA warning letters are not the same as a product recall. The agency has asked the companies to respond within 15 days and identify how they will correct the violations.

Failure to address the issues in the letters could result in the FDA taking legal action against these companies, which may include product seizure or a court order requiring them to stop manufacturing or distributing the unapproved products.

In the meantime, the FDA urged any consumers who are currently using these eye drops to speak to their healthcare professional.

How Could a Lawsuit Help?

A class action lawsuit, if filed and successful, could help consumers get back some of the money they spent on the unapproved eye drops. The attorneys believe many consumers would not have bought the products had they known they were not determined to be safe and effective.

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