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Dietary Fiber Regulations

Definition

CODEX Alimentarius was founded in 1963 as part of the World Health Organisation Food and Agriculture Organisation (WHO/FAO) and is the international body that sets guidelines for national regulatory authorities. In 2009, they finally reached consensus upon a definition of dietary fiber after almost 20 years of deliberation:
             Dietary fibre denotes carbohydrate polymers with 10 or more monomeric units, which are not hydrolysed by the endogenous enzymes in the small intestine of humans and belong to the following categories: Edible carbohydrate polymers naturally occurring in the food consumed. Carbohydrate polymers, which have been obtained from food raw material by physical, enzymatic or chemical means and which have been shown to have a physiological benefit to health, as demonstrated by generally accepted scientific evidence to competent authorities. Synthetic carbohydrate polymers that have been shown to have a physiological benefit to health, as demonstrated by generally accepted scientific evidence to competent authorities. NOTES: (1) Includes also lignin and other compounds if quantified by AOAC 991.43. (2) Decision on whether to include carbohydrates with a degree of polymerization from DP 3 to 9 should be left to national authorities.

Megazyme supply an enzyme assay kit , Catalogue Number K-INTDF for the measurement of dietary fiber according to AOAC 2009.01, AOAC 2011.25.

It should be noted that the McCleary method (AOAC 2009.01/2011.25) is the only method that correctly measures total dietary fiber as currently defined by CODEX in any/all samples. For more information on this aspect of dietary fiber, please see the section on measurement of dietary fiber.

 

The current CODEX definition was accepted in order to 1) reflect the current body of scientific knowledge on dietary fiber, 2) to promote the concept that any and all substances that behave like fiber in vivo, regardless of their source, can be included as dietary fiber provided that physiological health benefits can be demonstrated for them and 3) to guide international harmonisation for food labelling and food composition tables.

Since the new definition has been published, many national and international authorities have moved to redefine their regulations based on this. An excellent article published in 2014 by Dr. Julie Jonesoutlines the global situation: The European Food Safety Authority (EFSA – regulatory body for the entire European Union), Food Standards Australia and New Zealand (FSANZ), Health Canada and equivalent bodies in China, Brazil, Chile, Mexico, Thailand, Korea, Malaysia and Indonesia have all broadly accepted the CODEX definition (including carbohydrates with DP3-9 as described in footnote 1 of the definition) and the accompanying analytical method AOAC 2009.01. South Africa is currently the only country that has decided not to include oligosaccharides with DP3-9 in their definition of dietary fiber which may prove somewhat problematic in terms of regulation as there is no analytical method available to meet that definition precisely.

In the USA, the FDA has accepted the CODEX definition and the accompanying analytical methodology AOAC 2009.01/2011.25 (and to reject an analytically unmanageable definition given by the IOM in 2001). A major FDA rule change to 21 CFR part 1012, effective from July 26th2016, is discussed in detail below.

The UK has traditionally been the only country to use a completely different definition that is based on the use of the non-starch polysaccharide (NSP) method to measure ‘fibre’. It is unclear at this time whether they will take this opportunity to harmonise with the rest of the world in this regard.

National and International Regulations

Regulatory law in the United States and the European Union is described below.

United States

In May 2016, the FDA published two final rule changes to CFR 21 Part 101. These relate to nutrition facts labelling and official serving sizes. These are the first major changes that have been introduced in over 20 years. There are a number of implications for dietary fiber measurement and reporting.

What has changed?

Nutrition Facts Label

Samples of the old and new label formats are shown side by side for comparison.
                 nutritional facts

Dietary fiber definition

The FDA has adopted the definition of dietary fiber proposed by CODEX in 2009 – and now states that for regulatory purposes, dietary fiber is the non-digestible carbohydrates (with DP ≥ 3) and lignin that are intrinsic and intact in plants, and/or added (isolated or synthetic) non-digestible carbohydrates (with DP ≥ 3) that have been determined by the FDA to have physiological benefits.

