What does “clinically proven” mean? What is the future of “clinically proven” structure/function claims on dietary supplements?

These are two questions to arise from a recent ruling handed down from the National Advertising Review Board (NARB), the appellate advertising body for the Better Business Bureau (BBB) National Programs.

‘Clinically proven’ comes with a high bar.

“‘Clinically proven’ is a strong claim, and a reasonable consumer could think the finished product — or at least a very comparable product form, dose, strength and use pattern — has been clinically studied and shown to deliver the stated result,” said Asa Waldstein, founder and principal at Apex Compliance, a regulatory and marketing compliance firm specializing in dietary supplements.

Waldstein isn’t surprised by challenges to “clinically proven” claims, stating they are an easy target for litigation, but the threshold for such claims is higher than others.

“For a ‘clinically proven’ claim, the bar is high, and a double-blind, placebo-controlled human trial is often the gold standard for this kind of claim,” Waldstein said. “The real question is whether the evidence is competent, reliable and closely matched to what consumers are likely to take away.”

His key takeaway is that companies can still discuss NAD+ (nicotinamide adenine dinucleotide) and ingredient research, with a caveat.

“Once the language moves into ‘clinically proven’ territory, the claim needs to stay tightly aligned with the evidence,” Waldstein said. “If the evidence is narrower than the claim, the claim usually needs to be narrowed too.”