ARCHIVED - Policy Respecting Dietary Fibre in Meal Replacements - Health Canada

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 Regulations^a to provide nutrients in accordance with the recommended nutrient intakes (RNIs) and the Nutrition Recommendations for Canadians^{b ,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 1988^d, 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 Recommendations^e, 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

1. 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
2. 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
3. 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
4. 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 fibre^g , 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

1. 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.
2. 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.
3. 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.
4. 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.
5. 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

1. 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.
2. Health and Welfare Canada. 1976. Dietary Standard for Canada. Ottawa: Minister of Supply and Services Canada.
3. Health and Welfare Canada. 1977. Nutrition Recommendations for Canadians. Ottawa: Bureau of Nutritional Sciences.
4. Health and Welfare Canada. Feb. 5, 1998. Information Letter No. 736, Dietary Fibre. Ottawa: Health Protection Branch.
5. Health and Welfare Canada. 1990. Nutrition Recommendations: Report of the Scientific Review Committee. Ottawa: Minister of Supply and Services Canada.
6. 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.
7. Health and Welfare Canada. 1985. Report of the Expert Advisory Committee on Dietary Fibre. Ottawa: Minister of Supply and Services Canada.
8. 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.
9. 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.)

¹The use of dietary fibre in formulated liquid diets will be addressed in a separate document.