Walgreens Boots Allianc Inc. and CVS Health are among the companies the FDA sent letters to for violating federal law.
The FDA has issued warning letters to 8 companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.
These warnings come amidst an increased amount of complications and issues caused from unapproved eye drops, as the FDA states they are trying to “protect Americans from potentially harmful ophthalmic products.”1
As stated in a press release from the FDA, the products being addressed in these letters are “illegally marketed to treat conditions such as conjunctivitis (pink eye), cataracts, glaucoma and others.” While some of the letters also cite certain companies for quality issues related to product sterility.1
According to the FDA, concern is heightened because 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.1
For instance, the FDA states that some of the eye products are labeled to contain “silver,” which may be characterized as as silver sulfate, silver sulphate or argentum. Long-term use of drugs containing silver can cause arygyria, a condition caused by excessive exposure to chemical compounds of the element silver, or to silver dust, which can cause the skin to permanently turn gray or blue-gray.
Jill Furman, JD, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research discussed the letters in the press release.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality. 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,” said Furman. “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 8 companies the FDA issued letters to, as well as the products are:
DR Vitamin Solutions4
Natural Ophthalmics, Inc.5
Similasan AG/Similasan USA7
TRP Company, Inc.8
Walgreens Boots Alliance, Inc.9
Regarding all these products, the FDA said they were “especially concerning from a public health perspective.” The FDA stated that the products are “not generally recognized as safe and effective (GRASE) for [their] referenced uses and, therefore, [are] a ‘new drug.’”2
The FDA stated the companies must respond within 15 working days of receipt of the letter, stating the specific steps taken to correct these issues, with failure to adequately address the matter potentially resulting in “legal action including, without limitation, seizure and injunction.” The FDA has also placed some of the companies on “import alert” to stop their products from entering the US and reaching consumers.
The FDA also warned consumers currently using eye products included in the warning letters to speak to a health care professional.