FDA was created by Congress through the passage of the Food Drug and Cosmetic Act. Congress has modified FDA’s responsibilities through 30 amendments to the FDCA, notably those regarding prescription drugs in 1951 and generics in 1984.
FDA has been charged with protecting public health by ensuring safety, efficacy and security for, among other things, drugs for human use. FDA accomplishes this through the creation of regulations, all of which are publicly available in the Code of the Federal Register.
FDA’s regulations have the “force of law” although they are a little easier to attack in court than statutes. Nonetheless unless someone is prepared to incur the expense of litigation, they need to adhere to the requirements of the regulations.