Food Labeling: Policy Rationale IFT Food Policy Impact, 2011

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1 Food Labeling: Policy Rationale IFT Food Policy Impact, 2011 Barbara O. Schneeman, Ph.D. Office of Nutrition, Labeling and Dietary Supplements CFSAN-FDA

2 General Labeling Provisions FDA s authority to regulate food labeling is provided in three laws, as amended: o Federal Food, Drug, and Cosmetic Act (FFDCA) o Fair Packaging and Labeling Act (FPLA) o Public Health Service Act (PHSA)

3 From the U.S. Federal Food, Drug, and Cosmetic Act Section 403 Misbranded Food. A food shall be deemed to be misbranded--- o Sub-Sections (a) through (y) specify conditions for misbranding Section 201 contains Definitions o Several sub-sections are relevant to food, including (n) on material fact. (i.e. Labeling is misleading if it fails to reveal material facts).

4 Options for Implementation of FDA s legal authority Amendments enacted into law Title 21 of the Code of Federal Regulations Federal Food, Drug, and Cosmetic Act Notice and Comment As Amended <date> Guidance for Industry

5 Potential Steps for Development of Regulations for Food Labeling Review initiated by law, petition, judicial decisions, and/or through Agency priority-setting process Advanced Notice of Proposed Rule Making (ANPRM) o Opportunity to ask questions and seek information or relevant research. o Review comments to decide a course of action Notice of Proposed Rule Making o Present agency thinking on a regulation o Review of comments received to revise proposal Notice of Final Rule

6 Factors that must be considered in a rule Background Petitions and grounds Legal Authority (statutory and First amendment) The Proposed or Final rule (need for regulation, options considered, revision of the regulatory language) Regulatory Impact Analysis Additional sections: o Regulatory flexibility analysis, Unfunded Mandates, Executive order 13132: Federalism, Environmental Impact, Paperwork Reduction Act of 1995, comments, references

7 Scientific Input Reports from the National Academy of Sciences Peer-reviewed scientific literature Relevant Consumer Studies Expert consultations o Advisory committee o Public meetings o Consultants Comments to dockets o Independent evaluation o Identification of relevant resources & justification

8 Mandatory Label Requirements for foods, including dietary supplements The label must contain: o Identity of food o Ingredient statement o Amount of food in package o Name and place of business o Information disclosing material facts about the food o Nutrition information (unless exempt) o Allergen labeling

9 Nutrition Labeling Nutrition Labeling and Education Act (NLEA) o Made nutrition information mandatory on most packaged foods o Specified format and content for nutrition labeling o Provision for nutrient content claims and health claims on foods

Goals of NLEA, 1990 To make available nutrition information that can assist consumers in selecting foods that can lead to healthier diets, To eliminate consumer confusion by establishing definitions

10 Goals of NLEA, 1990 To make available nutrition information that can assist consumers in selecting foods that can lead to healthier diets, To eliminate consumer confusion by establishing definitions for nutrient content claims that are consistent, To help consumers maintain healthy dietary practices and to protect these consumers from unfounded health claims, and To encourage product innovation through the development and marketing of nutritionally improved foods.

11 Goals of NLEA Authorization of Health claims and Nutrient Content claims

12 Scientific Factors to consider for Regulations/Format of Nutrition Facts Public Health Significance of Nutrition information Mandatory nutrients o Need for quantitative recommendations Provision for Voluntary Nutrients Order of Nutrients on the Label Assist consumers to understand the nutritional value of the food and to understand the food in the context of the total daily diet

13 Nutrients to be Listed Calories Calories from fat Total fat Saturated fat Trans fat Cholesterol Sodium Total Carbohydrate Dietary Fiber Sugars Protein Vitamin A Vitamin C Calcium Iron

14 Elements needed in the nutrition label format to be useful for consumers 1. Presented in a manner that is simple and minimizes clutter 2. Presented in a tabular fashion to provide rapid access to and greater visibility of, key nutrient information 3. Include a quantitative amount of each nutrient and/or a listing as a percent of recommended amounts 4. Nutrient information must be linked to the dietary guidance that is considered important to public health.

to distinguish between consumer preference for information and

15 Importance of Consumer Research to Develop Nutrition Facts format Intent of legislation focused on consumer practices Need to distinguish between consumer preference for information and the information used by consumers to make judgments on nutritional content

Value of Consumer Research in Designing the Label Format Percent Daily Value o Few

g or mg) to assist with purchase decisions.

