BBB National Programs Archive

In Infant Formula Case, NAD Recommends Abbott Nutrition Discontinue Claims Challenged by Mead Johnson, Finds Company Can Support ‘pH’ Claim

New York, NY – Aug. 28, 2015 – The National Advertising Division has recommended that Abbott Nutrition, maker of Similac infant formula products, discontinue certain advertising claims challenged by Mead Johnson & Company, LLC, the maker of “Enfamil Human Milk Fortifier Acidified Liquid Formula.” The challenged claims related to Mead Johnson’s Enfamil Human Milk Fortifier Acidified Liquid (Enfamil LHMF) and they appeared on Similac’s website, in product detailers and sales materials provided to neonatologists and other healthcare professionals, in advertisements placed in neonatal medical journals, and in Abbott-sponsored medical presentations. NAD determined the advertiser could support a stand-alone claim related to its product’s pH level.

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

NAD noted in its decision that human milk fortifiers are powders or liquids that are added to breast milk and administered via tube-feeding to increase the amount of protein, calories and nutrients in the milk. They are used primarily in hospital neonatal intensive care unit settings and are used by neonatal specialists to meet the increased nutritional needs of premature and low-birth-weight newborns to help them achieve healthy growth.

The parties are the principal competitors in the United States market for human milk fortifiers, and the challenger’s Enfamil LHMF is believed to be the only acidified human milk fortifier on the market. Mead Johnson developed its acidified fortifier in response to concerns raised by the Food and Drug Administration and Centers for Disease Control regarding the non-sterility of powder fortifiers. Mild acidification facilitates sterilization, allowing for reduced heat-treatment in sterilizing the product. Similac’s competing liquid human milk fortifier is sterilized using another method that does not involve acidification.

NAD noted that it was cognizant, in examining Abbott’s evidence, that the challenged advertisements appeared in professional journals as well as in promotional sales pieces and literature directed to healthcare professionals. The challenged claims were not directed to a general consumer audience, but rather to sophisticated medical professionals, specifically neonatal specialists. While it is true that the degree of sophistication of the target audience is a factor in determining the reasonable messages conveyed by the advertising, NAD said, it is equally true that even a sophisticated audience is entitled to truthful and accurate messages about advertised products.

Express claims at issue included:

• “A recent study showed that acidification decreased the cellular and nutritional content of human milk. Acidification can destroy white blood cells in human milk, which are associated with immune protection. This acidic environment can decrease total protein levels by denaturing the casein proportion. Also, acidification causes human milk’s lipase activity, an important part of fat digestion, to be reduced.”
• “The nutritional changes in the composition of acidified breast milk documented by Erickson in vitro may have led to the in vivo growth deficiencies noted in our AHMF population.”

NAD determined that one of the messages conveyed by the challenged advertising was that challenger’s Enfamil LHMF is harmful to infants, results in growth deficiencies, or is otherwise inferior to Similac LHMF as a result of acidification. Following its review, NAD found that the advertiser’s evidence failed to support those claims.

NAD noted that it was troubled by several aspects of the studies that served as Abbott’s primary support for its claims. One such study did not examine Enfamil LHMF and was designed to evaluate the clinical effects of acidification on breastmilk’s cellular and nutritional composition, not to determine the effects of acidified infant fortifiers on preterm infants.

The challenged advertisements included quotes from the advertiser’s key study. NAD noted that advertisers are entitled to disseminate study results pertaining to their products to health care professionals. However, when a study is not reprinted in full, advertisers should take care to report study results in an accurate and non-misleading manner.

In this case, NAD noted, the advertising at issue contained excerpts from the advertiser’s key study and there were no disclosures regarding the study’s limitations, which would allow the target audience to make an informed decision about the parties’ respective products.

Following its review of the evidence in the record, NAD concluded that the advertiser provided a reasonable basis for a stand-alone claim that its Similac Human Milk Fortifier “[r]etains the pH of human milk to near neutral range, preserving the unique benefits of human milk.”

However, NAD recommended that the advertiser discontinue the remaining challenged claims.

Abbott, in its advertiser’s statement, said the company “strongly disagrees with NAD’s conclusion that Abbott communications to sophisticated neonatologists and health care professionals of important findings from scientific publications regarding the impacts of acidification of human milk fortifier communicated any messages that are unsupported. These sophisticated professionals are not ordinary consumers. Abbott firmly believes that these professionals can and should be told about emerging science that is directly relevant to the health and safety of their patient populations and that no principles of advertising law prevent Abbott from accurately communicating the results of emerging research. Out of respect for the self-regulatory process, however, Abbott will discontinue the claims that NAD identified as conveying other messages.”