An Experiment on a Bird in the Air Pump

FTC Asks for RCTs, Not Vague Health Claims

Who knew that FTC could be a source of support for scientific rigor? Well, late in December the agency issued new guidance – its first in 25 years – clarifying the standards it requires for businesses making health claims about their products. In this new guidance, FTC makes a clear call for RCTs (randomized controlled trials) to support health claims and issues a clear caution against counting on using vague language to protect against false advertising problems.

Even more interesting is the fact that FTC intends this guidance to apply to a broad range of products making health claims. Not just to dietary supplements, as the old guidance did.

The Pom (Not Quite So) Wonderful Case

In this update with a 25-year gestation, FTC draws upon extensive experience in litigating false advertising about health claims. One of the most notable examples is the case of POM Wonderful. That case went all the way to the Supreme Court. FTC found that POM deceptively advertised that its pomegranate juice could provide all kinds of health benefits. The health claims FTC rejected ranged from erectile disfunction to cancer and heart disease.

Noteworthy is the fact that the courts upheld the agency’s expectation for RCTs to support health claims. FTC even specifies that p-hacking – post-hoc analysis that deviates from a study protocol – cannot provide support for a health claim

“May Help” Might Not Help

Perhaps one of our favorite cautions from the agency is against using vague suggestions of a health benefit to shield a company from liability for false advertising. This is a classic technique for healthy food claims. Walnuts “may reduce the risk of coronary heart disease,” says the California Walnut Board. But they go on to say the evidence is not conclusive. Mayo Clinic offers up a vivid example of vague health claims that you might not want to bet your life on:

“Antioxidants are substances that may protect your cells against free radicals, which may play a role in heart disease, cancer and other diseases.”

Pretty amazing, eh? Just remember that the unspoken bookend to “may help” is maybe not.

Click here for the FTC’s new guidance on health claims and here for their explainer. For more reporting on this, click here, here, and here.

An Experiment on a Bird in the Air Pump, painting by Joseph Wright / WikiArt

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January 7, 2023

One Response to “FTC Asks for RCTs, Not Vague Health Claims”

  1. January 07, 2023 at 10:08 am, Allen Browne said:

    Or, as they say in Maine “Might. – might not!”