9

Background and Approach to Considering Food Package Options

Chapters 4, 5, and 6 of this report summarized the committee’s evaluation of nutrient intake, food intake, and health status of Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) participants. This information helped the committee to identify dietary gaps and food priorities for consideration during its phase II deliberations. Additionally, the committee was tasked with considering six other factors to support recommendations in phase II:

1. The role of the WIC food packages as intended by the U.S. Department of Agriculture’s Food and Nutrition Service (USDA-FNS),
2. The 2015 Dietary Guidelines for Americans (DGA) (here, the Scientific Report of the 2015 Dietary Guidelines Advisory Committee [2015 DGAC report] recommendations),
3. Science supporting the health benefits of functional ingredients in infant formulas and also foods,
4. The infant formula regulatory and market landscape,
5. Choice and flexibility within food packages, and
6. Cost.

This chapter summarizes the committee’s approach to considering each of these factors.

THE ROLE OF THE WIC FOOD PACKAGES

First, the committee reviewed the intended role of the WIC food packages as a supplemental program that promotes optimal health and development, supports breastfeeding, prevents food insecurity, and reinforces nutrition education messages. This section describes each component of this role in detail and its relevance to the committee’s charge, using information collected through a literature and report review. A description of the committee’s literature search methodology was provided in Chapter 3.

The Role of the WIC Food Packages as a Supplemental Program to Promote Optimal Health and Development

WIC was designed to be a supplemental food program. The definition of supplemental in this context has evolved since the program’s inception (see Appendix T). Most recently, as mentioned in Chapter 1, the 2007 interim rule defined supplemental foods as:

USDA-FNS’s task to the committee, as stated in Box 1-1 of Chapter 1, covers all components of this definition (i.e., nutrition, health, breastfeeding practices, and cultural norms of the WIC population), and all committee activities were (and will be, in phase II) conducted with an awareness of the intended supplemental nature of the food packages.

The Role of the WIC Food Packages in Supporting Breastfeeding

The primary way that the WIC program has endorsed and supported breastfeeding is through its “Loving Support” initiative (USDA/FNS, 2015a). Drawing on less than 5 percent of the WIC program’s overall budget (NWA, 2014), Loving Support is a social marketing effort that promotes breastfeeding to mothers, builds family and community support for breastfeeding women, and serves as the home for WIC’s breastfeeding peer counseling program that operates across the vast majority of local WIC agencies (USDA/FNS, 2015a,b). In addition to Loving Support, WIC supports breastfeeding by providing women who choose to breastfeed fully with substantially

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¹ 95th Congress. 1978. Public Law 95-627, § 17: Child care food program.

enhanced food packages, compared to packages received by women who breastfeed only partially or feed infant formula exclusively. As an additional incentive, breastfeeding women in WIC may participate for up to 1 year, whereas mothers who formula feed may participate only for up to 6 months postpartum. Additional details about breastfeeding trends, barriers, and promotion in the WIC population were provided in Chapter 7.

The Role of the WIC Food Packages in Preventing Food Insecurity

The 2015 DGAC report identified food insecurity as one of three significant nutrition-related health issues facing the U.S. population (USDA/HHS, 2015). Food insecurity occurs when individuals or families lack consistent access to enough food of adequate nutritional value for an active and healthy life.

National Prevalence of Food Insecurity

USDA assesses the prevalence of food security on an annual basis using an 18-item food security module that is administered as a supplement to the nationally representative Current Population Survey (CPS) (USDA/ERS, 2015b). The food security survey sampled 43,253 households in 2014 representative of the U.S. population and comprised a series of questions about behaviors and experiences that could indicate food insecurity, including inability to afford balanced meals and hunger due to inability to afford food. Household food security status was assigned based on the number of food insecurity indicators reported. Rates of food insecurity have been relatively stable since 2008. As detailed in the most recent assessment, 14.0 percent of all U.S. households experienced food insecurity at some point in 2014. Households with children were at higher risk. About one in five (19.9 percent) households with children less than age 6 experienced food insecurity. Food insecurity was higher among African American (26.1 percent) and Hispanic (22.4 percent) households, compared to white, non-Hispanic households (10.5 percent). Among low-income households (incomes below 185 percent of the federal poverty level), the prevalence of food insecurity was 33.7 percent.

Health and Social Effects of Food Insecurity

Research has shown that food insecurity is associated with the risk of a broad range of social and health consequences. These consequences include decreased food and nutrient intakes (Tarasuk, 2001), obesity (Larson and Story, 2011), increased rates of iron deficiency and anemia (Skalicky et al., 2006), maternal depression (Siefert et al., 2001), poorer health (Siefert

et al., 2001; Cook et al., 2004), and increased hospitalizations (Cook et al., 2004). Food insecurity may delay infant and toddler development (Rose-Jacobs et al., 2008) and have adverse effects on children’s academic performance and social skills (Jyoti et al., 2005). Specific to pregnancy outcomes, food insecurity has been associated with pregravid obesity, higher gestational weight gain, higher adequacy of weight gain ratio, low birth weight, and gestational diabetes (Ivers and Cullen, 2011). Recent studies conducted among the WIC population have found that those who live in food-insecure households score lower on mental health scales (Matthews et al., 2010), have lower diet quality (Kropf et al., 2007; Mathews et al., 2010), and are more likely to exhibit child feeding styles that are associated with development of childhood obesity (Gross et al., 2012). WIC children who live in food-insecure households may be at higher risk of being overweight or obese (Metallinos-Katsaras et al., 2011, 2012).

