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.
NARB upheld recommendations from the National Advertising Division (NAD) that Tru Niagen discontinue the use of “clinically proven” claims, among others related to immune, brain and heart health. (Check out this article for previous coverage on the division’s original recommendations.)
‘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.”
NAD is contradicting itself, Niagen fired back in appeal
“Niagen Bioscience is deeply disappointed by the NARB panel’s decision, which we believe applies an overly restrictive standard that is inconsistent with long-standing dietary supplement law, scientific practice and established advertising precedent,” said Carlos Lopez, senior vice president and general counsel at Niagen.
Niagen provided several arguments in its appeal, key among them that the National Advertising Division was inconsistent in its application of science on prior rulings.
Niagen argued that the NAD weighed each study on its ingredient individually instead of looking at all scientific evidence as a whole, noting that the division had previously credited studies even when concerned about methodology.
“It misapplies the substantiation standard by incorrectly recategorizing qualified cellular and structure/function statements as broader implied claims, and by critiquing individual studies in isolation rather than evaluating the totality of the evidence through an appropriately scientific lens,” Lopez said.
Niagen argued that “NAD’s decision fundamentally shifts the dietary supplement landscape and essentially undermines the essential purpose of these products.” — National Advertising Review Board panel decision
He also emphasized the issue in question is interpretation of adverting claims, not the safety or quality of Niagen’s products.
Niagen maintained that it thoroughly reviewed all product claims against NAD and Federal Trade Commission (FTC) standards, going so far as to avoid the use of “improves” or “promotes” anywhere in its language. Niagen believed the NARB decision diverged from legal precedent established by U.S. Food and Drug Administration (FDA), FTC and NAD and creates “an unworkable standard moving forward” as the decision document states.
Niagen also said in its appeal that NAD “flatly rejects the core purpose of dietary supplements” in its ruling, which the company defined as helping healthy persons to maintain their health. The company argued that “NAD’s decision fundamentally shifts the dietary supplement landscape and essentially undermines the essential purpose of these products.”
Challenging company Reus maintained Niagen is in the wrong
Supplement manufacturer Reus Research, a competitor of Niagen that was the challenger in the original decision, maintained the claims made on Tru Niagen were broad and that NAD applied standards consistent with precedents established by NAD and FTC.
Reus argued that “Niagen invoked in support of its position the same substantiation principles it now attacks,” according to the decision document. The challenger also stated that Niagen markets to older populations who may be particularly vulnerable to unsubstantiated claims.
Reus further submitted the issue at hand is not related to policy and that that the classification of questioned claims as structure/function claims holds no relevance.
Notably, Niagen previously lodged against Reus for claims made on its Cata-Kor branded supplements. NAD ruled that some claims were supported and others should be modified or discontinued. Niagen claimed the challenges from Reus following its actions were “clearly retaliatory.”
Reus was contacted for comment and had not responded as of this publication.
Who regulates structure/function claims?
The FDA regulates structure/function claims under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Niagen argued in its rebuttal that the claims called into question were structure/function claims and thus permitted under DSHEA.
The National Advertising Division thought otherwise.
In the final decision document, NAD adhered to guidance from the FTC, stating that “the Commission regards DSHEA status as a regulatory (FDA) matter, not as a consideration relevant to an assessment of whether a health claim is misleading or properly supported.”
The bottom line? NAD said claims substantiation depends on the message conveyed to consumers, not where the claim falls within regulatory framework.
National Advertising Review Board panel decision: Advertising Division recommendations stand
The NARB panel concluded that NAD “applied the proper legal standard” and adhered to FTC precedent. The decision maintained that the criteria for advertising claims are separate from FDA oversight of structure/function claims.
The panel also expressed gratitude to Niagen and Reus for “for participating in industry self-regulation in the interest of promoting truth in advertising.”