Discussion of a Conceptual Framework for
Structure and Function Claims
For Conventional Foods
Meeting Summary
Conceptual Framework for Structure and Function Claims for Conventional Foods
Summary Report
On February 16-17, 2000, a diverse group of interested parties (see attached
list) met to hold a preliminary discussion regarding a conceptual framework
for structure and function health claims for conventional foods. Sixteen people
attended the one-and-a-half day meeting in Washington, D.C. This document provides
an overview of discussion highlights and options for next steps.
Meeting Goals, Objectives, Ground Rules, and Agenda Overview
The
goals of the meeting were the following:
- Identify and discuss key elements of a conceptual framework for structure and function claims for conventional foods; and,
- Determine a process for finalizing and implementing a conceptual framework.
Participants were not expected to reach consensus on a specific framework,
but were asked to fully explore and develop a general sense of what the key
components of a framework might be. Outlining options for a process to further
develop a framework also was a meeting objective.
The following ground rules to govern the meeting deliberation
were established:
- Participants attended the meeting as individuals, not formal representatives of their respective organizations, agencies, or companies;
- Discussions were off-the-record and not for attribution; and,
- A summary of highlights would be drafted and circulated for review and comment by participants.
The agenda format (attached) facilitated reaching the above-mentioned
objectives. After addressing meeting preliminaries, including brief introductions,
review of meeting goals and objectives, and establishment of the ground rules,
the substantive deliberations began with an overview and discussion of the status
of structure and function claims for conventional foods. A discussion of the
potential goals of a conceptual framework followed this brief history. Participants
then brainstormed and discussed potential key elements of a conceptual framework.
The resulting list of key elements became the agenda for the next day. The second
day's deliberations focused on in-depth discussion of potential key elements of
a conceptual framework, as well as possible process options to more fully develop
such a framework. Highlights from each part of the agenda are below.
Background and Overview of Structure and Function Claims for Conventional Foods
A brief overview of the history the progression and evolution of issues addressing
the governance of structure and function claims provided the context for the
meeting deliberations. Structure and function claims on conventional foods
are not a new concept, but they were rarely used on conventional foods before
1994 and did not pose regulatory issues as long as the claims were "truthful
and not misleading." Recent history has resulted in a much more complex
set of circumstances surrounding the regulation of these claims, making their
use more interesting and their governance more challenging, including the following:
- advancement of science regarding the link between diet and health
and the ability to isolate, add, and modify foods and food components;
- increased interest in using and making structure and function
claims;
- increased concern regarding the interpretation of structure and
function claims;
- different legislative requirements for health claims and structure
and function claims on conventional foods and dietary supplements; and,
- court cases attempting to clarify associated issues.
Given this context, the Food and Drug Administration (FDA) is interested in
and open to a dialogue among interested parties to sort through and creatively
construct a conceptual framework for regulating structure and function claims
on conventional foods. The parameters under which such a dialogue must occur
include:
- Recognition
of the current legal framework. Structure and function claims are being
made now and, therefore, crafting a conceptual framework is very timely, pressing,
and cannot wait for legislative change. Therefore, creativity and flexibility
must be discovered within the current legal requirements.
- Recognition
that scientific issues are being addressed by other groups in other fora.
The scientific foundation associated with structure and function claims is an
important component of the ultimate public policy surrounding these claims and
would be part of the discussion. The Food Forum, under the auspices of the
Food and Nutrition Board (FNB) and National Academy of Science (NAS), is addressing
the specific details of the scientific aspects, such as the degree of scientific
substantiation in terms of number and types of studies. Therefore, these issues
are not the subject of this meeting
The current regulatory approach was outlined to give meeting participants a
sense of the FDA's approach to and current thinking concerning structure and
function claims. Structure and function claims are distinguished from other
claims by their focus not on disease, but on "maintaining" or "supporting"
particular body structures or functions, such as supporting bone cartilage integrity,
or maintaining healthy intestinal flora. Key components of the current framework
include:
- Safety - the active ingredient must be "generally
recognized as safe" (GRAS), and/or have passed food additive (FA) review.
- Scientific Basis - claims made must be "truthful and not
misleading," based on appropriate scientific criteria and appropriate endpoints.
- Nutritive Value - the active ingredient and vehicle
for the active ingredient must be a "food." A "food" has
been defined, from a court decision in the 1980's, as that which is consumed
"primarily for taste, aroma, or nutritive value." The qualification
of a food or food component being used "primarily" for taste, aroma,
or nutritional value has provided some degree of flexibility in considering
appropriate structure and function claims.
