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The Serving Size Proposed Rule Cherisa Henderson Nutrition Programs Staff Office of Nutrition, Labeling and Dietary Supplements FDA:CFSAN 1 Poll Question The current serving size on the nutrition facts label is based on… A. A recommended amount of a food product that consumers should aim to eat during a meal. B. The average amount of a food product that people usually eat during a meal. Serving (or Serving Size) § 101.9(b)(1) • An amount of food customarily (or usually) consumed per eating occasion by persons 4 years of age or older, which is expressed in a common household measure that is appropriate to the food. 3 Serving Size Vs. RACC • The Reference Amount Customarily Consumed or RACC is a number developed by FDA that manufacturers use to determine the serving size you see on the label. • The serving size is the actual number that you see on a product package. FDA determines the RACC. Manufacturers determines the serving size. Serving Size is critical! • It provides the basis upon which the number of calories and the levels of nutrients are determined. • It is not the same as portion sizes recommended in dietary guidance. 5 Check Serving Information Entire 1 Serving % DV Package % DV Serving Size Calories Calories from Fat Total Fat Trans Fat Saturated Fat Cholesterol Sodium Total Carbohydrate Dietary Fiber Sugars Protein Vitamin A Vitamin C Calcium Iron 1 cup (228 g) 250 2 cups (456 g) 500 110 12 g 1.5 g 3g 30 mg 470 mg 220 24 g 3g 6g 60 mg 940 mg 31 g 0g 5g 5g 18% 15% 10% 20% 10% 0% 4% 2% 20% 4% 62 g 0g 10 g 10 g 36% 30% 20% 40% 20% 0% 8% 4% 40% 8% Why do Manufacturers Care about Serving Size? If a manufacturer wants to make a label claim on their product, such as saying that the product is “low in fat” or “high in calcium” the information used to calculate serving size is used as the basis to determine if the product meets the standards for the claim. 7 Nutrition Labeling and Education Act of 1990 (NLEA) • Gave FDA the explicit authority to provide for nutrition labeling on packaged foods based on a serving size 8 Reference Amounts Customarily Consumed (RACCs) and Serving Sizes • In 1993 FDA established RACCs based on national consumption data • Provided manufacturers with rules to determine the serving size of their product from the appropriate RACC Why Update Serving Size Regulations? • Availability of newer consumption data • Research showing that consumption patterns of Americans have changed • Availability of recent consumer research on the use and understanding of the Nutrition Facts label • Numerous requests from food manufacturers requesting changes Advance Notice of Proposed Rulemaking (ANPRM) • 2005 – FDA issued a ANPRM that, among other things, requested comment on the following topics: – Single-serving Containers – Dual-column Labeling – Updating the RACCs • Comments to the ANPRM were considered during this proposed rulemaking Key Proposed Changes • Amend the definition of a single-serving container • Require dual-column labeling for certain packages • Update, modify and establish reference amounts customarily consumed 12 Current Definition of a Single Single-Serving Container A Package that can reasonably be consumed in a single-eating occasion • A product that is packaged and sold individually and contains less than 200 percent of the RACC. Except, that if a product has a large RACC (i.e., 100 grams or 100 milliliters or more) and contains more than 150 percent and less than 200 percent of the RACC, it may be labeled as one or two servings • A product is packaged and sold individually and contains 200 percent or more the RACC may be labeled as a single-serving container if the package can reasonably be consumed at a single-eating occasion 13 Basis for Allowing Large RACC Products to be Labeled as 1 or 2 servings FDA Analysis has determined that • It is less likely that an individual would consume about twice the amount of a product with a large RACC, than he or she would consume about twice the amount of a product with a small RACC • It is just as likely that an individual would consume about twice the RACC of a food with a large RACC as it is that he or she would consume twice the RACC of a food with a small RACC 14 Proposal for a Single-Serving