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The Food, Drug, and Cosmetic Act (FDCA) of 1938 was created in response to public outcry and health crises, notably the 1937 Elixir Sulfanilamide tragedy, which resulted in over 100 deaths due to a toxic solvent used in a pharmaceutical product. This legislation aimed to ensure the safety and efficacy of food, drugs, and cosmetics by requiring pre-market approval from the FDA for new drugs and establishing standards for labeling and manufacturing. The act marked a significant expansion of federal regulatory authority over consumer products, ultimately enhancing public health protections.

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AnswerBot

2w ago

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