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Posted November 29, 2023

Dr. Berne’s Whole Health Products Warned for Contaminated Eye Drop Products, Drug Claims

On November 22, 2023, the FDA issued a Warning Letter to Dr. Berne’s Whole Health Products following review of the company’s website, which found statements about the company’s Dr. Berne’s MSM Eye Drops 5%, Dr. Berne’s MSM Eye Drops 15%, and Dr. Berne’s MSM Eye Mist 15% products to be drug claims.

For example, Dr. Berne’s MSM Eye Drops 15% products were promoted with statements such as, “MSM has strong anti-inflammatory activity in the body, which can greatly assist in reducing inflammation that is common with allergic reactions. Both environmental and food allergies can be reduced with MSM. Asthma and hay fever sufferers also have reported significant relief with MSM.”

The company also recently recalled multiple eye drop products after FDA analysis found bacterial and fungal contamination in one lot (lot 6786) of Dr. Berne's MSM DROPS 5% Solution, which the FDA noted in the Warning Letter.

The FDA also stated in its letter that it considers these products to be “new drugs” because they are not recognized as safe and effective for their intended use.

The company must respond to the FDA in writing within 15 days of receipt of the warning explaining the specific steps taken to address these violations.

Consumers and healthcare providers can report any adverse reactions to the FDA’s MedWatch Voluntary Reporting Program.

See ConsumerLab’s Reviews of Joint Health Supplements and Vision Supplements for more information about related products.

Also see CL’s answers to the following questions:

Can castor oil eye drops improve or dissolve cataracts? Is castor oil or tea tree oil helpful for other eye conditions such as blepharitis or dry eye?

Can supplements, natural eye drops, or lifestyle modifications improve symptoms of dry eye?

Do any supplements help prevent or reduce eye floaters?

Do any supplements help prevent or improve cataracts?

For more information, use the link below.

Warning: Dr. Berne’s Whole Health Products

See related recalls and warnings:

Dr. Berne’s MSM and Castor Oil Eye Drops Recalled Due to Bacterial and Fungal Contamination

Recalled Eye Drops Linked to Vision Loss and One Death

Joint Pain Supplements Recalled Due to Undeclared Drug Ingredients

Dangerous Ingredients Found in Ten Arthritis and Pain Supplements

FDA Warns CVS, Walgreens, Similasan & Others for Eye Drop Violations