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Nutrition/Food Content Labeling Policy and Actions

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ID Author(s) Title / Description Publication Date
7632 Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN) Guidance for Industry: A Food Labeling Guide
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/FoodLabelingGuide/default.htm
Format: HTML
Questions and answers regarding food labeling, which are grouped by the food labeling area of interest. Appendices include "Definitions of Nutrient Claims", "Additional Requirements for Nutrient Content Claims", "Health Claims", "Qualified Health Claims", "Additional FDA Resources", "Calculate the Percent Daily Value (DV) for the Appropriate Nutrients", and more.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20080400Apr 2008
7633 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Frequently Asked Questions about Medical Foods
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/MedicalFoods/ucm054048.htm
Format: HTML
Questions and answers regarding the definition of and regulations for medical foods.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20070500May 2007
7352 Department of Health and Human Services (DHHS), Food and Drug Administration (FDA) Food Labeling--Gluten-Free Labeling of Foods
URL: http://www.uspto.gov/web/offices/com/sol/notices/72fr2770.pdf
Format: HTML
Proposed rule in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) regarding establishing a definition of the term 'gluten-free' and uniform conditions for its use in the labeling of foods, in order to provide truthful and accurate information with respect to foods so labeled to the individuals with celiac disease.
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Source: Federal Register, Vol. 72, No. 14, Jan. 23, 2007, p. 2795-2817./GPO Access, U.S. Government Printing Office

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20070123Jan 23, 2007
6827 Food and Drug Administration (FDA) Guidance for Industry and FDA Staff: Whole Grain Label Statements: Draft Guidance
URL: http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingNutrition/ucm059088.htm
Format: HTML
Draft guidance document that answers questions about the definition of and labeling of whole grains. Comments are requested in 71 FR 8597.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20060217Feb 17, 2006
6714 Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA) Food Labeling; Nutrient Content Claims, Definition of the Term: "Healthy"
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2006_register&docid=fr11ja06-1
Format: Text
Interim final rule regarding acceptable levels of sodium in individual meat and poultry products and in meal-type products that bear the claim "healthy".
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Source: Federal Register, Vol. 71, No. 7, Jan. 11, 2006, p. 1683-1686./GPO Access, U.S. Government Printing Office

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20060111Jan 11, 2006
6668 Food and Drug Administration (FDA) Food Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim "Lean"
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2005_register&docid=fr25no05-16
Format: Text
Proposed rule regarding the use of the nutrient content claim "lean" on foods categorized as "mixed dishes not measurable with a cup". Includes discussion of costs and benefits of the proposed rule.
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Source: Federal Register, Vol. 70, No. 226, Nov. 25, 2005, p. 71041-71057./GPO Access, U.S. Government Printing Office

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20051125Nov 25, 2005
6404 Food and Drug Administration (FDA) Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term "Healthy"
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2005_register&docid=fr29se05-8
Format: Text
Final rule regarding the maximum sodium levels permitted in foods that bear the term "healthy." Includes discussion of comments received on the proposed rule, the regulatory impact analysis, and more.
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Source: Federal Register, Vol. 70, No. 188, Sep. 29, 2005, p. 56828-56849./GPO Access, U.S. Government Printing Office

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20050929Sep 29, 2005
6036 Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA) Food Standards: Requirements for Substitute Standardized Meat and Poultry Products Named by Use of an Expressed Nutrient Content Claim and a Standardized Term
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2005_register&docid=fr10jn05-4
Format: Text
"In this final rule, FSIS is establishing a general definition and standard of identity for standardized meat and poultry products that have been modified to qualify for use of an expressed nutrient content claim in their product names in conjunction with a standardized term." Includes responses to comments on the proposed rule, discussion of costs and benefits, and more.
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Source: Federal Register, Vol. 70, No. 111, Jun. 10, 2005, p. 33803-33819./GPO Access, U.S. Government Printing Office

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20050610Jun 10, 2005
6008 Kuchler, F.; Golan, E.; Variyam, J.N.; Crutchfield, S.R. Obesity Policy and the Law of Unintended Consequences
URL: http://www.ers.usda.gov/AmberWaves/June05/Features/ObesityPolicy.htm
Format: HTML
Article that discusses potential intended, unintended, and likely effects of nutrition labeling at restaurants, a tax on snack food, and curtailing advertising, particularly to children, as policies to reduce overweight and obesity.
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Source: Amber Waves, June 2005/Economic Research Service, U.S. Department of Agriculture

