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

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