The current approach to regulating structure and function claims, which is
based on these three parameters has become increasingly complicated. This is
due to a growing inability to clearly define nutritive value due to the progression
and evolution of science and to new perspectives regarding nutrition. It has
become difficult to provide consistent and clear guidance that is based on common
sense. FDA has modified and adjusted the definition of "nutritive value" repeatedly,
including considering variations in the derivation, dose and metabolic effect
of the active ingredient and/or the vehicle containing the active ingredient. These efforts have not succeeded in developing a clear framework for regulating
this type of claim.
Nutritive value cannot be defined simply in terms of source, dose, or biochemical
composition. Requiring that the food ingredient be a "naturally occurring"
food or food component, for example, is not an adequate criterion as some naturally
occurring components have pharmacologic effects. The science of food and food
processing and the resulting food products also have complicated these issues.
In addition, it is difficult to clearly distinguish health claims, which are
about the relationship between a nutrient or food component and a disease, from
structure and function claims, which are about supporting or maintaining healthy
structure or function in the body.
Highlighting some of these issues are specific food and food components, such
as ginger, caffeine, coffee, and St. John's wort, which are used for a variety
of reasons in addition to their "taste, aroma, or nutritive value."
The current conceptual framework does not easily address all of these evolving
dimensions that contribute to or have influence over the governance of structure
and function claims for foods. A new conceptual framework would need to appropriately
address this myriad of issues.
FDA's current approach toward structure and function claims was further elaborated
through reviewing letters for products with stanol esters or sterol esters.
In these letters, FDA "failed to object" to the manufacturers' assertions these
ingredients have "nutritive value." "Failing to object" is reflective of FDA's
dilemma in affirmatively basing decisions on structure and function claims on
the anchoring criterion of "nutritive value."
The discussion also addressed the possibility of regulating structure and function
claims for foods similarly to dietary supplements, under the Dietary Supplement
Health and Education Act (DSHEA) and associated regulations outlined in final
rules, published in the Federal Register on September 23, 1997 and January 6,
2000.
Goals of a Conceptual Framework
Participants began by exploring the dimensions of a conceptual framework for
structure and function claims by first discussing its overall goals. Many features
were suggested and discussed, and different views concerning the status and
value of structure and function claims were presented. These ideas required
further elaboration and exploration of different perspectives. Briefly, the
additional perspectives were the following:
Increased interest in using structure and function claims on products:
- Dietary choices can support and maintain health.
- Positive messages are powerful for promoting healthy diets and
selling products.
- Claims that only relay information about disease or about negative
situations are not effective for some population groups.
- Clarity is essential in designing effective claims.
- Appropriate guidelines are required to avoid stifling innovation
in making structure and function claims for consumers.
- Consumers have greater expectations from foods now than in the
past, not only that foods will assuage hunger but that they also can have a
positive effect on health.
- Structure and function claims have different regulatory requirements
that are easier to meet than health claims.
Concerns about structure and function claims on products:
- The marketplace is confusing, with overwhelming amounts of information
for which no framework exists.
- A lack of confidence exists in the integrity of claims (i.e.,
Are they truthful and not misleading, what is their scientific underpinning?).
- Consumers lack the tools or the basic understanding needed to
evaluate messages and understand what they mean.
- There is no clear distinction among health claims, structure and
function claims, and drug claims.
Collectively, participants thought a conceptual framework for structure and
function claims should be effective, consistent, and dynamic. Further elaboration on these three goals and how they would be developed and
measured included the following:
An effective framework would:
- Maintain consumer confidence in foods generally.
- Establish and maintain confidence that structure and function
claims are "truthful and not misleading."
- Ensure food labels are effective tools for consumer education.
- Stimulate research.
- Encourage healthier eating trends.
- Eliminate components from foods that do not have GRAS or Food
Additive status.
- Provide a strong scientific foundation.
- Clarify the target audience for whom these claims may be beneficial
and, if relevant, identify those who should avoid the particular food or food
component.
- Prohibit inappropriate products from making claims.
- Improve substantiation of claims.
- Establish a minimum effective dose to bring about the specified
effect.
- Clarify the maximum dose beyond which no further effect or a negative
effect may occur.
A consistent framework would:
- Establish a clear, adequate, and appropriate regulatory process.
- Establish rational, understandable, enforceable regulations for
structure and function claims.
- Clarify guidelines for industry.
- Be simple to enforce.
A dynamic framework would:
- Create regulatory structures that can adapt to evolving science.
