BBB National Programs Archive

NAD Finds Abbott Can Support Certain Claims for Infant Formula with New Ingredient, but Only When Disclosing That Ingredient is Not From Human Milk

New York, NY – Aug. 23, 2017  – The National Advertising Division has determined that  “2’-FL human milk oligosaccharide,” a claim made by Abbott Nutrition in advertising for its Similac Pro-Advance and Pro-Sensitive infant formulas, doesn’t convey a misleading message, as long as the advertiser makes the necessary disclosure “not from human milk,” easier for consumers to notice, read and understand.

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

The claims at issue in this case were challenged by Mead Johnson Nutrition, the maker of competing infant formula. The challenge centers on a new ingredient in the advertiser’s infant formula – 2’-fucosyllactose human milk oligosaccharide or 2’-FL HMO.

NAD noted in its decision that HMOs are complex carbohydrates present in significant amounts in human milk.  HMOs represent the third largest solid component in human milk after lactose and lipids. While the types and amount of HMOs in human milk vary among women and change throughout lactation, 2’-FL HMO is the most abundant HMO in most American women’s milk.  It has also been shown to be a component of human milk that is beneficial to infants, providing prebiotic and immune boosting properties. The advertiser noted that, prior to the release of its formula, human milk was the only source of infant nutrition that had this component at a significant level.

NAD also said that it appreciates how important it is for advertisers to be able to distinguish their products from their competitors’ products by truthfully and accurately promoting distinctive product innovations and the benefits that those improvements provide to consumers.

Here, the fact that the advertiser’s Similac Pro Series formulas include such an innovation was not in dispute. Further, it was not disputed that the ingredient provides infants with health benefits.

Rather, the challenger argued that the advertiser’s use of the ingredient name “human milk oligosaccharide” conveys the misleading message that the formulas are derived from human milk.

Challenged claims included:

  • “Similac will be the first and only infant formula with 2’-FL HMO (human milk oligosaccharide), an immune nourishing prebiotic previously only found* in breast milk . . . *at significant levels.”
  • “Similac with 2’-FL Human Milk Oligosaccharide* helps strengthen the immune system to be more like the breastfed infants than ever before (*not from human milk).”
  • “Well tolerated formulas with 2’-FL HMO for immune support.”
  • “Discover the first and only formula with 2’-FL Human Milk Oligosaccharide, an immune-nourishing prebiotic previously only found in breast milk.”
  • “Similac with 2’-FL HMO supports babies’ developing immune system in the gut.”
  • “Closest to breast milk . . . Unlike other formulas, we have 2”-FL HMO, an immune-nourishing prebiotic that circulates throughout the body.”
  • “2”-FL HMO (Human Milk Oligosaccharide+) (+not from human milk).”

NAD also considered whether the advertising at issue implied that the

2’-FL oligosaccharide in Similac Pro-Advance and Similac Pro-Sensitive is derived from human milk or that only Abbott products provide immune nourishing benefits.

NAD noted in its decision that it has been reviewing advertising claims regarding infant formula for more than 30 years and that cases often address advertising claims concerning new ingredients promoted as providing benefits that might otherwise come from human milk.

NAD noted that parents of infants viewing such claims are particularly vulnerable to strong performance claims, particularly when those claims relate to a product’s closeness to human milk.  To that end, NAD said, advertisements that make such claims must be clear and accurate and supported by competent and reliable scientific evidence.

As a preliminary matter, the advertiser stated that certain challenged advertising, including advertising aimed at health-care professionals, had been permanently discontinued prior to the initiation of NAD’s review.  NAD did not retain jurisdiction over those claims. The advertiser also noted that it had inadvertently included the phrase “Closest to Breast Milk” on a page header at its website, but had permanently discontinued the claim except where it is comparing the new formulation to prior Similac formulas. NAD noted that the voluntarily discontinued claim will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.

Following its review of the evidence, NAD concluded that Abbott’s use of the ingredient name “2’-FL human milk oligosaccharide,” in its advertising, together with a clear and conspicuous disclosure, “not from human milk,” did not convey a misleading message regarding the source of the 2’-FL HMO in the advertiser’s formula. NAD recommended, however, that the advertiser modify its website advertising and a challenged web video advertisement to make the disclosure, “not from human milk,” easier for consumers to notice, read and understand.

NAD further concluded that Abbott’s claim, “unlike other formulas, we have 2’-FL HMO, an immune-nourishing prebiotic that circulates throughout the body” was not a comparative superior performance claim. Rather, the claim, as constructed, consists of an exclusivity claim about its new ingredient and a separate monadic claim about the ingredient’s benefits—both of which were supported by the evidence in the record.

Abbott, in its advertiser’s statement, said the company “appreciates NAD’s diligence and work on this matter and 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.