Final answer:
The Food, Drug, and Cosmetic Act of 1938 required that drugs must be proven safe before marketing and was a direct response to the tragic deaths caused by the sulfanilamide elixir incident in 1937. It granted broader regulatory powers to the Food and Drug Administration (FDA) to ensure the safety and efficacy of drugs, food, and cosmetics. The correct option is 4.
Step-by-step explanation:
The legislation that was precipitated by deaths due to the use of an anti-freeze ingredient in an elixir formulation of the antibiotic, sulfanilamide, and required that drugs be demonstrated as safe before marketing is the Food, Drug, and Cosmetic Act of 1938.
This Act was a significant extension of the regulatory powers of the government, specifically the Food and Drug Administration (FDA), ensuring that before any new drug could reach the market, it had to be proven safe for consumers' use under the prescribed conditions on the label.
This law came into existence following the 1937 sulfanilamide tragedy, where an untested solvent in an elixir led to the death of more than 100 people, prompting the federal government to overhaul the way it regulated pharmaceuticals.
Federal laws concerning the FDA are predominantly part of the Food, Drug, and Cosmetic Act. The Act has been amended numerous times to adapt to new scientific understandings and technological advances that impact the production, sale, and distribution of food, drugs, and cosmetics.
The FDA is entrusted with extensive responsibilities to regulate and ensure the safety, efficacy, and security of these products, aiding in protecting public health. The correct option is 4.