II. History and importance of defining Healthy : Government/regulatory science perspective

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1 II. History and importance of defining Healthy : Government/regulatory science perspective Barbara Schneeman, Ph.D. Professor Emerita of Nutrition University of California, Davis

2 Main Question What are the regulatory approaches for the term healthy (and related terms)? Two dimensions with regulatory implications: Maintaining the health of the gastro intestinal tract Producing a health benefit that may be associated with reducing risk of disease

3 Main Question What are the regulatory approaches for the term healthy (and related terms)? Two dimensions to consider Maintaining the health of the gastro intestinal tract Framework for nutrition related claims Producing a health benefit that may be associated with reducing risk of disease Framework for isolated and synthetic carbohydrate polymers to be considered a part of total dietary fiber in a food. Guidance on the review of scientific evidence for claims

4 Nutrition Related Claims Nature of nutrition related claims made in labeling Dietary Guidance statements that refer to the presence of certain food groups (e.g whole grains, fruits, vegetables ) Nutrient content claims that explicitly or implicitly characterize the nutrient profile of a food Structure function claims (maintain health) Health claims (disease risk reduction claims, including qualified health claims or health claims based on significant scientific agreement).

5 Nutrient Content claims Expressed claims describe the level These types of claims are typically used in conjunction with a Daily Value (i.e. reference value), e.g. high, low, good or excellent source Implicit claims are claims that a food may be useful in maintaining healthful dietary practices. E.g. healthy and related terms Regulatory approaches for nutrient content claims Specific criteria have been established, e.g. %DV for good or excellent source; levels of total fat, saturated fat, sodium, cholesterol, and beneficial nutrients for healthy

6 How does FDA derive reference values of nutrient content claims? Examples of Authoritative recommendations FDA has relied upon the Dietary Reference Intakes established by the National Academy of Sciences, Engineering, and Medicine (NASEM) as well as the recommendations in the Dietary Guidelines for Americans.

7 Structure Function Claims for Dietary Supplements Describes the role of a nutrient or dietary ingredient intended to affect a structure or function in humans (maintains health). Cannot convey an implied health claim by referring to a disease state or healthrelated condition unless product qualifies for a health claim. Manufacturer is responsible for accuracy and truthfulness (substantiation). All labeling must be truthful and not misleading If used on dietary supplements a disclaimer is required. This claim has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease. CFR (c) Subject to a notification within 30 days of marketing. When this type of claim wording is used in labelling of conventional foods, FDA s interpretation is to limit to claims based on nutritive value (or other food attributes such as taste and aroma).

8 Substantiation of Structure/Function claims* The meaning of the claim being made What is the expected effect or benefit that is being promoted when all of the statements being made for the product are considered together? The relationship of the evidence to the claim(s) Have the studies specified and measured the dietary supplement that is the subject of the claim? Have the studies appropriately specified and measured the nutritional deficiency, structure/function, or general well being that is the subject of the claim? Were the studies based on a population that is similar to that which will be consuming the dietary supplement product? Does the claim accurately convey to consumers the extent, nature, or permanence of the effect achieved in the relevant studies and the level of scientific certainty for that effect? The quality of the evidence The totality of the evidence: *

9 Substantiation of Structure/Function claims* The meaning of the claim being made The relationship of the evidence to the claim(s) The quality of the evidence Evidence that may substantiate a claim (intervention studies, observation studies) Evidence that is useful as background support (e.g. animal studies or in vitro studies) Design factors that affect the quality of a study The totality of the evidence: How well does the totality of evidence support the claims? *

10 Lessons Learned from Nutrient Content and Structure Function Claims Reference to healthy or healthy dietary practices can be considered an implied nutrition related claim Total nutrient composition must be considered The entire product label/labelling needs to be evaluated to understand context. Authoritative references for amount and type of substance to be consumed to maintain health are needed. Recommended intakes for probiotics have not been developed by an authoritative source. Scientific substantiation in line with the regulatory evidence based review is essential for establishing relevance to health.

11 Main Question What are the regulatory approaches for the term healthy (and related terms)? Two dimensions to consider Maintaining the health of the gastro intestinal tract Framework for nutrition related claims Producing a health benefit that may be associated with reducing risk of disease Framework for isolated and synthetic carbohydrate polymers to be considered a part of total dietary fiber in a food. Guidance on the review of scientific evidence for claims

12 FDA Dietary Fiber Definition Nondigestible soluble and insoluble carbohydrates (with 3 or more monomeric units),* and lignin that are intrinsic and intact in plants, or Isolated or synthetic nondigestible carbohydrates (with 3 or more monomeric units) determined by FDA to have physiological effects that are beneficial to human health *May require using newer AOAC methods (such as AOAC and )

13 Consequence of new definition for total fiber What can be considered intact and intrinsic? What physiologic benefits will be acceptable for isolated and synthetic non digestible carbohydrates? What criteria will be used to evaluate such benefits? Note: In countries that mandate labeling of dietary fiber on foods these questions will determine what is declared on the label.