The meeting participants also discussed the value of a conceptual framework
that would place structure and function claims in an appropriate context relative
to other types of claims. In other words, some parity between the type of claim
and the associated regulatory process is needed. Ultimately, in order to achieve
this broader goal, a framework for structure and function claims would need
to be established and clarified, and the whole continuum of claims would require
clarification. This latter dimension would not necessarily be part of a further
dialogue to develop a conceptual framework for structure and function claims.
Key Elements of a Conceptual Framework
Over the course of the meeting, three key elements of a conceptual framework emerged:
- Boundaries and Definitions
- Substantiation
- Regulatory Mechanics and Decision-Making Processes
I. Boundaries and Definitions
In order to develop an effective, consistent, and dynamic conceptual framework,
many key definitions and criteria or boundaries for distinguishing or evaluating
a structure and function claims must be established and clarified.
Key Questions and Issues
Some of the questions and issues raised and discussed during the meeting included
the following:
- What is a conventional food in the context of structure and function claims?
- Is there a need for another category (e.g., functional foods)?
- Is there a reasonable and useful definition of "nutritive value?"
(Is this a legal or a scientific question, and does it need to be challenged?)
- Is there a reasonable alternative to using "nutritive value?"
- Does nutritive value apply to the bioactive substance, the vehicle,
or both?
- How can structure and function claims be distinguished from other
claims (e.g., drug claims, health claims)?
- Would a requirement of GRAS and/or FA status be an appropriate
and adequate safety net, with or without additional criteria?
- Is it possible or important to distinguish "naturally-occurring"
ingredients from "added" ingredients?
- Is there a distinction between:
- Materials derived from plant or animal food sources
- Materials derived from sources other than plants or animal (e.g., mineral sources, chemical synthesis).
The following question was a central focus of the deliberations and the participants
believe it is fundamental for further development of a conceptual framework
for structure and function claims. "Can nutritive value have a meaningful
definition (serve as an appropriate and adequate anchor for providing guidance
and evaluating structure and function claims), or should a totally different
approach and anchoring concept be used that could be more effective?"
Options Discussed
-
Moving away from "nutritive value." Many ideas for strategies or approaches
to clarify or create a conceptual framework were suggested and discussed briefly.
One proposed approach was to de-emphasize the use of "nutritive value" as a
key requirement for the active ingredient. An alternative emphasis could be
on safety and substantiation. The rationale for this proposal includes the
observation that nutritive value ties the framework to old science and it doesn't
include food and food constituents now thought to be beneficial, such as fiber.
The emphasis on safety would assume that the active ingredient has GRAS and/or
FA status. Also, the vehicle for the active ingredient would have to be considered
a food. Food components that are the focus of the structure and function claim
and that have GRAS and/or FA status, and are delivered in a vehicle considered
a food, are eligible. If the proposed active ingredient does not have GRAS
and/or FA status, and/or is not conveyed in a food, it would not be eligible
for a structure and function claim. Questions regarding this approach included,
a) whether it provides enough safety for potential products and active ingredients
bearing structure and function claims; b) whether it is too permissive in allowing
undesirable claims; and, c) how to keep drugs distinct from foods.
- Using multiple continua to sort through criteria and identify appropriate
boundaries. The types of ingested active ingredients, their respective impacts,
and how they interact, overlap and differ could be helpful constructs. Some
continua discussed included:
- Continuum of added functional ingredients:
- An unaltered nutrient
- An enhanced nutrient
- An enhanced phytochemical
- A non-food ingredient (e.g., tree bark)
- A drug
- Continuum of derivation of the active ingredient and the vehicle:
- Ingredient or material that is a component of a food
- Ingredient or material that has never been in a food
- Ingredient or material that is a component of a food, but that
has been modified or enhanced beyond what is found in food.
- Other potential continua could be:
- Type of claim (what the statement says or intends to say)
- Intended population
- Mechanism of action (e.g., "type" of active ingredient, "type"
of vehicle, "type" of impact)
- Level of substantiation (e.g., drug-substantiation, significant
scientific agreement as substantiation for health claims)
A few potential problems were identified for these approaches. Specific challenges
include that minerals are not necessarily derived solely from food sources and
traditional nutrients are increasingly being derived from novel sources.
II. Substantiation
This element is critical to insuring that a structure and function claim is "truthful and not misleading."
Key Questions and Issues
- What constitutes substantiation?
- What is the level and type of information necessary to be confident
that the structure and function claim is based on adequate information (target
audience, safety, nutrient presence, and dosage)?
