Key takeaways

• In recent years, the Federal Trade Commission has tended to require companies to possess two “randomized and controlled human clinical trials,” or RCTs, before making advertising claims about certain health benefits of over-the-counter consumer products.  Companies have questioned the two-RCT standard as too broad and burdensome.
• Last week the U.S. Court of Appeals for the D.C. Circuit held that the two-RCT requirement that the FTC had imposed on drink and supplement maker POM was unconstitutional on First Amendment grounds.  Going forward, POM will have to possess only one RCT.
• Requiring just one RCT as opposed to two could significantly reduce the time and cost needed to bring products and claims to market.  The FTC has already hinted that it will look for cases in which to continue imposing a two-RCT standard, notwithstanding the new POM ruling.