FDA Warns Prominent Firms Against Marketing and Selling ‘Unapproved’ Eye Products

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

The U.S. Food and Drug Administration (FDA) issued warning letters to eight companies for manufacturing or selling unapproved eye products, which the agency says is “in violation of federal law.”

The warning letters cited concerns about eye products manufactured by the firms which are “illegally marketed” to treat multiple conditions like conjunctivitis or “pink eye,” cataracts, and glaucoma, among other ailments, the agency said in a Sept. 12 statement.

“The FDA is particularly concerned that 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.”

“Some of these eye products are labeled to contain silver, which may be characterized as silver sulfate, silver sulphate, or argentum. 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, which is called ‘argyria,’” the FDA warned.

In addition, unapproved drugs claiming to cure or prevent serious conditions may end up making people stop or delay medical treatments found safe and effective through the FDA review process, it said.

The eight letters were addressed to Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan AG/Similasan USA, TRP Company, and Walgreens Boots Alliance.

Affected Products

The products cited for safety issues are given below:

• Boiron’s Optique 1 Eye Drops
• CVS Health Pink Eye Relief Drops
• DR Vitamin’s Vision Clarity Eye Drops, Life Extension Brite Eyes III, Can-C Eye Drops, and Longevity Science Visual Ocuity
• Natural Ophthalmics’ 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 Eye Drops
• Similasan’s Dry Eye Relief, Complete Eye Relief, Allergy Eye Relief, Kids Allergy Eye Relief, Red Eye Relief, Pink Eye Relief, Kids Pink Eye Relief, Aging Eye Relief, Computer Eye Relief, Stye Eye Relief, Pink Eye Nighttime Gel, and Dry Eye Nighttime Gel
• TRP Company’s 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, and Stye Relief
• Walgreens’ Allergy Eye Drops, Stye Eye Drops, and Pink Eye Drops

Some of the letters cite quality issues related to the sterility of the products.

In late August, the agency issued a recall of eyedrop products manufactured by Dr. Berne’s Whole Health Products due to worries about contamination.

The voluntary recall is applicable to “all lots” of Dr. Berne’s MSM DROPS 5%, 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution, according to an Aug. 26 FDA recall notice.

An analysis by the agency had found a lot of MSM DROPS 5% Solution failed “sterility with both bacterial and fungal contamination found in the product.”

The recalled products are used as lubricating eyedrops and were distributed via Dr. Berne’s online store.

The recall comes a few days after the FDA issued a warning asking consumers not to buy and to “immediately stop” using two eyedrop products—Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops.

The products contain methylsulfonylmethane (MSM) as an active ingredient. The items are “unapproved drugs and illegally marketed” in the United States, the agency said. “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,”

Amniotic Fluid Eyedrop Warning

Earlier in April, the FDA had issued a public safety notification about manufacturers selling amniotic fluid eyedrops for dealing with eye disease. Amniotic fluid is the fluid that surrounds and cushions the fetus in the womb.

These products hadn’t received the necessary premarket review and approval, thus raising potential significant safety concerns.

“There are currently no FDA-approved amniotic fluid eyedrops to treat, mitigate, or cure eye diseases or conditions, and in order for a health care practitioner to offer these products to patients, there must be an investigational new drug application (IND) in effect,” the agency said.

The FDA advised consumers who use eye products mentioned in the latest warning letters to consult with their health care professional and to report adverse reactions to the agency’s MedWatch program. It asked the firms to respond to the letters within 15 days of receipt.

“Failure to correct the violations promptly may result in the FDA pursuing legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing an unapproved product,” the agency said.

“Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.”