- Does the science need to meet a threshold before making a structure
and function claim (qualified vs. non-qualified claims)?
Options Discussed
Time to develop this concept in more detail was limited. However, one theme
for options to be considered was the need for more flexibility in the kinds
of evidence offered, not more flexibility in the rigor of the science.
III. Regulatory Mechanics or Decision-making Process
A conceptual framework would first determine the boundaries, key definitions
and level and type of substantiation. Based on these critical dimensions, appropriate
decision-making processes would be determined to achieve the diverse goals inherent
in regulating structure and function claims. Participants supported the need
for clear regulatory guidelines.
Key Questions and Issues
- What is the interconnection between the decision to make a claim,
the decision to allow a claim, and the decision to purchase and use a product
because of a claim that achieves a framework that is consistent, effective,
and flexible?
- What regulatory requirements must be met?
- Should there be disqualifying nutrients or disqualified vehicles?
Is disclosure more appropriate?
- What implementation requirements are necessary (e.g., adverse
event reporting, post-market surveillance)?
- What is the role of consumer research in evaluating understanding,
interpretation, and effectiveness impact of claims?
- What form of enforcement would be necessary?
- Should disclaimers be required? Should they be specific or generic?
Do they have any impact?
- Should there be pre- or post-market notification requirements?
- What information should be publicly available and how should it
be made public?
- Should positive lists of permitted claims be maintained and/or
should the requirements for permitted claims be specified?
- How is a "level playing field" achieved for dietary supplement
claims and conventional food claims?
- Are there incentives for industry to make these claims?
Options Discussed
Regulatory options raised but not thoroughly discussed include the following:
- Regulating structure and function claims on conventional foods
on a case-by-case basis.
- Developing categories of appropriate criteria for structure and
function claims.
- Considering whether to maintain approved list of structure and
function claims.
Process for Further Development of a Conceptual Framework for Structure and Function Claims
Following this preliminary discussion of the key components of a conceptual
framework for structure and function claims, the group turned its attention
to outlining potential next steps for further developing a conceptual framework.
FDA representatives reiterated their interest in engaging stakeholders with
diverse perspectives to assist with the development of a conceptual framework,
frankly stating that they "need help to get more information and additional
input to decide how to move forward." Therefore, a process that fosters creative
thinking with different interest groups is of interest to FDA. Several kinds
of processes were discussed briefly, including focus groups, rulemaking, public
hearings, conferences, and a multi-stakeholder dialogue. A multi-stakeholder
dialogue was the only process discussed in any length. The primary concerns voiced with regard to a multi-stakeholder, consensus-building
process were the following:
- Time frame - Some participants expressed concern about becoming
involved in protracted discussions (e.g., two-year process) to develop a conceptual
framework.
- Resource issues - Some participants voiced concern that the process
could involve extensive resource investment, including staff time and financial
support.
- Broad or unfocused dialogue - Some participants raised concerns
with launching a discussion that might be too broad and unclear, or one engaging
so many diverse interests that a focused discussion would be very difficult.
- Complexity of the issues - Some participants suggested that the
challenge of creating a conceptual framework for structure and function health
claims would be significant, given the advancement of science, the constraints
of the current law, the multiple goals of a conceptual framework, and the objective
of merging these three dimensions to construct an effective regulatory structure.
Many concerns are inter-connected. The initial scope of the discussion, goal
of the process (e.g., information exchange or consensus-building), number of
participants, and time and number of meetings allocated for a multi-stakeholder
process all combine to determine the amount of resources necessary to complete
the project and meet the goal established in developing a conceptual framework
in a timely manner.
Enthusiasm for a multi-stakeholder process revolved around the following:
- Assist FDA - Participants wanted to be responsive to FDA's expressed
interest in getting assistance with developing a conceptual framework, believing
issues associated with structure and function claims and their governance merit
attention.
- Constructive opportunity - Participants noted that because these
issues are complex, engaging diverse perspectives could encourage creative and
constructive dialogue resulting in the development of a more effective conceptual
framework.
- Build on initial discussion - Some participants were encouraged
by the course of the two-day discussion and thought a process building on these
deliberations and gathering additional information could establish a more clearly
defined scope.
- Support for a conceptual framework - Some participants suggested
that engaging multiple stakeholders could result in a more broadly supported
framework for structure and function claims, assuming agreement could be reached.
