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
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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
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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
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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
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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
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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).
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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.
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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
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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
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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
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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
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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.
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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 info@nutraceuticalmedicalresearch.com.
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:
http://www.fda.gov/Food/DietarySupplements/GuidanceComplianceRegulatoryInformati
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:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocume
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:
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocume
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.
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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. http://frwebgate.access.gpo.gov/cgi-
bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h4913ih.txt.pdf
7. Food Products Association. NFPA Guidance. Available at: http://www.fpa-
food.org/upload/pdfs/guidance_claims.pdf. 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: http://www.hc-sc.gc.ca/fn-
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.
http://cspinet.org/new/pdf/food_labeling_chaos_report.pdf. Accessed on March 31,
2010.
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