Chapter 1: Does nutrition have a role in disease management?
4
clarifying when managing a disease or medical
conditions causes a product to be considered a
MF, FSDU, drug, or biologic can be challenging
to discern in the current regulatory environment.
The lack of clarity raises the question of whether
the current regulatory framework is sufficient for
this emerging area in healthcare. I do not have
answers to this challenge but view the discussion
and recognition of the issues as critically im-
portant to understand to recognize the value of
nutrition in managing disease and health-related
conditions.4
Conventional foods and dietary supplements
have had a framework for conveying nutrition in-
formation based on two landmark amendments to
the Federal Food, Drug, and Cosmetic Act, the
Nutrition Labeling and Education Act of 1990
(NLEA) and the Dietary Supplement Health and
Education Act of 1994 (DSHEA). A fundamen-
tal principle of the framework created by NLEA
and DSHEA is that nutrient requirements for ad-
equate nutrient intake can be established for the
general population and that scientific evidence
can be evaluated to determine when food or food
components can reduce the risk of chronic dis-
eases that are prevalent in the general population.
In addition, the most recent DGA are based on
the evaluation of scientific evidence on dietary
patterns associated with meeting nutrient require-
ments and reducing risk of chronic disease for the
general population.5 One of the dietary patterns
included in the DGA, is the Dietary Approaches
to Stop Hypertension (DASH), which is a dietary
approach specifically designed to manage a medi-
cal condition, hypertension. Because nutrition la-
beling for conventional foods and dietary supple-
ments focuses on meeting nutritional needs of the
general population, MFs, which are for individu-
als with distinctive nutrient requirements, are ex-
cluded from the nutrition labeling requirements
under NLEA. The category of FSDU was revised
to exclude products based on nutrient content
claims (e.g., low sodium) or health claims (e.g.,
sugar alcohols and dental caries), but still exists
for individuals with normal nutrient require-
ments, but with special needs for utilizing the
foods (e.g., difficulty swallowing). These catego-
ries within foods (i.e., MF, FSDU, conventional
foods plus dietary supplements) characterize a
spectrum of products that can be used to meet
nutritional needs based on metabolic, physiologic
and nutritional status of individuals.
A Federal Register Notice published in 1996
by FDA provided insight into the agency’s think-
ing about MF and FSDU the notice was with-
drawn in 2004 because of lack of resources to ana-
lyze comments and move forward. However, in
the withdrawal notice, the agency suggested the
principles articulated in the 1996 Notice were
consistent with current thinking and these princi-
ples recognized that MF and FSDU are intended
to help in the dietary management of diseases or
medical conditions.6 More recently, the final
guidance on MF published in 2016 appears to
narrowly define MF in a manner most focused on
inborn errors of metabolism.7
The MF market has grown steadily in the US
and various factors may contribute to ongoing
growth, including the interest in personalized
healthcare, but is complicated by regulatory action
from FDA that often appears minimal.6,8 In the
absence of a process for FDA recognition of sta-
tus as a MF or FSDU, manufacturers may learn
of a product’s status through regulatory action,
e.g., if FDA sends a warning letter that it does
not agree with the manufacturer’s determination
that the product meets criteria as a MF. Without
a consistent framework that clearly defines pa-
rameters for MF and FSDU, some manufacturers
may be reluctant to develop products due to un-
certainty about the market plus concern of regula-
tory action, and unfortunately, other manufactur-
ers may take advantage of the lack of clarity in the
regulatory framework to mislead consumers and
4
clarifying when managing a disease or medical
conditions causes a product to be considered a
MF, FSDU, drug, or biologic can be challenging
to discern in the current regulatory environment.
The lack of clarity raises the question of whether
the current regulatory framework is sufficient for
this emerging area in healthcare. I do not have
answers to this challenge but view the discussion
and recognition of the issues as critically im-
portant to understand to recognize the value of
nutrition in managing disease and health-related
conditions.4
Conventional foods and dietary supplements
have had a framework for conveying nutrition in-
formation based on two landmark amendments to
the Federal Food, Drug, and Cosmetic Act, the
Nutrition Labeling and Education Act of 1990
(NLEA) and the Dietary Supplement Health and
Education Act of 1994 (DSHEA). A fundamen-
tal principle of the framework created by NLEA
and DSHEA is that nutrient requirements for ad-
equate nutrient intake can be established for the
general population and that scientific evidence
can be evaluated to determine when food or food
components can reduce the risk of chronic dis-
eases that are prevalent in the general population.
In addition, the most recent DGA are based on
the evaluation of scientific evidence on dietary
patterns associated with meeting nutrient require-
ments and reducing risk of chronic disease for the
general population.5 One of the dietary patterns
included in the DGA, is the Dietary Approaches
to Stop Hypertension (DASH), which is a dietary
approach specifically designed to manage a medi-
cal condition, hypertension. Because nutrition la-
beling for conventional foods and dietary supple-
ments focuses on meeting nutritional needs of the
general population, MFs, which are for individu-
als with distinctive nutrient requirements, are ex-
cluded from the nutrition labeling requirements
under NLEA. The category of FSDU was revised
to exclude products based on nutrient content
claims (e.g., low sodium) or health claims (e.g.,
sugar alcohols and dental caries), but still exists
for individuals with normal nutrient require-
ments, but with special needs for utilizing the
foods (e.g., difficulty swallowing). These catego-
ries within foods (i.e., MF, FSDU, conventional
foods plus dietary supplements) characterize a
spectrum of products that can be used to meet
nutritional needs based on metabolic, physiologic
and nutritional status of individuals.
A Federal Register Notice published in 1996
by FDA provided insight into the agency’s think-
ing about MF and FSDU the notice was with-
drawn in 2004 because of lack of resources to ana-
lyze comments and move forward. However, in
the withdrawal notice, the agency suggested the
principles articulated in the 1996 Notice were
consistent with current thinking and these princi-
ples recognized that MF and FSDU are intended
to help in the dietary management of diseases or
medical conditions.6 More recently, the final
guidance on MF published in 2016 appears to
narrowly define MF in a manner most focused on
inborn errors of metabolism.7
The MF market has grown steadily in the US
and various factors may contribute to ongoing
growth, including the interest in personalized
healthcare, but is complicated by regulatory action
from FDA that often appears minimal.6,8 In the
absence of a process for FDA recognition of sta-
tus as a MF or FSDU, manufacturers may learn
of a product’s status through regulatory action,
e.g., if FDA sends a warning letter that it does
not agree with the manufacturer’s determination
that the product meets criteria as a MF. Without
a consistent framework that clearly defines pa-
rameters for MF and FSDU, some manufacturers
may be reluctant to develop products due to un-
certainty about the market plus concern of regula-
tory action, and unfortunately, other manufactur-
ers may take advantage of the lack of clarity in the
regulatory framework to mislead consumers and