Which provisions were authorized by the Federal Food, Drug, and Cosmetic Act of 1938?

Which provisions were authorized by the Federal Food, Drug, and Cosmetic Act of 1938?

• A. Mandate efficacy data before drug marketing
• B. Demand safety evidence for new drugs, issue standards for food, and conduct factory inspections
• C. Prohibit FDA from inspecting facilities
• D. Regulate only cosmetics

Answer: (B)

The main idea is understanding the authority the 1938 Federal Food, Drug, and Cosmetic Act gave the FDA. It required safety evidence for new drugs before they could be marketed, gave the FDA power to issue standards for food to ensure safety and proper labeling, and authorized factory inspections to enforce these rules. This combination mirrors what the act actually did. Note that safety—not efficacy—requirements were the focus in 1938 (efficacy data came later with the Kefauver-Harris amendments in 1962). The act did not prohibit inspections, and its reach extended beyond cosmetics to drugs and foods, so the option that mentions only cosmetics isn’t accurate.

The main idea is understanding the authority the 1938 Federal Food, Drug, and Cosmetic Act gave the FDA. It required safety evidence for new drugs before they could be marketed, gave the FDA power to issue standards for food to ensure safety and proper labeling, and authorized factory inspections to enforce these rules. This combination mirrors what the act actually did. Note that safety—not efficacy—requirements were the focus in 1938 (efficacy data came later with the Kefauver-Harris amendments in 1962). The act did not prohibit inspections, and its reach extended beyond cosmetics to drugs and foods, so the option that mentions only cosmetics isn’t accurate.