The Food and Drug Administration (FDA) sent warning letters on Tuesday to eight companies for allegedly illegally marketing drug products for eyes that could be “potentially harmful” and that were not FDA approved.
Many of these products claim to be drugs that could treat conditions and symptoms including conjunctivitis (“pink eye”), cataracts, glaucoma, dry eye, and irritation. The FDA expressed concern about some of the eye products’ sterility.
The FDA warned it would take legal action against the eight companies unless they replied within 15 days of receiving the letter outlining the steps they will take to address the violations.
The FDA sent the products to CVS Health, Walgreens Boots Alliance, Inc., Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan AG/Similasan USA, TRP Company, Inc.
The FDA outlined several reasons it claimed it was particularly concerned about eye products. The FDA warned that products applied directly to eyes “bypass some of the body’s natural defenses.” The FDA also said using some of the unapproved products might cause consumers to forgo treatment that has been FDA approved.
The FDA also warned of a specific condition called “argyria,” which can occur from long-term use of drugs that contain silver – which, the FDA claims, some of these drugs do – and the condition can cause areas of the skin and the eye to turn gray or blue-gray, according to the FDA.
The FDA said this latest round of warning letters comes amid an “ongoing effort” to protect people from potentially harmful eye products.
