Sept. 14, 2023 — The U.S. Food and Drug Administration (FDA) has issued warning letters to eight companies regarding unapproved, illegally manufactured and marketed ophthalmic drug products. Some letters also cite quality issues related to product sterility.
The FDA shares it is particularly concerned because drugs bypass some of the body’s natural defenses when applied to the eyes. Labeled to contain silver, these eye products are being illegally marketed to treat a variety of conditions including conjunctivitis, cataracts, and glaucoma.
The FDA shares that long-term use of drugs containing silver can cause argyria, a condition where skin and other body tissues, including the eyes, permanently turn gray. Additionally, consumers can opt for these unapproved products over safe and effective medications, potentially delaying their treatment and recovery.
The letters were issued to Boiron Inc., CVS Health, DR Vitamin Solutions, Natural Ophthalmics Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company Inc., and Walgreens Boots Alliance Inc. The companies were instructed to respond within 15 days of receiving the letters to explain how they will correct the violations. If the violations go uncorrected, the FDA may pursue legal action, potentially involving court orders to halt manufacturing and distribution of unapproved products and product seizure. Some of the companies have been placed on import alert to help stop their products from entering the U.S.
“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,” says 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 FDA encourages consumers and health care providers to report any adverse reaction to the MedWatch program.
To read the letters in full, click here.