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July 2011 Do Companies Fall Short in Promoting Nutrition and Can We Help? A Quick and Dirty Regulatory Introduction July 24, 2011Society for Nutrition Education, Bee Marks Symposium
Pop Quiz: Healthy ?!?! 2
Pop Quiz: What kind of claim is it? 3
Instant Expert All information on a label must be truthful and non-misleading All food label claims about nutrition and health are voluntary All foods that carry voluntary claims about nutrition and health must also have nutrition labeling Statements made on the label and in labeling must conform with federal regulations 4
Policy Issue: Front-of-Pack Labeling “Front of Pack” labeling commonly refers to nutrition and health information found in voluntary claims on the primary display panel of a product:  Nutrient Content Claims Structure Function Claims Health Claims Dietary Guidance Voluntary claims are put on pack to inform consumers about things like food groups, healthy diets, overall nutrient content, or “Better for You” choices 5
Policy Issue: Front-of-Pack Labeling Wide variety of icons are in use in the marketplace on front-of-pack and at point-of-sale The use of symbols, logos, and icons to communicate nutritional information on the front of pack has seen substantial growth during this decade  IOM Phase II report pending; FDA, in coordination with FSIS, is currently studying approaches to nutrition symbols  and may develop guidance or regulations surrounding their content and use on both front-of-pack and at point-of-sale 6
Nutrient Content Claims Nutrient content claims characterize the level of nutrients in foods There are two types of Nutrient Content Claims Expressed- Relative, % Comparisons, Quantitative Implied- Healthy All the provisions for nutrient content claims also apply if the claim is part of the brand name of the food Information from the Nutrition Facts Panel included elsewhere on the label is regulated as a nutrient content claim 7
Healthy: An Implied NCC 8
Structure-Function Claims Both express and implied claims communicating the benefits of food and food components in promoting and maintaining the health of the normal structures and functions of the body  The claimed effect in a structure function claim should be achieved through the nutritive value of the food  Structure Function claims about Non-nutritive characteristics associated with the product is  considered a drug claim FDA does not require conventional food manufactures to notify FDA about their S/F claims and disclaimers are not required for conventional foods  9
Health Claims Defined as any claim made on the label or in labeling of a food, including dietary supplements, that directly or by implication, characterizes the relationship of any substance to a disease or health condition Must follow specific provisions for the claim Must be stated in ways the public can understand the information provided and in relation to a total daily diet 10
Health Claims The food must reflect “low” regulations for nutrients to be reduced in the diet The food must reflect “high” regulations for nutrients to be increased in the diet Minimum Nutrient Contribution Requirement The food must contain 10 percent or more of the RDI or DRV for vitamins A, C, iron, calcium, protein, or fiber per RACC prior to nutrient addition  (“Jelly Bean Rule”) 11
Dietary Guidance Statements Dietary guidance statements can includestatements about food  and reduced risk of disease or health condition Refer to foods and not nutrients Provide information about a general food choice or about how to achieve a healthy lifestyle Do not require FDA authorization or approval needed for health claims Expect FDA to propose rules and issue draft guidance further regulating dietary guidance statements sometime in 2011/2012 12
Melissa Musiker, MPP, RD, LD Vice President, Food and Nutrition PolicyAPCO Worldwide700 12thStreet Suite 800Washington, DC 20005Email: mmusiker@apcoworldwide.comWebsite: www.apcoworldwide.com Follow APCO on Twitter:www.twitter.com/apcoworldwide 13

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Do Companies Fall Short in Promoting Nutrition and Can We Help?

  • 1. July 2011 Do Companies Fall Short in Promoting Nutrition and Can We Help? A Quick and Dirty Regulatory Introduction July 24, 2011Society for Nutrition Education, Bee Marks Symposium
  • 3. Pop Quiz: What kind of claim is it? 3
  • 4. Instant Expert All information on a label must be truthful and non-misleading All food label claims about nutrition and health are voluntary All foods that carry voluntary claims about nutrition and health must also have nutrition labeling Statements made on the label and in labeling must conform with federal regulations 4
  • 5. Policy Issue: Front-of-Pack Labeling “Front of Pack” labeling commonly refers to nutrition and health information found in voluntary claims on the primary display panel of a product: Nutrient Content Claims Structure Function Claims Health Claims Dietary Guidance Voluntary claims are put on pack to inform consumers about things like food groups, healthy diets, overall nutrient content, or “Better for You” choices 5
  • 6. Policy Issue: Front-of-Pack Labeling Wide variety of icons are in use in the marketplace on front-of-pack and at point-of-sale The use of symbols, logos, and icons to communicate nutritional information on the front of pack has seen substantial growth during this decade IOM Phase II report pending; FDA, in coordination with FSIS, is currently studying approaches to nutrition symbols and may develop guidance or regulations surrounding their content and use on both front-of-pack and at point-of-sale 6
  • 7. Nutrient Content Claims Nutrient content claims characterize the level of nutrients in foods There are two types of Nutrient Content Claims Expressed- Relative, % Comparisons, Quantitative Implied- Healthy All the provisions for nutrient content claims also apply if the claim is part of the brand name of the food Information from the Nutrition Facts Panel included elsewhere on the label is regulated as a nutrient content claim 7
  • 9. Structure-Function Claims Both express and implied claims communicating the benefits of food and food components in promoting and maintaining the health of the normal structures and functions of the body The claimed effect in a structure function claim should be achieved through the nutritive value of the food Structure Function claims about Non-nutritive characteristics associated with the product is considered a drug claim FDA does not require conventional food manufactures to notify FDA about their S/F claims and disclaimers are not required for conventional foods 9
  • 10. Health Claims Defined as any claim made on the label or in labeling of a food, including dietary supplements, that directly or by implication, characterizes the relationship of any substance to a disease or health condition Must follow specific provisions for the claim Must be stated in ways the public can understand the information provided and in relation to a total daily diet 10
  • 11. Health Claims The food must reflect “low” regulations for nutrients to be reduced in the diet The food must reflect “high” regulations for nutrients to be increased in the diet Minimum Nutrient Contribution Requirement The food must contain 10 percent or more of the RDI or DRV for vitamins A, C, iron, calcium, protein, or fiber per RACC prior to nutrient addition (“Jelly Bean Rule”) 11
  • 12. Dietary Guidance Statements Dietary guidance statements can includestatements about food and reduced risk of disease or health condition Refer to foods and not nutrients Provide information about a general food choice or about how to achieve a healthy lifestyle Do not require FDA authorization or approval needed for health claims Expect FDA to propose rules and issue draft guidance further regulating dietary guidance statements sometime in 2011/2012 12
  • 13. Melissa Musiker, MPP, RD, LD Vice President, Food and Nutrition PolicyAPCO Worldwide700 12thStreet Suite 800Washington, DC 20005Email: mmusiker@apcoworldwide.comWebsite: www.apcoworldwide.com Follow APCO on Twitter:www.twitter.com/apcoworldwide 13

Editor's Notes

  1. Standard APCO cover with images of Washington, D.C., office.
  2. What foods are healthy?What makes a food unhealthy?What foods are always healthy?What foods are never healthy?
  3. Some foods are exempt from the minimum nutrient contribution requirement for the “healthy” claimRaw fruits, vegetablesFrozen/Canned single ingredient fruits, vegetables and mixtures of single ingredient fruits/vegetablesEnriched cereal-grain products that conform to a standard of identityFor single ingredient seafood or game healthy may be used if the food qualifies as “extra lean”Fortification in accordance with the FDA fortification policy is acceptable to meet the minimum nutrient contribution requirement