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A&Z Pharmaceutical, Inc. was cited for marketing Chewable Calcium 600MG with Vitamin D for Kids as an unapproved drug by making disease claims on their website and social media platforms, including claims that the product could prevent osteoporosis, slow bone loss, protect against gum disease, and reduce depression. These therapeutic claims violated the Federal Food, Drug, and Cosmetic Act by establishing the product's intended use as a drug without FDA approval or proper new drug application. The company was operating the product as a dietary supplement while simultaneously making claims that brought it under the legal definition of a drug under section 201(g)(1)(B) of the Act, constituting both a misbranding and unapproved new drug violation.