CRN: 2015 may be the year when FTC finally gets the message

By Steve Mister, president and CEO, Council for Responsible Nutrition

- Last updated on GMT

CRN: 2015 may be the year when FTC finally gets the message

Related tags: Ftc, Scientific method, Dietary supplement

When I was a child, it seemed I could never get through an entire game of Candyland with my older brother. He kept changing the rules in the middle if his player started to fall behind. Don’t you hate it when someone changes the rules midstream? 

And yet, that feels like exactly what the Federal Trade Commission (FTC) has been trying to do over the past few years. Going all the way back to 2001, the FTC has imposed a requirement that advertising is not false or misleading if it is substantiated by “competent and reliable scientific evidence.” It has been a flexible standard that considers a variety of scientific evidence and evaluates the available data as it relates to the specific product at hand. Even when an advertiser is caught without the proper substantiation, the consent order imposed by the FTC demanded “competent and reliable scientific evidence” for all future advertising, holding the errant advertiser to the same standard as everyone else. 

In the past four years, however, that standard has been changing without any change in the statute or direction from the courts that this old standard is not adequate. The FTC has been out to rewrite the law. In particular, when the Commission finds inadequate substantiation, it has been trying to impose a more restrictive level of evidence in the ensuing consent order​sort of like if the police caught a speeding car and told its driver in the future he could only drive 45 in a 60 mph zone. However, 2015 may be the year when the issue “comes to a head.” 

Court decisions

Steve Mister CRN
Steve Mister, CRN

In the coming year, we should expect a couple of court decisions that will impact how the FTC  regulates advertising related to dietary supplements and functional foods making claims related to health. The Second Circuit decision in the POM Wonderful case should be announced soon. In that case, the FTC is pressing for the court to require any advertising by POM related to health benefits from the juice should be supported with two randomized, placebo-controlled clinical trials (RCTs). CRN filed an amicus brief in that case urging the court to tread carefully. For one thing, the FTC inserted its own judgment that the images in the ads created implied claims for consumers. In the past, the FTC would have conducted actual focus group testing to determine what the consumer takeaway would be. Now, in addition to insisting on an evidence-based medicine model for demonstrating the effectiveness of the products, FTC has injected the opinions of Washington-based attorneys for real consumers. The court may agree.

Separately, the District Court of New Jersey is likely to rule on a contempt petition with respect to Phillips Colon Health, a probiotic supplement. In that proceeding, filed by the FTC against Bayer, the Commission asserts that advertising claims to “defend against occasional bloating, gas, diarrhea and constipation” are disease claims requiring—you guessed it—“two randomized, placebo-controlled clinical trials” to substantiate them. In that case, the FTC retained a gastroenterologist as the expert witness who testified that these claims for gut health need multiple RCTs to support them. Again CRN filed an amicus brief in the case, this time questioning, among other things, why the Commission would identify a surgeon as the definitive expert on how to support advertising for a dietary supplement over other experts more keenly aware of the breadth of research in the field of probiotics. We again insisted that replacing a flexible standard with a rigid, two RCT requirement ignores a great deal of valid scientific evidence.

Setback for FTC

Both of these decisions will come on the heels of the District of Utah decision announced in November in the FTC’s litigation with Basic Research. In that case, the court granted summary judgment for the company, stating that the FTC had overreached by attempting to redefine the flexible “competent and reliable scientific evidence” standard to require RCTs and refusing to consider other kinds of data. The court indicated that the FTC’s imposed standard for substantiation imposes “higher criteria than are commonly expected in scientific research,” and being unable to meet that high threshold imposed by the FTC’s expert does not translate into lacking competent and reliable scientific evidence to support one’s claims. 

To be sure, these decisions won’t stop the FTC in its tracks. The FTC’s zealous enforcement of the law has been on display in a number of investigations announced in the past year involving infant formulas, cognitive health supplements, weight loss aids and skin care products.  However, these upcoming court decisions do suggest a standoff between advertisers and FTC may be decided by the courts. If judges are unwilling to uphold the overly stringent standards we have seen proposed for consent decrees over the past few years, the FTC will likely reassess whether it can continue to impose these unrealistic requirements for demonstrating the health benefits of these products to consumers. 

For its part, CRN plans to devote considerable effort this year to promoting the message of evidence-based nutrition. While RCTs certainly have a place in nutrition research, we believe that the totality of evidence, including observational studies, mechanistic research and even clinical trials on disease populations, can be informative of the benefits of dietary supplements and functional foods for a healthy population looking to maintain wellness. We welcome the opportunity to engage with the FTC to determine what is the appropriate balance for a flexible standard of advertising review. Maybe then, advertisers and regulators can play by the same set of rules. I hope my brother is reading. 

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3 comments

Scientific Evidence Goes Beyond the RCT

Posted by Steve Mister,

While I appreciate the importance of randomized clinical human trials, I would disagree that they are the only manner in which to substantiate advertising claims for these products. Many healthcare practitioners routinely practice medicine based on case studies, observational studies, etc. I’m not suggesting that research is anything but “evidence-based”; rather that the universe of evidence goes beyond RCTs. In some cases, and particularly in the field of nutrition, an RCT is impractical, unethical, or just plain impossible—how you would conduct a study with a zero vitamin C control group? Or a calcium study that assured half the study population didn’t drink milk or eat cheese or yogurt? Evidence-based nutrition accounts for these issues, examines the totality of data and develops the most plausible explanation for the observed differences in populations.

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Only 2 RCTs?

Posted by Ken,

By insisting on only 2 randomized double-blind, placebo-controlled trials, the FTC is not asking for nearly the level of evidence required for the approval of pharmaceutical products. In scientific, or so called "evidence-based" research (is there any other kind?), well-controlled human clinical trials are the minimum for establishing whether a substance is effective in humans or not. Population-based studies are not sufficient to establish cause and effect and the results from in vitro and animal studies may not be the same in humans from the ingestion or topical application of a substance.

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RCT's are not the gold standard, there is no gold standard

Posted by Dr RH Bennett,

Years ago, several statistical reports pointed out the flaws of RCT's and how they can be manipulated with inclusion and exclusion criteria that can be even applied post hoc. FDA's and the FTC's reliance on RCT's is a manifestation of the political power of pharma and little to do with good science

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