Container A Package that can reasonably be consumed in a single-eating occasion • A product that is packaged and sold individually and that contains less than 200 percent of the RACC must be labeled as a single-serving container regardless of the RACC • Eliminate the provision that packaged foods sold individually and containing 200 percent or more the RACC may be labeled as a single-serving container if the package can reasonably be consumed at a single-eating occasion 15 Dual-Column Labeling Pancake Mix Currently manufacturers can voluntarily provide dual-column labeling by listing nutrition information for two or more forms of the same food (e.g., both as “purchased” and “prepared”) Dual-Column Labeling (continued) CEREAL BOX Nutrition information can also be presented for foods commonly combined with other ingredients or otherwise prepared before eating Consumer Studies on Dual-Column Labeling • FDA conducted consumer research to help enhance our understanding of whether and how much modifications to the label format may help consumers use the label1 • The study compared participants’ ability to perform various tasks, such as evaluating product healthfulness and calculating the number of calories and other nutrients per serving and per container, when using the current label versus modified versions of the current label, and compared participants’ overall attitudes toward these labels 1Lando, A. M., S. C. Lo. "Single-Larger-Portion-Size and Dual-Column Nutrition Labeling May Help Consumers Make More Healthful Food Choices," Journal of the Academy of Nutrition and Dietetics, 113:241-50, 2013 Consumer Studies on Dual-Column Labeling Results Among other findings this research shows that dualcolumn labels resulted in more participants correctly identifying the number of calories per container and the amount of other nutrients per container and per serving Consumer Studies on Dual-Column Labeling Second Study • In another study, participants were given a snack food product and either a single-column nutrition label or dual-column nutrition label (i.e., labeling indicating the nutrition information per serving and per container)1 • Findings from the study suggested that dual-column labeling led consumers who are not dieting to reduce the amount of food they consumed • The authors of this study speculated that a dual-column label works as a contextual cue that raises awareness of the amount of food consumed in a package among certain consumers 1Antonuk, B., L. Block. "The Effect of Single Serving Versus Entire Package Nutritional Information on Consumption Norms and Actual Consumption of a Snack Food," Journal of Nutrition Education and Behavior, 38:365-70, 2006. Proposal for Dual-Column Labeling Packages likely to be consumed as one or multiple servings • Intended for products that can be consumed as one serving or as multiple servings • Dual-column labeling that would present nutrition information per serving and per container would generally be required for products in packages that contain at least 200% of the RACC and up to and including 400% Example: A 90 g bag of chips would now have to list nutrition information serving (30 g) and per package (90 g) 21 Proposal for Dual-Column Labeling (Continued) • Dual-column labeling for products with 400 percent or less of the RACC would capture the most frequent consumption habits for all product categories • Dual-column labeling would provide nutrition information for those who consume the entire container in one-eating occasion as well as those consumers who share the container with others and consumers who would consume the container over multiple-eating occasions Proposed Exempted Products • Products that meet the requirement to use the small tabular format in 21 CFR 101.9(j)(13)(ii)(A)(1) or the linear format in 21 CFR 101.9(j)(13)(ii)(A)(2) • Bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils) • Bulk products traditionally used for multi-purposes (e.g., eggs, butter, margarine) • Multipurpose baking mixes • Food products that require further preparation and voluntarily contain two columns of nutrition information on the “as purchased” and “as prepared” forms of the food per serving • Food products that are commonly consumed in combination with other foods