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20050600Jun 2005
5999 World Health Assembly (58th : 2005 : Geneva, Switzerland) Infant and Young-child Nutrition
URL: http://www.who.int/gb/ebwha/pdf_files/WHA58/WHA58_32-en.pdf
Format: PDF
Resolution regarding infant and young child nutrition, including issues related to the contamination of powdered infant formula with E. sakazakii and other microorganisms.
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Source: World Health Assembly (58th : 2005 : Geneva, Switzerland)

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20050525May 25, 2005
5983 Food and Drug Administration (FDA) Food Labeling; Guidelines for Voluntary Nutrition Labeling of Raw Fruits, Vegetables, and Fish; Identification of the 20 Most Frequently Consumed Raw Fruits, Vegetables, and Fish; Reopening of the Comment Period
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2005_register&docid=fr04ap05-23
Format: Text
Reopening of the comment period for a proposed rule to amend voluntary nutrition labeling regulations by updating names and nutrition labeling values for the 20 most frequently consumed raw fruits, vegetables, and fish in the U.S. (67 FR 12918). Includes some modifications to the nutrition labeling values.
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Source: Federal Register, Vol. 70, No. 63, Apr. 4, 2005, p. 16995-17007./GPO Access, U.S. Government Printing Office

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20050404Apr 4, 2005
5829 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: A Dietary Supplement Labeling Guide
URL: http://www.fda.gov/Food/LabelingNutrition/default.htm
Format: HTML
Questions and answers regarding the labeling of dietary supplements, including coverage of such topics as statement of identity, net quantity of contents, nutrition labeling, ingredient labeling, claims, premarket notification of new dietary ingredients, and more. Appendices include "Daily Values for Adults and Children 4 or More Years of Age," "Daily Values for Infants, Children Less Than 4 Years of Age, and Pregnant of Lactating Women," "Nutrient Content Claims," "Authorized Health Claims," "Qualified Health Claims," and more.
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20050400Apr 2005
6026 European Advisory Services The Introduction of Mandatory Nutrition Labelling in the European Union: Impact Assessment Undertaken for DG SANCO, European Commission
URL: http://europa.eu.int/comm/food/food/labellingnutrition/nutritionlabel/impact_assessment.pdf
Format: PDF
Assessment of the potential impact of mandatory nutrition labeling for pre- packaged food products in the EU. Includes discussion of a survey of nutrition labeling in retail foods, potential impact on consumer health, costs to the European food industry, and impact on member state administrations. Appendices include "Economic Impact Assessment Questionnaire (English version)" and "Nutrition labelling company questionnaire breakdown by country with indication of food category and turnover".
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Source: Health and Consumer Protection Directorate-General, European Commission

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20041130Nov 30, 2004
5000 Food Safety and Inspection Service (FSIS), U.S. Department of Agriculture (USDA) Nutrition Labeling: Nutrient Content Claims on Multi-Serve, Meal-Type Meat and Poultry Products
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2004_register&docid=fr01oc04-1
Format: Text
Final rule that affects nutrition labeling of meal-type products and main dishes. Includes responses to comments on the proposed rule, a discussion of costs and benefits of the rule, and more.
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Source: Federal Register, Vol. 69, No. 190, Oct. 1, 2004, p. 58799-58803./GPO Access, U.S. Government Printing Office

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20041001Oct 1, 2004
4174 Food and Drug Administration (FDA) Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims; Reopening of the Comment Period
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2004_register&docid=fr04my04-12
Format: HTML
Reopening of the comment period until July 6, 2004 and request for comments on specific topics related to this proposed rule first published in 60 FR 66206.
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Source: Federal Register, Vol. 69, No. 86, May 4, 2004, p. 24541-24547./GPO Access, U.S. Government Printing Office

