What is required on the labels of new drugs according to the Food, Drug, and Cosmetic Act of 1938?

The requirement for "adequate directions for use" on the labels of new drugs, as mandated by the Food, Drug, and Cosmetic Act of 1938, ensures that consumers and healthcare providers have the necessary information to use the medication safely and effectively. This includes specifics on dosage, administration, and any pertinent warnings or precautions. The purpose of this regulation is to promote safe medication practices and help prevent misuse or adverse effects that might arise from misunderstanding how to properly take the drug.

While ingredient lists can be valuable for consumers, the key regulatory requirement established by this act focuses heavily on providing clear and sufficient information on how to use the drug rather than just listing its components. Consumer endorsements and manufacturer contact information, while they may be found on some products, are not mandated by the 1938 Act for new drug labeling, as the primary concern is ensuring the safe and effective use of the medication.