Relationship Between WIC Participation and Food Insecurity

Inasmuch as the WIC program is only one policy instrument used in the national effort to reduce or prevent food insecurity in the United States, it is challenging to evaluate its independent contribution to this effort. This is because much of the literature that assesses the possible role of WIC in preventing food insecurity suffers from critiques about confounding (other factors that are associated with both WIC use and food insecurity), selection bias, reverse causality, or other concerns. The committee reviewed the literature to identify studies that examined the link between WIC participation and food insecurity while accounting for selection or other possible sources of bias to the estimated effects of WIC. Only one such study was identified (Kreider et al., 2016). The committee acknowledges the body of literature that examines the effects of other food assistance programs and demonstration projects on household food insecurity and related outcomes, such as food distribution among household members. However, it was beyond the committee’s charge to conduct a comprehensive review of this literature.

Kreider et al. (2016) examined the effect of WIC on food insecurity among infants and children using data from the 1999–2008 National Health and Nutrition Examination Survey (NHANES) and applied methods that control for selection bias (see Chapter 3 for a discussion of selection bias), as well as the under-reporting of WIC in household surveys. Specifically, they examined data from 4,614 infants and children less than the age of 5 who lived in households with incomes below 185 percent of the federal poverty threshold and measured food security status using the 18-item module. Under nonparametric assumptions about the nature of the selection and misreporting, they found that WIC participation reduced

the prevalence of food insecurity by 20 percent, while other assumptions led to smaller effects.

The Potential of the WIC Food Packages to Affect Food Insecurity

WIC may improve food security by increasing access to healthy foods. However, the relationship between food security and participation in nutrition assistance programs such as WIC is complex, and is difficult to capture in the cross-sectional survey that is used to monitor food security in the United States. Inasmuch as WIC provides food and nutrition education, one might expect that households that participate in WIC would have lower rates of food insecurity than comparable households that do not participate in the program. On the other hand, if food insecurity leads households to enroll in WIC, the proportion of households that are food insecure may be higher among participants than nonparticipants. (Again, see the discussion in Chapter 3 on selection bias and how it limits interpretation of results from WIC-only studies or comparisons of WIC and non-WIC participants.) Indeed, among WIC-eligible households in 2014,² 41.1 percent of households that received WIC benefits were food insecure and 32.1 percent of households that did not receive WIC benefits were food insecure (USDA/ERS, 2015b). Similar patterns were observed among households eligible for the Supplemental Nutrition Assistance Program (SNAP) and the National School Lunch Program (NSLP), and comparable patterns have been observed among WIC participants and nonparticipants in smaller, local studies (Burkhardt et al., 2012; Odoms-Young et al., 2014).

The Role of the WIC Food Packages in Nutrition Education

Nutrition education is key in supporting WIC participants’ choices to purchase healthy foods, prepare those foods in a healthful manner, and consume them as part of a diet in alignment with the DGA. Indeed, WIC is the only federal supplemental nutrition assistance program to have a nutrition education component required by law (as specified in sections 17(b)(7), 17(f)(1)(C)(x), and 17(j) of the Child Nutrition Act of 1966, as amended, and the federal WIC regulations in sections 246.2 and 246.11 [NARA, 2007]). Under these regulations, WIC nutrition education must “be available at no cost to participants, be easily understood by participants, bear a practical relationship to the participant’s nutritional needs, household situation, and cultural preferences, and be designed to achieve the regulatory nutrition education goals” (USDA/FNS/NAL, 2006).

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² Household income below 185 percent of poverty and WIC recipients meeting other eligibility requirements.

WIC state agencies have the responsibility to develop educational materials aligned with these federal requirements (USDA/NAL, 2006). In addition, the food packages themselves provide foods that serve as a tool to meet the dietary goals of the DGA and around which education can be designed.

Results from multiple studies document the effect of WIC nutrition education on participant knowledge, attitudes, and behavior change (USDA/ERS, 2007; Kavanagh et al., 2008; Ritchie et al., 2010; USDA/FNS, 2010; Sullivan et al., 2011; Whaley et al., 2012a,b; Hildebrand et al., 2014; Isbell et al., 2014). In California, Ritchie et al. (2010) demonstrated that nutrition education alone led to increased consumption of low-fat milk and whole grains even before the 2009 changes to the WIC food packages took place. Following the policy change, consumption of these foods increased further (Whaley et al., 2012a). A study of the effect of the 2009 breastfeeding food package change on rates of breastfeeding (Whaley et al., 2012b) demonstrated significant increases in exclusive breastfeeding in the 6 months prior to the policy change, when staff training and participant education focused on exclusive breastfeeding and the upcoming policy changes. Similar changes were not evident in other states where staff training and participant education specific to the breastfeeding food package changes were not a focus prior to the food package change. These studies suggest that the maximum intended health impact of the WIC food package and 2009 revisions is linked to staff training and participant education.

