Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistGreen Vitality dba Gr33n was warned for marketing "Jimerito Honey Eye Drops" as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The company made drug claims on its website and Instagram, including statements that the product provides "instant hydration and long-term support" to combat declining eye health, establishing it as a drug product requiring FDA approval before distribution. The FDA emphasized particular concern regarding ophthalmic products intended for eye administration, as this route of administration bypasses natural body defenses and poses greater risk of harm to users.