New York, NY – Jan. 17, 2019 – The National Advertising Division has concluded that certain claims made by Abbott Nutrition for its Human Milk Fortifier in a healthcare professional-directed sales brochure and a related poster were supported by the two studies discussed and promoted in these advertising pieces but recommended modifications to other claims, following a challenge by RB LLC, maker of competing infant nutritional products such as Enfamil Human Milk Fortifier.

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 challenged claims included:

• “PRETERM INFANTS FED SIMILAC HMF HP CL HAD IMPROVED TOLERANCE VS THOSE FED EHMF AL”
• “…preterm infants fed Similac HMF HP CL showed significantly less feeding intolerance than infants fed EHMF AL”
• “… 0% of feedings were withheld due to abdominal distention in preterm infants fed Similac HMF HP CL compared to 25% of infants fed EHMF AL”
• “…preterm infants fed Similac HMF HP CL had a lower incidence of metabolic acidosis vs those fed EHMF AL”
• “…preterm infants fed EHMF AL had early deficits in growth in the first weeks of life”
• “significantly greater weight gain velocity in preterm infants fed Similac HMF HP CL”

NAD determined that, generally speaking, the challenged healthcare professional-directed advertising materials accurately portrayed the results of the Kumar and Schanler studies offered by Abbott in support of its claims, and that the challenged claims did not falsely disparage the challenger’s product as alleged by RB LLC.

Specifically, NAD found that the Kumar Study used objective benchmarks and provided a reasonable basis for Abbott’s claim, “PRETERM INFANTS FED SIMILAC HMF HP CL HAD IMPROVED TOLERANCE VS THOSE FED EHMF AL” and that this claim was narrowly tailored to reflect the study’s specific findings. This study was also found to provide a reasonable basis for Abbott’s claim, “…preterm infants fed Similac HMF HP CL showed significantly less feeding intolerance than infants fed EHMF AL.”  NAD further determined that both studies, which went through a rigorous peer-review process anda which NAD found were reliable, provided a reasonable basis for the advertiser’s claims that  “… 0% of feedings were withheld due to abdominal distention in preterm infants fed Similac HMF HP CL compared to 25% of infants fed EHMF AL” and “…preterm infants fed Similac HMF HP CL had a lower incidence of metabolic acidosis vs those fed EHMF AL.”

NAD also found that the advertiser had a reasonable basis to make weight gain claims based on the Kumar and Schanler studies.  However, NAD recommended that Abbott qualify its specific claim that “…preterm infants fed EHMF AL had early deficits in growth in the first weeks of life” to disclose that in the Schanler study upon which this claim is based, there was no difference in the primary outcome measure of weight gain from study days 1 – 29.

NAD next addressed the advertiser’s weight gain velocity claim in its brochure that was based on the Kumar study (“Results from Kumar et al showed significantly greater weight gain velocity in preterm infants fed Similac HMF HP CL”). NAD found the overall result statistically significant and rooted in a reliable study. Accordingly, NAD determined that the Kumar study was appropriate support for Abbott’s overall weight gain velocity claim and that the advertiser’s claim was an appropriate reflection of the study’s results. However, NAD was troubled by the figures in the bar chart accompanying this claim.

Overall, infants in the Kumar study receiving both donors’ and mothers’ breastmilk did achieve greater median growth velocity in the Similac Human Milk Fortifier (SHMF) treatment group compared to the Enfamil Human Milk Fortifier (EHMF) treatment group to a statistically significant degree. However, the difference between the groups in this overall analysis was not as dramatic as observed in the mothers’ breastmilk subgroup.

NAD observed that the bar graph used to report the Kumar study results selectively featured figures from the results of the subgroup of infants receiving breastmilk, to visually depict a greater difference than was observed overall (both breastmilk and donor milk subgroups). As such, NAD recommended that Abbott either modify the bar chart to reflect the overall weight gain velocity figures in the Kumar study (13 g/kg/day vs. 16.5 g/kg/day) accompanying the unqualified weight gain velocity claim, or keep the bar chart as is and qualify the main claim to indicate that the weight gain velocity claim is based on infants receiving mother’s breastmilk.

In its Advertiser’s Statement, Abbott Nutrition stated that it is pleased with NAD’s decision and will comply with its 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.