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20040504May 4, 2004
3372 Food and Drug Administration (FDA) Food Labeling: Health Claims; Dietary Guidance
URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/03-29448.htm
Format: HTML
Advance notice of proposed rulemaking, issued to solicit comments regarding the regulation of health claims and dietary guidance statements in the labeling of conventional foods and dietary supplements. The comment period has been extended. See 69 FR 3868, available through GPO Access.
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Source: Federal Register, Vol. 68, No. 227, Nov. 25, 2003, p. 66040-66048./Division of Dockets Management, Food and Drug Administration

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20031125Nov 25, 2003
3090 Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Guidance for Industry: Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims: Small Entity Compliance Guide
URL: http://www.fda.gov/OHRMS/DOCKETS/98fr/2003d-0347-gdl0001.pdf
Format: PDF
Guidance document that explains the legal requirements set forth in 21 CFR 101.9 and 101.36 regarding the declaration of trans fatty acids on the nutrition labels of foods and dietary supplements.
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Source: Food and Drug Administration

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20030800Aug 2003
3901 Food and Drug Administration (FDA) Food Labeling: Trans Fatty Acids in Nutrition Labeling, Nutrient Content Claims, and Health Claims
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2003_register&docid=fr11jy03-14
Format: HTML
FDA's final rule requiring trans fatty acids to be declared on nutrition labels of foods and dietary supplements. Includes background information on nutrition labeling, nutrient content and health claims, discussion of the science behind the rule, further information on the nutrition labeling of trans fat, the final regulatory impact and flexibility analyses, and more.
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Source: Federal Register, Vol. 68, No. 133, July 11, 2003, p. 41433-41506./GPO Access, U.S. Government Printing Office

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20030711Jul 11, 2003
3900 Food and Drug Administration (FDA) Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer Research to Consider Nutrient Content Claims and Possible Footnote or Disclosure Statements
URL: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2003_register&docid=fr11jy03-17
Format: HTML
Advance notice of proposed rulemaking regarding trans fat nutrient content claims and a trans fat statement (as a footnote to the Nutrition Facts panel or as a disclosure statement). It includes a request for related information and data. The comment period has been reopened, as published in 69 FR 9559, available through GPO Access. The comment period has been extended, as published in 69 FR 20838, available through GPO Access.
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Source: Federal Register, Vol. 68, No. 133, July 11, 2003, p. 41507-41510./GPO Access, U.S. Government Printing Office

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20030711Jul 11, 2003
2865 Task Force on Consumer Health Information for Better Nutrition, Food and Drug Administration (FDA) Consumer Health Information for Better Nutrition Initiative: Task Force Final Report
URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/ucm096010.htm
Format: HTML
Report of this task force that was part of the Consumer Health Information for Better Nutrition Initiative. It includes the transmittal memorandum, an overview and executive summary of the situation and the work of the Task Force, and several attachments. Attachments include "Possible Regulatory Frameworks for Qualified Health Claims in the Labeling of Conventional Human Food and Dietary Supplements," "Guidance: Interim Evidence-Based Ranking System for Scientific Data," "Consumer Studies Research Agenda -- Improving Consumer Understanding and Product Competition on the Health Consequences of Dietary Choices," "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," "?One-Year? Time Line for Qualified Health Claim Activities," "Task Force Membership," "Stakeholder Meetings Summary," and "Public Dockets Comments Summary".
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Source: Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20030710Jul 10, 2003
2834 Food and Drug Administration (FDA) [ARCHIVE] FDA Acts to Provide Better Information to Consumers on Trans Fats
URL: http://web.archive.org/web/20080329103123/http://www.fda.gov/oc/initiatives/transfat/
Format: HTML
Release announcing FDA's regulation that requires manufacturers to include trans fatty acids on the Nutrition Facts panel of foods and some supplements.
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Source: Food and Drug Administration

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20030709Jul 9, 2003
2835 Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA) Questions and Answers about Trans Fat Nutrition Labeling
URL: http://www.fda.gov/Food/LabelingNutrition/ConsumerInformation/ucm109832.htm
Format: HTML
Q&A about trans fat labeling. Sections include "Fats, Trans Fatty Acid (Trans Fat), and Cholesterol," "Foods that Contain Trans Fat, Saturated Fat, and Cholesterol" (including discussion of intake of trans fat in the U.S.), "FDA's Regulation on Trans Fat Labeling," "Diet and Coronary Heart Disease," and "Background about FDA's Trans Fat Regulation" (including discussion of the costs and benefits of the final rule).
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Source: Office of Nutritional Products, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, Food and Drug Administration

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20030709Jul 9, 2003
2841 Sibbald, B. Canada's Nutrition Labels: A New World Standard?
URL: http://www.cmaj.ca/cgi/content/full/168/7/887
Format: HTML PDF
Article on Canada's new nutrition labeling regulations.
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Source: Canadian Medical Association Journal, Vol. 168, No. 7, Apr. 1, 2003.

