What’s Inside the New FTC Guidelines? - Today's Dietitian Magazine

What’s Inside the New FTC Guidelines?
By Carrie Dennett, MPH, RDN
Today’s Dietitian
Vol. 25 No. 5 P. 30

Their utility may go beyond combatting false health claims in advertising.

Dietitians know that just when we think health claims can’t get any more dubious, they do. Whether it’s rolling our eyes at television or social media ads or gently explaining to clients and patients why a certain food may be nutritious but isn’t a “miracle cure,” it can feel like playing Whac-A-Mole. Even worse, many advertisements containing sketchy health claims are slick and sophisticated, using “expert” endorsements and “real people” testimonials while citing so-called promising new research and cutting-edge results that sound good but are bogus.

To help tame the Wild West of the health claim landscape, the Federal Trade Commission (FTC) recently issued its “Health Products Compliance Guidance,”1 an update to the 1998 document “Dietary Supplements: An Advertising Guide for Industry.” This update reflects the fact that the agency has had success taking a variety of marketers of misleading health claims to court—not just dietary supplement manufacturers. Now any company—including food producers—that makes health claims about their products is fair game.

Since 1998, the FTC has gone to court over or settled more than 200 cases involving false or misleading advertising claims about the benefits or safety of dietary supplements or other health-related products, including foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests, and health-related apps. This updated guidance draws on the lessons from those cases to illustrate how the agency identifies whether a health claim is express or implied and how it evaluates the scientific support for those claims. The agency says one of its goals in issuing this guidance, with its plentiful real-world examples, is to correct “misunderstandings and ‘urban myths’ that have circulated about FTC substantiation standards.”2

The ultimate goal is to protect consumers’ ability to make informed decisions by preventing ads from making health claims that are misleading or can’t be substantiated by “competent and reliable scientific evidence.” This includes claims made via traditional TV, radio, print, and online ads—areas where the FTC has primary responsibility—as well as statements on labels, packaging, and promotional materials, where the FDA has primary responsibility, but the FTC also can take action. But perhaps more relevant to the dietetics profession, it also includes claims made through social media and influencer marketing, press releases, and media interviews conducted at trade shows, conferences, and seminars, and indirectly through health care practitioners or other third parties.

Express vs Implied Claims
Many companies have tried to hedge their bets by making vague and indirect claims when they can’t legitimately make a direct claim that their product has a causal link to a desired health benefit. However, the FTC is making it clear that marketers are just as responsible for the accuracy of “suggested” or “implied” claims as they are for claims they make directly and openly. The focus here isn’t on marketers’ intent—”We didn’t intend to imply that Product X prevents Disease Y” isn’t a legitimate defense—but on what consumers take away from the advertising content. This includes consumer interpretation based on written, visual, or auditory information.

For example, if a product uses an image of “doctors” in white lab coats, consumers likely will assume the product has clinically proven benefits, even if the marketer doesn’t say it does. Or, to give another example from the guidelines, if an ad for a vitamin supplement claims that 90% of cardiologists regularly take the product, which is an express claim, consumers likely will assume that the product offers heart health benefits, which becomes an implied claim.

In one court case brought by the FTC, the judge concluded that “based on the overall, common-sense, net impression” of the ad, “a significant minority” of “reasonable” consumers would interpret the ad to be claiming that consuming the product daily reduces the risk of heart disease. The advertiser didn’t directly say this, but, more importantly, it didn’t have sufficient scientific evidence to back up the implied claim.

Another way that some companies run afoul of the guidelines is by turning an express—and allowed—structure/function claim into an implied disease-based claim. Allowed structure/function claims describe how a nutrient or dietary ingredient may affect the normal structure or function of the human body. For example, “calcium builds strong bones,” or “fiber maintains bowel regularity,” or “antioxidants maintain cell integrity.”3 This is substantially different from disease-based claims, which state that a food or food component may reduce the risk of a disease or health-related condition.4

• Authorized health claims are disease-based claims that have been reviewed by the FDA and have significant scientific agreement, such as “Adequate calcium and vitamin D as part of a healthful diet, along with physical activity, may reduce the risk of osteoporosis in later life.”4

• Qualified health claims, which also have been reviewed by the FDA, are supported by some scientific evidence but don’t have significant scientific agreement. For example, “Scientific evidence suggests but does not prove, that whole grains (three servings or 48 g per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”5

Some manufacturers make allowed structure/function claims but also include information in imagery or words that imply the product prevents a disease. The guidance document cites an example of an ad for a herbal supplement that claims the product boosts the immune system to help maintain a healthy nose and throat during the winter season, features the product name “Cold Away,” and includes images of people sneezing and coughing. The FTC states that the various elements of the ad likely convey to consumers that the product helps prevent colds, which isn’t supported by evidence.

