CVS, Walgreens Among Companies to Receive FDA Warning for Marketing Unapproved Eye Drops

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On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

US Food and Drug Administration logo in black over a white background | Credit: US FDA

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has circulated warning letters to eight companies for manufacturing unapproved ophthalmic drug products in violation of federal law, including CVS Health and Walgreens.1

Announced on September 12, 2023, the companies addressed in the warning letters were indicated to have illegally marketed their eye products to treat conditions including conjunctivitis, cataracts, and glaucoma. Released in accordance with an agency-wide effort to protect citizens from potentially harmful ophthalmic products, many of the FDA letters also cite quality issues related to product sterility.

“The FDA is committed to ensuring the medicines Americans take are safe, effective, and of high quality,” said Jill Furman, director of the Office of Compliance for the FDA’s CENter for Drug Evaluation and Research. “We will continue to investigate potentially harmful eye products and work to ensure violative products stay off store shelves so that consumers can continue taking the medicines they need without concern.”

The full list of companies and products in the warning letters include:

  • Boiron, Inc.: Optique 1 Eye Drops
  • CVS Health: CVS Health Pink Eye Relief Drops
  • DR Vitamins, LLC dba DR Vitamin Solutions: Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity
  • Natural Ophthalmics, Inc.: Women’s Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin (Daytime) Eye Drops, Ortho-K Thick (Night) Eye Drops, Tear Stimulation Forté Dry Eye Drops, and Cataract Eye Drops with Cineraria
  • OcluMed LLC: OcluMed Nutritional/Lubricant Eye Drops
  • Similasan AG: Similasan Dry Eye Relief, Similasan Complete Eye Relief, Similasan Allergy Eye Relief, Similasan Kids Allergy Eye Relief, Similasan Red Eye Relief, Similasan Pink Eye Relief, Similasan Kids Pink Eye Relief, Similasan Aging Eye Relief, Similasan Computer Eye Relief, Similasan Stye Eye Relief, Similasan Pink Eye Nighttime Gel, and Similasan Dry Eye Nighttime Gel
  • TRP Company, Inc: Dryness Relief, Pink Eye Relief, Allergy Eyes Relief, Red Eye Relief, Eye Strain Relief, Eye Lid Relief, Aging Eye Relief, Blur Relief, Floaters Relief, Twitching Relief, Stye Relief, and Dryness Relief PF
  • Walgreens Boots Alliance, Inc: Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops

The agency cited concerns about a potentially raised risk of harm with the use of these illegally marketed, unapproved ophthalmic drug products, as ophthalmic products bypass many of the human body’s natural defenses. Many of the products listed were labeled to contain silver (silver sulfate, silver sulphate, or argentum). The agency reports the long-term use of drugs containing silver has been linked to argyria in various areas of the skin and other body tissues, including the eye.

The release suggests unapproved drugs claiming to cure, treat, or prevent serious medical conditions may result in consumers delaying or stopping safe and effective medical treatments tested in the rigorous FDA review process.

These companies have been asked to respond within 15 days of receipt of the letters, stating how they will correct the violations. The release states a failure to correct the violations could lead to legal action, including product seizure and/or a court order requiring the manufacturing and distribution process of the unapproved product to stop.

Some have been placed on import alert to prevent their products from entering the US and reaching consumers. As the FDA investigation remains ongoing, further regulatory or enforcement actions may be taken, as necessary.

The agency urges consumers using the eye products in these warning letters to contact their healthcare provider and to report any adverse reaction to their MedWatch program.

References

  1. Commissioner O of the. FDA issues warning letters to firms marketing unapproved Eye Products. U.S. Food and Drug Administration. September 12, 2023. Accessed September 12, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products.

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