FDA Warns of Methylsulfonylmethane Eye Drops Due to Contamination

FDA Warns of Methylsulfonylmethane Eye Drops Due to Contamination

August 24, 2023

The FDA has issued warning to consumers, advising them against purchasing and immediately discontinuing the use of two products: Dr. Berne's MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair. The warning is based on the potential presence of bacterial contamination, fungal contamination, or both, in these products.

These particular items are manufactured by two companies: Dr. Berne’s Whole Health Products distributes Dr. Berne’s products, while LightEyez Limited distributes LightEyez’ products.

The FDA is urging consumers to properly dispose of these items following the guidelines provided by the FDA. Using eye drops that are contaminated could lead to infections ranging from minor to severe, even life-threatening infections in some cases.

Currently, the FDA has not received any reports of adverse events associated with the use of either Dr. Berne’s or LightEyez products. However, individuals who experience symptoms indicative of an eye infection are strongly advised to consult a healthcare professional or seek immediate medical attention.

In addition to the above concerns, it's worth noting that both Dr. Berne’s and LightEyez eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. These products have not been approved by the FDA as drugs and are being illegally marketed within the U.S. Furthermore, there are no legally approved ophthalmic drugs containing MSM as an active ingredient.

In response to concerns related to the intended use of these eye drops and the ongoing manufacturing issues within the industry, the FDA conducted testing on the products. The results revealed contamination with various microbes, rendering the products non-sterile. According to the Federal Food, Drug, and Cosmetic Act, sterile conditions are crucial for ensuring the safety of eye drops for consumers. The table below lists specific examples of microbes that were identified through FDA testing.

On August 21, 2023, Dr. Berne verbally agreed to initiate a voluntary recall of the Dr. Berne’s MSM Drops 5% Solution.

The FDA communicated with LightEyez Limited via email on the same day, expressing concerns about the distribution of LightEyez products in the U.S. and the necessary actions to protect consumers from the use of contaminated eye drops. As of now, LightEyez has not responded to the FDA's communication nor taken any measures to safeguard consumers.



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