FDA WARNING_LETTER - Thea Pharma, Inc. - July 15, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to iVIZIA, located at 303 Wyman Street, Suite 205, Waltham, MA, on July 9, 2025, following a review conducted on August 29, 2024. The review focused on the labeling and marketing of the company"s IVIZIA sterile lubricant eye drops, available for purchase online without a prescription. The FDA identified significant regulatory violations under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary issue is that the IVIZIA eye drops are classified as an unapproved new drug, violating sections 505(a) and 301(d) of the FD&C Act. The product is intended for use as an ophthalmic demulcent, but it does not conform to the Over-the-Counter (OTC) monograph M018 for ophthalmic drug products. Specifically, the active ingredients, hyaluronic acid and trehalose, are not permitted for OTC monograph ophthalmic demulcent drug products, rendering the product non-compliant with the applicable conditions for lawful marketing.

Additionally, the product is deemed misbranded under section 502(ee) of the FD&C Act because it is marketed as a nonprescription drug without meeting the necessary regulatory requirements.

The FDA requires iVIZIA to cease the introduction or delivery of this unapproved and misbranded drug into interstate commerce. The company must take corrective actions to address these violations and ensure compliance with the FD&C Act to avoid further regulatory action.