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FDA Issues Warning Letters for Marketing Unapproved Ophthalmic Drugs
Eight companies marketing eye products violated federal marketing guidelines.
On September 12, 2023, the United States Food and Drug Administration (FDA) issued warning letters to eight companies, including Boiron Inc, CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc, OcluMed LLC, Similasan AG/Similasan USA, TRP Company Inc, and Walgreens Boots Alliance Inc, for illegally marketing ophthalmic products.
According to the FDA press release, the companies have improperly marketed some medications to manage conjunctivitis, cataracts, glaucoma, and other drugs. Additionally, some of the companies had quality issues and sterility violations.
The administration highlights concern about potential adverse drug events associated with using these medications. Some marketed drugs contain silver sulfate, silver sulphate, or argentum. Prolonged use of medications containing silver can cause discoloration in bodily tissues, including the eye.
In addition, the organization is concerned about the potential impacts of false or inappropriate marketing on consumer behavior. Some consumers may be misguided by false advertising claims and discontinue or delay effective medical treatments.
“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 of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, in the FDA 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.”
The companies will have 15 days from receiving the letter to respond with a detailed plan that outlines their plans to address and rectify the violations. If they do not do so, the FDA may pursue legal action, including product seizures or court-ordered manufacturing and distribution delays.
These warning letters are just another addition to the plethora of complications linked to ophthalmic drugs. Earlier this year, sterility issues prompted eye drop and other ocular drug recalls.
“The FDA’s investigation of eye products is ongoing, and the agency may take additional regulatory or enforcement actions, as warranted,” concluded the press release.