DIETARY GUIDANCE AND FOOD PACKAGE OPTIONS

Although recommended revisions in the WIC food packages for individuals ages 2 years and older will align with the 2015 DGA, those guidelines were not released during the committee’s phase I deliberations. For this report, the committee relied on recommendations in the 2015 DGAC report, on which the 2015 DGA will be based (USDA/HHS, 2015). For infants and children less than 2 years old, the committee relied on guidance issued by the American Academy of Pediatrics (AAP) and other authoritative bodies. The bulk of this section (1) summarizes findings from the 2015 DGAC report on nutrient and food intake inadequacies and excesses in the U.S. population at large, (2) compares these findings to findings from the committee’s analyses of nutrient and food intake in WIC and low-income subgroups (as detailed in Chapters 4 and 5), and (3) considers the role of the WIC food packages in providing these foods and nutrients. The section ends with a summary of dietary guidance for individuals less than 2 years old.

Findings from the 2015 DGAC Report: Inadequacies to Excesses

As mentioned in Chapter 1, the 2015 DGAC report stated that several nutrients are under-consumed (relative to their Dietary Reference Intakes [DRIs]) by the U.S. population ages 2 years and older (USDA/HHS, 2015). These “shortfall” nutrients include vitamins A, D, E, and C; folate; calcium; magnesium; potassium; and fiber (see Table 1-6). For adolescent and premenopausal females, iron is also a shortfall nutrient. Of the shortfall nutrients, calcium, vitamin D, fiber, and potassium are also classified as nutrients of “public health concern” because under-consumption of these nutrients is linked with adverse health outcomes. Iron is included as a nutrient of public health concern for adolescent and premenopausal adult females because of increased risk of iron deficiency for these groups. The 2015 DGAC report also identified two nutrients—sodium and saturated fat—that pose health risks because of overconsumption (USDA/HHS, 2015). Added sugars were also identified as a nutrient that is overconsumed and should be limited (USDA/HHS, 2015).

With respect to food intakes, the 2015 DGAC report found that the majority of the U.S. population is consuming less than the recommended intakes of vegetables, fruits, whole grains, and dairy, all of which are important food sources of the shortfall nutrients (USDA/HHS, 2015). Intakes of refined grains exceed recommendations. Children between the ages of 2 to 5 years, however, do consume the recommended amounts of fruit and dairy. Given that WIC served approximately 28 percent of U.S. children ages 2 to less than 5 years in 2012 (U.S. Census Bureau, 2013; USDA/FNS, 2013), it is likely that the WIC food packages contribute to these population estimates of both nutrient and food group intakes. The committee’s NHANES analysis of nutrient intakes comparing children participating in WIC with children eligible for WIC but not participating provides further insight (see Chapters 4 and 5).

Dietary Guidance for Specific Food Groups Applicable to the WIC Food Packages

Here, food groups that are under-consumed based on the 2015 DGAC report are considered first (vegetables and whole grains for women and children and fruit and dairy for women), followed by foods for which consumption is important but are not considered to be of concern in the 2015 DGAC report (protein foods). For ease of reference, Table 9-1 provides a summary of the 2015 DGAC report’s major food group categories and examples of one serving equivalents in each category (similar information for food subgroups can be found in Appendix T, Table T-1).

TABLE 9-1 2015 DGAC Major Food Groups, Definitions, and Serving Examples

NOTES: c-eq = cup equivalents; oz-eq = ounce equivalents; tsp-eq = teaspoon equivalents.

SOURCES: USDA/HHS, 2015; serving sizes from USDA/ARS, 2014b.

Vegetables

Vegetables are the source of many of the shortfall nutrients including nutrients of public health concern, including fiber, potassium, iron, folate, and vitamin A (USDA/HHS, 2015). According to the 2015 DGAC report, the U.S. population consumes few servings of vegetables. Specifically, at ages 1 to 3 years, only 10 and 15 percent of boys and girls, respectively, consumed the recommended amounts of vegetables (1 cup of vegetables per day) (USDA/HHS, 2015). According to the committee’s analyses (see Chapter 5), even fewer (at most, 6 percent) of children participating in WIC or from low-income households ages 1 to less than 5 years consumed the recommended amounts of vegetables. These trends were similar among young adult females in the United States. Less than 10 percent of women ages 19 to 30 years met the recommendation for 2 to 3.5 cups per day, and at most, 4 percent of pregnant, breastfeeding, or postpartum women participating in WIC or from low-income households consumed this amount.

With respect to vegetable subgroups, again based on the 2015 DGAC report findings, more than 90 percent of individuals in the United States do not meet the recommended intakes for red and orange vegetables and more than 80 percent do not meet intake recommendations for dark greens, starchy vegetables, and dry beans and peas. Based on the committee’s analyses, at least 74 percent of WIC participants and individuals from low-income households failed to meet recommended intakes of dark green vegetables. Intake of dry beans and peas was similarly poor for women in the committee’s analysis, but higher for younger WIC participants and low-income populations than the general U.S. populations. The computation of intake of dry beans and peas was slightly different in the committee’s analysis compared to that of the 2015 DGAC report.³

Vegetables in the WIC food packages WIC participants can acquire vegetables from the WIC food package either by choosing 100% vegetable juice with the juice allowance or by purchasing vegetables with the cash value voucher (CVV). Vegetable juice can be purchased within the same quantity limits allowed for fruit juice. The quantity of vegetables that can be purchased with the CVV varies greatly depending on the vegetables selected and local price. Using national price data, the committee estimated that an $11 CVV would permit women to purchase 0.4 cup-equivalents of vegetables and 0.5 cup-equivalents of fruit per day in total, assuming that 50 percent of the voucher would be spent on fruits and 50 percent on

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³ In the 2015 DGAC report analysis, dry beans and peas are first applied to the total protein group until requirements for that group are satisfied, and the remainder is allocated as a vegetable. In the analysis for this report, dry beans and peas are allocated to the vegetable group only.

vegetables (see Table 1-7). This equates to approximately 16 percent of vegetable intake recommendations.

