Why was the Food, Drug, and Cosmetic Act of 1938 implemented?

Why was the Food, Drug, and Cosmetic Act of 1938 implemented?

• A. To prevent food contamination
• B. To strengthen regulations on cosmetics
• C. To address the inadequacies of the Pure Food and Drug Act
• D. To replace the PDR as the primary drug reference

Answer: (C)

The Food, Drug, and Cosmetic Act of 1938 was implemented primarily to address the inadequacies of the earlier Pure Food and Drug Act of 1906. The earlier legislation lacked specific requirements for drug safety and did not adequately oversee the manufacturing practices of pharmaceutical companies. The sheer number of safety issues, including incidents of harm caused by unsafe or improperly labeled drugs, highlighted the need for more comprehensive regulations. The 1938 Act established a more robust framework, requiring that new drugs be proven safe before they could be marketed. This legislation also mandated labeling standards and initiated more stringent regulations concerning food safety and cosmetics, thus broadening the regulatory scope but fundamentally aimed at ensuring public safety and enhancing consumer protection in healthcare. The other options focus on narrower aspects of regulation or imply a shift in reference materials rather than addressing the foundational need to provide stronger oversight of drug safety that was missing in earlier laws.

The Food, Drug, and Cosmetic Act of 1938 was implemented primarily to address the inadequacies of the earlier Pure Food and Drug Act of 1906. The earlier legislation lacked specific requirements for drug safety and did not adequately oversee the manufacturing practices of pharmaceutical companies. The sheer number of safety issues, including incidents of harm caused by unsafe or improperly labeled drugs, highlighted the need for more comprehensive regulations.

The 1938 Act established a more robust framework, requiring that new drugs be proven safe before they could be marketed. This legislation also mandated labeling standards and initiated more stringent regulations concerning food safety and cosmetics, thus broadening the regulatory scope but fundamentally aimed at ensuring public safety and enhancing consumer protection in healthcare.

The other options focus on narrower aspects of regulation or imply a shift in reference materials rather than addressing the foundational need to provide stronger oversight of drug safety that was missing in earlier laws.