# FDA WARNING_LETTER - Dr. Berne’s Whole Health Products - August 21, 2023

Source: https://www.keypedia.com/records/warning_letter/dr-bernes-whole-health-products/c99b7890-d49a-4030-b76a-a852d6c9b058

> FDA WARNING_LETTER for Dr. Berne’s Whole Health Products on August 21, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Dr. Berne’s Whole Health Products
- Inspection Date: 2023-08-21
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On November 22, 2023, the FDA issued a Warning Letter to Samuel Berne regarding products sold on https://shop.drsamberne.com/, specifically "Dr. Berne’s MSM Eye Drops 5%," "Dr. Berne’s MSM Eye Drops 15%," and "Dr. Berne’s MSM Eye Mist 15%."

The FDA determined these products are unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), because they are intended for disease treatment/prevention or to affect body structure/function, and are not generally recognized as safe and effective (GRASE). Introducing them into interstate commerce violates sections 301(d) and 505(a).

Furthermore, FDA laboratory testing of "Dr. Berne’s MSM Eye Drops 5%" (lot 6786) revealed microbial contamination, including Exophiala sp. and Bacillus spp., failing USP <71> sterility tests. This renders the product adulterated under section 501(a)(1) of the FD&C Act, 21 U.S.C. 351(a)(1), violating section 301(a). The FDA highlighted the high public health risk posed by contaminated ophthalmic products.

The company initiated

## Related Officers

- [Director](https://www.keypedia.com/people/jill-p-furman/984bfbfc-3f4e-46bc-8d3b-3d82e56c6ac9)

Company: https://www.keypedia.com/companies/dr-bernes-whole-health-products/b500434c-cda5-43b9-8113-f5e17059af54

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c