Functional Foods: Conclusions

Conclusions
Developing functional foods to improve public health
requires contributions from ongoing basic and applied
research and modifications to the current regulatory
framework to facilitate the review of new functional
components and their health claims. The IFT Expert Panel
believes the following recommendations are particularly
critical to the continued development of functional foods.
Expand research into traditional nutrients, other
bioactive food components, and the intersection of
genomics and molecular nutrition. Continued basic and
applied nutritional research must further explore the roles
and mechanisms of action for traditional nutrients. In
addition to traditional nutrients, other bioactive food
components with the ability to improve health must be
identified and their efficacy proven. The intersection of
genomics and molecular nutrition presents opportunities
for more definitively understanding diet and health in
individuals and population groups, with the potential for
personalized diets for optimal health.
Expand research on biomarkers and physiological
endpoints. Additional biomarkers that signal changes in
health status are urgently needed, and the meaning of changes
in those biomarkers must be clearly demonstrated relative to
a defined health condition. Research is needed to expand the
validated biomarkers of health status including assessing
how genes and gene products relate to disease risk.
Use generally recognized as efficacious (GRAE)
panels to evaluate health claims and streamline the
regulatory approval process. Good science is the foundation for health- and nutrition-related claims. A GRAE panel
composed of scientists with in-depth knowledge of the
particular subject area would use the Hill criteria to evaluate
the evidence and prepare a publicly available, comprehensive report of their findings. FDA implementation of the
GRAE concept would provide a more predictable regulatory
process. Because the GRAS notification procedure implemented in 1997 has proven to be both effective and efficient, FDA should establish a similar procedure whereby a
GRAE report would be received and reviewed. FDA would
evaluate whether each submitted notice provides sufficient
basis for a GRAE determination and would respond to the
notifier within a predetermined time frame.
Allow product labeling and health claims to accurately
reflect the scientific data without triggering drug status.
Attempts to avoid classification as a drug have resulted in
misleading (if not outright false) statements of the underlying
science. Enormous public health benefits would result from
having consumers clearly understand and act on the accurately claimed product benefit.
Modify the current definition and application of the
term “nutritive value.” Given the current interpretations of
applicable statutes and advancements in nutritional sciences,
Expert Report
it is appropriate to replace “nutritive value” with a more
inclusive definition: that benefits for functional foods should
be based on nutritive value or through the provision of a
physical or physiological effect that has been scientifically
documented or for which a substantial body of evidence
exists for a plausible mechanism.
Allow health claims based on significant scientific
agreement (SSA) and qualified health claims based on
the weight of the scientific evidence (WOSE). The
ultimate success of functional foods will depend on delivering bioactive components in a predictable and assured
manner to effectively reduce the risk of disease and/or
improve body structure or function. To achieve this goal,
FDA should allow health and nutrition claims that are
truthful, non-misleading, and consistent with available
science, including qualified health claims. To this end, SSA
and the WOSE approaches are valuable assessment methods. While application of WOSE must be tempered by the
“credible evidence” test, FDA should not allow claims when
the scientific basis is extremely limited and supported only
by preliminary studies.
Indicate the degree of scientific certainty for approved and qualified health claims. Appropriate qualifying language should clearly indicate the degree of scientific
support or certainty associated with a biological effect or
modification of disease risk. FDA’s interim guidelines for
qualified claims provide limited language options for claims
with varying levels of scientific evidence. The Agency is
encouraged to allow flexibility in language, when equivalent
language can communicate effective messages that adequately qualify the level of science supporting such claims.
Develop incentives for companies to invest in functional
food research and development. The lack of exclusivity of
health claims discourages companies from investing in
functional food research. Incentives such as a period of
exclusivity or tax incentives would encourage food companies
to pursue functional food development as a profitable venture.
Use health claims on food labels as the foundation for
consumer education regarding dietary components for
health. Consumer education is an important component of
the success of functional foods. Accurate claims on food
labels help consumers select products that satisfy their desire
to promote self-care and improve health. All food communicators, including food scientists and health professionals,
must work together to improve consumer education by
accurately characterizing new scientific developments.
Achieving the potential benefits of functional foods
requires contributions from basic and applied scientists in
academia, government and industry. Consumers want and
need these products, and mechanisms must be developed
to ensure that the next steps are undertaken now to foster
their availability.
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