MAKING A DIFFERENCE FOR DAIRY

Transcription

1 1250 H Street NW, Suite 900 Washington, DC P: F: April 26, 2017 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA-2016-D-2335: Use of the Term 'Healthy' in the Labeling of Human Food Products; Request for Information and Comments. To Whom It May Concern: We appreciate the opportunity to provide comments on the current and future definition of healthy. Changes in the understanding of the term healthy by nutrition professionals and the general public make this a timely topic for review. The International Dairy Foods Association (IDFA), Washington, D.C., represents the nation's dairy manufacturing and marketing industries and their suppliers, with a membership of 550 companies representing a $125 billion a year industry. IDFA is composed of three constituent organizations: the Milk Industry Foundation (MIF), the National Cheese Institute (NCI) and the International Ice Cream Association (IICA). IDFA's 220 dairy processing members run more than 600 plant operations, and range from large multi national organizations to single plant companies. Together they represent more than 85% of the milk, cultured products, cheese and frozen desserts produced and marketed in the United States. Healthy is not an easy claim to define. There have been significant changes in how consumers understand the term since the original regulatory definition. Additionally, the recent public health use of the term healthy has related to overall diets and how those diets meet the nutritional needs of Americans. This makes is difficult to set criteria that apply to individual foods, especially when attempting to make one set of criteria apply to all foods. The current regulatory definition for a healthy claim already sets different nutrient levels for fruits and vegetables, meal products, seafood and cereal grain products. We urge FDA to set criteria for a healthy claim specifically for the dairy food category, taking into consideration the full nutrient profile and dietary contributions of dairy. MAKING A DIFFERENCE FOR DAIRY

2 Criteria for a Healthy Claim Should Vary Based on Food Categories The word healthy can be used in a number of different ways, both as part of a food label and also in more general usage. In many cases, these different uses imply different meanings of the word and it would not be appropriate to make one definition fit all these different uses. Healthy has been defined as an implied nutrient content claim in 21 CFR (d). This regulation defines healthy products as meeting several nutrient levels, both limits on certain nutrients and, in many cases, minimum requirements for other nutrients. The criteria for a healthy claim should only apply to the claim itself. With the various uses of the term healthy, there are many ways that the word may be used, either on the label, in additional information from a food manufacturer, or in general conversation. If the use of the word healthy in a particular context does not imply a beneficial nutrient profile, the definition for the claim should not apply to healthy in this case. When labels make general dietary guidance statements that do not refer solely to the specific food, these statements should be allowed as long as they are truthful and not misleading, without considering the nutrient profile of the particular food. As will be explained further in our comments, these criteria for the claim should vary based on food categories. Each of these food categories should have their own criteria. For products to be included in the dairy group criteria, it must contain a dairy product as the first ingredient in the ingredient list or as the second ingredient if water is the first ingredient. We believe that the following points would be most important in considering criteria for dairy products making healthy claims: No limit on total fat No limit on saturated fat when the source of saturated fat is milkfat o If milkfat is not exempted from saturated fat limits, all lowfat and fat free dairy products should be included in healthy claim Flavored milk should be less than 13 grams added sugar per 8 fluid ounce serving Flavored yogurt should be less than 23 grams total sugar per 6 ounce serving For other dairy products, less than 35% total sugar by weight At least a good source of one of the following: calcium, protein, vitamin A Other Uses of the Term Healthy Should Not Be Required to Meet the Claim Definition Additionally, the word healthy may also be used in labeling as a dietary guidance statement. The way that healthy is used in these kinds of statements may refer to an overall diet or to an entire lifestyle. These statements should not be required to align with the regulatory definition of healthy as a claim referring to a specific product. A statement such as part of a healthy breakfast on a package should not require the food to meet the nutrient requirements of a healthy claim. As long as it is a truthful and not misleading statement and in line with current dietary guidance, these statements should continue to be acceptable. Additionally, the use of the word healthy to define foods or eating patterns is widespread in general conversations. People use the word to talk about the way they eat, which food or beverage choices they 2

