CVS, Walgreens Boots Among Firms Receiving Warning Letter Against Selling Unapproved Eye Products

The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products violating federal law. 

The companies include CVS Health Corp CVS, Walgreens Boots Alliance Inc WBA, DR Vitamin Solutions, Natural Ophthalmics, Inc, OcluMed, Similasan AG/Similasan USA, TRP Company Inc, Boiron Inc. 

Eye products addressed in the eight warning letters are illegally marketed to treat conditions such as conjunctivitis (“pink eye”), cataracts, glaucoma, and others. 

Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility. 

The FDA is particularly concerned that these illegally marketed, unapproved ophthalmic drug products pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. 

Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulfate, or argentum. 

Long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including the eye, to permanently turn gray or blue-gray, which is called “argyria.” 

The U.S. health regulator has asked the companies to respond within 15 days of receipt of the letters and state how they will correct the violations.

Price Action: CVS shares are up 2.73% at $70.63, and WBA shares are up 1.96% at $21.85 on the last check Tuesday.