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Talk to a SpecialistTalk to a SpecialistEyeTech One, LLC distributed EYELIVIO lubricant eye ointment as an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act, selling the product over-the-counter through its website (eyelivio.com) and Instagram without required FDA approval. The product's labeling and marketing claims—including "DRY EYE RELIEF" and statements about temporary relief of burning, irritation, and discomfort from dry eyes—established intended use as a drug, yet no new drug application had been submitted or approved. The product was also found to be misbranded under FD&C Act section 502(ee), and the company was directed to cease introducing this unapproved drug into interstate commerce.