Marketing Opinion Blog April 2010


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Marketing Opinion Blog April 2010

  1. 1. NMR News: Volume 3, Issue 4, April 2010 MARKETING OPINION BLOG: A CASE FOR STRUCTURE/FUNCTION CLAIM AND SCIENTIFIC SUBSTANTIATION GUIDANCE FOR FUNCTIONAL FOODS & BEVERAGES By: Latesha Richards, Marketing Coordinator April 2010 In light of the recent warning letters sent to seventeen food/beverage companies concerning alleged unauthorized and misleading claims, it is no coincidence that some of these companies and others in the past have been prime targets for the Food and Drug Administration (FDA) over the years. Structure/function claims for functional foods and beverages are prone to continual misinterpretation, misunderstanding and worse, intentional misuse. Why? The FDA issued guidance for expressing and substantiating structure/function claims for dietary supplements, but has not taken such action for foods. Making FDA compliant structure/function claims have long been put in the back-burner of FDA action. Therefore, I recommend, like many others, that the FDA provide clearly-defined guidance for making structure/function claims, specifically for conventional foods and beverages. THE CASE FOR STRUCTURE/FUNCTION GUIDANCE A. Foods, an essential part of human nutrition 1
  2. 2. NMR News: Volume 3, Issue 4, April 2010 My case for structure/function guidance for foods rests partly on this truth: foods are most essential to human nutrition and should be treated as a separate entity. First, foods, for the most part, are more accessible to the public. Second, they are essential to the growth, development and functioning of the human body. Third, foods, like drugs, have health and physiological benefits or repercussions when consumed, which affects nearly all organ systems of the body. Foods are far too important for human nutrition and should have separately- documented and comprehensive labeling and substantiation requirements from dietary supplements. B. Regulatory Ambiguities with Expressing and Substantiating Structure/Function Claims for Foods In addition, there are regulatory ambiguities that require clarification as it pertains to foods. As it now stands, the FDA requires that structure/function claims for foods meet the same requirement as structure/function claims for dietary supplements according to the Dietary Supplement Health and Education Act (DSHEA) in that they must be “truthful and not misleading.”1 The same dietary supplement guidance for adequate substantiation applies to structure/function claims for foods as well. Foods and beverages must be substantiated by “competent and reliable scientific evidence.”2 2
  3. 3. NMR News: Volume 3, Issue 4, April 2010 But considering the explosive manufacture of functional ingredient-infused foods and beverages and the use of structure/function claims to characterize health benefits, there are several things about the dietary supplement guidance that raise further questioning and need more clarification, as it pertains to this category of foods and beverages: 1. The word “misleading” is not clearly defined for structure/function claims for foods. 2. What are the phrasing requirements for foods and beverages containing functional ingredients that provide benefits above and beyond basic nutrition, and may contribute to the structure/function benefit? 3. The requirement for statements to be supported by competent and reliable scientific evidence in order ensure that claims are “truthful and not misleading” is not well- defined. C. Previous and Recently Proposed Guidances on Foods and Beverages Are Not Enough The recently proposed draft guidance “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods” sheds light on the FDA‟s concern about the formulation and safety issues of using novel ingredients, unapproved food additives or generally recognized as safe (GRAS) ingredients in excess of their traditional use in functional foods and beverages,3 which may compromise the integrity of claims and product labeling. But this is only 3
  4. 4. NMR News: Volume 3, Issue 4, April 2010 part of the problem. This and other previous guidances fail to define what adequate substantiation looks like and the precise expression of structure/function claims made for foods, namely functional foods and beverages. In the case of these functional foods and beverages that contain novel ingredients that have purported health benefits, many food manufacturers have worded claims in ways that express or imply disease prevention. Therefore, there must be clarification in terms of the structure/function claims that can be made and the type of evidence required to make such claims. MY STRUCTURE/FUNCTION RECOMMENDATIONS In my research of these issues, I came across guidance put forth by Health Canada, the Canadian Food Inspection Agency (CFIA), Food Products Association (FPA), as well as new legislation recently proposed by Congress entitled “Free Speech About Science Act of 2010.” Many of the recommendations contained in these guidances are useful and fundamental for expressing and substantiating structure/function claims for foods in the U.S., while others I approach with serious reservations. For the most part, the recommendations that I made below were cherry-picked from the guidelines proposed by these organizations/legislations, but with some very important caveats added to address the issues of claim expression and substantiation. A. The Definition of a “Misleading” Structure/Function Claim 4
