New York, NY – April 3, 2019 – The National Advertising Division has concluded that Mead Johnson provided a reasonable basis for its compositional claims for its Enfamil NeuroPro  MFGM (Milk Fat Globule Membrane)-Supplemented Infant formulas but recommended modification of other claims in both consumer and healthcare professional advertisements, and discontinuance of its use of a certain bar graph in its consumer-directed commercial, following a challenge by Abbott Nutrition, maker of Similac Infant Formulas.

NAD is an investigative unit of the advertising industry’s system of self-regulation and is administered by the Council of Better Business Bureaus.

The claims challenged by Abbott included, but were not limited to:

• “NeuroPro – A revolutionary brain-first formula that provides cognitive outcomes like breast milk.*” “*in amounts supported by clinical research”
• Bar chart comparing Bayley Scale scores with bars for “Breast Milk,” “NeuroPro,” and “Other Studied Formula.”
• “Brain-building nutrition….”
• “NeuroPro, a fat-protein blend of MFGM & DHA previously found only in breast milk.*” “*in amounts supported by clinical research”
• “Enfamil offers brain-building nutrition inspired by breast milk, backed by decades of research and multiple clinical studies.”
• “Support immune health—like breast milk.”
• “Nourish the brain first with Enfamil NeuroPro.”
• “Introducing Enfamil NeuroPro—A revolutionary brain-first formula that provides cognitive outcomes like breast milk.”

NAD concluded that the advertiser supported its compositional claims that “Enfamil NeuroPro has a fat-protein a blend of MFGM and DHA previously only found in breast milk* (*in amounts supported by clinical research),” “MFGM and DHA for Brain Building,” “MFGM Brain Building nutrition inspired by breast milk,” and “Brain-building nutrition inspired by breast milk.”  NAD further found that these claims did not convey a message of nutritional equivalency to breast milk in terms of cognitive development or were otherwise comprised solely of qualified general cognitive benefits stemming from the inclusion of the MFGM ingredient in the product.

NAD also concluded that the advertiser’s consumer-directed claim, “[e]merging evidence from a recent clinical study showed MFGM in formula supports cognitive development similar to breast milk” was a carefully qualified claim ensuring that consumers understand the extent of the support for the advertiser’s claim. However, with respect to the advertiser’s website claim, “NOURISH THE BRAIN FIRST. Enfamil NeuroPro is the first formula that has an MFGM & DHA blend for brain-building benefits similar to those of breast milk…” NAD recommended that this language be modified to make clear that any cognitive development support (brain-building) benefit similar to those of breast milk is limited to the ingredients MFGM and DHA that help support cognitive development and avoid any implication that the cognitive benefit conferred by the formula itself is like that conferred by breast milk.

Based on the evidence, NAD recognized that when product performance claims are not supported by testing on the specific product itself but, rather, are based on testing of a certain ingredient in the product, an advertiser can rely upon that testing to support claims about a product that contains essentially the same ingredients. The advertiser should demonstrate with reliable evidence that the ingredient evidence appropriately applies to its product because any differences between the tested product and the advertised product would not have any bearing on the results.  The advertiser here met that burden.

Both of the main underlying studies and Enfamil NeuroPro contain the same bovine MFGM, from the same source and in the same amount. The submitted research establishes that bovine MFGM provides the relevant components found in breast milk that are associated with certain cognitive and immune health benefits. The advertiser also provided evidence comparing the nutritional makeup of the test formulas and Enfamil NeuroPro formulas. Although there are variations among the formulas (i.e., different levels of other certain nutrients), on balance, none can be deemed as having a significantly different nutrient profile for purposes of compositional claim substantiation. Additionally, with respect to cognitive and immune benefits, the Enfamil NeuroPro formulas contain the same level of these other nutrients as the study formulas (or higher). The evidence also demonstrated that any differences between underlying studies’ formulas and Enfamil NeuroPro are immaterial to the efficacy of MFGM and would not impact the cognitive benefits provided by MFGM or DHA as contained in NeuroPro.

However, as concerns the advertiser’s claim on its product packaging that “Enfamil offers brain-building nutrition inspired by breast milk backed by decades of clinical research and multiple clinical studies,” NAD recommended that the advertiser modify its product packaging to separate the claim from its claims about MFGM to  limit the message conveyed to the research underlying the Enfamil brand of infant formulas (and not the MFGM-supplemented NeuroPro formula itself). NAD also recommended that the advertiser avoid (1) any implication that its “backed by decades of clinical research and multiple clinical studies” language pertains to its research with respect to the MFGM supplementation in its infant formulas or (2) any overstatement as to the extent of the research upon which it relies in support of the specific MFGM supplementation in its formulas. NAD believed this recommendation to be consistent with an advertiser’s responsibility to qualify claims in a manner that ensures that consumers understand the extent of the support for the claim.

NAD also recommended that the advertiser either discontinue its website claim “MFGM has been clinically shown to help close the cognitive gap between formula fed and breastfed infants,” or modify this claim to reflect the emerging nature of the science and, for example, track the most recent 2017 underlying study’s conclusion that “MFGM supplementation of infant formula may be an important step toward narrowing the gap between formula fed and breastfed infants with respect to neurodevelopment.

