Which act required evidence of safety before marketing and placed drug advertising under the FTC?

• A. Kefauver-Harris Amendments 1962
• B. Durham-Humphrey Amendments 1962
• C. Food, Drug, and Cosmetic Act 1938
• D. Drug Importation Act 1848

Answer: (C)

The main idea is that the law established that a drug must have evidence of safety before it can be marketed, and it assigns the advertising of drugs to the Federal Trade Commission. The Food, Drug, and Cosmetic Act of 1938 did exactly that: it required manufacturers to prove a drug’s safety before it could be sold and it placed drug advertising under FTC regulation, enforcing truthful and nonmisleading claims. This marked a shift from earlier statutes by tying premarket safety to regulatory approval and by moving the promotional claims oversight to the FTC.

In contrast, later developments focused on other aspects. The Kefauver-Harris Amendments in 1962 strengthened the requirement for evidence of effectiveness (not just safety) and expanded FDA authority over drug manufacturing and advertising content, but the specific premarketing safety requirement with FTC advertising is characteristic of the 1938 Act. The Durham-Humphrey Amendments clarified prescription versus over-the-counter status, and the Drug Importation Act deals with import controls rather than safety proof or FTC advertising oversight.