3 make, or the other lifestyle or physical activity choices they select. Consumers are shifting from diets that focus on foods with a particular nutrient profile to diets that include foods and beverages that provide an overall profile that is nutritious, wholesome, and healthy. These individual definitions of a healthy diet may vary from person to person, but for many Americans these healthy diets may include foods that may not individually meet the specific requirements of the healthy claim. In many of these instances, there is no similarity between the healthy definition in the Code of Federal Regulations, or the way that people use the word healthy to refer to food products. Public health and dietary guidance has also changed how it considers healthy, focusing on achieving healthy diets, rather than healthy individual foods. The Dietary Guidelines for Americans encouraged Americans to consume healthy diets, defined as including vegetables, fruit, grains, fat free and low fat dairy, protein foods and oil and limiting saturated fat, trans fat, sodium and added sugars. 1 The Dietary Guidelines for Americans included a sample day s meals that would meet the recommendations of a healthy eating pattern. These sample meals included individual foods that have more fat, saturated fat or sodium than would currently be allowed to use a healthy claim. However, these foods can clearly fit into a healthy eating pattern. This highlights the importance of setting criteria that are flexible enough to allow choices of healthy foods. While it may not be possible to update the definition of healthy as a claim to consider all of these uses, it is important for FDA to be fully aware of the situations where healthy may be used. It would be inappropriate for the definition of a healthy claim to apply in these situations. FDA s Definition for Healthy Should Consider Several Criteria While some criteria for healthy diets were identified in the Dietary Guidelines, it is challenging to make these criteria apply to individual foods. Eating patterns are composed of a number of foods and beverages that are eaten in different amounts, at different times of day, for different reasons and often in combination with other foods or beverages. The nutrient profile of each food and beverage eaten during the day may be very different from each other, but all contribute to the overall nutrient profile of the total diet. Almost all foods provide some sort of essential nutrient. In addition, the Dietary Guidelines define foods or food groups that contribute to a healthy diet, rather than a collection of nutrients. In many nutrient-dense foods, it is the overall nutrient package provided by the food, rather than one or two nutrients, that makes the product a healthy choice, or a key part of a healthy diet. A healthy claim should help consumers identify a food or beverage that helps contribute to a healthy eating pattern. The claim should be based on a number of different criteria. It should help contribute to the consumption of a main food group identified by the Dietary Guidelines for Americans, such as dairy, fruits, vegetables, whole grains and protein. Milk-based beverages, smoothies, cultured dairy snacks and other non-standard products, also contribute toward the essential nutrient package provided by dairy, so these products should be eligible to make a healthy claim using the dairy group criteria. Inclusion in the dairy group should include foods and beverages that declare milk or another dairy ingredient as the first ingredient in their ingredient list. For products where water is the first ingredient, if milk or 3

4 another dairy ingredient is the second ingredient, then this product would also be subject to the nutrient criteria for dairy products. This aligns with the nutrition standards for competitive foods in schools. However, dairy-based foods for special dietary use should be exempted from the ingredient requirement, since these are specially formulated for unique nutrient needs. Any additional nutrient criteria should be tailored to different food categories. Different food groups and food products provide different nutrients. Dairy foods have a unique nutrient profile, including calcium, vitamin D, protein, and a variety of other nutrients. It would be inappropriate to have one standard for nutrient content that lumps the nutrient contribution of dairy products with the nutrient profile of fruits or grain products. Criteria should take into account what makes particular foods a contributor to a healthy eating pattern. In developing the criteria for each food group category, the levels of nutrients should be set in such a way that there are multiple foods in each category that meet the standards of a healthy claim. This will provide consumers with a choice in selecting a nutrient-dense option that meets their particular needs and preferences. Foods and Beverages Should Meet the Requirements Solely on the RACC Currently products that have a small Reference Amount Customarily Consumed (RACC) of less than 30 grams must meet the requirements of the healthy claim on the RACC amount, and also based on 50 grams of the product. We believe that only the RACC amount should be used as the basis for healthy claims. Included in the recent update of the Nutrition Facts panel was a review of the amounts of foods actually consumed by Americans, with a comparison to the previous RACCs. When the amount of food eaten at one sitting deviated from the existing RACC by more than 25%, FDA updated the RACC. This indicates that the RACCs as published in May 2016 reflected the amount of a particular food that Americans generally consumed. If the amount consumed of a particular product was found to be less than 30 grams, there is no reason to base claims on a higher level that is not generally eaten at one sitting. While the 50 gram rule was originally intended to prevent products from qualifying for a claim based solely on a very small serving, this works against nutrient-dense foods that have high levels of nutrients in a relatively small serving. If a product such as cheese contains at least one beneficial nutrient in a 28 gram serving, then the basis for meeting the limits should be that same serving size. The 50 gram requirement for products with small RACCs should be removed from the definition of a healthy claim. Total Fat Should No Longer Be a Consideration for Healthy Claim IDFA encourages FDA to completely eliminate fat levels as a specific nutrient criteria for all food categories. In keeping with nutrition research and recent public health recommendations, it is more important to focus on the type of fat, rather than the total amount. 4

