According to the Food, Drug and Cosmetic Act (1938), what is required for a new drug to be marketed?

Under the Food, Drug, and Cosmetic Act of 1938, for a new drug to be marketed, it must be proven safe for use. This legislation established the requirement that drug manufacturers demonstrate the safety of their products before they can be sold to the public. The act was a response to the increasing public concerns about drug safety and aimed to ensure that new drugs undergo sufficient testing and review to establish their safety profile.

While efficacy, or proving that a drug is effective for its intended use, is also crucial in later stages of drug approval (notably with the subsequent Drug Amendments in 1962), the primary requirement established by the original 1938 Act focused solely on safety. Therefore, the correct answer centers on the safety requirement as the foundational component for the marketing of new drugs, setting the stage for more rigorous standards that would develop over time. Other aspects of drug marketing, like having a marketing plan or being branded, are not stipulations of the initial legislation and do not play a role in the approval process under the Food, Drug, and Cosmetic Act.