Chapter
FDA’s Framework for Overseeing Claims on Food Labels
FDA’s Organization for Overseeing Food Labels
FDA HAS ALLOWED THE USE OF 12 QUALIFIED HEALTH
CLAIMS ON FOOD LABELS AND PROVIDED LIMITED
OVERSIGHT FOR THESE CLAIMS
FDA Has Allowed the Use of 12 Qualified Health Claims for
Food
FDA Officials Estimated Spending at Least $12.8 Million to
Implement and Administer Health Claims and Qualified Health
Claims since 2000
Companies Minimally Use Qualified Health Claims
FDA Oversight of Qualified Health Claims Is Limited
CONSUMERS HAVE DIFFICULTY UNDERSTANDING
THE LEVEL OF SCIENTIFIC SUPPORT FOR QUALIFIED
HEALTH CLAIMS AND HOW THESE CLAIMS DIFFER
FROM OTHER CLAIMS
Consumers Have Difficulty Understanding the Level of Scientific
Support for Qualified Health Claims, According to Research
and Stakeholders
Research and Stakeholders Find Consumers Have Difficulty
Distinguishing among Health, Qualified Health, Structure/
Function, and Nutrient Content Claims
INDUSTRY MORE WIDELY USES STRUCTURE/FUNCTION
CLAIMS ON FOOD WITH MINIMAL FDA OVERSIGHT, BUT
FTC HAS TAKEN SOME ACTION WHEN THESE CLAIMS
WERE DECEPTIVE
Industry More Often Uses Structure/Function Claims on Food
with Minimal FDA Oversight
FTC Has Taken Some Enforcement Action on Deceptive
Structure/ Function Claims on Food
RECOMMENDATIONS FOR EXECUTIVE ACTION
AGENCY COMMENTS AND OUR RESPONSE
APPENDIX I: FDA’S ADMINISTRATION OF HEALTH
CLAIMS IN RESPONSE TO PEARSON V. SHAL ALA
APPENDIX II: OBJECTIVES, SCOPE, AND METHODOLOGY
APPENDIX III: TYPES OF CLAIMS FDA RECOGNIZES,
AND INDUSTRY MAY USE, ON FOOD
Structure/Function Claims
Implied Nutrient Content Claims
APPENDIX IV: HEALTH CLAIMS THAT MAY BE
USED ON FOOD LABELS
APPENDIX V:WARNING LETTERS ISSUED FOR CLAIM
VIOLATIONS ON FOOD LABELS AND WEB SITES,
DECEMBER 2009 THROUGH FEBRUARY 2010
Chapter 2:
COUNTRY-OF-ORIGIN LABELING
FOR FOODS
OTHER LAWS WITH LABELING PROVISIONS
Meat and Poultry Products Inspection Acts
Federal Food, Drug, and Cosmetic Act
IMPLEMENTATION OF FARM BILL COOL REQUIREMENTS
Record-Keeping, Verification, and Penalties
ECONOMIC AND TRADE ISSUES
North American Livestock Trade
WTO Case Brought against COOL by Canada and Mexico
Expansion of COOL in Food Safety Measures
Food Labeling: FDA Protections and Country-of-Origin Labels
( Government Procedures and Operations )
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