It is noteworthy that in the case of added (isolated/synthetic) digestible carbohydrates that have not been determined to have physiological benefits, food manufacturer record keeping must be used to subtract these from the dietary fiber content. Applications highlighting beneficial physiological effects of an ingredient can be made to the FDA to seek approval for dietary fiber status for that ingredient.

Dietary fiber daily value (DV):

The FDA has recognised the importance of dietary fiber in the average American diet and has now increased the recommended daily reference value for dietary fiber from 25g to 28g for a 2,000 calorie diet.

Serving size (RACC):

The reference amount customarily consumed (RACC) is the quantity of food or beverage that the FDA consider to be the typical amount consumed in a single sitting. Some food types have had their RACC increased while some have decreased. This can affect dietary fiber nutrient content claims.

Dietary fiber nutrient content claims:

Claim thresholds are set by the FDA and are based on the % DV present in the RACC for any given product.

  • 10-19% of DV (2.8g – 5.4g for dietary fiber) in the RACC allows “good source” claim.
  • 20+% of DV (> 5.5g for dietary fiber) in the RACC allows “high” or “excellent” source claim.

As an example, rice has an associated RACC of 45g (dry weight basis). To make a “good source” of dietary fiber content claim, a rice product must contain between 6.2% (i.e. 2.8g / 45g) and 12% (i.e. 5.4g / 45g) dietary fiber.

With the number of ingredients classed as dietary fiber now being curtailed due to the stricter FDA definition requiring proof of physiological benefits and the increase in the recommended daily intake for dietary fiber, some existing products that previously fulfilled the requirement for a nutrient content claim will no longer do so.

Health claims

Dietary Fiber Health Claims

Four separate health claims have been approved by the FDA on fiber containing products. These health claims are:

1) Fiber-Containing Grain Products, Fruits, and Vegetables and Cancer (21 CFR 101.76)

2) Fruits, Vegetables and Grain Products that contain Fiber, particularly Soluble Fiber, and Risk of Coronary Heart Disease (21 CFR 101.77)

3) Fruits and Vegetables and Cancer (21 CFR 101.78)

4) Soluble Fiber from Certain Foods and Risk of Coronary Heart Disease (21 CFR 101.81)

FDA Modernization Act Health Claims

Two health claims authorized based on an authoritative statement by federal scientific bodies are associated with dietary fiber:

  1. Whole Grain Foods with Moderate Fat Content and Risk of Heart Disease (Docket No. 03Q-0547)
  2. Whole Grain Foods and Risk of Heart Disease and Certain Cancers (Docket No. 1999P-2209)

There are strict guidelines governing the suitability of one of these claims for a given product and the wording that can be used in such a claim. The rules are quite complex and are outlined in full on the FDA website.

Compliance

Measurement of dietary fiber

In terms of analytical methods, the FDA has stated that appropriate AOAC methods can be employed for the measurement of dietary fiber. However, the FDA has also stated:

 “newer methods (AOAC 2009.01 and AOAC 2011.25) measure all low molecular weight non-digestible carbohydrates (i.e., non-digestible oligosaccharides) in addition to the higher molecular weight non-digestible carbohydrates, and … that the newer, more inclusive AOAC methods would be more consistent with our proposed definition of dietary fiber” – 81 FR 33864, FDA document number 2016-11867


Ingredient composition databases

The FDA document, “Guidance for Industry: A Food Labeling Guide” was last updated in 2015. This provides the latest guidance information on the use of ingredient composition databases for the generation of nutrition facts label information as opposed to the use of official analytical methods. This document states:

“If manufacturers choose to use ingredient data bases, they should be assured of the accuracy of the databases and validate the resulting calculations by comparing them with values for the same foods obtained from laboratory analyses. Manufacturers are responsible for the accuracy of the nutrition labelling values on their products.”  - See Point N37 

FDA surveillance activities

The FDA document, “Guidance for Industry: A Food Labeling Guide”, also addresses the question of regulatory oversight for the accuracy of nutrition facts labels.

