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FDA Warns Walgreens, Seven Others Against Promoting Unapproved Eye Products


Effort aims to protect Americans from potentially harmful ophthalmic products.

Washington, D.C., USA- January13, 2020: FDA Sign at its headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA. Image Credit: Adobe Stock Images/JHVEPhoto

Image Credit: Adobe Stock Images/JHVEPhoto

Hoping to prevent the continual use of harmful eye products, the FDA has issued a warning letter to eight companies due to manufacturing or marketing unapproved ophthalmic drug products. Citing a need to protect US citizens from severe risk, the agency has deemed these products a violation of federal law. Among issues stated in the letters include low quality and the unlawful marketing of products to treat conditions such as conjunctivitis, cataracts, and glaucoma.

Warning letters were sent to:

  • Boiron Inc.
  • CVS Health
  • DR Vitamin Solutions
  • Natural Ophthalmics, Inc.
  • OcluMed LLC
  • Similasan AG/Similasan USA
  • TRP Company, Inc.
  • Walgreens Boots Alliance, Inc.

“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. When we identify illegally marketed, unapproved drugs and lapses in drug quality that pose potential risks, the FDA works to notify the companies involved of the violations,” said Jill Furman, director, office of compliance, FDA’s center for drug evaluation and research, in a company press release. “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.”

Reference: FDA Issues Warning Letters to Firms Marketing Unapproved Eye Products. FDA. September 12, 2023. Accessed September 13, 2023. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letters-firms-marketing-unapproved-eye-products

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