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

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Legislation Project Federal Food, Drug, and
Cosmetic Act 1938

• Catherine DeMarco

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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.

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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 FDC. Also in that
  year the FDA formed the Drug Efficacy Study
  Implementation (DESI) to incorporate into FDC
  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.