“FDA will collect surveillance samples to monitor the accuracy of nutrition information. The manufacturer, packer or distributor would be advised of any analytical results that are not in compliance. Additionally, depending on circumstances, FDA may initiate regulatory action.” – See Point N33 

Timelines

The final rule becomes effective on July 26, 2016. However, the FDA has advised that a two-tier approach for compliance will be employed. Manufacturers with $10 million or more in annual food sales will have until July 26, 2018, while manufacturers with less than $10 million in annual food sales will have until July 26, 2019, to achieve compliance.


European Union

The European Food Safety Authority (EFSA) panel on Dietetic Products, Nutrition and Allergies recently published a scientific opinion on dietary reference values for carbohydrates and dietary fiber at the request of the European Commision (EC).3 This opinion recommends acceptance of the CODEX definition of dietary fiber and the accompanying analytical method AOAC 2009.01 and also recommends a daily allowance of 25 g of dietary fiber for an adult. The European Commission has also accepted the CODEX definition and AOAC 2009.01 as the most suitable analytical method for this definition and this has been included in Annex 1 of Regulation 1169/2011/EU on the provision of food information to consumers. Regulation 1169/2011/EU will apply from 13 December 2014 and at the same time Directive 90/496/EEC will be repealed.4

Dietary Fiber Nutrient Content Claims

According to EFSA, a food can be referred to as a “source of fibre” or “containing fibre”, provided that the product contains at least 3 g/100 g or 1.5 g/100 kcal of dietary fibre. Correspondingly, a food can be referred to as “high in fibre” or “containing a large amount of fibre”, provided that the product contains at least 6 g/100 g or 3 g/100 kcal of dietary fibre.

Dietary Fiber Health Claims

All health claims in the EU are covered by the Nutrition and Health Claims Regulation (NHCR). This includes all commercial presentations (product labels, print media, spoken or video presentations, company websites and social media). Health claims are split into four categories outlined below and are the evaluation of every claim is carried out by EFSA with final authorisation coming from the EC.

  • General function [Article 13(1)]
  • Emerging science [Article 13(5)]
  • Disease risk reduction [Article 14(1)a]
  • Children’s health [Article 14(1)b]. 

The EFSA panel on Dietetic Products, Nutrition, and Allergies published a scientific opinion in 2010 after investigating the link between dietary fiber consumption and a wide range of health benefits including satiety, weight management, normal blood glucose concentrations, normal blood cholesterol concentrations, normal bowel function and regularity, reduction of postprandial glycaemic response, decreasing potentially pathogenic gastro-intestinal microorganisms, increasing the number of gastrointestinal microorganisms and fat absorption. Their judgement at that time was that there was insufficient evidence to warrant an official health claim for dietary fiber (as a general food ingredient) for any of these physiological effects,5 however, seven health claims for individual fiber components have been successfully approved separately. A table detailing these successful health claims is shown here. Over time, substantiated health claims will undoubtedly continue to appear on the EU Register of Nutrition and Health Claims in response to applications made by food manufacturers.

References

1Jones, J.M. (2014) CODEX-aligned dietary fiber definitions help to bridge the ‘fiber gap’. Nutrition Journal, 13(34) Link to article

2Food Labeling: Revision of the Nutrition and Supplement Facts Labels – Department of health and human services, food and drug association. Link to document

3Scientific Opinion on Dietary Reference Values for Carbohydrates and Dietary Fibre by EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. 

4European Commission Guidance Document: With regard to methods of analysis for determination of the fibre content declared on a label. Link to document

5Scientific Opinion on the substantiation of health claims related to dietary fibre by EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA), European Food Safety Authority (EFSA), Parma, Italy. Link to document