The Food, Drug and Cosmetic (FDC) Act of 1938 was enacted after more than 40 persons died upon ingesting the drug sulfanilamide in a toxic formulation containing diethylene glycol [6,7]. The FDC Act set forth requirements for the testing of products and their components to ensure they are safe for human use. It also clearly defined the terms. |
Drug: A substance intended to be used in the cure, diagnosis, mitigation, ^
prevention, or treatment of disease in man or in other animals. It is a non- c food substance that affects the structure or function of the human body or of animals [1,6,7]. 4
Cosmetic: A substance applied to the human body for the purpose of altering the appearance, beautifying, cleansing, or promoting attractiveness. Soaps do not fall under the definition of cosmetics [1,6].
Note that if a product is classified as both a cosmetic and a drug, it must meet the regulatory requirements for both cosmetics and drugs .
The FDA was created in 1938 to administer and enforce the FDC Act. In 1962, after the drug thalidomide was found to cause birth defects, the FDC Act was amended to require a greater amount of safety testing for drug products, as well as proof that drugs are effective to treat indicated ailments . From a regulatory standpoint, courts follow the definitions and requirements outlined in the FDC Act in then evaluations of drug and cosmetic products, including product components, claims, labeling, and advertising . The EC directives serve a similar purpose in Europe.
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