Dry Eye Foundation Launches Mermaid Tears™

Fictitious eye drop exposes regulatory shortfalls for over-the-counter drugs

POULSBO, WASHINGTON – July 19, 2023 –The Dry Eye Foundation announces the launch of Mermaid Tears™, a fictitious eye drop intended to highlight gaps in Federal regulation of over-the-counter drugs. Mermaid Tears™ is formally registered with the FDA and its drug label has been available since May 2023 through NIH’s drug information database, DailyMed. While promising mermaid-like underwater vision, Mermaid Tears™ boasts of improper packaging and a mystery proprietary ingredient that is unknown to the Poison Control Center. It cautions about sharks and warns that it may change the shape of one’s pupils. Mermaid Tears™ stands as a testament to an obsolete, over-automated OTC drug regulatory system.

New manufacturers of OTC eye drops are not required to be inspected or to prove that their products are safe before being sold, as long as they list those products with the FDA (like Mermaid Tears™). “Federal regulation of over-the-counter eye drops has unfortunately not kept up with the times,” says Sandra Brown MD, Dry Eye Foundation’s medical advisor. “This system is ripe for exploitation by unscrupulous domestic and international companies, which reach customers through e-commerce.”

OTC drug regulation relies on the “honor system”, devised in an era when eye drop makers were household names, always registered their products with Federal regulators, and were assumed to be following the rules. In today’s global e-commerce marketplaces, new eye drop manufacturers and distributors are finding that the drug listing system can be manipulated.

“However, we’re even more worried about companies that are totally ignoring the regulatory systems. We’ve reported more than 200 eye drops this year that are completely flying under the FDA’s radar,” says Dry Eye Foundation president Rebecca Petris. “Anyone can sell an eye drop on Amazon, Walmart.com, or Ebay. Unfortunately, as we found with Mermaid Tears™, anyone who tries hard enough can list their eye drop with the FDA too.”

Dry Eye Foundation is seeking improved Federal oversight of OTC eye drops through the following measures:

  • Requiring inspection of manufacturing facilities for new OTC eye drops before they can be sold;

  • Enforcing Federal regulations regarding correct packaging of preservative-free eye drops to prevent contamination during use;

  • Excluding drug listings with unidentifiable “proprietary” ingredients; and

  • Addressing the flood of unregulated eye drops entering the country through e-commerce

Dry Eye Foundation has shared its concerns about the proliferation of unsafe OTC eye drops with the FDA, and is meeting with agency representatives in September.

Learn more about Mermaid Tears™ at mermaidtearsusa.com.

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