The National Advertising Review Board (NARB) has recommended that OLLY Public Benefit Corporation (OLLY) discontinue certain claims for its children’s supplement, Chillax, following a challenge by Bayer Healthcare LLC.
In the underlying National Advertising Division (NAD) case (#7350), Bayer challenged several advertising claims for Olly’s Kids Chillax, and “in evaluating these claims, NAD had concluded inter alia that a number of flaws with the Olly-commissioned clinical study rendered it unreliable to support the challenged express claims,” NAD’s case decision detailed.
NARB panel’s final decision
NARB, the appellate body of BBB National Programs, reviewed advertising claims suggesting that Chillax “supports a calm and relaxed mood.” After evaluating the supporting clinical evidence, NARB determined that the substantiation was not sufficiently tailored to the product’s marketed demographic.
Specifically, the panel found the age range in OLLY’s study to be broader than the target audience implied by the advertising.
In its decision, NARB stated that the Chillax study “did not, and could not, provide statistically relevant data to show that young children received the advertised benefits from consuming Chillax.” The panel also concluded that the study presented “no evidence that child users of Chillax would ‘stay engaged,’” according to the NAD’s case decision.
The panel’s review centered on six claims defended by OLLY, including statements on the benefits of L-theanine, such as that it “functions as ‘Captain Calm’ and works to support a relaxed state of mind.” NARB also evaluated non-ingredient-specific claims that “Chillax supports a calm and relaxed mood” and promotes a “relaxed state of mind.”
“Turning to the Chillax Study, the advertiser argues that NAD applied too rigorous a standard in assessing the study, holding OLLY to a standard more appropriately applied to clinical studies assessing drug products,” the panel wrote.
In its final decision, the panel noted that it “observes that the standard for dietary supplements is competent and reliable scientific evidence,” adding that “here, the only arguably competent evidence relied upon by OLLY is its Chillax Study...the panel notes further that the scientific analysis should have a high degree of rigor when the product at issue is ingested by children and designed to ameliorate a behavioral issue.”
Based on these findings, the panel affirmed the NAD’s original decision and recommended that Olly stop using the challenged advertising claims for Kids Chillax, while noting that Olly is free to modify its advertising “to be consistent with the results of the underlying testing and research.”
OLLY’s response and study defense
In a statement to NutraIngredients, an OLLY spokesperson confirmed the company will adhere to the decision “despite its disappointment with the NARB Panel’s assessment of OLLY’s clinical study, supporting evidence and the endorsements by four experts in the relevant field.”
The spokesperson added that OLLY had relied on a randomized, double-blind, placebo-controlled human clinical trial, “using reliable, widely-accepted assessments to measure the effects of Chillax on children four years and older.” OLLY maintains that the data showed statistically significant improvements in the subjects taking Chillax, “which our experts also agreed supported the Chillax claims.”
Despite data supporting the efficacy of L-theanine in the scientific literature, the spokesperson said OLLY supports industry self-regulation and “will modify its claims accordingly.”
Expert commentary on substantiation standards
Commenting on the decision, Jennifer Adams, an attorney at Amin Wasserman Gurnani, emphasized the implications for study design in claim substantiation.
“This case highlights that study design matters more than the results,” she told NutraIngredients. “NARB’s decision reemphasizes long-standing FTC guidance that the study population must match the targeted demographic.”
Adams noted that while OLLY’s study included children, “NARB considered the age range too large and that the product was marketed to only the youngest in the range.”
She advised that “narrowly tailoring study populations can help ensure a good fit with the product’s advertising,” and added that “if there is a reason the study demographic is perhaps broader than the product’s target, carefully pre-planned and powered subgroup analyses can protect credibility and applicability.”