Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistProper Nutrition Inc. was cited for marketing four dietary supplement products—Colostrum 70/40, Intestive, Seacure, and SeaVive—as unapproved new drugs based on disease claims made on their website. The company violated the Federal Food, Drug, and Cosmetic Act by making therapeutic claims such as wound healing, treating Crohn's disease, IBS, and malabsorption without FDA approval, thereby establishing the products as drugs rather than dietary supplements. The FDA identified specific website claims describing the products' intended use in curing, mitigating, treating, or preventing disease, which brought them under drug regulations and made their marketing illegal.