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