Whole Grains

Whole grains are good sources of several key shortfall nutrients, including fiber, iron, folate, magnesium, and vitamin A. The U.S. Food and Drug Administration (FDA) defines whole grains as “cereal grains that consist of the intact, ground, cracked, or flaked kernel, which includes the bran, the germ, and the inner most part of the kernel (the endosperm)” (FDA, 2009). If the kernel is no longer intact, the grain mixture must have the same relative proportions of bran, germ, and endosperm as the original grain, with the rationale that the balance of nutrients is maintained. The Whole Grains Council issues two related stamps (symbols placed on food packaging). Products eligible for the “100% Whole Grain” stamp must contain at least 16 g of whole grains per serving. Products eligible for the “Whole Grain” stamp must contain at least 8 g of whole grains per serving (Oldways Whole Grains Council, 2013). Examples of whole grains include brown rice, popcorn, bulgur, whole wheat, oats, and barley. Whole grain product availability in the marketplace has grown substantially, from approximately 360 new product introductions in 2005 to more than 900 new product introductions in 2012. Whole grain product innovations in the marketplace include whole grain ready-to-eat cereals, pancakes, French toast, breads, pasta, crackers, snacks, wraps, entrees, and pizza crusts (Mintel International, 2012).

The 2015 DGAC report included the recommendation that half of all grain intake come from whole grains and reported that, overall, whole grain intake of the U.S. population is too low (nearly 100 percent of women 19 to 50 years of age had intakes below recommendations). Intake of refined grains, in contrast, is too high. The same was the case for all subgroups analyzed in this report (see Chapter 5).

Whole grains in the WIC food packages Whole grains in the WIC food packages may come from either the whole wheat bread or breakfast cereal food categories. Whole grains must be the primary ingredient by weight in all whole grain bread products, and all whole grain bread products must conform to the FDA standard of identity specifying that “whole wheat flour” and/or “bromated whole wheat flour” are the only flours that can be listed in the ingredient list (USDA/FNS, 2015c). WIC food package substitutions permitted for whole grain bread include brown rice, bulgur, oats, and whole grain barley, pasta/macaroni, and tortillas (USDA/FNS, 2014). For the WIC cereals food package category, at least 50 percent of breakfast cereals on state agency food lists are required to contain a whole grain as

the primary ingredient. This parallels the National School Lunch and Breakfast programs requirements that half of the grains offered during the school week must meet the whole grain rich criteria⁴ (USDA/FNS, 2012a). All foods in both the whole wheat bread and breakfast cereal categories must meet FDA labeling requirements for making a health claim as a whole grain food of moderate fat content (FDA, 2003; USDA/FNS, 2011). In terms of what participants may ultimately redeem, options in the whole wheat bread category must be whole grain, but options selected for breakfast cereals from the state-authorized food lists may or may not be whole grain.

As noted in Chapter 6, the FDA does not require fortification of whole grain products with folic acid. For example, “bread, whole wheat, commercially prepared” (from the USDA Standard Reference Database, Release 27 [USDA/ARS, 2014a]) provides 12 μg of dietary folate equivalents (DFE) per ounce, whereas “bread, white, commercially prepared” provides 48 μg DFE per ounce. Assuming that grain intake of women in the NHANES analysis conducted for this study was 100 percent bread (realizing that in reality it is a combination of different grain-based foods), current daily intake of folate from whole grains would be 7.2 μg DFE and, from refined grain sources, 313 μg DFE. If all grain intakes were changed to whole grain sources, total daily intake (from grains) would drop from 321 to 86 μg DFE. Thus, there is a trade-off between increasing consumption of whole grains versus increasing consumption of folic acid from enriched, but not whole grain, products.

Fruits (Including Fruit Juice)

According to the 2015 DGAC report, fruit contributes substantial amounts of fiber and potassium, two nutrients of public health concern. The majority of children 1 to 8 years of age in the general U.S. population meet recommended intakes for total fruit (1 cup and 1.5 cups per day, respectively). However, few adult women consume the recommended daily amount (2.5 cups per day). More than half the fruit intake for Americans 1 year of age and older comes from whole fruit. Fruit intake is composed of slightly less whole fruit for children ages 1 to 3 years of age. In the analyses conducted for this report, children ages 2 to less than 5 years in both the WIC and low-income subgroups consumed approximately half the recommended fruit intakes (including 100% juice), and women (pregnant, lactating, or postpartum) consumed even less.

