FDA WARNING_LETTER - Little City Dogs

This FDA Warning Letter, NYK-2015-1, addresses Little City Dogs' marketing of numerous veterinary products, including various wormers, cardio care, and flea control capsules. The FDA determined that these products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) because their labeling and website claims indicate they are intended to mitigate, treat, or prevent disease, or affect the structure/function of animals. Furthermore, these products are classified as unapproved new animal drugs under section 201(v) of the Act, as they are not generally recognized as safe and effective by qualified experts and lack an approved new animal drug application, conditional approval, or index listing. Consequently, these products are deemed unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act. The introduction of such adulterated drugs into interstate commerce is prohibited by section 301(a) of the Act. Little City Dogs is required to respond in writing within fifteen working days, outlining corrective actions taken to achieve compliance, with supporting documentation. Failure to promptly address these violations may result in enforcement actions, including product seizure and/or injunction.