2008). One mixture had B. animalis ssp. lactis Bb12 (DSM 15954), the other B. breve 99 (DSM 13692). Because the two studies used the same product but in two different probiotic combinations, the combined evidence was insufficient to establish a causal relationship between the product and a reduction in abdominal discomfort. Salminen noted that it is not clear whether the difference between each strain would have an impact on effect, but noted the fact that there are biological differences among different strain combinations.

The health effect of xylitol, a prebiotic, on caries risk is an example of a well-supported health claim. Dental caries is very common among Europeans, and a review article estimated the prevalence of caries to be up to 100 percent, depending on the country (Bagramian et al., 2009). A well-recognized risk factor for dental caries is thickness of dental plaque at specific sites in the mouth. Several intervention studies have demonstrated a reduction in dental caries risk as a result of chewing xylitol-sweetened gum, as reviewed in Deshpande and Jadad (2008).

In conclusion, Salminen remarked that most researchers do not usually think about health claims when designing their studies, but in many cases, redirecting studies to address health claims requires making only small changes to the study design.

EVALUATION OF VIABLE MICROBES USING REGULATORY REQUIREMENTS DEVELOPED FOR NONVIABLE INGREDIENTS8

FDA is, as Dan Levy expressed, “a creature of the statutes.” FDA must operate within parameters laid out in the law, which, in the case of foods, is primarily the Federal Food, Drug, and Cosmetic Act (FD&C Act) initially passed in 19389 and amended many times thereafter. Of particular relevance to probiotic-containing food products is the 1994 Dietary Supplement Health and Education Act (DSHEA).10 The DSHEA defined a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more … dietary ingredients.” The statute includes a list of substances that can be dietary ingredients. Substances not on the list cannot be dietary ingredients. The list consists of vitamins, minerals, amino acids; herbs or other botanicals; dietary substances for use by man to supplement the diet by increasing total dietary intake; and concentrates, metabolites, constituents, extracts, or combinations of any of the

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8 This section summarizes the presentation of Dan Levy.

9 For more detailed information on the FD&C Act, visit the FDA website: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/default.htm.

10 Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Cong. (Oct. 25, 1994).



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