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⁴ “Foods that qualify as whole grain-rich for the school meal programs are foods that contain 100 percent whole grain or contain a blend of whole-grain meal and/or flour and enriched meal and/or flour of which at least 50 percent is whole grain” (USDA/FNS, 2012a).

Recommendations specific to fruit juice The fruit category in the 2015 DGAC report includes both whole fruit and 100% fruit juice (see Box 9-1 for the regulatory definition of 100% fruit juice), with 1 cup (8 ounces) of 100% fruit juice being equivalent to 1 cup of whole fruit (USDA/HHS, 2015). Although whole fruit is not distinguished from 100% fruit juice in either the 2010 DGA or the 2015 DGAC report, the 2010 DGA recommended limiting the amount of 100% juice consumed in place of whole fruit given the lack of fiber and potential to contribute excess calories to the diet (USDA/HHS, 2010). Likewise, the AAP recommends that 100% fruit juice be limited to 4 to 6 ounces per day for children ages 1 to 6 years (AAP, 2014). The AAP rationale was that 100% fruit juice is easily overconsumed because it tastes good, but it lacks the fiber contained in whole fruit and offers no nutritional advantages over whole fruit. For infants younger than 6 months, the AAP recommends no juice be provided (AAP, 2014). Its rationale was to avoid displacement of other key nutrients from human milk, formula, or complementary foods.

In the analyses presented in Chapter 5, children ages 2 to less than 5 years had a mean usual intake of fruit of 1.43 c-eq per day (compared to a recommended intake of 1.19 c-eq per day). Applying the 2015 DGAC report estimate that approximately 42 percent of fruit intake is from juice (USDA/HHS, 2015), this equates to approximately 0.6 cup-equivalents of juice per day, which falls within the AAP recommended limit of 4 to 6 ounces per day.

Fruit juice and health Although the 2015 DGAC report did not review the effect of fruit juice on health, several groups have conducted evidence-based reviews to examine the impact of 100% juice consumption on health. They

failed to find a link with the risks of developing either type 2 diabetes (Xi et al., 2014) or childhood obesity unless the portion sizes were large (AND, 2014). The results of other reviews suggest potential positive effects of consumption of 100% juice on a number of health outcomes, including cancer, cardiovascular disease, cognition, hypertension, urinary tract infections, and disease-related processes (i.e., inflammation, oxidation, platelet function, vascular reactivity) (Coelho et al., 2013; Lamport et al., 2014; Hyson et al., 2015). Authors of the Academy of Nutrition and Dietetics review (AND, 2014) reported that children who consume 100% fruit juice tend to consume more calcium and potassium and are therefore at lower risk of inadequacy for these nutrients.

Fruit juice in the WIC food packages Fruit juice (100% only) is provided in the WIC food packages as a separate food category. The juice provided must adhere to the FDA standards of identity for fruit (NARA, 2014a) or vegetable juice (NARA, 2014b), be pasteurized and unsweetened, and contain at least 30 mg of vitamin C per 100 mL of juice. Vegetable juice may be reduced in sodium. The 2009 food package revisions eliminated juice for infants and reduced juice for children from 288 to 128 fluid ounces, which is the equivalent to 4 ounces per day, the lower end of the AAP recommendation (AAP, 2001) (see Table 9-2). Currently, both children 1 to 4 years of age and women (depending on the food package) may receive up to 128 fluid ounces of juice, or the equivalent of 4.27 ounces per day, for a 30-day period. Andreyeva et al. (2013) evaluated the effect of the reduction in the juice allotment in the 2009 food packages on juice consumption in Connecticut and Massachusetts. They found that purchases of 100% juice declined by 25 percent in WIC households and were not offset by non-WIC funds used for additional juice or other beverages.

TABLE 9-2 American Academy of Pediatrics Recommendations for Fruit Juice Consumption

SOURCE: AAP, 2001.

Dairy

Dairy foods provide vitamin D, calcium, and potassium, all nutrients of public health concern. Consumption of dairy foods is associated with lower risk of diabetes, metabolic syndrome, cardiovascular disease, and obesity (USDA/HHS, 2015). Dairy foods in the USDA food patterns include fluid milk, cheese, yogurt, ice cream, milk-based replacement meals, and some nondairy milk products, including fortified soy milk, but not almond or other plant-based milk-type products. The 2015 DGAC report identified low- or nonfat dairy as part of a healthy dietary pattern. (A summary of evidence on the health effects of dairy fat is provided later in this chapter.) Among the U.S. population at large, dairy intake begins to decline in adolescence and persists at very low levels among adult females, with fewer than 5 percent of women consuming the recommended 3 cup-equivalents of dairy per day (USDA/HHS, 2015). In contrast, in the analyses for this report, dairy intakes were met by approximately 50 to 70 percent of WIC participant children and low-income children ages 1 to less than 5 years and an even greater proportion of women (86 to 92 percent).

Dairy in the WIC food packages In the WIC food packages, dairy foods include milk, cheese, and yogurt. The milk category includes several possible dairy substitutions (e.g., cheese, yogurt), depending on the state, and non-dairy substitutions (e.g., soy beverage, calcium-set tofu). The substitutions are intended to provide calcium when milk is not selected for the participant’s food package. Currently, the U.S. population consumes similar amounts of milk and cheese (53 percent of dairy intake comes from milk and 45 percent comes from cheese) (USDA/HHS, 2015).

