FDA Warns Against Use of Contaminated Eye Drops: Dr. Berne’s and LightEyez Products Under Scrutiny
The U.S. Food and Drug Administration (FDA) has issued a warning to consumers regarding the use of certain eye drop products due to potential bacterial and fungal contamination. The affected products are Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair. The FDA advises consumers not to purchase these products and to immediately cease their use.
Dr. Berne’s Whole Health Products and LightEyez Limited are the respective distributors of these products. The contamination of these eye drops raises concerns of either bacterial or fungal presence, or possibly both. The FDA’s primary concern is that using contaminated eye drops could lead to various levels of eye infections, ranging from minor to severe, and in the worst cases, even life-threatening infections.
As of now, the FDA has not received any reports of adverse events associated with the use of these products. However, the agency is urging individuals who experience any signs or symptoms of an eye infection after using these products to consult a healthcare professional immediately.
Both the Dr. Berne’s and LightEyez eye drop products contain methylsulfonylmethane (MSM) as an active ingredient. These products have not received FDA approval and are being unlawfully marketed in the United States. Notably, there are no ophthalmic drugs that are legally authorized to contain MSM as an active ingredient.
The contamination issue came to light following recent manufacturing concerns within the eye drop industry. The FDA undertook sampling and testing of the products in question to assess their safety for intended use in the eyes. The testing revealed the presence of microbes, rendering the products non-sterile. According to the Federal Food, Drug, and Cosmetic Act, sterility is a crucial factor in ensuring the safety of eye drops for consumers.
In response to the FDA’s findings, Dr. Berne verbally agreed on August 21, 2023, to initiate a voluntary recall of the Dr. Berne’s MSM Drops 5% Solution. On the other hand, despite the FDA’s outreach and concerns, LightEyez Limited, the distributor of LightEyez MSM Eye Drops, has not yet taken any action to address the issue or protect consumers.
The table below provides details of the specific microbial contaminants found in the tested products:
| Product | Bacterial contamination | Fungal contamination |
|---|---|---|
| Dr. Berne’s MSM Drops 5% Solution | Bacillus, spp. | Exophiala, sp. |
| LightEyez MSM Eye Drops – Eye Repair | Pseudomonas, spp.; Mycobacterium, spp.; Mycolicibacterium, spp.; Methylorubrum, spp. | N/A |
In light of these developments, the FDA strongly encourages both healthcare professionals and consumers to report any adverse events or quality concerns related to these or any other medicines through the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online via MedWatch or by downloading the form and faxing it to 1-800-FDA-0178.
As at August 22, 2023, the FDA continues to investigate the situation and work towards ensuring the safety and well-being of consumers across the United States.
