The Food and Drug Administration (FDA) has issued a stern warning to consumers against the purchase and use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair. This warning comes as concerns are emerging regarding potential bacterial and fungal contamination, or even a combination of both, in these products. The FDA urged users to immediately stop their use and to dispose of these eye drops.
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Which products are affected?
The products at the center of this recall are Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair. These products are distributed by Dr. Berne’s Whole Health Products and LightEyez Limited, respectively. Both companies have gained attention for their eye care solutions, but recent revelations about potential contamination have raised serious concerns.
What are the health risks?
The primary concern surrounding the use of these products lies in the potential for bacterial and fungal contamination. The FDA emphasizes that employing contaminated eye drops, in this case, could lead to a range of consequences, varying from minor eye infections to more serious ones that could pose a threat to vision, and in some severe cases, even escalate into life-threatening infections. Given the delicate nature of ocular health, any compromise in the sterility of eye drops can have far-reaching implications.
Here’s what to do if you bought the product
If you have purchased either Dr. Berne’s MSM Drops 5% Solution or LightEyez MSM Eye Drops – Eye Repair, it is crucial to take the FDA’s advice. Immediately cease using the products and ensure their proper disposal. The FDA has outlined specific procedures for the safe disposal of these contaminated eye drops to prevent any further risk.
Additionally, the FDA encourages individuals who are displaying signs or symptoms of an eye infection, possibly due to the use of these products, to urgently reach out to their healthcare professional or seek medical care without delay.
Unapproved drugs and lack of sterility
One significant point of concern is that both Dr. Berne’s and LightEyez eye drop products contain an active ingredient called methylsulfonylmethane (MSM). The FDA categorizes these products as unapproved drugs and stresses that they are illegally marketed in the United States. It is worth noting that there are no FDA-approved ophthalmic drugs containing MSM as an active ingredient.
Moreover, the FDA’s rigorous testing showed that the products were contaminated with various microbes, rendering them non-sterile. Under the Federal Food, Drug and Cosmetic Act, eye drops are required to be sterile to ensure their safety for use. Unfortunately, both Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair fell short of this standard, posing a substantial risk to consumers.
Microbial Contaminants Found
FDA testing revealed a worrying list of microbial contaminants present in the affected products. The FDA shows the specific types of bacterial and fungal contamination that have been identified:
1 - Dr. Berne’s MSM Drops 5% Solution:
- Bacterial Contamination: Bacillus, spp.
- Fungal Contamination: Exophiala, sp.
2 - LightEyez MSM Eye Drops – Eye Repair:
- Bacterial Contamination: Pseudomonas, spp.; Mycobacterium, spp.; Mycolicibacterium, spp.; Methylorubrum, spp.
- Fungal Contamination: Not Applicable
Recall actions and lack of response
In response to the FDA's findings and concerns, Dr. Berne has taken a proactive stance. On August 21, 2023, Dr. Berne verbally committed to a voluntary recall of the Dr. Berne’s MSM Drops 5% Solution. This recall is an essential step in preventing further exposure to the contaminated product.
However, the situation is somewhat different with LightEyez Limited. Despite the FDA reaching out via email on the same date to discuss their concerns regarding LightEyez products distributed in the U.S. and the necessary steps to protect consumers, LightEyez has yet to respond or take any discernible action to address the issue. This lack of response raises concerns about the company’s commitment to consumer safety and product quality.
Reporting adverse events
The FDA strongly encourages both healthcare professionals and consumers to report any adverse events or quality problems related to these or any other medicines. This valuable feedback helps in maintaining drug safety and ensures prompt action when issues arise.
Reports can be submitted online through the FDA’s MedWatch Adverse Event Reporting program. Alternatively, individuals can download the reporting form and submit it via fax.
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Source:
FDA: FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination
