POLICY RESPECTING DIETARY FIBRE IN MEAL REPLACEMENTS
1
Bureau of Nutritional Sciences
Food Directorate
Health Protection Branch
September, 1993
INTRODUCTION
Meal replacements are single foods which are intended to replace one or
more meals or serve as the sole source of nourishment. As such,
their composition is regulated under the Food and Drug Regulationsa to provide nutrients in accordance with the
recommended nutrient intakes (RNIs) and the Nutrition Recommendations
for Canadiansb ,c . Meal replacements must contain
approximately 25% of the RNIs of 12 vitamins and 10 minerals in a
serving. In addition, the quantity and quality of protein and the
quantity of fat are controlled.
Information Letter No. 736, Dietary Fibre, issued by the Health
Protection Branch in February 1988d, stated
that,
"Meal replacements ... are formulated foods which are usually
made from purified ingredients and which may be used as the sole
source if nourishment ... Based on present knowledge,
it is not possible to establish arbitrarily an amount or an
appropriate mixture of dietary fibres which, when incorporated into a
formulated product, will achieve the desired effect."
(emphasis added)
Published reports since that information letter was written
have supported this viewpoint.
In Nutrition Recommendationse, the
Scientific Review Committee concluded,
"...the various kinds of fibre perform different functions
[which provides a ] sound rationale for recommending that a variety
of fibrecontaining foods be included in the diet. The same
evidence illustrates the folly of adding large amounts of a single
source of purified fibre to the diet." (P. 37.)
Nutrition Recommendations calls for Canadians to eat foods that
provide complex carbohydrate, dietary fibre and betacarotene in
achieving the goal of 55 % energy as carbohydrate. No target level
of dietary fibre intake is given. Foods are complex materials and
it is not possible to attribute fully the beneficial effects of a diet
high in complex carbohydrate, dietary fibre and betacarotene to specific
components.
The US Food and Drug Administration (FDA)f in their review of the relationship between
dietary fibre and disease stated that "the evidence is not
sufficient to fully explain the role of total dietary fiber, fiber
components, and the multiple nutrients and other substances contained in
these foods in reducing cancer risk." On the other hand, the
FDA did conclude that diets low in saturated fat and cholesterol and
high in fruits, vegetables and grain products that contain fibre were
related to a reduced risk of coronary heart disease, and diets low in
fat and high in fibrecontaining grain products, fruits and vegetables to
a reduced risk of cancer. These relationships clearly emphasize
whole foods rather than the component, dietary fibre.
These comments form the basis of the following policy for dietary
fibre in meal replacements.
DEFINITIONS
"Dietary fibre" means the endogenous
components of plant material in the diet that are resistant to digestion
by enzymes produced by man and consists primarily of nonstarch
polysaccharides and lignin.
(Note: that it is not enough to measure analytically the amount of
dietary fibre in a material and assume that this represents a substance
that has the physiological function of dietary fibre.)
"Novel fibre source" is a food ingredient
that has been manufactured to be a source of dietary fibre or is
intended to be used as a source of dietary fibre, and
-
that has not traditionally been used for human consumption to any
significant extent, e.g. cane sugar stalks (bagasse), cocoa bean
hulls, oat hulls, psyllium, rice bran, sugar beet pulp, wheat straw,
or
-
that has been chemically processed, e.g. extracted with acid or
alkali, and/or bleached with hydrogen peroxide (not permitted as a
food additive in Canada), e.g. bleached oat hulls, bleached pea hulls
(seed coats), bleached wheat straw, or
-
that has been physically processed, e.g. very finely ground to modify
the properties of the fibre e.g. finely ground wheat or corn bran,
or
-
that has been extracted and/or highly concentrated from its plant
source, e.g. betaglucans from barley and oats, corn bran containing
more than 65% Total Dietary Fibre (TDF), pea hulls (seed coats), soy
cotyledon fibre, apple pomace oat bran, pectin, carrageenan, guar
gum.
Note: the novel fibres used as examples above are not necessarily
acceptable for use as ingredients in foods or as sources of dietary
fibre but some are.
NOVEL FIBRE SOURCES IN FOODS - GENERAL
A novel fibre source must meet both safety and
efficacy criteria before it can be considered an acceptable source of
dietary fibre.i In some cases, novel
fibre sources may not be acceptable for use even as food ingredients
due, for example, to the use of nonpermitted additives, to levels of
heavy metals or to an unsafe characteristic inherent in the substance.
