{"topic_id":"ECFR_pet_food_drug_product_FDCA","category":"ecfr","context":"The Federal Food, Drug, and Cosmetic Act (FDCA) Article 321(g)(1) defines 'drug' as any product 'intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.' Pet food making therapeutic claims (e.g., 'treats joint disease', 'cures kidney disease', 'kills intestinal parasites') triggers drug classification under FDCA — NOT food. Such products then require: (1) New Animal Drug Application (NADA) approval per 21 CFR 514; (2) approval of labeling, manufacturing, target species, dose, indications; (3) post-market pharmacovigilance. FDCA distinction between food and drug is the primary FDA enforcement tool for pet food. Common violations: joint health supplements making implicit claims like 'for arthritic dogs' (drug); calming supplements containing alpha-casozepine 75 mg/day (food if 'for stress', drug if 'for separation anxiety' - clinical claim).\n","sources":["generated from .md only"],"tokens_estimated":167,"generated_at":"2026-07-16","tip":"Use /api/v1/topics to discover more topics. /api/v1/nutrient for precise single-point queries. /api/v1/cross_compare for 2-3 standard comparisons."}