Pure Food, Drug and Cosmetics Act 1938

Pure Food, Drug and Cosmetics Act 1938 would provide for the establishment of 3 kinds of food standards
*Standard of identity
*Standards of quality
*Standards regulating the fill in container

In 1933, Rexford G. Tugwell, with help of Professors Milton Handler of Columbia and David Cavers of Duke, drafted new regulation. The bill greatly expanded government control over the drug and food processing industry.

A major push for the enactment of the Food, Drug and Cosmetics Act of 1938 was the sulfanilamide elixir tragedy of 1937, which caused 107 deaths. Sulfanilamide was one of the first of the miracle anti-infective sulfa drugs marketed, but a manufacturer mistakenly used diethylene glycol as an agent in its preparation of sulfanilamide elixir.

The incident made the limits of the 1906 law quite clear. Because there were provision against dangerous drugs, the FDA could move only on the technically of misbranding. The new law required that no new drug could be marketed until proven safe for use when used according to directions on the label.

Pure Food, Drug and Cosmetics Act 1938 simply eliminated the ‘distinctive name proviso’ and required instead that the label of a food ‘bear its common or usual name’.

The food would be illegal (misbranded under the law) if ti represented itself as a standardized food unless it conformed to that standard.
Pure Food, Drug and Cosmetics Act 1938