5 Milkfat Should Be Considered Differently from other Saturated Fats In announcing enforcement discretion for total fat content when the primary fat in a product is monounsaturated or polyunsaturated fat, FDA demonstrated that not all fat is the same. While all fats provide the same level of calories per gram, the health effects of different fats can vary. Just as nutrition research has shown that polyunsaturated fats and monounsaturated fats have different health effects, so is nutrition science beginning to demonstrate that milkfat has different health effects from other saturated fats. Whole milk contains about 3-4% dairy fat by weight, and dairy fat is made up of more than 400 different types of fatty acids, making it the most complex fat naturally occurring in a food. 2 In the U.S., about twothirds of the fatty acids in milk are saturated, and one third are unsaturated (including monounsaturated and polyunsaturated fatty acids) 3, though the types and proportions of fatty acids in milk can vary. 4 Milkfat is different from other types of saturated fats, and since it is found in dairy products, it is accompanied by other essential nutrients, such as protein and calcium. Recent research 5-22 indicates that higher consumption of milk, cheese and yogurt is not linked to higher risk for heart disease or stroke, and in some cases, consumption is linked to lower risk. This result has been observed with consumption of all fat levels of dairy foods, not only with low fat or fat free. Consumption of dairy products, regardless of fat content, has neutral or beneficial associations with risk for heart disease. Based on these health effects, IDFA urges FDA to exclude milkfat from contributing toward the saturated fat limit. If a product that is primarily composed of milk or other dairy does contain a saturated fat other than milkfat, then this fat would be counted toward an appropriate saturated fat limit. Lowfat Dairy Products Should be Included in the Definition for Healthy Even if FDA chooses not to exempt milkfat from contributing toward the saturated fat limit, saturated fat levels should be set at a level that allows all low fat dairy products to meet the definition. Currently, the saturated fat limit for the healthy claim bars most low fat dairy products from making the claim. This stands in direct opposition to aligning the claim definition with the Dietary Guidelines for Americans, which specifically recommended increased consumption of lowfat dairy products. When criteria are set for dairy products, the levels of saturated fat should allow lowfat dairy products to be labeled healthy. Added Sugars Should be Considered Together with the Nutrients They Accompany The Dietary Guidelines for American recommended that Americans reduce their overall intake of added sugars as part of a healthy diet. However, the Dietary Guidelines also accepted the importance of some small level of added sugars can help Americans meet the goal of a healthy diet. The Dietary Guidelines include sweetened dairy, such as flavored milk and yogurt, in the consumption of adequate amounts of dairy products. As with other nutrients, the added sugars content should be considered in conjunction with the product it is being added to, the nutrients also present in the food and the amount of sugar contributed to the overall diet. Sweetened dairy products are healthy and should be eligible for a healthy claim because they contribute to dairy consumption and therefore to an overall healthy eating pattern. 5

