The U.S. Food and Drug Administration last week issued warning letters to a slew of companies about unapproved ophthalmic drug products.
The FDA says eight companies are in violation of federal law for manufacturing and marketing eyecare products that have yet to be approved or proven effective in treating various eye conditions. The administration specifically mentioned pink eye (conjunctivitis), glaucoma, and cataracts among the conditions these products are marketed to treat.
National pharmacy chains CVS (CVS Health) and Walgreens (Walgreens Boots Alliance, Inc.) were the two most prominent companies to receive warnings. Letters also were sent to: Boiron Inc., DR Vitamin Solutions, Natural Ophthalmics, Inc., OcluMed LLC, Similasan Ag/Similasan USA, and TRP Company, Inc.
“The FDA is committed to ensuring the medicines Americans take are safe, effective and of high quality,” says Jill Furman, director of the Office of Compliance for the FDA’s Center for Drug Evaluation and Research, in a press release. “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.”
The FDA noted that some of the eye products it flagged contain silver, in the form of silver sulfate, silver sulphate or argentum. Silver has proven effective as an antimicrobial in topical medications. However, more research is needed to prove silver’s effectiveness and understand the human risks of silver exposure.
According to the FDA, “long-term use of drugs containing silver can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray.”
The FDA also cited the companies for product sterility issues. The companies have 15 days from the date they received their respective letters to respond.
Products
Here are products the FDA has called into question:
Boiron Inc: Optique 1 Eye Drops
CVS Health: CVS Health Pink Eye Relief Drops
DR Vitamins: Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity
Natural Ophthalmics, Inc.: Women’s Tear Stimulation Dry Eye Drops, Allergy Desensitization Eye Drops, Ortho-K Thin (Daytime) Eye Drops, Ortho-K Thick (Night) Eye Drops, Tear Stimulation Forté Dry Eye Drops, and Cataract Eye Drops with Cineraria
OcluMed LLC: OcluMed Nutritional/Lubricant Eye Drops
Similasan Ag/Similasan USA: Similasan Dry Eye Relief, Similasan Complete Eye Relief, Similasan Allergy Eye Relief, Similasan Kids Allergy Eye Relief, Similasan Red Eye Relief, Similasan Pink Eye Relief, Similasan Kids Pink Eye Relief, Similasan Aging Eye Relief, Similasan Computer Eye Relief, Similasan Stye Eye Relief, Similasan Pink Eye Nighttime Gel, and Similasan Dry Eye Nighttime Gel
TRP Company, Inc.: Dryness Relief, Pink Eye Relief, Allergy Eyes Relief, Red Eye Relief, Eye Strain Relief, Eye Lid Relief, Aging Eye Relief, Blur Relief, Floaters Relief, Twitching Relief, Stye Relief, and Dryness Relief PF
Walgreens Boots Alliance, Inc: Walgreens Allergy Eye Drops, Walgreens Stye Eye Drops, and Walgreens Pink Eye Drops
Early responses
CNN Health reported that CVS and Walgreens have stopped the sale of their products named in the warning letters. Both companies said customers can return their products for full refunds.
In an email to CNN, TRP says its “homeopathic drug products are not illegally marketed.” Furthermore, “TRP will continue to work with FDA to ensure consumer access to products of their choosing. We will timely respond to the FDA’s warning letter.’
The FDA sent TRP a similar letter in September 2022. The FDA also corresponded with the company’s legal counsel in February 2023.
Further reading
U.S. Food & Drug Administration press release here.
Research: Clinical Application and Efficacy of Silver Drug in Ophthalmology here.