Regulation Gap Persists in OTC Eye Care Products

Derick Alison
Derick Alison
7 Min Read

It’s been a bad year for over-the counter (OTC) eye care products and their consumers, with serial government warnings and company recalls of ocular washes, drops, tears, and ointment. And the current state of the OTC industry has U.S. ophthalmologists worried on two fronts, according to a viewpoint overview in JAMA Ophthalmology.

“On one side, we see a system that appears to inadequately protect public health due to limited regulatory oversight, as evidenced by recent eye drop recalls; on the other side, we find the medical community grappling with insufficient information about these products, making it challenging to provide empirically informed guidance to patients,” said Timothy Janetos, MD, MBA, of Northwestern University Feinberg School of Medicine in Chicago, and colleagues.

“People think of eye care products as benign and having no potential for harm, but there is a small, probably less than 1%, potential for harm,” Janetos told MedPage Today. “So 99.9% of items are safe, but issues with products are under-recognized and under-reported.”

He said he gets frequent questions from patients about what OTC eye care products they can safely use, but reliable information on these products is unfortunately lacking. Physicians are left to rely on manufacturers’ samples, market trends, and their own anecdotal experience.

Product recalls this year have amplified public doubts about the safety of OTC eye preparations and increased the frequency of questions posed by patients to ophthalmologists.

In February, for example, bacterial contamination concerns led the FDA and CDC to issue a warning against EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears, both manufactured by Global Pharma Healthcare and linked to infections with the multidrug-resistant pathogen Pseudomonas aeruginosa. The company voluntarily recalled all unexpired bottles of both products.

By mid-May, CDC said the drug-resistant strain associated with EzriCare and Delsam eyedrops had been found in 81 people in 18 states. These recalled products have collectively been associated with serious adverse events, including four deaths, four surgical enucleations, and 14 cases of vision loss.

Pharmedica issued a recall in March for lots of its anti-irritation Purely Soothing 15% MSM eye drops owing to compromised sterility, although the company noted that to date it had not received any reports of adverse events or illness related to the product.

In September, FDA sent warning letters to eight companies including CVS and Walgreens about their marketing of unapproved products for medical conditions such as conjunctivitis, cataracts, and glaucoma. Some letters also cited the companies for quality issues related to product sterility.

Most recently, an additional 26 eye care products were pulled from pharmacy shelves late last month after the FDA found unsanitary conditions and positive bacterial tests at a manufacturing plant.

“Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses,” the FDA’s statement said.

An Under-regulated Market

The OTC eye care market is huge: in 2022, revenue in the U.S. reached nearly $1.6 billion, according to market research firm Statista, and in 2020 some 117 million Americans used various washes and drops for dry eyes, red eyes, and itchy eyes.

“This market is massive, with hundreds of millions of units sold every year,” Janetos said. Despite the potential for injury posed by these products, however, this market is largely self-regulated. “But it would be impossible for government to regulate this industry like the drug industry,” he added.

Notwithstanding FDA’s diligence this year in issuing recall-triggering product warnings, the agency could do more, Janetos said. “Inspections of manufacturing sites have fallen off since COVID, and the manufacturing process needs better and more frequent inspections.”

Furthermore, FDA’s OTC drug policies themselves “present an additional layer of consumer safety concern that warrants attention,” Janetos and co-authors wrote. For starters, the OTC monograph exempting products from preapproval review has minimal guidance on what constitutes an artificial tear and lacks guidance on the selection of preservatives or formulary use of potential allergens.

Janetos and colleagues said they strongly believe the current scenario requires more objective data on commonly sold eye care products. To that end, the group is developing an open-source centralized database where patients and ophthalmologists can seek reliable information on product characteristics, allergens, reported adverse events, pricing, and patient satisfaction.

“We envision a constantly updated ‘Wikipedia’ for OTC eye medications with metrics like average prices of products and patient reviews,” said Janetos, who expects the site to launch next year. “The FDA reporting system is cumbersome and hard to use for both physicians and patients.”

Such a database could be a useful tool for ophthalmologists and patients alike to make informed decisions on the plethora of OTC products, the team wrote. “Ultimately, it is clear that both improved regulatory oversight and enhanced knowledge accessibility are essential to safeguard the public and optimize patient care within this vast market.”

  • author['full_name']

    Diana Swift is a freelance medical journalist based in Toronto.

Disclosures

Janetos reported an unrestricted departmental grant from Research to Prevent Blindness and a grant from the Illinois Society for the Prevention of Blindness during the conduct of the study; no other disclosures were reported.

Primary Source

JAMA Ophthalmology

Source Reference: Younessi DN, et al “Regulatory and informational gaps in the over-the-counter eye care product industry — Over the counter, under the radar” JAMA Ophthalmol 2023; doi:10.1001/jamaophthalmol.2023.4961.”

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