Alice Mushrooms case tests limits of ingredient substantiation

"Our decision is consistent with our precedent - there needs to be a good fit between the claims and support," said Annie M. Ugurlayan, assistant director at National Advertising Division.
"Our decision is consistent with our precedent - there needs to be a good fit between the claims and support," said Annie M. Ugurlayan, assistant director at National Advertising Division. (Getty Images)

A recent case decision offers a closer look at how the National Advertising Division (NAD) approaches ingredient-level research when companies make claims for multi-ingredient products, including when that evidence can be extrapolated to the finished formulation.

The National Advertising Division has found support for a qualified saffron claim for Alice Mushrooms’ Zen-X chocolate but said evidence on L-theanine, kanna and saffron did not collectively substantiate a broader calming claim for the finished product.

Alice Mushrooms had claimed that “cool, calm and collected is one delicious bite away,” relying on studies of the three ingredients as support.

“Our decision is consistent with our precedent—there needs to be a good fit between the claims and support,” Annie M. Ugurlayan, assistant director at NAD, told NutraIngredients.

When ingredient evidence fits

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“As a general rule, an advertiser making a product performance claim needs reliable testing on the product,” Ugurlayan said, but that does not necessarily mean companies need a clinical trial on every finished formulation.

Ugurlayan explained NAD has accepted ingredient studies as support for product performance claims under limited circumstances, including when the product contains essentially the same ingredients as those tested.

But combining research on several individual ingredients does not resolve questions about how those ingredients perform as part of the marketed formulation.

“We have reviewed studies on multiple ingredients provided as support for a product performance claim, but the question remains about the effects of the other ingredients in the product,” Ugurlayan said.

Without reliable evidence showing that the tested ingredients are responsible for the product’s efficacy, she added, the claim must be qualified.

NAD also looks beyond whether an ingredient simply appears in both the study and finished product. Ugurlayan said considerations include the study population, quantity tested and method of administration, as well as whether the results are statistically significant and meaningful to consumers.

NAD separates saffron evidence

Those distinctions played out across the three ingredients Alice Mushrooms cited for Zen-X.

For L-theanine and kanna extract, NAD found that “the evidence in the record was not a good fit” to demonstrate the claimed benefits of feeling cool, calm and collected or clear-headed, according to its case summary.

NAD reached a different conclusion on saffron. One clinical study evaluated the same dose of saffron contained in Zen-X and reported statistically significant results on measures including tension, stress and vigor.

The organization said the study included “many indicia of reliability” and recommended that Alice Mushrooms modify its claim to make clear that the benefit was limited to saffron.

“When an advertiser’s evidence is limited to an ingredient, the studies must be reliable and may support a qualified claim based on the results,” Ugurlayan said. “The evidence must be a good fit to support the claims being made.”

During the inquiry, Alice Mushrooms voluntarily discontinued the challenged claims for its Brainstorm product and all but one of the challenged claims for Zen-X. NAD said the permanently discontinued claims would be treated for compliance purposes as though it had recommended their discontinuation and the company had agreed to comply. Alice Mushrooms said it “will comply with NAD’s recommendations.”