FDA WARNING_LETTER - Scope Health Inc - August 28, 2024

The U.S. Food and Drug Administration (FDA) issued a warning letter to Optase, located at 79 Madison Ave, New York, NY, on July 9, 2025, following a review conducted on August 28, 2024. The review focused on the labeling of Optase"s ophthalmic drug products available for purchase online without a prescription. The products in question include MGD Advanced Dry Eye Drops, Dry Eye Intense Drops (multi-use bottle and single dose), Allegro Eye Drops, HYLO Night Eye Ointment, Tea Tree Oil Eyelid Wipes, Tea Tree Oil Eyelid Gel, and Protect Eyelid Cleansing Spray.

The FDA identified these products as unapproved new drugs, violating sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a) and 331(d). Additionally, certain products were found to be misbranded under sections 502(f)(2) and 502(ee) of the FD&C Act, 21 U.S.C. 352(f)(2) and 352(ee). The violations stem from claims made on the product labeling and website, suggesting these products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, which classifies them as drugs under section 201(g)(1) of the FD&C Act.

The FDA requires Optase to cease the introduction of these unapproved and misbranded products into interstate commerce. Optase must either obtain FDA approval for these products or ensure they meet the conditions specified in the applicable Over-the-Counter (OTC) monograph. Failure to comply may result in regulatory action, including seizure or injunction. Optase is expected to respond promptly with a plan to address these violations.