“Government Perspectives and Consumer Insights on Label Claims” An Information Webcast from the International Food Information Council Foundation Welcome! Please dial in to the audio portion: Dial: 800-658-3095 Access Code: 964856914#
Welcome! • Moderators: – Elizabeth Rahavi, RD Associate Director, Health and Wellness International Food Information Council Foundation – Eric Mittenthal, MS Director, Media Relations International Food Information Council Foundation To Join the Audio Portion Dial: 800-658-3095 Access Code: 964856914#
Questions and Answers At any time during the webcast you can send questions to: foodandhealth@ific.org We will answer questions at the end of the web cast. Please follow us @foodinsight, @ificmedia A PDF copy of these slides will be available after the web cast at FoodInsight.org, search “Hot Topics” and “Government Perspectives and Consumer Insights on Label Claims” CPE Certificates will also be available on the same page
Today’s Agenda and Speakers Food Labeling: Health Claims Crystal Rasnake Rivers, MS Food and Drug Administration The Federal Trade Commission’s Approach to Health Benefits Claims Anne V. Maher, JD Kleinfeld, Kaplan & Becker, LLP Claims, Consumers, Communication: A Quick Look at Food Culture and Consumer Behavior Nancy Childs, PhD St. Joseph’s University To Join the Audio Portion Dial: 800-658-3095 Access Code: 964856914#
International Food Information Council Foundation Mission: To effectively communicate science- based information on health, nutrition, and food safety for the public good. Primarily supported by the broad-based food, beverage and agricultural industries. To Join the Audio Portion http://www.foodinsight.org Dial: 800-658-3095 Access Code: 964856914#
International Food Information Council and Foundation Consumer Research • Food & Health Survey: Consumer Attitudes toward Food, Nutrition, and Health (2006-2010) • Functional Foods/Foods for Health Consumer Trending Survey (1998-2009) • Food Label Quantitative Web Survey and Experiment (2008) • Food Label Ethnographic and Focus Group Research (2006) • Qualified Health Claims Consumer Research Project – Focus Groups and Web Survey and Experiment (2005) • Food Label & Calorie Research: Qualitative Research Findings (2004) • Impact of Trans Fat Label Information on Consumer Food Choices (2003) www.foodinsight.org
Food Labeling: Health Claims Crystal Rasnake Rivers, MS Nutrition Science Review Team, Nutrition Programs Staff Office of Nutrition, Labeling, and Dietary Supplements Center for Food Safety and Applied Nutrition Food and Drug Administration
Nutrition Labeling & Education Act of 1990 (NLEA) • Amended the Federal Food And Drug Cosmetic Act • Basis for modern food label • Provided for – Mandatory Nutrition Facts panel – Voluntary nutrition claims • Nutrient content claims when defined by FDA • Health claims when authorized by FDA
Nutrition Labeling & Education Act of 1990 (NLEA) • Rationale: – Assist consumer in maintaining healthy dietary practices – Provide level playing-field for claims – Encourage reformulation of food products
Types of Claims • Health Claims – Authorized (Significant Scientific Agreement, SSA) – Qualified Health Claim – Food Drug and Modernization Act (FDAMA) • Structure/Function Claims • Dietary Guidance Statements • Nutrient Content Claims – FDAMA
Labeling Claims Pre-Market Authorization Required? • Health Claims (SSA and QHC) - Yes • Nutrient Content Claims - Yes • Structure/Function Claims - No • Dietary Guidance- Health Messages - No
Structure/Function Claims • Describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans – “Calcium builds strong bones” • May characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function – “Antioxidants maintain cell integrity” – “Fiber maintains bowel regularity” http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm
Structure/Function Claims (Contd.) • Not pre-approved by agency • All claims must be truthful and not misleading • Dietary supplements must notify FDA of claim within 30 days after marketing • Dietary supplements must include a disclaimer that states FDA has not evaluated the claim and the supplement is not intended to "diagnose, treat, cure or prevent any disease,“ • Foods do not need disclaimer statement
Dietary Guidance – Health Messages – Not a specific substance (food or food component) • Category of food (Fruits & Vegetables) • General dietary guidance – Dietary Guidelines Choose fiber-rich fruits, vegetables, and whole grains often
Health Claim • “Health Claim” is an expressed or implied statement in food labeling about the relationship of a food substance to a disease or health- related condition. (21 U.S.C. 343(r)(1)(B); 21 CFR 101.14(a)(1)) • Not just “any claim about health” • Require Pre-approval by FDA • Can be used on conventional foods and dietary supplements
Elements of a Health Claim Substance “ A specific food (tomato) or component of food (lycopene), whether in conventional food or dietary supplement form …” (21 CFR 101.14(a)(2)) Disease or Health-Related Condition “Damage to an organ, part, structure, or system of the body such that it does not function properly (e.g. CHD), or a state of health leading to such dysfunctioning (e.g. hypertension)” (21 CFR 101.14(a)(5))
Elements of a Health Claim (SSA and QHC) Causal relationship between a substance and a disease or health-related condition for the general U.S. population or subpopulation (e.g., women, elderly) – Ability to reduce the risk of disease Not treat, prevent, cure or mitigate Drug ( Whitaker v. Thompson , 353 F.2d 947 (D.C. Cir. 2004))
Health Claims Characterize a Risk Reduction Relationship Between Diet and Disease or Health-Related Condition Food or Food Component Drug Treat/Cure Health-Related Disease, Disease Risk Condition mitigate Reduction (e.g., hypertension or Symptoms elevated LDL cholesterol) or Signs
1990 Health Claim Standard • NLEA permits authorization…only when it has determined, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement (SSA) , among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.
SSA Standard • “…represents the agency’s best judgment as to whether qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim.” • “SSA does not require a consensus or agreement based on unanimous and incontrovertible scientific opinion. However, on the continuum of scientific discovery that extends from emerging evidence to consensus, it represents an area on the continuum that lies closer to the latter than to the former.”
Health Claims (SSA) • Authorized claims (NLEA) Notice and Comment Rulemaking (540 days) • Food and Drug Modernization Act (FDAMA 1997) Notification (120 days)
FDAMA • Such claims (health or nutrient content) are based on current, published, authoritative statements from certain federal scientific bodies, or the National Academy of Sciences or any of its subdivisions • Intended to expedite the process by which the scientific basis for such claims is established Example: Potassium and reduced risk of high blood pressure and stroke
Process for Authorizing SSA Health Claims • Review petition for completeness • File petition (publicly available – dockets) • Conduct regulatory and science review • Draft denial, proposed or interim final rule (Fed Reg) • Public comment • Draft final rule (Fed Reg) (540 days) • If needed, request extension
Reviewing the Scientific Evidence Define substance/disease relationship Identify relevant studies Classify studies Rate studies for quality Rate for strength of body of evidence: quantity, consistency, relevance
Evidence Based Review of Health Claims
Selected Authorized Health Claims • Calcium and osteoporosis • Dietary fat and cancer • Dietary saturated fat and cholesterol and heart disease • Fiber containing grain products, fruits and vegetables (certain foods) and cancer • Fruits, vegetables and grain products (soluble fiber) and heart disease • Non-cariogenic sweeteners and dental caries • Soy protein and heart disease • Plant stanols /sterols ester and heart disease For full wording of these claims and eligibility criteria please see http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodLabelingN utrition/FoodLabelingGuide/default.htm
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