Screenshot 2023-06-22 at 02-12-12 How the FDA’s new clinical trials guidance affect supplements brands(1)
How the FDA’s new clinical trials guidance affect supplements brands
The U.S. Food and Drug Administration is advancing the use of decentralized clinical trials—a system in which some or all of the trial-related activities occur at locations other than traditional clinical trial sites—according to a press release and draft industry guidance issued in May.
This news comes on the heels of the Federal Trade Commission’s December 2022 updated Health Products Compliance Guidance, which touted randomized clinical trials as the gold standard for the substantiation of health benefits claims, and the April 2023 notices of penalty offenses to nearly 700 of America’s leading supplement brands on product claims requiring substantiation.