6 While the Dietary Guidelines for Americans recommended an overall limit on added sugars of 10% of total calories, this limit applies to the entire diet, not to individual foods. When considering the healthfulness of a food and its contribution to a healthy diet, it is important to consider not just the amount of added sugars in a product, but the total nutrient profile, including the essential nutrients that are provided by the product. This is demonstrated by the Dietary Guidelines own sample menus that illustrate one way to meet the recommendations of the Dietary Guidelines, which includes strawberry, sweetened yogurt as part of breakfast. Flavored, sweetened versions of dairy products contain the same nutrients as plain, unsweetened versions. In many cases, these flavors appeal to more people and therefore provides more Americans with a chance to get important dairy nutrition in a form and flavor that they like. Flavored milks provide all of the same nutrients as white milk, but with a flavor that many children and adults prefer. In a position paper from the American Academy of Pediatrics about foods and beverages in schools, the AAP s Council on School Health and Committee on Nutrition declared that [c]onsideration of a beverage such as flavored milk provides a good example of the balance needed to limit added sugars and yet promote nutrient-rich foods. 23 Over the past years, many milk processors have developed lower sugar options that provide the same nutrients and flavor, but with fewer calories and lower sugar content. For flavored milk that makes a healthy claim, IDFA would support a limit of no more than 13 grams of added sugar, per cup (8 fluid ounces) serving. This level of added sugar would add about 50 calories per serving, while providing an additional healthy option with all the same nutritional benefits of unflavored milk. Setting a limit on total sugar for flavored milk could be particularly difficult for milks that meet the California standard of identity for market milk. Milk sold in California must meet the state standard, which requires 8.5% milk solids, with the combination of milkfat and milk solids equal to or more than 12%. 24 This is higher than the 8.25% milk solids nonfat required for milk sold in other states, which follow the standard of identity in the federal Code of Federal Regulations. 25 In order to meet the California standard, dairy companies add milk solids, such as nonfat dry milk. These additional milk solids include naturally occurring lactose, which therefore increases the total sugar level in milk. If the flavored milk were limited by total sugar content, milk sold in California would be unduly burdened by trying to meet this standard. Yogurt, including flavored yogurt, is a nutrient-dense food. Yogurt is naturally tart, and for many people, flavored yogurt is more appealing than plain yogurt, meaning that they are more likely to consume the many important nutrients present in each serving of flavored yogurt. While all flavored yogurt provides a number of essential nutrients and health benefits, IDFA would support allowing all yogurts with 23 grams of total sugar per 6 ounces or less to qualify for a healthy claim. This is in line with the levels allowed for in the Child and Adult Care Food Program 26 and in the IOM committee for competitive foods in schools. 27 This total sugar limit for yogurt making healthy claims will maintain product palatability while reducing intake of sugars. 6

7 Many yogurt companies have already or are currently working on reformulating yogurts to lower sugar content, so many products with 23 grams or less of total sugar per six ounces of yogurt are already available, meaning that consumers will have a choice of healthy products. For other dairy products that are more variable in their ingredients than flavored milk and yogurt, a limit of 35% of total sugar by weight, such as the limit set for competitive foods sold in schools, would be appropriate. This provides for a range of naturally-occurring and added sugars, while still limiting the total calories. The DGAC report also noted the vast majority of added sugars intake comes from the major categories of beverages (not including milk and 100% fruit juice) (47 percent) and snacks and sweets (31 percent). 28 This means that beverages, snacks and sweets represent nearly 80 percent of all added sugar intake. The DGAC report also noted that Grains, including breakfast cereals and bars, contribute 8 percent, mixed dishes contribute 6 percent, and dairy, including sweetened flavored milks and yogurts contribute only 4 percent of total added sugars intake. When considering limitations for added sugars, it makes sense to consider the overall contribution of those foods toward added sugar intake, and also the other nutrients provided in that food. Therefore, sweetened dairy products with a moderate level of added sugars as defined by the above levels should be allowed to use the claim healthy. Sodium Should Be Considered Based on Function and Contribution to Overall Diet As with added sugar, sodium content needs to be considered by the amount each food group contributes to the American food supply, as well as in conjunction with the other nutrients provided by the particular food. Within the dairy group, cheese is often singled out for sodium reduction. However due to the function of sodium in cheese and the contribution of cheese to overall sodium intake, it is not necessary for cheese to have lower sodium levels in order to contribute to a healthy diet. Cheese is the second highest source of calcium 29, yet it contributes less than four percent of the sodium to the diet. 30 Salt plays a crucial role in the manufacture and ripening of natural and processed cheeses and impacts overall product functionality, safety, and quality. Unlike in other foods, sodium is added in specific amounts for specific purposes in each specific cheese type, is not added in excess, and is not added in amounts beyond that needed for microbial safety, stability and physical integrity. Setting low sodium limits for cheese in order to meet a healthy definition could actually reduce consumer demand for these products through adverse impacts on quality, and in some cases the safety of the product may be seriously adversely affected. Cheese contributes to calcium and protein intake and counts toward dairy consumption. Since cheese contributes less than 4% of sodium intake to the diet, it is not necessary for cheese to have lower sodium levels in order to contribute to a healthy diet. Specific Recommendations for Dairy Group Criteria In order to maintain consistency with the Dietary Guidelines for Americans and to help consumers identify healthy options in food groups that are underconsumed, such as dairy products, IDFA recommends the following criteria for dairy foods. 7

