Legislation Project: Federal Food, Drug, and Cosmetic Act 1938 Catherine DeMarco

Federal Food, Drug, and Cosmetic Act of 1938  The Federal Food, Drug, and Cosmetic Act was passed by Congress in 1938 in reaction to the growing public safety demands. Food adulteration continued to flourish because judges could find no specific authority in the law for the standards of purity and content which FDA had set up. Such products as "fruit" jams made with water, glucose, grass seed, and artificial color undercut the market for honest products. The primary goal of the Act is to protect the health and safety of the public by preventing deleterious, adulterated or misbranded articles from entering interstate commerce. Under section 402(a)(4) of the Act, a food product is deemed “adulterated” if, inter alia, the food was “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.” A food product is also considered “adulterated” if it bears or contains any poisonous or deleterious substance which may render it injurious to health.

Federal Food, Drug, and Cosmetic Act of 1938 cont.  The Act authorizes factory inspections and added injunctions to the enforcement tools at the Food and Drug Administration's (FDA) disposal. Following hearings in the early 1950s, a series of laws addressing pesticide residues (1954), food additives (1958), and color additives (1960) gave the FDA much tighter control over the growing list of chemicals entering the food supply, putting the obligation on manufacturers to establish their safety. The Act stands today as one of the primary means by which the federal government enforces food and pharmaceutical safety standards.  In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.  The introduction of this act was influenced by the death of more than 100 patients due to a sulfanilamide medication where diethylene glycol was used to dissolve the drug and make a liquid form. It replaced the earlier Pure Food and Drug Act of 1906.