Dry Eye Foundation Notifies Authorities of over 200 Potentially Unsafe Eye Drops

Surge of unregulated eye drops continues on popular e-commerce websites

POULSBO, WASHINGTON – June 22, 2023 – Dry Eye Foundation has identified over 200 eye drops (62 brands) sold online that have potential safety issues. Of these, the majority are packaged exclusively for sale in a country other than the USA. Many are advertised as preservative-free but are pictured in bottles designed only for preserved eye drops. Over 60 individual products have been found on Amazon. Dry Eye Foundation has reported all products of concern to the Food and Drug Administration, and continues to maintain a watch list for consumers and physicians at eyedropsafety.org.

Digital marketplaces are flooded with eye drops from sellers that ignore Federal drug regulations, from safe packaging rules to FDA registration requirements. The manufacturing locations and conditions for many of these eye drops are unknown to the FDA. “Most people are not aware that over-the-counter drugs, including eye drops, are regulated on an honor system,” says Sandra Brown MD, Dry Eye Foundation’s medical advisor. “Unfortunately, online marketplaces such as Amazon and Walmart take no steps to vet eye drop products, so it’s becoming very difficult for consumers to tell the good from the bad.”

Dry Eye Foundation has reported 205 eye drops that are not found in the FDA’s database, although registration with the FDA is a legal requirement for all over-the-counter eye drops.

Examples of products reported to the FDA:

  • Counterfeits and clones of national brands

  • Preservative-free eye drops packaged in standard eye drop bottles

  • Unregistered imports: 72% of all reported products appear to be packaged for sale exclusively in a country other than the USA, and may or may not be authentic

  • Trending scams, e.g. eye drops that claim to change eye color

  • “Natural” eye drops, many of which claim to treat numerous unrelated medical eye diseases

“Raising awareness about the safety hazards of purchasing eye drops online has become our top priority for 2023,” says Dry Eye Foundation’s Executive Director, Rebecca Petris. “In 2022 we were worried about three incorrectly packaged biologic eye drops. Then came the Ezricare tragedy earlier this year, which increased our sense of urgency. Since then our list grew to 10, 20, 50, 100, and now over 200. We have been sharing all our research with the FDA, and in the meantime, we need eye care providers to know what’s going on.”

Health care professionals and consumers are encouraged to learn more about eye drop safety issues and review current product alerts at eyedropsafety.org.

The Dry Eye Foundation

The Dry Eye Foundation is a 501(c)(3) nonprofit organization based in Poulsbo, Washington.

Its mission is to improve patients’ quality of life. The ocular surface diseases and ocular surface pain disorders that many patients face have profound functional, financial and emotional impact. Dry Eye Foundation is working to restore hope, redefine disease and reshape the future for people with these conditions, through its community service, education, research and advocacy programs.

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Aidan Moore
Rebecca Petris
800-484-0244
media@dryeyefoundation.org