Yet another way companies make unsubstantiated claims without making them directly is through testimonials, “expert” endorsements, or sponsored blog posts. The FTC is making it clear that if a claim made through these avenues doesn’t hold up to scientific scrutiny, the advertiser is liable even though they didn’t directly make the claim themselves. The person who’s making the claim also could be liable. This puts the burden on advertisers who have any type of financial or in-kind relationship with, for example, dietitians on social media to ensure accurate messaging is communicated. It also puts the burden on dietitians to not overextrapolate any research that’s been done on the product. One example of overextrapolation is communicating disease-prevention benefits when the research doesn’t support that link. Another would be communicating purported health benefits derived from low-quality research.

Burden of Proof
Part of correctly understanding, interpreting, and communicating the research—especially when dietitians have a financial tie to the company making health claims—is to ensure the evidence supporting the claims is in alignment with the FTC guidance. Specifically, health claims used in advertising should have rigorous evidence to back them up, including at least one high-quality randomized human clinical trial.

This requirement was upheld as part of a 2014 appeals court case, although the three-judge panel stopped short of upholding the FTC’s initial order requiring two such clinical trials. Instead, the panel left the door open by saying there could come a time when two high-quality randomized human clinical trials might be warranted. Health claims that already meet the FDA’s “significant science agreement” also meet the FTC guidance.

While more than one randomized controlled trial (RCT) adds to the weight of the evidence, the guidelines emphasize that the quality of the evidence is more important than the quantity: “Numerous flawed and inadequate studies are unlikely to add up to competent and reliable scientific evidence sufficient to substantiate a claim.” Similarly, a marketer can’t publicize one study that shows benefit while ignoring other research that shows no benefit or even harm.

The measures of “quality” are consistent with best scientific practice. Double blinding is required when feasible, but the FTC recognizes that it may not be possible to conduct blinded clinical trials of some food products. The results must be statistically significant (not due to pure chance or the placebo effect) and clinically meaningful to consumers. And research that hasn’t been peer-reviewed is subject to greater scrutiny. While there are a few exceptions to the RCT guideline, such as using high-quality epidemiologic research when experts in the field consider it an acceptable substitute for RCTs or when RCTs aren’t otherwise feasible—two situations that commonly occur when investigating food-disease links—there are some forms of research that can’t be used at all, including the following:

• Animal and in vitro studies. These can provide supporting or background information but aren’t enough to substantiate health-related claims because they have limited value in predicting a product’s effect on humans.

• Anecdotal evidence from a few individuals or from consumer surveys. “Even if consumer experiences are genuine, they may be attributable to a placebo effect or other factors unrelated to the product,” the guidelines state. “Individual experiences aren’t a substitute for scientific research.”

• Public health recommendations or advisories from medical organizations. “Public health recommendations and advisories reflect a judgment based on the best currently available evidence. They aren’t equivalent to a finding that there is a causal link between the recommended course of action and the health benefit.”

While results from observational studies can be used in advertising to show an association between a product and a health benefit, they can’t be used to support a claim about a causal link. For example, one food manufacturer used results from a nonrandomized, nonplacebo-controlled study to say that “Medical studies have shown that consuming X amount of Product Y daily minimizes factors that lead to atherosclerosis, a major cause of heart disease.” The courts ruled that the manufacturer was claiming a scientifically established causal link between its product and heart disease where none existed.

An advertiser could make a health-related claim that’s backed by research less stringent than an RCT if it includes an effective disclaimer disclosing the research’s limitations. Even when supporting research checks off the right quality boxes, the level of proof must match the level of the claim in the ad and convey that information in a nonmisleading way. This includes clearly communicating qualifying information. For example, if a placebo-controlled, double-blinded clinical study of a weight loss supplement shows that the intervention group lost more weight than the control group but participants also restricted calories and engaged in regular exercise, the product’s advertising must make that clear to avoid consumers believing that the supplement alone produced the advertised effects.

Qualifying information also applies to side effects and potential interactions between dietary supplements and prescription drugs. Qualifying statements must be clear and conspicuous, and easily noticed, read, and understood—or heard and understood—by the group of consumers being targeted. This means ads that target children should be understood by children, not just by adults. On the internet and social media, disclosures must be unavoidable, which means hyperlinks to the disclosure aren’t sufficient.

