## Facts

- POM Wonderful marketed pomegranate-based juices and supplements and ran extensive advertising campaigns asserting health benefits.
- The advertisements claimed or implied the products could treat, prevent, or reduce the risk of serious diseases, including heart disease, prostate cancer, and erectile dysfunction.
- Many ads referenced scientific studies and suggested the benefits were clinically proven.
- The FTC alleged the disease-related claims were false, misleading, or not adequately substantiated under § 5(a) of the FTC Act.
- An FTC administrative law judge found the ads conveyed (1) efficacy claims (the products provide disease benefits) and (2) establishment claims (the benefits were scientifically proven), and that the claims lacked adequate substantiation.
- The FTC issued a cease-and-desist order that, among other requirements, barred similar claims unless supported by at least two randomized, controlled human clinical trials (RCTs).

## Issues

1. Whether substantial evidence supported the FTC’s findings that POM’s ads conveyed disease-related efficacy and establishment claims that were deceptive or inadequately substantiated.
2. Whether the FTC could require RCT evidence as substantiation for disease-related claims, including non-specific establishment claims.
3. Whether the FTC was required to use notice-and-comment rulemaking rather than adjudication to impose an RCT substantiation standard.
4. Whether a corporate officer with authority over advertising decisions could be held individually liable without having the “final say.”
5. Whether requiring two RCTs (or one RCT) for future disease-related claims violated the First Amendment protections for commercial speech.

## Decision

- The court largely affirmed the FTC’s liability findings and remedial order, applying substantial-evidence review to the Commission’s factual determinations.
- The court upheld the FTC’s conclusion that POM’s advertisements conveyed disease-related efficacy and establishment claims and that the claims were deceptive or inadequately substantiated.
- The court upheld the FTC’s determination that competent and reliable scientific evidence for POM’s disease claims could require properly conducted RCTs, including for non-specific establishment claims.
- The court rejected the argument that the FTC had to proceed by rulemaking and held the Commission could develop and apply substantiation standards through adjudication.
- The court affirmed individual liability for an officer who had authority to determine which advertisements were published, even without ultimate control over all ads.
- The court modified the order’s substantiation requirement: it struck the categorical two-RCT requirement as insufficiently justified and required at least one RCT for future disease-related claims.
- The FTC’s order was affirmed as modified.

## Legal Principles

- The FTC may find advertising deceptive by determining (1) what claims the ad conveys, (2) whether the claims are false, misleading, or unsubstantiated, and (3) whether the claims are material to consumers.
- Disease-related efficacy claims and establishment claims require substantiation consistent with what experts in the relevant fields would expect for causal disease-benefit assertions.
- The FTC may require, as substantiation for disease-related claims, at least one properly randomized and controlled human clinical trial when supported by the evidentiary record.
- The FTC may announce and apply substantiation standards through adjudication; notice-and-comment rulemaking is not a prerequisite to imposing liability or remedies in an enforcement action.
- Individuals may be held liable for deceptive advertising where they had authority to control advertising practices, even if they lacked final approval authority.
- Misleading commercial speech receives no First Amendment protection; forward-looking remedial orders restricting future claims must still be appropriately tailored, and a blanket two-RCT requirement can be more restrictive than necessary.

## Conclusion

The D.C. Circuit sustained the FTC’s findings that POM’s disease-related advertising claims were deceptive or inadequately substantiated and upheld an RCT-based substantiation remedy, but narrowed the cease-and-desist order by replacing the FTC’s categorical two-RCT requirement with a requirement of at least one properly conducted RCT for future disease claims.


POM Wonderful, LLC v. Fed. Trade Comm’n, 777 F.3d 478 (D.C. Cir. 2015)