and voluntarily include another column with information regarding the combined food per serving (e.g., cereal and skim milk) It is helpful to consumers to include nutrition information based on the food in the prepared form or the combination of the foods Proposal for Dual-Column Labeling Alternate Formats • FDA also requested comments on other options for requiring certain nutrition information per serving and per container - Calories only - Calories, saturated fat and sodium • In these options the information listed per serving and per container would be beneath the serving size information and the remaining nutrients would be listed on a per serving basis in a single column Current 1993 RACCs • The 1993 RACCs represent the amount of a food product customarily consumed per eating occasion and are based primarily on 1977–1978 and 1987–1988 nationwide food consumption surveys conducted by the U.S. Department of Agriculture • Currently, there are 11 product categories for infants and children 1 to 3 years of age and 129 product categories for individuals 4 years or older • The RACCs are organized so that foods that have similar dietary usage and product characteristics are grouped together in product categories • Uniform RACCs help consumers to make nutritional comparisons of similar products in the marketplace. Current 1993 RACCs (continued) • Other factors considered: – Consistency between product categories within a product category – Dietary guidance documents – Canadian serving size – Commonly used serving size – Industry practice – Public comments Reasons for Updating, Modifying and Establish RAACs • Newer consumption data to update RACCs • Requests from industry and agency initiative to modify RACCs • Establish RACCs for products not currently in the Tables in 21 CFR 101.12 based on requests and agency initiative Scenarios for Updating, Modifying and Establishing the RACCs • Update the 1993 RACCs - When intake data significantly increases or decreases from the 1993 RACCs • Modify existing RACCs - When intake data does not significantly increase or decrease from the 1993 RACCs but instead are based on requests from manufactures and agency initiative • Establishing RACCs - For products that do not have RACCs Data Sources Used to Update, Modify and Establish the RACCs • What We Eat in America (WWEIA), National Health and Nutrition Examination Survey (NHANES) • The WWEIA provides gram amounts of each food reported consumed in the past 24-hours from each survey participant • Combined 2003-2004, 2005-2006, and 2007-2008 from the NHANES because starting in 2003 2 days of consumption data have been available • Include reliable intake data • Populations: infants through 3 years of age and 4+ Methods • Analyze each product within product category – Calculate minimum sample size – Estimate the median – Determine if there was a significant increase or decrease in consumption levels from the 1993 RACCs Other Factors Considered when Updating the 1993 RACCs • • • • Consistent RACCs for products in a product category Consistent RACCs for products that have similar dietary usage, product characteristics and are used interchangeably If the median estimates varied for products in a product category, greater consideration was given for the product with the largest sample size The reasonable consumption amount suggested in the Food and Nutrient Database for Dietary Studies Summary of RACCs to be Updated for General Food Supply Food Product Current RACC Proposed RACC Bakery products: Bagels 55 g 110 g Toaster Pastries 55 g 110 g Muffins (excluding English muffins) 55 g 110 g Updated RACCs Beverages Product Categories Food Product Beverages: Carbonated and noncarbonated beverages Wine Coolers Water Coffee flavored and sweetened Tea flavored and sweetened Current RACC Proposed RACC 240 mL (8 fl oz.) 360 mL (12 fl oz.) 240 mL (8 fl oz.) 240 mL (8 fl oz.) 360 mL (12 fl oz.) 360 mL (12 fl oz.) 240 mL (8 fl oz.) 360 mL (12 fl oz.) 240 mL (8 fl oz.) 360 mL (12 fl oz.) Updated RACCs Fish and Fruit Product Categories Food Product Current RACC Proposed RACC Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Canned fish, shell fish, or game meat Fruits and Fruit Juices: 55 g 85 g Fruits used primarily as ingredients, avocado 30 g 50 g Updated