otic health claims cannot make any reference to treatment or mitigation of disease or disease symptoms. If so, they are considered drug claims, which require pharmaceutical approval.

The most common probiotic product claims are digestive and immune structure-function claims. In the United States, 28 percent of all probiotic yogurts make structure-function claims. About one-third of those claims are for digestive health only and another one-third for both digestive and immune health. Only 3 percent are for immune health only.

U.S. consumers are becoming increasingly aware of the digestive health benefits of probiotics. In an International Food Information Council (IFIC) online survey, when asked about awareness of the digestive health benefits of probiotics, the percentage of respondents answering positively increased from 58 percent in 2007 to 81 percent in 2011.3 Steele wondered whether a similar awareness among European Union (EU) consumers might be driving growing sales in probiotic yogurt despite the softening of claim language.

Steele urged manufacturers to focus on clear, relevant, and substantiated claims on the front of their products’ packages. A DuPont survey conducted in 2011 showed that 75 percent of consumers look at the front of the package for nutrition information. Most people tend to read the Nutrition Facts Panel and ingredient lists only when they are making a change.

What Can Industry Do?

Steele identified three major activities of industry that can move the field of probiotics forward in the face of a changing regulatory landscape: (1) demonstrate efficacy and help the scientific and regulatory communities to recognize the effects of probiotics on human health; (2) educate and increase dialogue with doctors, nutritionists, key opinion leaders, and journalists to communicate the results of human studies conducted on probiotics; and (3) explore new end points (i.e., different populations, new health areas).

As an example of efficacy research in which Danisco and DuPont4 have been involved, Steele highlighted a study on two probiotics (Lactobacillus acidophilus NCFM and a blend of L. acidophilus NCFM and Bifidobacterium lactis Bi-07) in children aged 3-5 years (Leyer et al., 2009). The study was a 26-week prospective, double-blinded trial of 326 children randomized across three treatments (the two probiotic treatments and one placebo

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3 More information on the IFIC 2011 Functional Foods/Foods for Health Consumer Trending Survey is available online at http://www.foodinsight.org/Resources/Detail.aspx?topic=2011_Functional_Foods_Foods_For_Health_Consumer_Trending_Survey (accessed August 20, 2012).

4 In May 2011, Danisco was acquired by DuPont.



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