Similac Advance Immune Development Claims Upheld By NAD

Claims touting Ross Products' Similac Advance infant formula's effect on immune system development fall short of implying it protects the immune system as effectively as breast milk, the National Advertising Division concludes in a recent review.

Enfamil LIPIL marketer Mead Johnson challenged Ross' claim in patient handouts, direct mail and print and TV ads that "Similac Advance can help develop a baby's immune system like breast milk." The review will be published in an upcoming Case Reports.

The Advance formula is supplemented with nucleotides - components of DNA and RNA also found in breast milk - which are purported to help babies acquire antibodies to fight off disease.

Mead argued studies have not yet indicated that "nucleotide-supplemented formula enhances immune system development like that of the breast-fed infant, or that nucleotide-supplemented formula enhances immune system development any better than formula without nucleotide supplementation."

The differentiation between "development" and "protection" of the infant immune system has no basis in science or otherwise, the Enfamil marketer maintained.

"An immune system is considered more 'developed' only if it offers more immune protection, i.e. better resistance to infection and disease," Joseph Bellanti, MD, Georgetown University, said on behalf of Mead.

Ross submitted three studies in support of its claims: the Pickering and Schaller studies measured antibody levels in blood samples after the infants received vaccinations, while the Buck study examined immune cell development of 88 cell types.

All studies assessed three arms: breastfed infants, infants fed unsupplemented formula, and infants fed nucleotide-supplemented formula.

The most effective methodology to test the level of immune protection afforded by different formulas is a clinical study comparing the number of times that infants in different formula groups become sick, Bellanti contended. The Ross studies are not clinical studies, but rather are lab tests on blood samples and the "claims are false for that reason alone," Mead asserted.

Although Similac Advance did not significantly improve all of the antibody responses in the studies, NAD upheld Ross' immune system development claim because the infant formula significantly improved some of the antibody responses.

In addition, "the tests were all consistent and established a pattern of results showing an improved immune system response and development in infants fed supplemented formula," the Council of Better Business Bureaus division points out.

"This significant research has shown improved immune response in infants in two different respects: first, to actual immune response to several of the childhood vaccinations, and second in increased immune cell production as measured by cell populations," NAD concludes.

Mead also was troubled by claims that the formula aids infant immune system development "like breast milk," contending the statement falsely implies Advance is nutritionally equivalent to breast milk.

In response, Ross argued the claim is appropriate with its accompanying disclaimer, which states: "whether this development provides immune protection like breast milk has not been shown. Breast milk also contains antibodies not found in infant formulas that are important for a baby's immune protection."

NAD determined the disclaimer was sufficiently worded to "limit the potential takeaway," but advises Ross to remove the word "like" from its claims to avoid implying Similac Advance and breast milk are equally beneficial.

The product's exclusivity claim to be the only formula to contain "a patented blend of special breast milk nutrients called nucleotides," also was contested by Mead, who pointed out its Enfamil LIPIL also contains nucleotides.

NAD agreed, and referred to a previous case involving Nestle's Good Start Supreme infant formula.

Nestle was asked to remove the word "only" from ads because it implied Good Start Supreme was the only formula on the market to contain DHA and ARA, which was inaccurate (¹ (Also see "Nestle DHA, ARA Infant Formula Claims Must Be “Compositional” – NAD" - Pink Sheet, 30 Aug, 2004.), p. 14).