  5. 5. NMR News: Volume 3, Issue 4, April 2010 To avoid any misinterpretation as to the meaning of “misleading,” the FDA should suggest a clear definition of the word. CFIA for example defines a “misleading” claim as one that/where: 1. “lead to multiple interpretations (too broad, with poorly defined health effects, not specific) 2. “does not reflect the substantiated health outcome” 3. “is not based on [scientific evidence]” 4. “leads the consumer to believe that this food product is „safer‟ or „has higher nutritional value‟ than other food products not bearing the claim” 5. “[the] food constituent in the food product does not lead to the substantiated health outcome in a balanced diet”4 B. Clarification of Structure/Function Claim Expression To avoid any language that may promote a physiological effect or purport to “cure, treat or mitigate disease,” whether expressed or implied, the structure/function guidance should also make clear the subject and language of the claim that the FDA will deem acceptable. Health Canada suggests that. 1. A “claim about the specific benefit that the consumption of a food or constituent of a food [will have] on normal [structure/] functions or biological activities of the body,” 2. A claim “related to positive contribution to health, or physical or mental performance,” 3. A claim “based on the role that the food or the food constituent plays when 5
  6. 6. NMR News: Volume 3, Issue 4, April 2010 consumed as part of normal dietary patterns,” are acceptable forms of claim expression.5 Other solutions to issues of claim expression should be addressed as follows, based on current FDA allowances: 1. Structure/function claims may not explicitly or implicitly link the relationship to a disease or health related condition, [other than those caused by nutrient deficiency]. 2. Structure function claims must be phrased in a way that indicates that the structure/function, along with consuming the functional food or ingredient, can also maintained by a number of factors including a healthy and balanced diet and exercise. 3. The Free Speech about Science Act 2010 suggests that the claim “enables the public to comprehend the information provided in the claim and the relative significance of such information in the context of a total daily diet.”6 4. The wording must “clearly [state] a physiological effect relevant to health or performance and meaningful to consumers.”5 This should also list examples of acceptable claims. 5. The subject of structure/function claims can be: nutritive benefit, whole food benefit, or ingredient benefit.7 6. FDA should define each of the above-mentioned claims as FPA has, and the subsequent type of evidence that will adequately substantiate each one (discussed later). 6
  7. 7. NMR News: Volume 3, Issue 4, April 2010 a. Structure/function claims concerning nutritive value: Structure-function claims concerning nutritive value are based on known, “well-established nutritional benefits of nutrients [or vitamins], consumed at ordinary levels” such as calcium or vitamin C.7 b. Structure/function claims concerning the health benefit of the whole food: The statement implies that [2 or more ingredients or] the whole food provides the benefit.7 c. Structure/function claims concerning the health benefit of a particular ingredient: Claims that give credit to a specific functional ingredient as the source of the health benefit to a structure or function of the body.7 C. Substantiation Requirement Recommendations for Structure/Function Claims for Functional Foods/Beverages The substantiation standard for structure/function claims for foods should follow the same guidance as for “competent and reliable scientific evidence” for dietary supplements in terms of the meaning of the claim(s) being made; the relationship of the evidence to the claim; the quality of the evidence; and the totality of the evidence. 7
