Nutrition, Health, and Disease
5
patients about products and their ability to man-
age disease or medical conditions. A review of the
mechanisms of action of various medical foods in
gastrointestinal disorders suggests that various
products can be valuable in managing certain
medical conditions.8 However, such an analysis
raises the question of what standards have been
agreed upon for the scientific evaluation of a MF
product and specifically what evidence is neces-
sary to establish that a medical condition has a
distinctive nutrient requirement that requires spe-
cial formulation and processing to meet these spe-
cial needs. An additional question raised is to un-
derstand the difference between managing a dis-
ease or medical condition and an intervention that
mitigates or treats symptom, an effect which
makes a product more drug-like in scope. A key
concern from a regulatory perspective is protec-
tion of public health and having a level playing
field for the standards that must be met for a
product to meet the criteria of a MF or FSDU
consumers, patients, and healthcare providers
must have confidence in the efficacy of such prod-
ucts.1
The European Commission has recently re-
vised its regulations and created a category of
Foods for Special Groups (FSG), which includes
Foods for Special Medical Purposes (FSMP).
The FSG category includes other categories such
as foods for infants and young children, meal re-
placement for weight control, and gluten-free and
lactose-free foods but these are not within the
scope of FSMP.9 Thus a characteristic of products
within the FSMP category reflect the degree to
which the “medically determined nutrient re-
quirements…cannot reasonably or realistically
[be] satisfied by modifying the normal diet, i.e.,
the extent to which it is impossible, impractical or
un-safe… and/or the extent to which patients
would have a nutritional or clinical disadvantage
from consuming foodstuffs…that are not
FSMPs.”10 To facilitate this approach EFSA, has
published scientific and technical guidance that
focuses on the key characteristics of a FSMP, in-
cluding characteristics of the food product, char-
acterization of the disease, disorder, or medical
condition, characteristics of the patients use of the
product and its role in their dietary management.
The establishment of criteria for determination of
whether a product is a FSMP will facilitate the
ability of food manufacturers to develop products
that fit the FSMP category and enable the EC to
decide if a product falls with the scope of the reg-
ulation and where it belongs within the scope.10
Understanding the EU approach in creating the
FSG category and the criteria for approving prod-
ucts, can be useful in developing a way forward.
The value of diet and nutrition in prevention
of disease is often highlighted and yet as Harvey
Fineberg has pointed out, disease prevention is
“celebrated in principle, resisted in practice.”11 Be-
ing able to manage certain disease states or medi-
cal conditions using dietary approaches can help
manage quality of life for individuals living with
such conditions and help manage healthcare
costs.4,11 RAPS has opened and sustained an im-
portant dialogue about the role of MF and FSDU
in managing health and disease. This dialogue
and discussion are important for addressing ques-
tions about the contribution of food and nutrition
to manage disease and medical conditions. To
move forward the discussion needs to identify and
address the question of the scientific and regula-
tory frameworks necessary to evaluate products to
determine the validity of claims made about their
role in managing disease or medical conditions so
that individuals and healthcare providers can have
confidence in the use of such products.
Original article citation: Schneeman, B. Does nutrition
have a role in disease management? Regulatory Focus.
Published online 13 October 2017.
https://www.raps.org/regulatory-fo-
cus%E2%84%A2/news-articles/2017/10/guest-
5
patients about products and their ability to man-
age disease or medical conditions. A review of the
mechanisms of action of various medical foods in
gastrointestinal disorders suggests that various
products can be valuable in managing certain
medical conditions.8 However, such an analysis
raises the question of what standards have been
agreed upon for the scientific evaluation of a MF
product and specifically what evidence is neces-
sary to establish that a medical condition has a
distinctive nutrient requirement that requires spe-
cial formulation and processing to meet these spe-
cial needs. An additional question raised is to un-
derstand the difference between managing a dis-
ease or medical condition and an intervention that
mitigates or treats symptom, an effect which
makes a product more drug-like in scope. A key
concern from a regulatory perspective is protec-
tion of public health and having a level playing
field for the standards that must be met for a
product to meet the criteria of a MF or FSDU
consumers, patients, and healthcare providers
must have confidence in the efficacy of such prod-
ucts.1
The European Commission has recently re-
vised its regulations and created a category of
Foods for Special Groups (FSG), which includes
Foods for Special Medical Purposes (FSMP).
The FSG category includes other categories such
as foods for infants and young children, meal re-
placement for weight control, and gluten-free and
lactose-free foods but these are not within the
scope of FSMP.9 Thus a characteristic of products
within the FSMP category reflect the degree to
which the “medically determined nutrient re-
quirements…cannot reasonably or realistically
[be] satisfied by modifying the normal diet, i.e.,
the extent to which it is impossible, impractical or
un-safe… and/or the extent to which patients
would have a nutritional or clinical disadvantage
from consuming foodstuffs…that are not
FSMPs.”10 To facilitate this approach EFSA, has
published scientific and technical guidance that
focuses on the key characteristics of a FSMP, in-
cluding characteristics of the food product, char-
acterization of the disease, disorder, or medical
condition, characteristics of the patients use of the
product and its role in their dietary management.
The establishment of criteria for determination of
whether a product is a FSMP will facilitate the
ability of food manufacturers to develop products
that fit the FSMP category and enable the EC to
decide if a product falls with the scope of the reg-
ulation and where it belongs within the scope.10
Understanding the EU approach in creating the
FSG category and the criteria for approving prod-
ucts, can be useful in developing a way forward.
The value of diet and nutrition in prevention
of disease is often highlighted and yet as Harvey
Fineberg has pointed out, disease prevention is
“celebrated in principle, resisted in practice.”11 Be-
ing able to manage certain disease states or medi-
cal conditions using dietary approaches can help
manage quality of life for individuals living with
such conditions and help manage healthcare
costs.4,11 RAPS has opened and sustained an im-
portant dialogue about the role of MF and FSDU
in managing health and disease. This dialogue
and discussion are important for addressing ques-
tions about the contribution of food and nutrition
to manage disease and medical conditions. To
move forward the discussion needs to identify and
address the question of the scientific and regula-
tory frameworks necessary to evaluate products to
determine the validity of claims made about their
role in managing disease or medical conditions so
that individuals and healthcare providers can have
confidence in the use of such products.
Original article citation: Schneeman, B. Does nutrition
have a role in disease management? Regulatory Focus.
Published online 13 October 2017.
https://www.raps.org/regulatory-fo-
cus%E2%84%A2/news-articles/2017/10/guest-