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Dexterity Health, LLC (DBA Zazzee Naturals) was cited for marketing Liquid MSM Drops as an unapproved new drug in violation of sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act. The product, sold through Amazon, made disease-treatment claims (such as healing eye damage and improving eye membrane permeability) that established it as a drug rather than a dietary supplement or cosmetic, yet it lacked required FDA approval. The violation was particularly serious because the product is an ophthalmic formulation intended for direct eye administration, a route of administration that poses greater risk of harm due to bypassing the body's natural defenses.