A novel fibre source for which only safety has been demonstrated
may be used as an ingredient in foods (including meal replacements as
discussed below) but the dietary fibre from that source may not be
included in the calculation of the dietary fibre content of that food
for the purposes of labelling and advertising.
Testing is required to demonstrate whether a novel fibre source
will have any of the beneficial effects (efficacy) attributed to dietary
fibreg , i.e. laxation (fecal bulking),
serum lipid (cholesterol) lowering, and improved glucose tolerance
(decreased rate of absorption of products of carbohydrate
digestion). This is because these effects are functions not only
of the chemical composition of the material but also its physical
structure and even the food matrix in which the substance is consumed,
aspects which are not measured when a product is simply analysed for
dietary fibre.
FIBRE SOURCES AS INGREDIENTS IN MEAL REPLACEMENTS
No objection will be taken to the incorporation
into meal replacements of any ingredients considered acceptable for use
in foods including novel fibre sources whose safety has been
demonstrated.
CLAIMS FOR DIETARY FIBRE IN MEAL REPLACEMENTS
-
No objection will be taken to the quantitative declaration of
the dietary fibre content of a meal replacement grouped with the
other nutrition information on labels of meal replacements when the
dietary fibre source is whole foods such as whole grain flours,
coarse wheat bran, oatmeal, nuts, legumes and fruit, provided that
these ingredients have not been finely ground. In whole foods,
dietary fibre is an integral component of the structure of the plant
material.
-
Novel fibre sources may not be included in the calculation of the
dietary fibre in a meal replacement unless the manufacturer of the
meal replacement has evidence from human studies that the novel fibre
source results in one or more of the beneficial effects attributable
to dietary fibre when consumed in the specific meal
replacement in the appropriate context.
-
No statements or claims with respect to the dietary fibre in a meal
replacement, including the use if the word "fibre" in the
name of the product, may be made unless the manufacturer has evidence
from human studies that the dietary fibre source(s) result(s) is one
or more of the beneficial effects attributable to dietary fibre when
consumed in the specific meal replacement in the appropriate
context.
-
No claims of "moderate", "high" or "very
high" in dietary fibre may be made for any meal replacement
since these terms were developed to be used with single servings of
food.
-
Claims or statements with respect to the dietary fibre in a meal
replacement, except as in No. 4 above, may be made if the meal
replacement contains 7 grams of dietary fibre from coarse wheat bran
(i.e. >0.75 mm average particle size) h per serving of the
product.
REFERENCES
-
Health and Welfare Canada. 1992. Departmental
Consolidation of the Food and Drugs Act and the Food and Drug
Regulations. Ottawa: Minister of Supply and Services
Canada. Section B.24.200.
-
Health and Welfare Canada. 1976. Dietary Standard for
Canada. Ottawa: Minister of Supply and Services Canada.
-
Health and Welfare Canada. 1977. Nutrition
Recommendations for Canadians. Ottawa: Bureau of Nutritional
Sciences.
-
Health and Welfare Canada. Feb. 5, 1998.
Information Letter No. 736, Dietary Fibre. Ottawa: Health
Protection Branch.
-
Health and Welfare Canada. 1990.
Nutrition Recommendations: Report of the Scientific Review
Committee. Ottawa: Minister of Supply and Services Canada.
[ Back to top ]
-
U.S. Food and Drug Administration. Federal
Register. Vol. 58, No. 3, Wed. Jan. 6, 1993, Part
IV. Food Labelling: Health Claims and Food Labelling
Statements; Dietary Fibre and Cancer, pp. 25372551; Dietary Fibre and
Cardiovascular Disease, pp. 25522605.
-
Health and Welfare Canada. 1985. Report
of the Expert Advisory Committee on Dietary Fibre. Ottawa:
Minister of Supply and Services Canada.
-
Mongeau R. and Brassard, R. 1982. Insoluble
dietary fibre from breakfast cereals and brans: bile salt binding and
waterholding capacity in relation to particle size. Cereal
Chem. 59(5) : 413417.
-
Food Directorate Guideline No. 9, Guideline
concerning the safety and physiological effects of novel fibre
sources and food products containing them, Food Directorate, Health
Protection Branch, Health Canada, Tunney's Pasture, Ottawa, 1994,
slightly revised November, 1997. (Reference added, in
1999.)
[ Back to top ]
1The use of dietary fibre in formulated
liquid diets will be addressed in a separate document.
|