it examines the relevance of the science to the claim being made. Rusk highlighted two recent FTC actions, one against claims made about two of Dannon’s yogurt products, the other against claims made about a Nestlé probiotic drink. She assured the workshop audience that FTC is not raising its standards, but rather is trying to be more transparent and concrete so that companies know exactly what is expected in terms of compliance.

Looking through the lens of DuPont, Stuart Craig, director of regulatory and scientific affairs for DuPont Nutrition and Health, described how the changing regulatory landscape is affecting the food industry. He noted that the EFSA evaluations in particular have drawn on many of DuPont’s regulatory affairs resources in the past couple of years. The EFSA evaluations reflect a general global trend toward a higher scientific standard for safety and efficacy with respect to health claims on food products, but the higher standard creates a significant challenge for the food industry. Not only are human clinical studies expensive, threatening return on investment, but also it is more difficult to demonstrate health maintenance than disease intervention. Compounding the challenge is the fact that there is no global system for scientific substantiation. Different regions, sometimes different countries, operate according to their own rules and standards for scientific substantiation, making collaboration and comparison difficult. Craig mentioned some tools that DuPont uses when conducting its own internal scientific substantiation evaluations.

Finally, Sarah Roller, partner with the law firm Kelley Drye & Warren LLP, suggested that many of the regulatory challenges addressed by workshop speakers relate to the fact that “we are struggling to fit” an emerging science into an old legal paradigm. In the United States, the regulatory landscape for health claims on food products was codified in law in 1938, as part of the Federal Food, Drug, and Cosmetic (FD&C) Act. Added to the FD&C Act are the many other federal and, importantly, state laws that govern health claims on food products. Roller explained how an FDA warning letter about a probiotic-containing food product can quickly cascade into a series of state-level actions—namely, class action lawsuits—that have a “chilling” effect not only on the truthful communication of information, but also on industry investment in products that Roller believes have “huge promise for public health.” She wondered whether the type of ecological approach that is used in environmental law might be a more useful way to think about food, health, and the microbiome.


Although research on the microbiome is still widely considered an emerging area of science, the field is progressing quickly. Researchers are making significant headway in understanding not just what the microbi-

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