Participants then developed a preliminary process for a continued dialogue
on the development of a framework. Some thought a multi-stakeholder process
might be an appropriate vehicle for further developing this framework if a clear
scope were determined in the beginning involving a relatively small dialogue
group (e.g., 15 people) and a time frame of approximately one year. If a multi-stakeholder
process were to be established it would be important to include the following
characteristics and parameters:
- Determination of the goals and objectives of a conceptual framework for structure and function claims.
- Clarification of parameters within which a conceptual framework would be developed and, in
particular, determining the basic statutory requirements and the issues and
parameters that would be open for discussion and possible modification.
- Discussion of the "gold standard" vision for a conceptual framework. This discussion would
provide an opportunity for consideration of a conceptual framework outside the
current legal constraints. The purpose of this exercise would be to outline
an "ideal" model ("gold standard") that could serve as a
goal for a conceptual framework structured within the context of the current
law while providing a model for future statutory decisions.
- Integration of #2 and #3.
Taking as a fundamental premise that structure and function claims are desirable,
that they should be truthful and not misleading, and that the process should
focus on creating a framework that makes these claims "work" for all
interests, several key components were suggested for a structural framework. These components therefore would be categories for future discussion:
- Boundaries and Definitions
- Substantiation
- Regulatory Mechanics or Decision-Making Process, (based on A and B).
Additional suggestions for structuring a multi-stakeholder dialogue process included the following:
- The charge to the dialogue group would be to develop a regulatory
framework within the context of the current law.
- The process should take place in a "reasonable" (e.g.,
six to 12 months) time frame.
- Participation should be limited to a "small" sized group
(e.g., approximately 15 people) with diverse representation (e.g., food industry,
academia, public health groups (e.g., AHA, ACS, ADA), consumer advocates, professionals
who work with consumers (e.g., public health educators, nutrition educators,
dietitians, consumer researchers), and the Food and Drug Administration). Participants
discussed, but did not reach any conclusion concerning participation of dietary
supplement representatives. While the focus of the discussion would be on conventional
foods, some thought these representatives could provide a different perspective,
especially if equity is sought.
- The process should be flexible enough to accommodate outside experts
on an "as needed" basis to provide additional information in key areas of discussion.
- Relevant materials should be provided early in the process. Suggestions
for materials included background documents and information concerning the technical
aspects of structure and function claims, as well as an analysis of statutory
requirements contrasted with requirements or components that potentially could
be modified.
- A brief report (e.g., 25-50 pages) would be the final product.
Next Steps
Participants discussed the next steps for determining in development of a conceptual
framework for structure and function claims on conventional foods, including:
- Drafting this meeting summary;
- Circulating the summary for comment, including requesting additional
thoughts on an appropriate process;
- Depending on whether an appropriate and supportable process model
could be determined, the interested group or groups could further explore funding
such an effort.
The meeting was adjourned.
Attachments
Participant List:
- Dr. Ellen Anderson
Office of Nutritional Products, Labeling, and Dietary Supplements, FDA
- Dr. Fergus Clydesdale
University of Massachusetts Department of Food Science, Amherst, MA
- Professor Marsha Cohen
Hastings College of the Law, University of California, San Francisco, CA
- Dr. Darla Danford
Office of Nutritional Products, Labeling, and Dietary Supplements, FDA
- Ms. Alta Engstrom
Consultant, Edina, MN
- Ms. Tracy Fox
Food, Nutrition, and Public Policy Consultant, Bethesda, MD
- Dr. William Franke
Lipton, Englewood Cliffs, NJ
- Dr. Nancy Green
Tropicana Products, Inc., Bradenton FL
- Dr. Christine Lewis
Office of Nutritional Products, Labeling, and Dietary Supplements, FDA
- Dr. Lynn Larsen
Office of Nutritional Products, Labeling, and Dietary Supplements, FDA
-
Dr. John Milner
Nutrition Department, Pennsylvania State University, University Park, PA
-
Dr. Donna Porter
Library of Congress, Washington, DC
-
* Mr. Mark Silbergeld
Consumers Union of U.S., Inc., Washington, DC
-
Mr. Bruce Silverglad/Dr. Eileen Heller
Center for Science in the Public Interest, Washington, DC
- *Mr. Mike Taylor
Monsanto Company, Washington, DC
- Dr. Virginia Wilkening
Office of Nutritional Products, Labeling, and Dietary Supplements, FDA
- Dr. Beth Yetley
Lead Scientist for Nutrition, FDA
Facilitators:
-
Abby Dilly
RESOLVE, Inc., Washington, DC
-
Judy O'Brien
The Keystone Center, Washington, DC
* Did not attend.