Protein Foods

Protein foods provide essential amino acids, and some protein foods are important sources of iron. As previously mentioned, iron is a nutrient of public health concern for adolescent and adult females. Meat foods in the protein group provide heme iron, which is more bioavailable than non-heme plant-derived iron. Heme iron is especially important for young children and pregnant women (USDA/HHS, 2015). Protein foods include meat, poultry, fish, seafood, eggs, soy, nuts, and seeds. Dairy foods also provide protein, but are part of a separate food group in the food patterns.

The 2015 DGAC report stated that nearly 80 percent of boys and 75 percent of girls ages 1 to 3 years meet or exceed the recommended intake of protein foods, approximately 60 percent of boys and girls ages 4 to 8 years also meet or exceed these recommendations, and approximately 40 percent of females ages 19 to 30 years meet the recommendation for intake of pro-

tein foods. (USDA/HHS, 2015). Most of the protein foods consumed across all age groups are from the meat, poultry, and eggs group. In the analyses presented in this report for WIC participants and low-income individuals, fewer than 20 percent of children ages 1 to less than 2 years and slightly less than 50 percent of children ages 2 to 5 years met recommended intakes for total protein foods. For women, approximately 30 to 40 percent met recommended intake amounts. Intakes of seafood and nuts, seeds, and soy were very poor across all age groups.

Protein foods in the WIC food packages Protein foods are included in several WIC food categories, including peanut butter (which can be substituted with legumes), eggs, fish, and infant (baby food) meats. Protein is also provided by milk and some milk food package substitutions and cheese.

Nutrients to Limit: Saturated Fat, Sodium, and Added Sugars

In addition to identifying many shortfall nutrients, the 2015 DGAC report identified several “nutrients to limit,” namely saturated fat, added sugars, and sodium. This section summarizes the 2015 DGAC report’s findings related to these three nutrients, the committee’s findings for WIC and low-income populations (detailed in Chapter 4), and the role of the WIC food packages in providing these nutrients (see Table 9-3). The 2015 DGAC report’s changes to recommended cholesterol intakes are also covered in this section.

Saturated Fat

Although the 2015 DGAC report did not include an upper limit for total fat intake, recommendations included replacing saturated fats with polyunsaturated alternatives and replacing solid animal fats with non-tropical vegetable oils and nuts (USDA/HHS, 2015). Additionally, the 2015 DGAC report noted, “a potential approach to increasing intake of shortfall nutrients and nutrients of public health concern while simultaneously decreasing intake of overconsumed nutrients of public health concern would be to increase intake of fat-free or low-fat fluid milk in lieu of cheese” (USDA/HHS, 2015, p. 108). Major sources of saturated fat in the American diet include mixed dishes (burgers, pizza, sandwiches, and tacos), snacks and sweets, protein foods (meats, deli and cured meats, and poultry), and dairy (higher-fat milk, yogurt, and cheese) (USDA/HHS, 2015).

Since 2012 the National School Lunch Program (a federal nutrition assistance program that is also required to align with dietary guidance) has required that all milk served in schools be low fat or fat free and, if flavored, fat free (USDA/FNS, 2012b). Similarly, the current WIC food package

TABLE 9-3 Sodium, Saturated Fat, and Added Sugars Content of Representative Currently Allowable WIC Foods

NOTES: c-eq = cup-equivalents; DGAC = Report of the Dietary Guidelines Advisory Committee; NA = not applicable; oz-eq = ounce-equivalents; T = tablespoon. Cup-equivalents and ounce-equivalents generally equate to consumer serving sizes. However, serving sizes may vary for processed consumer foods.

^a The 2015 DGAC report recommendation for sodium is 2,300 mg/day for adults.

^b The 2015 DGAC report recommendation is for total daily intake; therefore, the values should be interpreted in this context. “DGAC report daily recommendations” are based on a 2,200 kcal food pattern, which was the mean Estimated Energy Expenditure of WIC women in the NHANES analysis conducted for this report.

^c The limit for solid fats for a 2,200 kcal food pattern is 18 g/day. Saturated fat was compared to the recommended limit for solid fats. The limit for solid fat for the 1,000–1,300 kcal weighted diet applied to children ages 1 to less than 5 years in this report was 7.8 g/day.

^d Added sugars were calculated by subtracting naturally occurring sugar from total sugars. The limit for added sugars for a 2,200 kcal food pattern is 32 g/day. The USDA final rule permits ≤ 40 g total sugar per cup of yogurt and ≤ 6 g per ounce of breakfast cereal. The limit for added sugars for the 1,000–1,300 kcal weighted diet applied to children ages 1 to less than 5 years in this report was 13.6 g/day.

^e Not applicable because the nutrient to limit is not present in the food, as allowed under the WIC program.

^f Dairy equivalents of cheese range from 1 to 2 ounces. One ounce was selected as a conservative example.

^g Serving sizes vary for processed consumer cereals. For example, an ounce-equivalent of cereal is 28.35 g according to the Food Patterns Equivalents Database 2011–2012, whereas the product label for the brand name cereal specifies a serving size of 32 g. Naturally occurring sugars accounted for 0.28 g in cereal.