14 Intact and Intrinsic Dietary Fiber* Plant based foods that contain non digestible carbohydrates Fruits, Vegetables, whole grains, legumes, and nuts Seaweed and fungi consumed as food These foods contain other food components, which may be associated with beneficial physiological effects Non digestible carbohydrates in fiber containing foods that are produced using mechanical processes (e.g. milling) Cereal bran, cocoa powder, flours, vegetable purees or pomace, vegetable protein extracts, parts of a food (e.g. outer coat of peas) Non digestible carbohydrates (e.g. resistant starch) that are created during the normal processing of food (e.g. flaked corn cereal) *U.S. FDA guidance documents and final rule on Nutrition and Supplement Facts label

15 Evidence of physiological effects that benefit health of isolated or synthetic non digestible carbohydrates used by U.S. FDA Authorized Health Claim (i.e. disease risk reduction claim) Soluble fiber from psyllium husk Beta glucan soluble fiber from oats or barley FDA review of scientific evidence for a physiological effect of benefit to health, such as Lowering blood glucose and cholesterol levels Lowering blood pressure Improving laxation and bowel function Increasing mineral absorption Reducing energy intake Mixed cell wall fibers that contain 2 or more of the following plant cell wall fibers in varying proportions: cellulose, pectin, lignin, beta glucan, and arabinoxylan.

16 Evidence of physiological effects that benefit health of isolated or synthetic non digestible carbohydrates used by U.S. FDA Authorized Health Claim (i.e. disease risk reduction claim) Soluble fiber from psyllium husk Beta glucan What has soluble not fiber been from considered oats or barley as a physiological effect FDA review of scientific evidence of benefit for to a health? physiological effect of benefit to health, such as Lowering blood Fermentation glucose and cholesterol by micro organisms levels Lowering blood Variation pressure in the microbial population Production of short chain fatty acids Viscosity Improving laxation and bowel function Increasing mineral absorption Reducing energy intake Mixed cell wall fibers that contain 2 or more of the following plant cell wall fibers in varying proportions: cellulose, pectin, lignin, beta glucan, and arabinoxylan.

17 Questions FDA intends to consider: Have the studies specified and measured the isolated or synthetic nondigestible carbohydrate? Have the studies appropriately specified and measured a physiological endpoint that has a demonstrated beneficial physiological effect? Were the study subjects healthy or did they have a disease associated with the physiological effect being studied? Did the study include an appropriate control group? How were the results from the intervention and control groups statistically analyzed? Where were the studies conducted?

18 Health Claims: Disease Risk Reduction Risk reduction claims: Characterizes a relationship between a food or food component (i.e. substance) and reducing risk of disease or health related condition Allow foods (includes dietary supplements) to bear certain science backed claims about reducing disease risk in their labeling without being regulated as drugs Health claims are about reducing the risk of a disease or health related condition, not treating, mitigating, or curing diseases.

19 CFSAN/Office of Nutrition, Labeling and Dietary Supplements January 2009 Guidance for Industry Evidence Based Review System for the Scientific Evaluation of Health Claims

20 Process for Evaluation of Health Claims at FDA

21 Are the studies useful in an evidence based review? Studies not suitable for evidence based review, e.g. Review articles Meta analysis Book Chapters Abstracts Animal studies in vitro studies Studies that do not pertain to the substance or disease Studies suitable for use in an evidence based review Human studies that evaluate the substance disease relationship Intervention studies Observational studies

22 Can scientific conclusions be drawn from the human studies? Examples of Fatal Flaws: No control Lacks relevant statistics Key confounders of risk not controlled Non validated biomarker as endpoint Independent effect not evident from study design Observational data without intake validation Malnourished populations Diseased population

23 Lesson learned from fiber definition and health claim reviews A specific physiological effect must be measured The physiological effect must be related to a health benefit. Health benefits have included validated biomarkers (i.e. surrogate endpoints) for disease risk (e.g. blood cholesterol or glucose levels) Effects that maintain the structure and function of the body (e.g. laxation, mineral absorption) Established health claims are relevant Reference to a disease state or health related condition can result in a product considered an unapproved new drug. Health claims (i.e. disease risk reduction claims) create a safe harbor for use on foods. Scientific substantiation in line with the regulatory evidence based review is essential for establishing relevance to health.

24 Issues on use of term healthy identified in FR 81(188); Only a nutrient content claim? What other criteria? If criteria other than nutrients are relevant, how to comply? What types of foods to consider? Is healthy the best term? Others? What nutrient criteria should be considered? Basis for selecting nutrients (e.g. intrinsic, fortified, inadequate intake )? References for nutrient criteria? Public health benefits to define? Consumer understanding of healthy? Impact on consumer behavior? Impact of food industry? Costs?

25 Potential lessons learned from discussion on updating healthy Moving beyond a specific nutrient profile of a food to consider how food fits within a recommended dietary pattern and overall nutrient profile/density. Some consideration of food groups to encourage as well as nutrients to limit. Revision of nutrients to limit. Consumer perception of other values associated with health.

26 Main Question What are the regulatory approaches for the term healthy (and related terms)? Two dimensions with regulatory implications: Maintaining the health of the gastro intestinal tract Producing a health benefit that may be associated with reducing risk of disease

27 Discussion Points Short term Decisions regarding the role of the microbiome in maintaining the health of the gastro intestinal tract. Are there physiological effects associated with the microbiome that maintain the structure or function of the gastro intestinal tract? Long term Decisions on health benefits related to physiological effects of the microbiome that can be measured in humans. Are the physiological effects of the microbiome associated with reduced risk of chronic disease?

Defining Whole Grains: Challenges and Regulatory Implications

Defining Whole Grains: Challenges and Regulatory Implications Michael Falk, Ph.D. Life Sciences Research Office, Inc. For Fiber: The heart of whole grain IFT 2009 The Process Since 1962 LSRO has provided