FDA Issues Safety Warning on MSM Eye Drops Due to Contamination
The U.S. Food and Drug Administration (FDA) has issued a formal advisory to consumers, urging them to avoid purchasing or using specific eye drops containing methylsulfonylmethane (MSM), due to concerns over bacterial and fungal contamination. This warning specifically targets Dr. Berne’s MSM Drops (both 5% and 15% Solution) and LightEyez MSM Eye Drops – Eye Repair.
Key Points:
- FDA Warning Issued: The U.S. Food and Drug Administration issued a warning to consumers advising against the purchase and use of certain eye drops containing methylsulfonylmethane (MSM) due to risks of bacterial and fungal contamination.
- Specific Products Targeted: The warning specifically pertains to Dr. Berne’s MSM Drops (both 5% and 15% Solution) and LightEyez MSM Eye Drops – Eye Repair, which have been identified as potentially contaminated.
- Voluntary Recall: Dr. Berne’s Whole Health Products voluntarily recalled their MSM Drops 5% and 15% Solution Eye Drops on August 26, 2023, following the discovery of bacterial and fungal contaminants.
- Risk of Infection: The use of these contaminated eye drops could result in a range of infections, from minor to serious, potentially leading to vision-threatening or life-threatening conditions.
- Products Considered Unapproved Drugs: The eye drops in question, containing MSM as an active ingredient, are classified as unapproved drugs and are illegally marketed in the U.S. No legally marketed ophthalmic drugs in the U.S. contain MSM as an active ingredient.
On August 26, 2023, Dr. Berne’s Whole Health Products initiated a voluntary recall of their MSM Drops 5% and 15% Solution Eye Drops, following the detection of bacterial and fungal contaminants. Prior to this, on August 22, 2023, the FDA had cautioned against the use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair, citing potential bacterial and fungal contamination.
The products in question are distributed by Dr. Berne’s Whole Health Products and LightEyez Limited, respectively. The FDA has advised consumers to appropriately dispose of these products as per their guidelines. The use of contaminated eye drops can lead to infections ranging from minor to severe, potentially escalating to vision-threatening or even life-threatening conditions.
To date, the FDA has not received any reports of adverse events related to the use of these products. However, they advise individuals experiencing symptoms of an eye infection to seek immediate medical attention.
These eye drops, containing MSM as an active ingredient, are considered unapproved drugs and are illegally marketed in the U.S. Currently, there are no legally approved ophthalmic drugs in the U.S. market that contain MSM.
The FDA’s decision to test these products stemmed from their intended use for the eyes and recent manufacturing issues in the industry. The tests revealed microbial contamination, demonstrating that the products were not sterile. Under the Federal Food, Drug, and Cosmetic Act, sterility is a requisite for the safety of eye drop products. The FDA’s testing identified various specific microbial contaminants in these products.
On August 21, 2023, Dr. Berne verbally agreed to a voluntary recall of Dr. Berne’s MSM Drops 5% Solution. The same day, the FDA reached out to LightEyez Limited regarding concerns with their products distributed in the U.S. and necessary steps to protect consumers. As of the current date, LightEyez has not responded to the FDA or taken any action regarding the contaminated eye drops.
