Scientific substantiation of claims in the USA: Focus on functional foods

European Journal of Nutrition

Volumn 48, Issue SUPPL. 1, 2009, Pages

  Lupton, Joanne R ^a  

^a TEXAS A AND M UNIVERSITY   (United States)

Author keywords

Efficacy safety; Functional foods; Heath claims; USA

Indexed keywords

CONFERENCE PAPER; DIET SUPPLEMENTATION; FOOD AND DRUG ADMINISTRATION; FOOD SAFETY; FUNCTIONAL FOOD; HEALTH; NUTRITIONAL VALUE; UNITED STATES;

CONSUMER PRODUCT SAFETY; EVIDENCE-BASED MEDICINE; FOOD LABELING; FUNCTIONAL FOOD; HEALTH FOOD; HUMANS; LEGISLATION, FOOD; NUTRITION POLICY; NUTRITIVE VALUE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 75649143309     PISSN: 14366207     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00394-009-0073-3     Document Type: Conference Paper

References (17)

1. CSPI (2002) Citizen petition 2002P-0122. Petition for rulemaking on functional foods and request to establish an advisory committee. www.fda.gov/OHRMS/DOCKETS/98fr/02p-0122-nhc0001.pdf
2. FDA 1993 Food labeling: general requirements for health claims for food Fed Reg 58 2478 2536
3. FDA 1997 Food labeling: requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements Fed Reg 62 49859 49868
4. FDA 2004 Food labeling: nutrient content claims, general principles; health claims, general requirements and other specific requirements for individual health claims Fed Reg 69 24541 24547
5. FDA 2006 Conventional foods being marketed as "functional foods". Public hearing; request for comments. 21 CFR Parts 101 and 170 Fed Reg 71 62400 62407
6. FDA/CFSAN (1998) Guidance for industry: notification of a health claim or nutrient content claim based on an authoritative statement of a scientific body. http://www.cfsan.fda.gov/~dms/hclmguid.html
7. FDA/CFSAN (2004) Label claims. Structure/function claims http://www.cfsan.fda.gov/~dms/labstruc.html
8. FDA/CFSAN (2007a) Guidance for industry and FDA. Dear manufacturer letter regarding food labeling. http://www.fda.gov/Food/ GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ ucm053425.htm
9. FDA/CFSAN (2007b) Guidance for industry. Evidence-based review system for the scientific evaluation of health claims. Draft Guidance. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/FoodLabelingNutrition/ucm053850.htm
10. FDA/CFSAN (2007c) Qualified health claims subject to enforcement discretion. http://vm.cfsan.fda.gov/~dms/qhc-sum.html
11. FDA/CFSAN/OSN (1999) Guidance for industry: significant scientific agreement in the review of health claims for conventional foods and dietary supplements. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/ GuidanceDocuments/FoodLabelingNutrition/ucm059132.htm
12. HHS, USDA (2005) Dietary Guidelines for Americans, 2005, 6th edn. Washington DC, USA
13. IFT (2005) Expert report. Functional foods: opportunities and challenges. http://members.ift.org/IFT/Research/IFTExpertReports/
14. ILSI Japan (2000) The second report of study committee of functional food: health claims on functional foods-proposals on scientific substantiation and regulatory systems, Tokyo, Japan
15. US Congress (1958) Food Additives Amendment (the 1958 amendment) to the Public Law 85-929, Stat L 1784
16. US Congress (1990) The National Nutrition Labeling and Education Act (NLEA). Pub L101-535
17. US General Accounting Office (2000) Report to Congressional Committees. Food safety. Improvements needed in overseeing the safety of dietary supplements and "functional foods". http://www.gao.gov/new.items/rc00156.pdf