Because consumers may not fully understand the significance of scientific findings that are limited or still emerging, using qualifying terms like preliminary, promising, initial, and pilot to describe the research supporting ambiguous health claims is insufficient. Whereas dietitians, other health providers, and researchers understand that it’s important to have multiple studies with similar findings, consumers are likely to interpret these qualifying terms as a positive attribute.

Similarly, using qualifying terms like “may” or “helps” when making claims based on less-than-robust research data—such as “Product X may have Benefit Y” or “Product X helps achieve Benefit Y”—are inadequate because consumers are likely to interpret them as saying the product will produce a health benefit or prevent or reduce disease risk. Unfortunately, it’s not uncommon to see double qualifiers such as “Product X may have Benefit Y, which may reduce the risk of Disease Z.”

If it’s impossible to make an effective disclosure, the claim should be modified so a disclosure isn’t necessary, or the marketer shouldn’t make the claim at all. And if a claim, whether direct or indirect, is patently false, even a clear disclaimer that contradicts the claim will still open up the marketer to legal scrutiny.

The Problem of P-Hacking
Just as marketers can’t publicize one study that shows benefit while ignoring other research that shows no benefit, or even harm, they can’t use the results of p-hacking to support health claims. P-hacking, otherwise known as data mining, is a post hoc analysis of data that departs from the original study protocol. It’s generally an attempt to find some positive result to report from a study that otherwise failed to show any effects or benefits.

Since the more post hoc comparisons a researcher examines, the more likely the data will yield what looks like a significant difference that’s usually the result of chance, the FTC has ruled that health claims can’t be supported by the results of p-hacking. Post hoc analysis that departs from the study’s originally stated protocol—for example, an analysis that looks at various smaller subgroups of the study population—may identify areas for future exploration, but it usually doesn’t provide reliable evidence to substantiate a claim.

To Whom This Guidance Applies
As mentioned, the FTC guidelines specifically pertain to advertising, which is a broad definition. It includes the following:

• traditional TV, radio, print, and online ads;
• statements on product labels and packages;
• promotional materials;
• social media and influencer marketing;
• press releases;
• media interviews;
• trade shows;
• conferences and seminars; and
• indirectly through health care practitioners or other third parties.

What the guidelines don’t apply to is the accuracy of health claims in independently published articles, books, blogs, social media posts, podcasts, and other media. Nevertheless, dietitians may want to take this guidance to heart when communicating nutrition information.

When communicating about foods or products that have a research base, make sure you understand what the research says and what it doesn’t, especially as it relates to causal links to disease. This is best practice for any nutrition communicator, but there’s an extra layer of importance for media RDs and others who attend media tours or sponsored conferences and receive any financial compensation, including being compensated for travel, lodging, or meals. It also has relevance for dietitians who work booths at trade shows promoting foods, supplements, or other health-related products. It remains important to appropriately disclose any financial relationship—even if it’s just a free product—but now it’s also necessary to be careful about what you say.

The guidelines also can be a useful tool for identifying areas where clients and patients—and readers of social media posts and other written or recorded materials—may misinterpret health claims or the accompanying research. It’s not uncommon to see press releases—or articles based on those press releases—that tout the results of a pilot study or preliminary research. Dietitians who have interns writing blogs or social media posts also may find this to be a useful teaching resource.

— Carrie Dennett, MPH, RDN, is the nutrition columnist for The Seattle Times, owner of Nutrition By Carrie, and author of Healthy for Your Life: A Non-Diet Approach to Optimal Well-Being.

References
1. Federal Trade Commission. Health Products Compliance Guidance. https://www.ftc.gov/system/files/ftc_gov/pdf/Health-Guidance-508.pdf

2. Fair L. What’s new—and what isn’t—in the FTC’s just-published Health Products Compliance Guidance. Federal Trade Commission website. https://www.ftc.gov/business-guidance/blog/2022/12/whats-new-what-isnt-ftcs-just-published-health-products-compliance-guidance. Published December 20, 2022.

3. Structure/function claims. FDA website. https://www.fda.gov/food/food-labeling-nutrition/structurefunction-claims. Updated March 7, 2022.

4. Authorized health claims that meet the significant scientific agreement (SSA) standard. FDA website. https://www.fda.gov/food/food-labeling-nutrition/authorized-health-claims-meet-significant-scientific-agreement-ssa-standard. Updated March 7, 2022.

5. Questions and answers on health claims in food labeling. FDA website. https://www.fda.gov/food/food-labeling-nutrition/questions-and-answers-health-claims-food-labeling. Updated December 13, 2017.