16 Value of Consumer Research in Designing the Label Format Percent Daily Value o Few consumers were able to interpret absolute amounts of nutrient (e.g. g or mg) to assist with purchase decisions. o % Daily Value concept resulted in more accurate use of label information for choices based on nutrition. o Effective use of %Daily Value improves with educational material. Useful to determine high and low for a nutrient Can be used to estimate context for total diet o %Daily Value is linked to Nutrient Content claims

17 Information is based on serving size or the amount customarily consumed. Nutrient information is provided per serving in both amounts and as % Daily Value. Scientific information and public health significance was used to select nutrients and order presented. Footnote provides reference amounts at two energy levels.

18 Labeling Initiatives: Modernizing the Food Label Food Labeling; Prominence of Calories (70 FR 17008; 4/4/05) ANPRM Food Labeling: Serving Sizes of Products That Can Reasonably Be Consumed At One Eating Occasion; Updating of Reference Amounts Customarily Consumed; Approaches for Recommending Smaller Portion Sizes (70 FR 17010; 4/4/05) ANPRM Food Labeling: Revision of Reference Values and Mandatory Nutrients. Docket No. 2006N-0168 (2007) ANPRM.

19 Scientific Information Dietary Reference Intakes (IOM-NAS)

Child and Adolescent Overweight Decrease desired Percent 2010 Target: 5 40 30 20 Male 12-19 Male 6-11 Female 12-19 Female 6-11 10 0 1963-65 1971-74 1976-80 1988-1994 2003-06 1966-70* 1999-2002 *Data

20 Child and Adolescent Overweight Decrease desired Percent 2010 Target: Male Male 6-11 Female Female * *Data for are for adolescents years of age. Note: Overweight is defined as BMI gender- and age-specific 95th percentile from the 2000 CDC Growth Charts for the United States. Source: National Health Examination Surveys II (ages 6-11) and III (ages 12-17), National Health and Nutrition Examination Surveys I, II, III and National Health and Nutrition Examination Survey, NCHS, CDC Obj. 19-3a, b

21 Serving size information Prominence of Calorie information Presentation of Information Daily Values

22 Goals of NLEA Authorization of Health claims and Nutrient Content claims

24 Current Priorities Related to Nutrition at FDA Modernizing Nutrition Facts Addressing labeling on the Principal Display Panel (PDP) o Front-of-Pack Labeling (FOP) Menu and Vending Machine labeling Reducing Sodium and trans fat in the food supply

25 Policy Rationale for Elements of the Food Label: the Canadian Perspective William Yan, PhD Director, Bureau of Nutritional Sciences, Food Directorate, Health Products and Food Branch, Health Canada FPI Food Policy and Regulatory Conference, Arlington, Virginia December 1, 2011

26 Outline Food and Drugs Act and Regulations Modernized approach to manage health claims for foods Goal of food policy and regulations Examples Nutrition Facts table Plant sterols health claim Challenges and opportunities Additional resources 26

27 Food and Drugs Act and Regulations Health Canada (HC) regulates the labelling of food products in Canada through the Food and Drugs Act Section 5.(1): No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. Food and Drug Regulations (FDR) include provisions for nutrition labelling and claims for food 27

28 Food and Drugs Act and Regulations Nutrition labelling regulations published on January 1, 2003: Made nutrition labelling mandatory on most food labels (FDR B , B , Schedule L, Schedule M) Updated requirements for nutrient content claims (FDR B ) Permitted diet-related health claims for foods, function claims (FDR B , B ) Work to modernize the food regulatory framework is ongoing 28

29 Modernized approach to manage claims for foods Disease risk reduction or therapeutic claims: Such claims do not automatically bring a food into the drug definition Health effect is substantiated through premarket assessment and is not in violation of subsections 3(1) and (2) of the FDR (Schedule A diseases) Health benefit comes as a result of: Food s normal use as part of the diet Product containing an added substance in controlled amount being safe for consumption as food Regulatory amendments would be made only to affirm the status of products carrying such claims as foods and the conditions of use for such claims Foods with these claims can be marketed following publication of the health claim summary of assessment 29

30 Goal of nutrition labelling regulations Goal of nutrition labelling regulations is to help Canadians maintain or improve their health by providing information to assist in making informed food choices HC employs a range of strategies to achieve this: Scientific evidence Consumer research Market research Consultation with experts and stakeholders Collaboration / comparison with international partners Performance measurement and evaluation 30

