More than $1 trillion of economic activity is regulated by the US Food and Drug Administration (FDA). FDA regulates not only foods and drugs but also medical devices, biologics (including vaccines), veterinary drugs, tobacco products (including electronic cigarettes and e-liquids), radiation-emitting products, food additives, and dietary supplements. It is critically important for innovators developing or marketing any FDA-regulated product to understand the path to market – whether FDA clearance or approval is required for the product to be marketed, for example – and the limits of what may lawfully be said about the product in its labeling.
The Federal Food, Drug, and Cosmetic Act (FDCA) confers substantial authority upon FDA to regulate the products under FDA’s jurisdiction. Under the FDCA, FDA promulgates regulations that can have the force of law. In addition, FDA continually issues Guidance Documents that disclose FDA’s current thinking about issues of importance to product developers and marketers. Not only because FDA can take enforcement action against unlawfully marketed products, but also because willful violation of various provisions of the FDCA can be a criminal offense, it is important to understand the legal requirements for FDA-regulated product marketing.
The resources below provide additional information about FDA regulatory matters that may prove helpful to anyone with FDA issues, regardless of whether you wish to retain an FDA lawyer. We encourage you to take a look.