What act requires that a product must be proven safe before being marketed?

The Food, Drug, and Cosmetic Act of 1938 is the legislation that mandates that products must be proven safe before they can be marketed to the public. This act was a significant milestone in pharmaceutical regulation, as it was primarily a response to public distress following incidents involving harmful products. It established the requirement for pre-market safety testing of drugs, requiring manufacturers to provide evidence of safety through various studies and trials before a new drug could be approved and sold.

Under this act, the FDA gained the authority to oversee drug safety and evaluate new products. This regulatory framework helped to ensure that consumers were protected from unsafe medications and that only products demonstrating safety could enter the market, thus laying the foundation for modern drug approval processes.

The Kefauver-Harris Amendment, while important in refining drug regulation by requiring evidence of effectiveness in addition to safety, came later in 1962. The FDA Modernization Act significantly updated several regulatory processes, but it did not introduce the original safety requirement. The Controlled Substances Act primarily focuses on the regulation of drugs with potential for abuse and does not directly address the safety of drugs for consumer use.