8 To qualify for these criteria, the product must be a dairy product or a dairy-based food for special dietary use. To include the variety of standardized and non-standardized dairy products that contribute toward dairy and nutrient consumption, products would be included in the dairy group criteria should include a dairy ingredient, such as milk, yogurt, or cheese, as the first ingredient in the ingredient list. For products where water is the first ingredient, if milk or another dairy ingredient is the second ingredient, then this product would also be subject to the nutrient criteria for dairy products. These levels should be based on the Reference Amount Customarily Consumed (RACC) of the food. No limit on total fat No limit on saturated fat when source of saturated fat is milkfat o If milkfat is not exempt from saturated fat limits, all lowfat and fat free dairy products should be included in healthy claim Flavored milk should be less than 13 grams added sugar per 8 fluid ounce serving Flavored yogurt should be less than 23 grams total sugar per 6 ounce serving For other dairy products, less than 35% total sugar by weight At least a good source of one of the following: calcium, protein, vitamin A Conclusion IDFA is aware of the importance of providing healthy options to Americans, with appropriate statements, to aid consumers in making choices that align with the Dietary Guidelines goal of consuming healthy diets. These labeling statements may be made in a number of ways, but for a specific healthy claim, it is important that the criteria for that claim take into account the overall nutrient package of the food. Criteria should be set for different food groups, and when appropriate, for different products within that group. We feel that the criteria proposed above for dairy products would help encourage the consumption of dairy foods while also helping consumers select the options that meet their health, taste and lifestyle needs. Sincerely, Cary Frye Vice President, Regulatory & Scientific Affairs International Dairy Foods Association 1 Dietary Guidelines for Americans , 8 th edition. 2 Mansson HL. Fatty acids in bovine milk fat. Food Nutr Res Epub 2008 Jun 11. DOI:3402/fnr.v52i US Department of Agriculture, Agricultural Research Service, Nutrient Data Laboratory. USDA National Nutrient Database for Standard Reference, Release 28. Version Current: September Internet: 8