* These values were corrected from the prepublication version of this report. Naturally occurring sugars in yogurt was corrected from 10.3 g to 17.3 g and for peanut butter was corrected from 0.76 to 0.67 g. Corresponding corrections were made to the amount of added sugars in “yogurt, vanilla, low fat,” and in “peanut butter, salted.” The contributions to the daily recommendation for added sugars were correspondingly lowered. Values for tuna were corrected from the prepublication version of this report, which were expressed per 100 grams of tuna instead of oz-equivalents.

SOURCES: Recommended intakes from the Scientific Report of the 2015 Dietary Guidelines Advisory Committee (USDA/HHS, 2015). Sodium, saturated fat, and added sugars amounts from the USDA National Nutrient Database for Standard Reference Release 27 (USDA/ARS, 2014a). Cup- and ounce-equivalents are per the Food Patterns Equivalents Database 2011–2012: Methodology and User Guide (USDA/ARS, 2014b).

allows only 1% or fat-free milk for individuals ages 2 years and older, and quantities of cheese were reduced in 2009 to a maximum of 1 or 2 pounds per month, depending on the food package. Rehm et al. (2015) modeled replacement of whole, reduced-fat, or flavored milk with plain low-fat or skim milk and found that replacement reduced intakes of energy and saturated fat and did not compromise calcium or potassium intakes. Table 9-3 illustrates that consumption of 1 ounce of cheese plus 1 cup of 1% milk per day provides approximately 40 percent of the recommended daily limit for saturated fat (18 g) for a 2,200 kcal food pattern.

Considerations for dairy fat Some emerging data suggest that dairy fat consumption may have different implications for health than other types of saturated fats (Holmberg and Thelin, 2013; Kratz et al., 2013, 2014; Scharf et al., 2013; Da Silva et al., 2014; Yakoob et al., 2014; DeBoer et al., 2015; Keast et al., 2015). This topic was not covered by the 2015 DGAC report because these data were just appearing in the published literature at the close of DGAC deliberations (Personal communication, A. Lichtenstein, Tufts University, as commented to the committee in their workshop held on March 12, 2015). The committee reviewed studies published since the DGAC 2015 completed their deliberations. Highlights are summarized here.

Kratz and colleagues (2013) reviewed 16 studies on the relationship between consumption of dairy fat or high-fat dairy foods and obesity or cardiometabolic disease. They found no positive associations between intake of dairy fat or high-fat dairy foods and either adiposity at baseline or adiposity over time. Most of the studies that they reviewed (11 of the 16) showed an inverse association between high-fat dairy consumption and indices of adiposity. Studies in which the relationship between high-fat dairy consumption and metabolic health was examined reported either an inverse or no association. The authors concluded that observational evidence does not support the hypothesis that either dairy fat or high-fat dairy foods contribute to either obesity of cardiometabolic risk. Keast and colleagues (2015) analyzed data from the 2005–2008 NHANES and found that despite greater energy and saturated fat intakes, dairy consumption was not associated with greater body weight or measures of adiposity. Scharf et al. (2013) examined 10,700 children at age 2 and 4 years participating in the Early Childhood Longitudinal Study-Birth Cohort (ECLS-B), a representative sample of U.S. children. Across racial, ethnic, and socioeconomic status subgroups, 1%/skim milk drinkers had higher body mass index (BMI) z-scores than 2%/whole milk drinkers. As the ECLS-B was an observational study, it is possible that reverse causality was an issue and the results may be a reflection of parents of children with higher BMIs being more likely to be counseled by their health care provider and more likely

to adhere to recommendations to select low-fat milk. Scharf and colleagues (2013) speculated that one explanation for the inverse association with dairy fat and childhood adiposity may be that the presence of fat in milk may induce satiety and reduce the appetite for other energy-dense foods.

Added Sugars

Added sugars are sweeteners of various types added to foods (i.e., corn syrup, fruit juice concentrate, fructose, maltose, among many others), and do not include naturally occurring sugars such as those in 100% fruit juice or lactose in dairy products (USDA, 2015). The 2015 DGAC report recommended that added sugars not exceed 10 percent of total energy intake (USDA/HHS, 2015). Specifically, the 2015 DGAC report recommended replacing soft drinks and other sugar-sweetened beverages (including sports drinks) with nonfat milk to reduce the intake of added sugars and increase the intake of calcium, vitamin D, and magnesium (USDA/HHS, 2015). As discussed in Chapter 6, one concern with added sugars (and dietary carbohydrates in general) is the development of dental caries, particularly early childhood caries (ECCs).

Major sources of added sugars in the American diet include beverages (not including unflavored milk and 100% fruit juice), snacks and sweets, breakfast cereals and bars, and some dairy foods (such as flavored milks and sweetened yogurt). With few exceptions, foods with added sugars are generally not permitted in the WIC food package. However, although the FDA has issued a proposed rule, at present manufacturers are not required to label added sugars. Therefore, total sugars are limited in the WIC food specifications (USDA/FNS, 2014). Specifically, cereals may contain no more than 6 grams of sucrose and other sugars per dry ounce (a typical serving size), and yogurt must contain no more than 40 grams of total sugars per 1 cup (USDA/FNS, 2014). Fruited yogurts generally exceed the 40 g regulatory limit and are therefore not permitted for purchase. One serving of yogurt that meets WIC specifications (i.e., based on the USDA Standard Reference Database, Release 27 [USDA/ARS, 2014a]), for example lowfat vanilla yogurt, provides 52 percent of the recommended added sugars limit (32 g per day) for women consuming a 2,200 kcal diet. One serving of a breakfast cereal containing the limit of 6 grams of added sugars would contribute 19 percent of the recommended added sugars limit per day for an individual adhering to a 2,200 kcal diet.

