Dr. Berne’s Whole Health Products Warning Letter Details

Summary

Dr. Berne's Whole Health Products was cited for marketing three unapproved new drug products—MSM Eye Drops (5% and 15%) and MSM Eye Mist (15%)—without FDA approval, violating sections 505(a) and 301(d) of the FD&C Act. FDA laboratory testing found that the MSM Eye Drops 5% batch was adulterated, containing filthy, putrid, or decomposed substance, constituting a violation of section 501(a)(1). The violations were particularly concerning because ophthalmic products administered directly to the eyes pose greater risk of harm due to bypassing the body's natural defenses.