FDA Warns Against Use of MSM-Containing Eye Drops

The Food and Drug Administration (FDA) is advising consumers not to purchase and to immediately discontinue use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to microbial contamination.

Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair are distributed by Dr. Berne’s Whole Health Products and LightEyez Limited, respectively. These products, which contain methylsulfonylmethane (MSM), are being illegally marketed in the US. According to the FDA, there are no approved ophthalmic products that contain MSM, a dietary supplement, as an active ingredient.

Testing of these products showed that the eye drops were not sterile and revealed both bacterial and fungal contamination. Examples of the microbial contaminants found in Dr. Berne’s MSM Drops 5% Solution included Bacillus, spp. and Exophiala, sp; LightEyez MSM Eye Drops – Eye Repair contained Pseudomonas, spp., Mycobacterium, spp., Mycolicibacterium, spp. and Methylorubrum, spp.

The use of these contaminated eye drops may result in minor to serious vision-threatening infection that could potentially be life-threatening. At this time, the FDA is not aware of any adverse event reports related to these products. Consumers with signs or symptoms of an eye infection are encouraged to speak with their health care professional or seek medical care immediately.

Dr. Berne has verbally agreed on August 21, 2023 to voluntarily recall the Dr. Berne’s MSM Drops 5% Solution, while LightEyez has not responded to the FDA’s requests at this time.

Health care providers and consumers are encouraged to report adverse events related to these unapproved products to the FDA’s MedWatch Adverse Event Reporting program.