  8. 8. NMR News: Volume 3, Issue 4, April 2010 As suggested by Health Canada, there should be “guiding principles” that a company must follow when substantiating a food health claim and how it assesses whether the claim is valid.8 This should also be outlined in the current FDA guidance. This may be a useful way of determining in a clear and detailed manner the type, quality, and quantity of the research needed to adequately substantiate a claim. These principles may also help to create a framework that will aid in decision-making and due-diligence before engaging in research. We will highlight a few important principles that I believe the FDA should propose and elaborate on in guidance for food: 1. The type of evidence [human evidence]: The FDA should define in absolute terms what type of research constitutes “competent and reliable” evidence. FPA Guidance suggests that “[all] claims must be based on substantiation from the peer-reviewed scientific literature, proprietary research, or other authoritative sources.”7 Health Canada is interested in “original research in humans [based on intervention and/or prospective observational studies] that measures the food and health effect of interest.”8 2. “Comprehensiveness: All original research [in humans], pertaining to the health claim, is captured, including evidence in favor and not in favor of the claim.”8 3. “High level of Certainty: The health claim is supported by a high level of certainty. This means that the majority of high quality human studies support a statistically significant favorable effect…”8 8
  9. 9. NMR News: Volume 3, Issue 4, April 2010 4. “Feasibility of Consumption of Effective Dose: The amount of food to be consumed to achieve a beneficial effect can be incorporated into a healthy, balanced diet by the target population.”8 In other words, studies would need to be done to determine the amount of ingredient that is needed to have the effect on the structure/function that is stated in the claim7, or what is known as dose-response studies. 5. “Demonstration of Causality:” …will consider the quality and quantity of original research [in humans] that support a beneficial effect of food; the strength of the food/health effect relationship and the dose-response effect.8 6. “Biological Relevance of the Claimed Effect:” a. Is the claimed effect “biologically/physiologically relevant and expected to benefit the health of the target population?”8 b. Are the endpoints used both “[methodologically] and [biologically valid]” in humans? 8 c. Are the biomarkers “part of the causal pathway between the food and health outcome?”8 7. The type and amount of substantiation would be based on the type of structure/function claim made; e.g. nutritive benefit, whole food benefit, or ingredient benefit7 as outlined below. The FDA must define and communicate the type of research design and amount of scientific support it requires, whether it will need to go through a rigorous evaluation of the scientific evidence and meet a significant 9
  10. 10. NMR News: Volume 3, Issue 4, April 2010 agreement among the experts (“Significant Scientific Agreement” (SSA) standard), or by any other standard. The Center for Science in the Public Interest strongly advocates for the use of the SSA standard for structure/function claims.9 Of course, the standard chosen is subject to FDA‟s own discretion. Let‟s take a look at the suggested substantiation requirements by FPA and Health Canada for these types of claims: a. Substantiation for claims based on nutritive benefit i. “For structure-function claims concerning well established nutritional benefits of nutrients or foods consumed as ordinary levels, the evidence providing a reasonable basis for the claim can [be] documented from scientific texts, consensus reports, or other secondary sources which authoritatively characterize the relevant body of scientific evidence.”7 ii. Health Canada suggests and requires that there be consensus among the broad scientific community and proposes required documentation for the claim such as name of the authoritative body, the exact wording of the claim, copy of the source document, description of the process undertaken by the authoritative body to develop the statement, and an indication of no conflicting authoritative statement.5 10
  11. 11. NMR News: Volume 3, Issue 4, April 2010 iii. Health Canada suggests and requires that nutrients or food constituents are recognized by the Institute of Medicine of the National Academies, U.S.5 iv. Health Canada also proposes that evidentiary submissions must “at least include intervention studies and relevant observational studies, if available to substantiate a claim based on a food constituent.8 v. Health Canada proposes that dietary reference intakes (DRIs) must be determined for nutrients with no established DRI. FPA also recommends establishing DRI and conducting dose-response studies to their food company members.7 b. Substantiation for claims based on 2 or more ingredients or whole food benefit i. “If the statement implies that [2 or more ingredients] or the whole food provides the benefit, then substantiation must address the whole food, as opposed to research conducted solely on an ingredient isolated from the finished product.”7 c. Substantiation for claims based on a particular functional ingredient i. Novel ingredients and GRAS ingredients not previously used in foods: Where claims give credit to a specific functional ingredient or novel ingredient as the source of the health benefit, care should be taken to provide safety (toxicology) evaluations and obtain approval as food 11
