The Human Microbiome, Diet, and Health Workshop Summary (2013) / Chapter Skim
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6 Societal and Policy Implications
6 Societal and Policy Implications
Pages 121-146
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From page 121... ...
For example, NPD data indicate that the top breakfasts consumed in the United States, based on annual eatings per capita, were more or less the same in 2011 as 1 This section summarizes the presentation of Darren Seifer.
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From page 122... ...
The same stability has been observed for lunch and dinner. NPD data indicate that the top five lunches consumed in the United States in 2001, again based on annual eatings per capita, were, in order, sandwiches (including burgers)
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The fast growth of yogurt consumption raises the question, Why are people choosing yogurt? NPD data show that the number one reason people choose yogurt is because it is nutritious and has a health benefit (15 percent)
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The simple act of eating yogurt provides health benefits. Consumers would rather ingest their way to health than restrict their way to health.
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She referred to Darren Seifer's remarks on the appeal of the health benefits of yogurt to consumers. Yet as markets for probiotic yogurt and other products continue to grow, Steele observed a trend toward stricter regulation and enforcement of health claims on those products.
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Because of the changing regulatory pressures, major players such as Danone are softening their claim language. Previously, Danone's claims on its probiotic products were focused on structure-function claims.
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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)
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From page 128... ...
She also commented on Danone's pioneering work in educating consumers about probiotic yogurt and the company's role in promoting d igestive health, including its use of a celebrity (Jamie Lee Curtis) to promote the digestive benefits of probiotic yogurt.
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While the new EU claim regulation addresses free and fair trade of goods, including foods, and promotion of innovation, its most important principle is consumer protection: "Nutrition and health claims on food must be substantiated by scientific evidence." The regulation creates several new challenges for claim applicants. First, evidence should be collected from a population that is representative of the generally healthy population or from which results can be extrapolated to the general population, which Salminen noted varies even within Europe (e.g., there are significant differences in microbiota composition and activity in individuals from northern versus southern Europe)
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With respect to disease risk reduction claims, disease risk reduction must be demonstrated using a commonly accepted risk factor and changes in relevant biomarkers that relate to the risk of the particular disease. These categories of claims were not decided by EFSA, but rather by "word of law." Examples of function claims are claims about bowel function and constipation, gastrointestinal discomfort, and defense against pathogens.
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From page 131... ...
Yet a number of bacteria currently being marketed in the European Union as probiotics have no demonstrated health-promoting properties, and different strain combinations are advertised without any proven association with health benefits. One of the goals of the 2006 health claim regulation was to improve consumer protection by more clearly identifying actual probiotic and prebiotic products and their benefits to the consumer.
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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)
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The FDA Food Safety Modernization Act (FSMA) of 201111 required FDA to publish guidance on new dietary ingredients to help industry and other stakeholders understand when new dietary ingredients (NDIs)
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used in the safety comparison. Levy noted that the challenge is very similar to what EFSA is dealing with in terms of characterization of strains in probiotic products (see the summary of Seppo Salminen's presentation)
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If the microbial NDI is resistant to any clinically relevant antibiotics, it is also recommended that you perform an assessment of the ability of the anti biotic resistance genes to mobilize and transfer to human pathogens under the conditions of use of the dietary supplement.… If your notification cites the history of use of a live microorganism as evidence of safety, FDA recommends a careful assessment of the relative level of historical exposure compared to the proposed conditions of use of the NDI, including a discussion of how the form of the dietary supplement and any excipients used in it affect delivery of the NDI to various points in the human gastrointestinal tract.… If history of use data are inadequate to support the safety of the microbial NDI, you should include safety studies in hu mans or appropriate animal models in your notification. FDA considers pigs to be the most appropriate animal model for the human digestive tract.
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He referred to the same Agency for Healthcare Research and Quality (AHRQ) study on probiotic safety that Mary Ellen Sanders had mentioned previously (Hempel et al., 2011)
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GRAS determinations, however, are limited to ingredients in conventional foods, not dietary supplements. Mary Ellen Sanders added that she knew of about six GRAS notices for probiotics posted on the FDA website.
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Rusk noted that the substantiation standard in the FDA draft guidance for dietary supplement claims closely mirrors the FTC substantiation standard (FDA, 2011a)
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It also challenged the claims made during the Jamie Lee Curtis campaign that Activia yogurt, with its Bifidus regularis probiotic, relieves irregularity. One of the issues with the Activia campaign was that 8 of 10 studies showed no significant effect at the advertised dose.
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Recent FDA actions include the agency's new strategic plan for regulatory science (FDA, 2011a) , the Food Safety Modernization Act of 2011,15 and draft guidance on NDI notifications (FDA, 2011b)
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The EFSA health claim evaluations have drawn on many of DuPont's resources over the past couple of years. Craig noted the high level of EFSA rejections industry-wide, a lack of dialogue, and misunderstanding about what is required of health claims for food products.
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THE REGULATORY ENVIRONMENT: A SYNTHESIS16 Some of the regulatory challenges addressed by previous workshop speakers stem from the fact that "we are struggling to fit" an emerging science into "an outdated paradigm" for conceptualizing the relationship between food and health, Sarah Roller said. The paradigm recognizes that by virtue of essential nutrients it contributes to the body, food is capable of supporting nutritional needs, promoting normal growth and development, and otherwise affecting the structures and functions of the body.
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Roller explained that consumer class action lawsuits of this kind are commonly filed in the wake of FDA warning letters and FTC consent orders challenging food marketing claims based on the outdated paradigm. As a result, inadequate federal policies can have a cascading effect under state law, which has costly liability implications for and may deter companies from communicating accurate scientific information about the health benefits of food and dietary supplements, including prebiotics and probiotics.
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In Roller's opinion, between these two food categories, FDA has a "huge amount of discretion." Changing the Legal Framework To strengthen the legal framework in the ways that are necessary, Roller urged that the outdated and dualistic "food versus drug" conceptual framework be reconsidered, in view of the distinctions between the cause-and-effect relationships that explain the mechanisms by which pharmaceuticals commonly deliver benefits and those that characterize the mechanisms by which food and dietary patterns deliver benefits. She urged that environmental health and ecological models of causation be given careful consideration in the development of regulatory policies governing food marketing claims for food and dietary supplement products.
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Ultimately, Roller expressed hope that the health benefits that are being linked to prebiotics and probiotics with respect to supporting and maintaining a healthy microbiome will help inspire the kinds of policy reforms that are needed to allow food and dietary supplement manufacturers to convey accurate and substantiated information about the benefits of prebiotics and probiotics and the products that contain them, consistent with sound science and First Amendment standards. In Roller's opinion, the current legal framework -- the existing "food versus drug" construct that is codified in the FD&C Act -- is based on outdated science and is too rigid to allow FDA to account for current science or future advances in science.
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European Food Safety Authority Journal 9(4)
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