9 4 Benbrook CM, Butler G, Latif, MA, Leifert C, Davis DR. Organic production enhances milk nutritional quality by shifting fatty acid composition: A United States-wide, 18-month study. PLOS One 2013;8: Larsson SC, Virtamo J, Wolk A. Dairy consumption and risk of stroke in Swedish women and men. Stroke 2012;43: Patterson E, Larsson SC, Wolk A, Akesson A. Association between dairy food consumption and risk of myocardial infarction in women differs by type of dairy food. J Nutr 2012;143: Sonestedt E, Wirfalt E, Wallstrom P, Gullberg B, Orho-Melander M, Hedblad B. Dairy products and its association with incidence of cardiovascular disease: the Malmo diet and cancer cohort. Eur J Epidemiol 2011;26: Dalmeijer GW, Struijk EA, van der Schouw YT, Soedamah-Muthu SS, Verschuren WM, Boer JM, Geleijnse JM, Beulens JW. Dairy intake and coronary heart disease or stroke-a population-based cohort study. Int J Cardiol 2013;167: Soedamah-Muthu SS, Ding EL, Al-Delaimy WK, Hu FB, Engberink MF, Willett WC, Geleijnse JM. Milk and dairy consumption and incidence of cardiovascular diseases and all-cause mortality: dose-response meta-analysis of prospective cohort studies. Am J Clin Nutr 2011;93: Hu D, Huang J, Wang Y, Zhang D, Qu Y. Dairy foods and risk of stroke: a meta-analysis of prospective cohort studies. Nutr Metab Cardiovas 2014;24: Qin L-Q, Xu J-Y, Han S-F, Zhang Z-L, Zhao Y-Y, Szeto IMY. Dairy consumption and risk of cardiovascular disease: an updated meta-analysis of prospective cohort studies. Asia Pac J Clin Nutr 2015;24: Soedamah-Muthu SS, Masset G, Verberne L, Geleijnse JM, Brunner EJ. Consumption of dairy products and associations with incident diabetes, CHD and mortality in the Whitehall II study. Br J Nutr 2013: Louie JC, Flood VM, Burlutsky G, Rangan AM, Gill TP, Mitchell P. Dairy consumption and the risk of 15-year cardiovascular disease mortality in a cohort of older Australians. Nutrients 2013;5: van Aerde MA, Soedamah-Muthu SS, Geleijnse JM, Snijder MB, Nijpels G, Stehouwer CD, Dekker JM. Dairy intake in relation to cardiovascular disease mortality and all-cause mortality: the Hoorn Study. Eur J Nutr 2013;52: Bonthuis M, Hughes MC, Ibiebele TI, Green AC, van der Pols JC. Dairy consumption and patterns of mortality of Australian adults. Eur J Clin Nutr 2010;64: Kondo I, Ojima T, Nakamura M, Hayasaka S, Hozawa A, Saitoh S, Ohnishi H, Akasaka H, Hayakawa T, Murakami Y, Okuda N, Miura K, Okayama A, Ueshima H; NIPPON DATA80 Research Group. Consumption of dairy products and death from cardiovascular disease in the Japanese general population: the NIPPON DATA80. J Epidemiol 2013;23: Goldbohm RA, Chorus AM, Galindo Garre F, Schouten LJ, van den Brandt PA. Dairy consumption and 10-y total and cardiovascular mortality: a prospective cohort study in the Netherlands. Am J Clin Nutr 2011;93: Avalos EE, Barrett-Connor E, Kritz-Silverstein D, Wingard DL, Bergstrom JN, Al-Delaimy WK. Is dairy product consumption associated with the incidence of CHD? Public Health Nutr 2013;16: Praagman J, Franco OH, Ikram MA, Soedamah-Muthu SS, Engberink MF, van Rooij FJ, Hofman A, Geleijnse JM. Dairy products and the risk of stroke and coronary heart disease: the Rotterdam Study. Eur J Nutr 2014;54: de Oliveira Otto MC, Mozaffarian D, Kromhout D, Bertoni AG, Sibley CT, Jacobs DR, Nettleton JA. Dietary intake of saturated fat by food source and incident cardiovascular disease: the Multi-Ethnic Study of Atherosclerosis. Am J Clin Nutr 2012;96: de Oliveira Otto MC, Nettleton JA, Lemaitre RN, L MS, Kromhout D, Rich SS, M YT, Jacobs DR, Mozaffarian D. Biomarkers of dairy fatty acids and risk of cardiovascular disease in the multi-ethnic study of atherosclerosis. J Am Heart Assoc 2013;2:e Warensjo E, Jansson JH, Cederholm T, Boman K, Eliasson M, Hallmans G, Johansson I, Sjogren P. Biomarkers of milk fat and the risk of myocardial infarction in men and women: a prospective, matched case-control study. Am J Clin Nutr 2010;92: Council on School Health and Committee on Nutrition. Snacks, Sweetened Beverages, Added Sugars and Schools. Pediatrics. 2015; 135; 575; originally published online February 23, California Food and Agricultural Code, Section CFR Milk 26 Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010; Final Rule. Federal Register, Vol. 81, No

10 27 IOM (Institute of Medicine) Nutrition Standards for Foods in Schools: Leading the Way Toward Healthier Youth. Washington, DC: The National Academies Press. 28 Dietary Guidelines Advisory Committee. Scientific Report of the 2015 Dietary Guidelines Advisory Committee. 29 Keast DR, Fulgoni VL, Nicklas TA, et al. Food sources of energy and nutrients among children in the United States: National Health and Nutrition Examination Survey Nutrients 2013;22;5(1): O Neil CE, Keast DR, Fulgoni VL, et al. Food sources of energy and nutrients among adults in the US: NHANES Nutrients 2012;4(12): U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, th Edition. Washington, D.C.: U.S. Government Printing Office. December