As we have discussed before, the FTC launched an effort in 2010 to amend the standard language in its orders governing health-related advertising. Rather than simply requiring “competent and reliable scientific evidence” for future health benefit claims, most orders since 2010 have included rigid requirements that a company possess a certain type and amount of clinical trials. New provisions, for instance, require “human clinical testing that is randomized, double-blind, and placebo-controlled.” Apart from the language in new orders, the FTC has also shifted gears to argue that, even under the basic legal requirement for “competent and reliable scientific evidence,” many health benefit claims require controlled clinical studies.
The FTC’s push for clinical trial support for non-drug products has prompted litigation. The FTC has prevailed in some cases in requiring clinical trials. See FTC v. POM Wonderful, 777 F.3d 478 (2015); FTC v. Wellness Support Network, Inc., 2014 WL 644749, No. 10-cv-04879 (N.D. Cal. Feb. 19, 2014). In other cases, it has not. See Basic Research LLC v. FTC, No. 2:09-cv-0779 (D. Utah Nov. 25, 2014); FTC v. Garden of Life, 845 F. Supp. 2d 1328 (S.D. Fla. 2012), aff'd in part and vacated in part, 516 F. App'x. 852 (11th Cir. 2013); United States v. Bayer Corp., No. 2:07-cv-00001-JLL-JAD (D.N.J. Sept. 24, 2015). In the most recent victory for industry, Bayer successfully argued that a clinical trial requirement advanced by the FTC and its scientific expert impermissibly sought to require “drug-level clinical trials” for a probiotic dietary supplement. Bayer had promoted its product with allowed structure/function claims, rather than unapproved disease treatment or prevention claims.
What’s perhaps ironic – and helpful for industry – is that even where prescription drug promotion is concerned, regulators are facing increasing difficulty in defending rigid standards. Generally, prescription drugs require FDA approval and can be promoted only for their approved uses. The FDA has long taken the position that “off-label” promotion – which is promoting unapproved uses to doctors – is prohibited, end of story, regardless of the underlying substantiation or use of clarifying disclosures. However, decisions inAmarin Pharma, Inc. v. FDA, No. 15-3588 (S.D.N.Y. Aug. 7, 2015), and United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), have cast grave doubt on that prohibition where off-label promotion consists solely of truthful and non-misleading statements. The courts have found that a rigid prohibition against all off-label promotion, regardless of truthfulness, conflicts with First Amendment protections. The courts have found that some lesser evidence than perfectly executed clinical studies can be used to support properly qualified off-label claims.
In arguing against clinical trial requirements advanced by the FTC, companies have often pointed to First Amendment cases, like Pearson v. Shalala, 164 F.3d 650 (D.C. Cir. 1999), to support the proposition that regulators cannot prohibit commercial speech as long as it is based on credible evidence. The drug cases discussed above provide additional support for this idea. The body of law, together, suggests that, regardless of the product at issue – whether it be a dietary supplement, food, health app, or even in some situations, a prescription drug – unreasonably high and inflexible standards often fail to withstand First Amendment scrutiny.