In January 2013, the Federal Trade Commission released its final ruling against POM Wonderful, unanimously upholding administrative law Judge D. Michael Chappell's May 2012 decision that POM lacked adequate substantiation for advertising claims that POM products could treat, prevent or reduce the risk of heart disease, prostate cancer and erectile dysfunction.
The earlier decision by Judge Chappell had been met with significant excitement by food and supplement advertisers. While the judge found that POM had engaged in deceptive advertising, he also rejected the commission's arguments that POM must obtain FDA pre-approval for future disease claims and that all claims must be substantiated with randomized, double-blind, placebo-controlled human clinical trials (also known as RCTs), calling into question the FTC's recent move toward imposing more rigorous substantiation requirements for disease claims. Critics of the FTC have argued that recent consent orders requiring advertisers to support health-related claims with such studies have had a chilling effect on food and supplement marketers who are fearful of enforcement action and therefore do not provide the public with truthful health information about products, even where they have competent and reliable scientific evidence. Thus, advertisers felt vindicated by the judge's decision.
The commission was careful to limit its legal findings in the January 2013 ruling to the facts of the POM case, refusing to make a broad pronouncement regarding substantiation requirements for health claims. Instead, the commission endorsed its prior statements requiring that advertisers support health claims with "competent and reliable scientific evidence" and limited its stricter testing requirements to disease-prevention and -treatment claims. Those who have faced enforcement action by the FTC, however, know that the line between disease-treatment and -prevention claims and broad health claims can often be blurred. Thus advertisers making any health-related claims for their food products would be well advised to have human clinical support for those claims.
While this ruling is not likely the last word on this issue, food and supplement marketers can take some important lessons from it:
First, the commission explicitly rejected the "conclusion that RCTs are not required to convey information about a food or nutrient supplement where ... the safety of the product is known; the product creates no material risk of harm; and the product is not being advocated as an alternative to following medical advice." The ruling states that "experts in the relevant fields would require RCTs ... to establish a causal relationship between a food and the treatment, prevention or reduction of the risk of the serious diseases at issue in this case." Therefore, the commission concluded that it could appropriately impose the at-least-two-RCT requirement as a fencing-in provision in its order against POM.
Second, while the FTC did not explicitly say that two RCTs are always required to substantiate disease claims, advertisers making any health claims linked to any disease or specific medical conditions would be prudent to have two RCTs.
Third, the commission limited the two-RCT requirement "only to claims for disease prevention, risk reduction and treatment," adding that "future representations relating to efficacy or health benefits of covered products that fall short of disease claims ... requires substantiation consisting of competent and reliable scientific evidence." In other words, given the FTC's recent enforcement posture, advertisers making any specific health-related claims for food products would still be well advised to have at least one clinical study.
Fourth, the commission refused to include a provision in the order that would prohibit POM from making any disease claim without the FDA's prior approval -- a provision that had become common in orders against food and dietary-supplement advertisers. The ruling states that this requirement was "not warranted as part of the remedy in this case," noting that the two-RCT fencing-in requirement satisfies the goal of applying a "clear, bright-line standard that would be easy to enforce and, at the same time, provide certainty for respondents."
Advertisers should be very cautious when making any disease-treatment or -prevention claims for foods and dietary supplements. While POM likely will appeal the commission's decision before a federal circuit court, the two-RCT requirement for disease claims seems to be the new normal.
The FTC's traditional "competent and reliable scientific evidence" requirement continues to apply to the substantiation of health claims that are not disease claims. While the commission did not specifically address whether one or two RCT's would be required for more general health claims, based on recent commission enforcement actions and posture, marketers would be well advised to have some clinical evidence to support such claims as well.
Although the commission pushed back on the FDA preapproval requirement, you still need to comply with FDA regulations. It is possible that an advertiser, even one who satisfies the two-RCT requirement, could receive an FDA warning letter for mislabeling a dietary supplement.
All advertisements must be carefully reviewed to ensure that all express and implied claims are supported by your scientific evidence and are not overstated. Remember, advertisers are responsible for all claims in an advertisement, even those they do not intend to make.