RACCs Sugars and Sweets Food Product Current RACC Proposed RACC Sugars and Sweets: All other candies Syrups Sugar 40 g 30 g 30 mL for syrups used primarily as an ingredient (e.g., light or dark corn syrup); 60 mL for all others 30 mL 4g 8g Modifying the 1993 RACCs • When intake data does not significantly increase or decrease from the 1993 RACCs - Based on requests from manufactures - Comments to the 2005 ANPRM - Agency initiatives Modified RACCs Dairy and Dessert Product Categories Food Product Dairy Products and Substitutes: Yogurt Current RACC Proposed RACC 225 g 170 g Ice cream, ice milk, frozen yogurt, sherbet, bulk ½ cup 1 cup frozen flavored and sweetened ice, frozen fruit juices, bulk 85 g 1 cup frozen flavored and sweetened ice, frozen fruit juices: novelties 85 g ½ cup Desserts: Modified RACCs Fruits and Miscellaneous Product Categories Food Product Current RACC Proposed RACC Fruits and Fruit Juices: Fruits used primarily as ingredients, others (cranberries, lemon, lime) Miscellaneous: Drink Mixes (without alcohol): all other types (e.g., flavored syrups, and powdered drink mixes) 55 g 50 g Amount to make 240 mL (without ice) Amount to make 360 mL (without ice) Establishing New RACCs • Factors considered - USDA Guidance document - Guidance for Industry: A Food Labeling Guide - Industry practices (e.g., Mintel, Gladson databases) - Recipe calculation - National Nutrient Database for Standard Reference -Determine main dietary usage (e.g., Food Lover’s Companion, allrecipes.com, etc.) New RACCs Bakery and Egg Product Categories Food Product Proposed RACC Bakery products: Eggroll, Dumpling, Pot sticker, Wonton wrappers 20 g Crepes 110 g Scones and Crumpets 55 g Pie Shells and Pastry Sheets The allowable declaration closest to an 8 square inch surface area Egg and Egg Substitutes: Sugared eggs, and Sugared egg yolk Amount to make 1 large (50 g) egg New RACCs Fish and Miscellaneous Product Categories Food Product Fish, Shellfish, Game Meats, and Meat or Poultry Substitutes: Seafood substitutes Proposed RACC 55 g Miscellaneous: Cocoa powder, carob powder, unsweetened Milk, milk substitutes and fruit based drink mixers (without alcohol) e.g., drink mixers, fruit flavored powdered drink mixes, sweetened coca powder Seasoning oils and seasoning sauces (e.g., coconut concentrate, sesame oil, almond oil, chili oil, coconut oil, walnut oil) 1 tbsp. Amount to make 240 ml drink (without ice) 1 tbsp. New RACCs Miscellaneous, Mixed Dishes and Sauces Product Category Food Product Proposed RACC Miscellaneous: Seasoning pastes (e.g. garlic paste, ginger paste, curry paste, chili paste, miso paste), fresh or frozen Mixed Dishes: 1 tsp. Appetizers, hors d’oeuvres, mini mixed dishes, e.g., mini bagel pizzas, breaded mozzarella sticks, egg rolls, 85 g add 35 g for gravy or topping dumplings, pot stickers, wontons, mini quesadillas, sauce mini quiches, mini sandwiches, mini pizza rolls, potato skins Sauces, Dips, Gravies and Condiments: Alfredo sauce ¼ cup New RACCs Soups and Sugars Product Category Food Product Proposed RACC Soups: Dry soup mixes and bouillons Amount to make 245 g Sugars and Sweets: After dinner confectionaries 10 g Powdered candies 15 g Liquid candies Fruit pastes and fruit chutney 15 mL 1 tbsp. New RACCs Vegetables Product Category Food Product Proposed RACC Vegetables: Dried vegetables, dried tomatoes, sun-dried tomatoes, dried mushrooms, dried seaweed Dried Seaweed sheets 5 g, add 5 g for products packaged in oil 3g Jalapeno and other hot peppers 30 g Pickled vegetables 30 g Vegetables: Dried vegetables, dried tomatoes, sun-dried tomatoes, dried mushrooms, dried seaweed Sprouts, all types: fresh or canned 5 g, add 5 g for products packaged in oil ¼ cup Impact of Changes in RACCs on Claims • The agency recognizes that changes in RACCs and the Daily Values will affect the eligibility of foods to bear nutrient content claims and health claims • Changes in the ability to make claims may be appropriate in light of the change in the amounts of foods customarily consumed • The agency requested comments related to changes to current claims that will be affected if the RACCs are finalized as proposed To begin shortly… Label Claims Vincent de Jesus Office of Nutrition, Labeling, and Dietary Supplements FDA:CFSAN 47