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• Policy and Regulatory Developments Related to Prebiotics

Policy and Regulatory Developments Related to Prebiotics

The policy and regulatory resources listed below may be specific to prebiotics, dietary fiber, and/or functional foods which may include prebiotics as a functional ingredient.  

Canada

• DRAFT – Health Canada guidance on the use of the term “prebiotic(s)” on food labels and in advertising. 2012. This document clarifies the acceptable use of the term “prebiotic(s)” on food labels and in advertising and complements the Guidance documents for preparing health claim submissions previously developed by Health Canada’s Food Directorate. Last modified, 2011.
• Elements within the Nutrition Facts table. Last updated, 2014.
• Policy for labelling and advertising of dietary fibre containing food products. 2012.
• Proposed policy: definition and energy value for dietary fibre. Last modified, 2010.
• Guideline concerning the safety and physiological effects of novel fibre sources and food products containing them. Last modified, 2005.

CODEX

• In 2009, the Codex Alimentarius Commission finalized the definition of dietary fiber. Guidelines on Nutrition Labelling. Last revised, 2013.

European Union

• The European Food Safety Authority (EFSA) has issued scientific opinion on the substantiation of health claims for the following prebiotics:
• Fructooligosaccharides, 2011
• Galactooligosaccharides, 2011
• Polydextrose, 2011
• Wheat dextrin, 2010.
• The EFSA has issued scientific opinion on the substantiation of health claims related to various food(s)/food constituents(s) (including prebiotics and probiotics) and increasing numbers of gastro-intestinal microorganisms, and decreasing potentially pathogenic gastro-intestinal microorganisms. 2010.
• The European Commission amended its Council Directive on nutrition labelling for foodstuffs as regards recommended daily allowances, energy conversion factors and definitions to include dietary fiber. 2008.

FAO/WHO

• FAO technical meeting on prebiotics. This meeting of experts was convened to discuss guidelines, recommended criteria and methodology for conducting a systematic approach for the evaluation of prebiotics, leading to their safe and efficacious use in foods. 2007.

France

• The French Agency for Food, Environment, and Occupational Health and Safety has issued a report titled “Effects of probiotics and prebiotics on flora and immunity in adults.” 2005.

Ireland

• The Food Safety Authority of Ireland has issued a report titled “Probiotic health claims” which includes information on prebiotics.  Last reviewed, 2014.

Japan

• The Japanese Ministry of Health, Labor and Welfare has classified foods containing oligosaccharides, fructooligosaccharides and other dietary fibers as foods for specific health uses.

Korea

• The Health Functional Food Code developed by the Korean Ministry of Food and Drug Safety provides general provisions, general standards and specifications, and prerequisite for health claim for each functional ingredient including some prebiotics such as inulin, chicory and fructooligosaccharides.

Malaysia

• The Ministry of Health Malaysia in its Guide for Nutrition Labelling and Claims allows for nutrient function claims for prebiotics such as inulin and oligosaccharides. 2010.

Singapore

• The Agri-Food and Veterinary Authority of Singapore has approved inulin and oligofructose as prebiotics and allows function claims for foods containing prebiotics. Last updated, 2014.

South Africa

• The Department of Health in its draft amendment “Foodstuffs, Cosmetics and Disinfectants Act (54/1972): Regulations relating to the Labelling and advertising of foods: Amendment” allows for content and function claims for prebiotics (trans-galactooligosaccharide, inulin, oligofructose, fructooligosaccharides, xylooligosaccharides, polydextrose, galactooligosaccharides). 2014.
• The Department of Health has issued draft guidelines related to the regulations on labeling and advertising of foods for compliance purposes. 2014.

United States

• In the “Food Labeling: Revision of the Nutrition and Supplement Facts Labels; Proposed Rule,” the FDA proposes changes: to the declaration of non-digestible carbohydrates as dietary fibers; related to the substantiation of health claims for non-digestible carbohydrates; to voluntary declaration of “other carbohydrates” such as starch and oligosaccharides on the nutrition facts panel.  2014.
• The 2010 Dietary Guidelines Advisory Committee performed a review of systematic reviews on prebiotics and probiotics and health since 2004 and concluded that the role of gut microbiota is an important emerging area of research, but not enough research is available to make dietary recommendations for either prebiotics or probiotics. 2010.
• IOM report on Dietary Reference Intakes: Proposed definition of dietary fiber. http://www.iom.edu/Reports/2001/Dietary-Reference-Intakes-Proposed-Definition-of-Dietary-Fiber.aspx. 2001.
• In the United States, functional foods can be regulated as conventional food, a dietary supplement, a food for special dietary use, a medical food, or a drug. Often these distinctions depend on the claims made for the product and how they are marketed. The addition of prebiotics to foods may classify the food as functional foods. Regulations that may apply to prebiotics or foods containing functional ingredients include:
• Inulin, fructooligosaccharides and galactooligosaccharides have been evaluated by the FDA and confirmed as safe for addition in foods. Last updated, 2014
• Guide to nutrition labeling and education act (NLEA) requirements—Nutrition Labeling and Education Act of 1990 (NLEA), Pub. L. No 101-535, 104 Stat. 2353 and subsequent legislation. Last updated, 2014.
• Guidance for Industry:  Evidence-Based Review System for the Scientific Evaluation of Health Claims.  Last updated, 2014.
• FDA Guidance on Nutrient Content Claims. Last updated, 2014.
• FDA Guidance on Structure/Function Claims. Last updated, 2014.
• FDA Guidance for Industry on Food Labeling. Revised, 2013.
• The Federal Food, Drug and Cosmetic Act of 1938 (FD&C Act), Pub. L. 75-717, 52 US Stat. 1040, codified 21 USC §301 et seq. Last updated, 2011.
• Food Labeling:  FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims. GAO-11-102. 2011.
• FDA Modernization Act of 1997 (FDAMA), Pub. L. 105-115. Last updated, 2009.
• Amended health claim regulation “Soluble fiber from certain foods and risk of coronary heart disease (CHD)" to include barley betafiber as an additional source of beta-glucan soluble fiber and risk of coronary heart disease. 2008.
• Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. 103-417. 1994.
• Improvements Needed in Overseeing the Safety of Dietary Supplements and “Functional Foods”. GAO/RCED-00-156. 2000.

Disclaimer: Resources on this webpage are for informational purposes only and not for the purpose of providing legal advice.