Warning letters issued to companies selling unapproved eye products

The U.S. Food and Drug Administration has issued warning letters to eight companies for violating federal law by manufacturing or selling unapproved ophthalmic drugs. These warning letters are part of the agency’s ongoing efforts to protect Americans from potentially harmful eye products.

The eye products mentioned in eight warning letters are illegally marketed to treat conjunctivitis (“conjunctivitis”), cataracts, glaucoma and other conditions. Some of the FDA’s warning letters also name companies involved in quality issues related to the sterility of their products.

The FDA is particularly concerned that these unapproved and illegally marketed eye medications pose a greater risk of harm to users because the drugs applied to the eyes bypass some of the body’s natural defenses. Some of these eye products are labeled as containing silver, which can be characterized as silver sulfate, silver sulfate, or silver. Long-term use of silver-containing medications can cause certain areas of the skin and other body tissues, including the eyes, to permanently turn gray or bluish-gray, called “argyria.” Additionally, unapproved drugs that claim to cure, treat, or prevent serious illnesses may cause consumers to delay or stop treatments that have been found to be safe and effective through the FDA review process.

“The FDA is committed to ensuring that the drugs Americans take are safe, effective, and of high quality. When we identify illegal sales, unapproved drugs, and drug quality defects that pose potential risks, the FDA works to notify the companies involved of the violations.” said Jill Furman, director of the Office of Compliance’s Assessment and Compliance Center. . . “We will continue to investigate potentially harmful eye products and work to ensure that infringing products are not on store shelves so consumers can continue to take the medications they need with confidence.”

The agency issued warning letters to the following companies:

• Boiron
• CVS Health
• DR Vitamin Solutions
• Natural Eyes Inc.
• oklund gmbh
• Similasan AG/Similasan United States
• TRP Company
• Walgreens Boots Alliance Inc.

Consumers currently using eye products included in these warning letters should consult their health care professional. The FDA encourages consumers and health care professionals to report any adverse reactions to the agency’s MedWatch program.

The FDA has asked companies to respond within 15 days of receiving the letters to indicate how they will correct the violations. If violations are not promptly corrected, the FDA may take legal action, including product seizure and/or court orders requiring companies to stop manufacturing and distributing unapproved products. In addition, the agency has placed some of these companies on import alert to help prevent their products from entering the United States and reaching consumers.

The FDA’s investigation into eye products is ongoing, and the agency may take additional regulatory or enforcement actions as necessary.

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