The challenged advertisements also included a bar graph depicting the expected and comparative cognitive outcomes for infants fed breast milk compared to those fed NeuroPro and those fed some “Other Studied Formula” without MFGM as found in the underlying 2014 study.  Problematic for NAD was the fact that the three bars in the graph were labeled: (1) “BREAST MILK,” (2) “NEUROPRO,” and (3) “OTHER STUDIED FORMULA”. On either side of the bold type “NEUROPRO” label, in far smaller text, appears “formula with” and “MFGM.” Below the bold type, “OTHER STUDIED FORMULA” appears the words, also in far smaller type, “without MFGM.” All of the text in each of the graph’s bar labels appears in a vertical orientation. NAD concluded that one reasonable take away from the labels on the bars in the graph is that MFGM-supplemented NeuroPro itself was the subject of the study represented in the graph when that is not the case. Additionally, as for the third bar in the graph (“OTHER STUDIED FORMULA”), the formula represented is not merely some “other” formula; it was specifically a test formula without MFGM. Despite the absence of a named competitor, NAD determined that consumers could reasonably take away the unsupported message that Abbott’s Similac—as the advertiser’s main competitor—is the producer of that “other” formula.

As such,  where the graph appearing on the advertiser’s website, NAD recommended that the advertiser modify the labels in the bars in the graph to more accurately state that the latter two represent, “Formula with MFGM” (without the NeuroPro name) and “Formula without MFGM” or “Standard Formula without MFGM.” NAD further recommended that a clear and conspicuous disclosure appear beneath the graph (as it does in the HCP-directed brochure) that the graph is “Based on a study comparing a different formula with MFGM added as an ingredient to a similar formula without it.”

Insofar as this graph appears in the advertiser’s 30-second consumer-directed commercial, NAD determined that reasonable consumers would be unlikely to notice, read and comprehend the nuanced message intended by the advertiser and its graph. As such NAD recommended that the graph be discontinued in its entirety in the spot. NAD also recommended that the advertiser limit claims about “brain-building” benefits to the ingredients MFGM and DHA, and avoid the implication that these benefits are tied to NeuroPro formula itself or that NeuroPro has been shown to close the cognitive gap between formula-fed and breastfed infants.

As concerns the advertiser’s healthcare provider-directed advertising, NAD recommended that the claim, “[a] revolutionary brain-first formula that provides cognitive outcomes like breastmilk*…” be modified to state, “NeuroPro—A revolutionary brain first blend of MFGM and DHA, nutrients shown in a clinical study to help support cognitive outcomes similar to breast milk*…” NAD further recommended that the bar graph appearing in the HCP-directed brochure be modified to change the label as stated above and that the claim, “help narrow the cognitive gap between formula-fed and breastfed infants” be modified to reflect the emerging nature of the science and, for example, more closely align with the language in the Timby authors’ 2017 abstract, that, “MFGM supplementation of infant formula may be an important step toward narrowing the gap between formula fed and breastfed infants with respect to neurodevelopment…”

With respect to the advertiser’s HCP-directed video, NAD recommended that the language, “and we also know that formulas that are supplemented with MFGM provide specific cognitive and health benefits to the infant similar to those of breastfed infants,” be modified so the claim reflects the emerging nature of the science.

Lastly, to the extent that the advertiser’s HCP-directed video is made available online through the advertiser’s website (or elsewhere) to general consumers, NAD recommended that it be discontinued. Should the advertiser wish to publish this video on its website or elsewhere, NAD recommended that it establish a secure portal through which only health care professional can gain access to this video.

In its advertiser’s statement, Mead Johnson stated that it appreciated NAD’s thoughtful attention in this matter and finding both that the evidence provided a reasonable basis for its claims that brain-building benefits are conferred by the added MFGM and DHA ingredients in Enfamil NeuroPro and that emerging evidence from a recent clinical study showed MFGM in formula supports cognitive development similar to breast milk.  Mead Johnson also appreciates NAD’s conclusion that the evidence provided a reasonable basis for its claims that Enfamil NeuroPro has a fat-protein blend of MFGM and DHA, previously found only in breast milk in amounts supported by clinical research and that these added nutrients  in Enfamil NeuroPro provide “Brain Building Nutrition inspired by breast milk.” Mead Johnson further stated that it will comply with NAD’s recommendations.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.

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About Advertising Industry Self-Regulation:  The Advertising Self-Regulatory Council establishes the policies and procedures for advertising industry self-regulation, including the National Advertising Division (NAD), Children’s Advertising Review Unit (CARU), National Advertising Review Board (NARB), Electronic Retailing Self-Regulation Program (ERSP) and Online Interest-Based Advertising Accountability Program (Accountability Program). The self-regulatory system is administered by the Council of Better Business Bureaus.

Self-regulation is good for consumers. The self-regulatory system monitors the marketplace, holds advertisers responsible for their claims and practices and tracks emerging issues and trends. Self-regulation is good for advertisers. Rigorous review serves to encourage consumer trust; the self-regulatory system offers an expert, cost-efficient, meaningful alternative to litigation and provides a framework for the development of a self-regulatory solution to emerging issues.

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