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CalmCo LLC was warned that its "Colic Calm" and "Colic Calm +" products were unapproved new drugs being sold in interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act, based on disease-treatment claims made on product labels and the company website (e.g., "symptomatic relief of infant colic, gas & reflux"). The FDA identified these violations as particularly concerning because the products are directed at infants and the manufacturing partner, Denison Pharmaceuticals LLC, had received a separate warning for significant current good manufacturing practice (CGMP) violations in producing the finished pharmaceuticals.