President & CEO of BBB National Programs, a non-profit organization dedicated to fostering a more accountable, trustworthy marketplace.
Boost your immunity. Sharpen your mind. Get better quality sleep. Claims about the benefits of health products and services seem ubiquitous. According to McKinsey & Company, the health and wellness industry, which includes everything from nutrition and weight loss products to breathing and mental health apps, has grown to a $1.5 trillion market.
This growth did not happen overnight. I have seen a steady increase in health-related claims in advertising during the Covid-19 pandemic. This is not surprising, given that McKinsey reported a “substantial increase in the prioritization of wellness over the past two to three years.”
And because many of the products and services in the health and wellness industry do not require approval from the Food and Drug Administration (FDA), consumers often rely on truthful advertising to make choices that can have big effects on their health. Unfortunately, though, case trends have shown that misleading health-related claims are too prevalent, gaining the attention of regulators.
As the Federal Trade Commission (FTC) has explained: “Hundreds of marketers began making deceptive claims as they peddled Covid-19 related products and services. Schemes proliferated in response to demand for scarce goods, to peddle treatments and cures.” Since the onset of the coronavirus, the FTC has sent more than 400 letters to businesses “demanding that they cease making false promises that various pills, potions and treatments could prevent, treat or cure Covid-19.”
Beyond sending letters, the FTC, FDA and the U.S. Department of Justice have all been further empowered to act after the passage of the Covid-19 Consumer Protection Act in December 2020, which imposes monetary penalties on those who violate the statute. Recently, the Department of Justice and FTC filed an action against the marketers of a nasal spray, alleging that it “has been deceptively advertised to offer ‘up to four hours’ of protection from Covid-19 and ‘as part of a layered defense to prevent getting Covid-19.’”
But misleading health claims extend far beyond Covid-19. For example, take the FDA and FTC’s recent action calling out 10 companies for selling purported diabetes treatments. These companies did not appear to have scientific support, and that can have serious consequences. Samuel Levine, director of the FTC’s Bureau of Consumer Protection explains: “The prohibitive price has caused many patients to ration their insulin or forgo it altogether, often with catastrophic health consequences. Sadly, these high prices are driving many to turn to questionable products that imply without solid science that users can reduce their dependence on insulin.” The FTC has also focused on unproven CBD claims, fertility-related product claims and more.
What can businesses do to stay out of trouble when making health and wellness claims?
It is all about understanding what claims you are making and how to support those claims. To mitigate the risk of an unsupported health-related claim, businesses and nonprofits should:
• Substantiate all claims with competent and reliable scientific evidence. Advertisers must be mindful that health-related claims are held to a higher standard of proof by the FTC — i.e., competent and reliable scientific evidence, or CARSE. This FTC standard has been defined in FTC guidance as “tests, analyses, research, studies or other evidence-based on the expertise of professionals in the relevant area, that have been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.” CARSE could include methodologically-sound tests, analyses, research studies or other evidence based on the expertise of professionals in the relevant area, but I have found the gold standard is human clinical trials that are double-blind, placebo-controlled, with an adequate number of subjects assessing relevant endpoints and eliciting statistically significant and consumer-meaningful results.
• Ensure support for all claims — express and implied. Advertisers are responsible for both express and implied claims. It does not matter whether advertisers intended to convey those implied messages or not. Context is key when it comes to the implied messages consumers may take away from an ad. Take a claim that a service can help “stave off serious illness” from a chiropractic center ad — the claim may not be problematic in isolation, but paired with it being presented on a page titled “Battle the Coronavirus Bug with Chiropractic,” the overall message changes because of the context.
• Conduct tests in consumer-relevant conditions and produce consumer-meaningful results. Product testing should reflect how the product will work in practice. For example, you should not conduct a study on a dietary supplement among a sample group of elite athletes if the claim that you are making is directed to the general population. There are going to be significant differences between those two populations in their diet, lifestyle and exercise habits, all of which influence how the product works.
In sum, tread lightly when making health-related claims. Avoid making any claims that you cannot support with the appropriate level of scientific evidence.
The information provided here is not legal advice and does not purport to be a substitute for advice of counsel on any specific matter. For legal advice, you should consult with an attorney concerning your specific situation.
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