The FDA issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drugs that have questionable sterility and the potential to harm users.
The eye products are illegally marketed to treat conditions such as conjunctivitis, cataracts and glaucoma, according to a Sept. 12 news release from the agency. The letters also cite the companies for quality issues related to product sterility.
The unapproved ophthalmic drugs pose a risk to users because they are applied directly to the eyes, according to the release. Some contain silver, which can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray with long-term use. Additionally, consumers may stop proven safe and effective medical treatments in lieu of these unapproved drugs due to their claims to cure, treat or prevent serious conditions.
The FDA sent warnings to the following companies:
- Boiron
- CVS Health
- DR Vitamin Solutions
- Natural Ophthalmics
- OcluMed
- Similasan AG/Similasan USA
- TRP Company
- Walgreens Boots Alliance
The agency asked the companies to respond within 15 days of receiving the letters, stating how they will correct the violations, according to the release. The FDA also placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.