31 Basis for decision making examples Nutrition Facts table Plant sterols health claim 31

32 Nutrition Facts table scientific evidence Scientific evidence was used to support mandatory declaration of nutrients Trans fat declaration in core list of nutrients was a key factor to move forward with mandatory nutrition labelling Convincing scientific evidence that trans fat was a risk factor for heart disease Surveillance data that consumption of trans fat was high among Canadians Institute of Medicine DRI Report recommendation that consumption of trans fat be as low as possible 32

33 Nutrition Facts table consumer research Consumer use and understanding of NFt was tested before and after the regulations were implemented In 1999: Consumers liked information presented in relative (%) terms It was decided to include % DV, including for macronutrients In 2010: Results confirmed usefulness of % DV concept but showed a need for clearer guidance Does it provide a lot or a little of a nutrient? 33

34 Nutrition Facts table market research Market sampling is used to confirm labelling issues that require policy/regulatory action Prior to 2003: Results showed a patchwork of formats Prescriptive requirements were therefore implemented to maximize use of the standard format In 2011: Results showed inconsistent serving sizes for similar foods Guiding principles are being developed to more closely align serving sizes with the regulated reference amounts 34

35 Nutrition Facts table consultation & collaboration Consultation is a key activity throughout the policy and regulatory development process Consumers, health professionals, academia, industry, other governments, experts Different types of public involvement employed, depending on need (e.g., workshops, on-site visits, targeted meetings, electronic consultations) E.g. targeted consultation with literacy experts led to prescriptive format requirements for the NFt Collaboration is an important way to leverage knowledge US FDA - to enhance harmonization where possible Provincial governments and industry - to improve provision of nutrition information in restaurants and food services 35

36 Nutrition Facts table performance measurement HC committed to assess the effectiveness of the nutrition labelling regulations 2011/12: Development of logic model and framework 2012/13: Data collection and analysis; recommendations Results will help identify successes, gaps, and whether changes to the regulations should be explored Foods sold in restaurants? Front of package labelling? Regulated parameters for determining serving sizes? 36

37 Basis for decision making examples Nutrition Facts table Plant sterols health claim 37

38 Plant sterols claim scientific evidence HC accepted an application prepared for EFSA as the basis for substantiation of the claim Evidence included 84 clinical trials published from 1994 to 2007 Application was evaluated to ensure our standards for claim validity were met Interim Guidance Document - Preparing a Submission for Foods with Health Claims: Incorporating Standards of Evidence for Evaluating Foods with Health Claims HC concluded that acceptable scientific evidence exists to support the claim 38

39 Plant sterols claim consumer research HC undertook consumer research to determine the type of wording that consumers would find useful Consumer research results The health claim should be stated in simple terms Consumers expect key information on the label: What is the ingredient? What is the health benefit? How is the ingredient linked to the health benefit? How much should be consumed to get the health benefit? 39

40 Plant sterols claim consistency with partners Country US FDA (2000) EC (2009) HC (2010) Wording Foods containing at least 0.65 grams/serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 grams, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies X grams of plant sterol esters. Plant sterols have been shown to lower blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease. (The beneficial effect is obtained with a daily intake of grams plant sterols). [serving size] of [name of the product] provides X% of the daily amount* of plant sterols shown to help reduce/lower cholesterol in adults. Optional: Plant sterols help reduce [or help lower] cholesterol. High cholesterol is a risk factor for heart disease. * The daily amount is 2 grams 40

41 Plant sterols claim consistency with partners Message behind the Canadian claim and the US claim is similar, with differences in how they are conveyed Efficacious daily intake is 2g vs. 1.3g Health effect is cholesterol lowering vs. heart disease risk reduction Canadian claim is very similar to the European claim Efficacious daily intake of plant sterols is 2g vs g Health effect is cholesterol lowering Mention of high cholesterol as a risk factor for coronary heart disease 41

42 Challenges and opportunities Challenges Canadians are increasingly interested in choosing foods that maintain or improve their health Industry is eager to meet consumer demand for such foods It takes time to build base of scientific and social research evidence to support policies and legislation Opportunities Collaboration and partnership E.g. Quadrilateral Social Research Group (Australia, New Zealand, US, Canada) 42

43 Additional information NL Regulations & Regulatory Impact Analysis Statement (2003); p : Report of the on-line survey on consumer use and understanding of the NFt (2010): Health Claims Assessments: Guidance for preparing health claims submissions: 43

Nutritional Criteria for Labeling Claims

Nutritional Criteria for Labeling Claims Barbara O. Schneeman, Ph.D. Office of Nutrition, Labeling and Dietary Supplements Center for Food Safety and Applied Nutrition/ Food and Drug Administration Department