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20030401Apr 1, 2003
2035 Canadian Department of Justice Fresh Fruit and Vegetable Regulations
URL: http://laws.justice.gc.ca/en/C-0.4/C.R.C.-c.285/index.html
Format: HTML
Unofficial version of the Canadian Fresh Fruit and Vegetable Regulations, provided for reference. Includes regulations regarding grades and standards, safety, packaging, labeling, trade, inspection, and more.
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Source: Canadian Department of Justice

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20021126Nov 26, 2002
7355 Office of Regulatory Affairs, Food and Drug Administration (FDA) Guide to Nutrition Labeling and Education Act(NLEA) Requirements
URL: http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm114100.htm
Format: HTML
Information provided as assistance for reviewing food labels for compliance with new requirements for nutrition labeling and nutrient claims. Quick reference attached at the end.
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Source: Office of Regulatory Affairs, Food and Drug Administration

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19940800Aug 1994
4082 Food and Drug Administration (FDA) 1993 Federal Register Vol. 58 Part IV: Dept. of Health and Human Services
URL: http://foodrisk.org/exclusives/NLEA/
Format: HTML PDF MS Word
This page provides access to Part IV of Federal Register Vol. 58 No. 3 (1993), "Food Labeling; General Provisions; Nutrition and Labeling; Label Format; Nutrient content Claims; Health Claims; Ingredient Labeling; State and Local Requirements; and Exemptions; Final Rules". Documents are available in pdf and Microsoft Word format.
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Source: Federal Register, Vol. 58, No. 3, Jan. 6, 1993, p. 2066-2786./FoodRisk.org

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19930106Jan 6, 1993
2864 Task Force on Consumer Health Information for Better Nutrition, Food and Drug Administration (FDA) Better Health Information for Better Nutrition
URL: http://www.fda.gov/Food/LabelingNutrition/LabelClaims/QualifiedHealthClaims/QualifiedHealthClaimsPetitions/ucm096010.htm
Format: HTML
This page provides information and related documents for FDA's Better Health Information for Better Nutrition initiative to combat obesity and make nutrition information available to consumers.
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Source: Office of the Commissioner, Food and Drug Administration

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8029 Food and Drug Administration (FDA) FDA Modernization Act (FDAMA) Claims
URL: http://www.fda.gov/food/labelingnutrition/labelclaims/fdamodernizationactfdamaclaims/default.htm
Format: HTML
This page provides access to the documents and label claims that came about as a result of the FDA Modernization Act..
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Source: Food and Drug Administration

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1769 Leatherhead Food International FoodlineWeb
URL: http://services.leatherheadfood.com/foodline/index.aspx
Format: HTML
This site provides news and events related to the food and drink industries. It also hosts several databases containing bibliographic information, abstracts, market research, legislation, news, and reports. The news features are free, but use of the databases requires a subscription. Database coverage includes food additives legislation, food processing, microbiology, nutrition, shelf-life, biotechnology, hygiene, quality assurance, crisis management, novel products, market and sales data, and more.
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Source: Leatherhead Food International

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6242 Health and Consumer Protection Directorate-General, European Commission Health & Nutrition Claims
URL: http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm
Format: HTML
Information about proposed EU legislation related to nutrition and health claims.
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Source: Health and Consumer Protection Directorate-General, European Commission

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8027 Food and Drug Administration (FDA) Health Claims Meeting Significant Scientific Agreement (SSA)
URL: http://www.fda.gov./food/labelingnutrition/labelclaims/healthclaimsmeetingsignificantscientificagreementssa/default.htm
Format: HTML PDF
This page provides access to many FDA documents of Health Claims Meeting Significant Scientific Agreement (SSA). A listing of many commodities and their associated approved health claims and final rules are given. One denied health claim is also provided..
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Source: Food and Drug Administration

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