Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your “Dr. Berne’s MSM Eye Drops 5%,” “Dr. Berne’s MSM Eye Drops 15%,” and “Dr. Berne’s MSM Eye Mist 15%” products are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p).
Passage 2FDA laboratory testing of a batch of Dr. Berne's MSM DROPS 5% Solution drug product (lot 6786, “Best By 032025”) found that it contained microbial contamination. The sample results failed to meet USP <71>, sterility tests. Therefore, this drug product is adulterated under section 501(a)(1) of the FD&C Act, in that it consists in whole or in part of any filthy, putrid, or decomposed substances.