Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistCalroy Health Sciences marketed Arterosil as a dietary supplement on its website while making disease claims that classified it as an unapproved drug under the Federal Food, Drug, and Cosmetic Act. The company's website claims that Arterosil could stabilize and regress vulnerable plaque, reduce atherosclerotic plaque, prevent leukocyte adhesion, and treat conditions including coronary heart disease, diabetes, and stroke—all statements establishing intent to treat or prevent disease without FDA approval. By promoting the product with these therapeutic claims while distributing it in interstate commerce, the company violated the Act's requirements for drug approval and proper labeling.