AOA urges eye care provider consultation before use, purchase of MSM eye drops

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The American Optometric Association (AOA) has issued a new alert urging consumers to consult with their local AOA OD before purchasing or using OTC eye drops that claim to change eye color.¹ The alert follows a warning letter² that was issued in February by the US FDA to LightEyez Limited, a company manufacturing the products, according to a news release. The FDA had originally warned consumers about Dr. Berne’s MSM Drops 55 Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both in August 2023.³

The AOA emphasized in the release that there are currently no FDA-tested or approved color-changing eye drops. “When talking with a doctor of optometry, it’s important to share any prescribed and over-the-counter medications currently in use and ask for their professional opinion. This can also help ensure that the correct treatment plan is in place,” the release said.

According to the FDA warning letter, microbial contaminants found in LightEyez Limited eye drops include Pseudomonas spp., Mycobacterium spp., Mycolicibacterium spp., and Methylorubrum spp.² “The presence of microorganisms in conjunction with the route of administration poses a high risk to patients. Using contaminated eye drops could result in a range of ocular infections, from minor to serious vision-threatening infections which could progress in some cases to a life-threatening infection,” the letter stated.

The letter states that in August 2023, the company agreed to voluntarily recall its sterile drug products and that the US manufacturer would process the voluntary recall. The FDA reported that between August and February, the company and its US manufacturer has yet to initiate the recall through the FDA. The FDA also conducted an on-site investigation in September 2023, but LightEyez was not found at the location.²

“Your MSM, color changing, and eye lightening eye drop products are especially concerning from a public health perspective,” the letter stated. “Ophthalmic drug products, which are intended for administration into the eyes, in general pose a greater risk of harm to users because the route of administration for these products bypasses some of the body’s natural defenses.”

References:

1. Consumer alert: eye color changing eye drops. News release. American Optometric Association. August 12, 2024. Accessed August 20, 2024. https://www.aoa.org/about-the-aoa/press-room/statements/consumer-alert-eye-color-changing-eye-drops?sso=y

2. Warning Letter. LightEyez Limited. US FDA. MARCS-CMS 665450. February 27, 2024. Accessed August 20, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/lighteyez-limited-665450-02152024

3. FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination. FDA. News release. August 22, 2023. Accessed August 20, 2024. https://www.fda.gov/drugs/drug-safety-and-availability/fda-warns-consumers-not-purchase-or-use-certain-methylsulfonylmethane-msm-eye-drops