  12. 12. NMR News: Volume 3, Issue 4, April 2010 additives 3, 7, and the “intended use of the ingredient…with information on anticipated levels of consumption.”7, even if these novel ingredients have been historically used in dietary supplements. CONCLUSION Nutrient-content and health claims for foods are very well-defined in FDA guidelines. Structure/function claims have been sitting in a gray area for some time, and have not been appropriately dealt with. Well, there‟s no better time for guidance than the present. No one can dispute that with clearer and more meaningful FDA guidance, providing consumers with reliable, scientifically valid structure/function claims for foods they eat will finally become reality. Thus, it will be a matter of how the FDA chooses to clarify ambiguities in expressing and substantiating claims for foods and beverages. The recommendations outlined in this article serve as suggestions and solutions to these ambiguities. More importantly, I hope that the FDA tackles these structure/function claim issues with a clear, comprehensive system of “guiding principles” to foster more responsible and careful behavior on the part of food manufacturers. As functional foods/beverages and likewise dietary supplements become more of an integral part of our healthcare, let there be no mistakes or misinterpretations about what can or what cannot be said. About Nutraceutical Medical Research: We are a premiere contract research organization dedicated to substantiating your product or ingredient claims and efficacy with clinical research. We provide medical writing services which include product brochures, literature reviews and journal publication. 12
  13. 13. NMR News: Volume 3, Issue 4, April 2010 For foods and beverage companies specifically, we are here to help you/your team design and manage clinical trials, write medical literature to help support your claims, or simply, comply with FDA/FTC label and claim requirements, using documented science and evidence-based approaches. Our goal is to partner with natural product, cosmeceutical, food, ingredient, and pharmaceutical companies to help them establish efficacy and safety of their products using evidence-based approaches. Contact NMR at 1-914-220-8325 or email REFERENCES 1. Food & Drug Administration. 1997. Federal Register Final Rule - 62 FR 49859 September 23, 1997 - Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements. Available at: on/ucm107274.htm. Accessed on March 31, 2010. 2. Food & Drug Administration. 2008. Guidance for Industry: Substantiation for Dietary Supplement Claims Made Under Section 403(r) (6) of the Federal Food, Drug, and Cosmetic Act. Available at: nts/DietarySupplements/ucm073200.htm. Accessed on March 31, 2010. 3. Food & Drug Administration. 2009. Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods. Available at: nts/ucm192702.htm. Accessed on March 31, 2010. 4. A presentation entitled “Health Claims – Compliance & Enforcement” presented by Johanne Beaulieu Director, Consumer Protection Division the Canadian Food Inspection Agency from PowerPoint slides entitled: “Health Claims in Canada: An Update on Function Claims and Probiotic Claims for Food” presented during a webinar on January 20, 2010. 13
  14. 14. NMR News: Volume 3, Issue 4, April 2010 5. A presentation entitled “Health Canada - Function Claims and Probiotic Claims for Food – Revised Guidance and Requirements for Scientific Evidence to Validate Claims” presented by Eunice Chao, PhD of Nutrition Evaluation Division, Bureau of Nutritional Sciences Food Directorate, Health Products and Food Branch, from PowerPoint slides entitled: “Health Claims in Canada: An Update on Function Claims and Probiotic Claims for Food” presented during a webinar on January 20, 2010. 6. The Free Speech about Science Act of 2010. bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h4913ih.txt.pdf 7. Food Products Association. NFPA Guidance. Available at: http://www.fpa- Accessed on March 31, 2010. 8. Health Canada. Guidance Document for Preparing a Submission for Food Health Claims by Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch, Health Canada. March 2009. Available at: an/alt_formats/hpfb-dgpsa/pdf/legislation/health-claims_guidance- orientation_allegations-sante-eng.pdf. Accessed on March 31, 2010. 9. Silverglade B, Heller IR; Center for Science in the Public Interest. Food Labeling Chaos: Case For Reform Report, December 2009. Accessed on March 31, 2010. 14