Sodium

The 2015 DGAC report recommended lowering sodium intakes to less than 2,300 mg per day (USDA/HHS, 2015). Sodium is ubiquitous in the

U.S. food supply and is contained in many food categories, with the exception of fruits and fruit juices, which contain little sodium. The Centers for Disease Control and Prevention (CDC)-dubbed “salty six” food categories that contribute the most to sodium consumption among Americans include breads and rolls, cold cuts and cured meats, pizza, poultry, soup, and sandwiches (AHA/ASA, 2014). The 2015 DGAC report encouraged efforts to reduce sodium in prepared and processed foods, as well as in home cooking by using recipes with small amounts of sodium (USDA/HHS, 2015).

In the WIC food packages, sodium intake comes primarily from cheese, canned vegetables, and canned fish. It is otherwise limited in most other food categories, and lower-sodium options are generally encouraged (USDA/FNS, 2014). For some products, the low-sodium version costs more, which may affect inclusion of these products on state WIC food lists.⁵ For example, the typical sodium content of a 1 ounce-equivalent serving of representative WIC cheese (cheddar) contributes 12 percent of the recommended sodium intake for women who consume a 2,200 kcal diet (see Table 9-3).

Cholesterol

Previously, the DGA recommended that cholesterol intake be limited to no more than 300 mg/day (USDA/HHS, 2010). The 2015 DGAC report did not make this recommendation; it stated that available evidence shows no appreciable relationship between consumption of dietary cholesterol and serum (blood) cholesterol. This position is consistent with recommendations made by the American College of Cardiology/American Heart Association (ACC/AHA, 2014). In addition, the 2015 DGAC report analysis of national survey data indicated that cholesterol was not overconsumed (USDA/HHS, 2015). Eggs, a primary source of cholesterol in the American diet, are currently included in the WIC food packages for children and women. Amounts were reduced in the 2009 revisions, primarily to allow room for additional foods and secondarily to reduce the total amount of cholesterol in the package (protein was not considered a priority nutrient) (IOM, 2006). Although cholesterol appears to be of less concern at this time, eggs also contain saturated fat (9 percent of the daily recommended limit per egg on a 2,200 kcal diet), which, as previously mentioned, is considered a nutrient to limit. The WIC food packages provide 0.4 eggs per day in all packages, with the exception of the package for fully breastfeeding women, which provides approximately 0.8 eggs per day.

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⁵ States may implement cost-containment practices in order to reduce the average food cost per WIC participant. This may include limiting food selection by branch, package size, form or price, or mandating the use of particular brands.

Dietary Guidance for Infants and Children 0 to 24 Months of Age

To establish a basis for intake evaluation for WIC participants from birth up to 2 years of age, the committee evaluated the most recent recommendations of the AAP, AND, the World Health Organization (WHO), and other published sources, as presented in Chapter 3, Table 3-1.

The AAP recommends human milk as the sole food for healthy, full-term infants for approximately the first 6 months of life and supports continued breastfeeding for at least 12 months (AAP, 2014). The AAP (2014) further recommends that, in the absence of human milk, iron-fortified formulas are the most appropriate substitutes for feeding healthy, full-term infants during the first year of life. WHO recommends exclusive breastfeeding for the first 6 months of life (WHO, 2013).

The introduction of complementary foods should begin at approximately 6 months of age, depending on an individual infant’s development (e.g., whether the infant has attained the necessary oral motor skills, whether growth faltering has occurred) (AAP, 2014). Acknowledging that iron and zinc deficiencies may occur in older breastfed infants, the AAP further recommends the introduction of meats, vegetables with higher iron content, and iron-fortified cereals for infants and toddlers as the first foods (Baker and Greer, 2010). Cow’s milk is not recommended before 1 year of age by the AAP because of the increased risk of iron-deficiency anemia (i.e., because of low bioavailability of iron from cow’s milk, low concentration of iron in cow’s milk, and potential for intestinal blood loss) (AAP, 2014). WHO recommends porridge and a wide variety of pureed foods, including meats, to initiate the transition from a fluid to a solid diet (WHO, 2013).

Some infants may be developmentally ready for finger foods or foods of different textures at an earlier age. In alignment with the AAP guidance, WIC educates participants that infants may be ready to take solids earlier than 6 months (USDA/FNS, 2014). Chapter 5 (Tables 5-2, 5-3, and 5-4) summarizes results from the committee’s analyses of food intakes for infants and children under the age of 2 years, which indicated concerns around early introduction of complementary foods including cow’s milk and foods of poor nutritional value, as well as iron supplementation. The committee recognizes that the WIC food packages provide complementary foods only as early as 6 months of age (USDA/FNS, 2014).

FOODS CONTAINING FUNCTIONAL INGREDIENTS

The committee was asked to consider the current science on functional ingredients (e.g., docosahexaenoic acid [DHA], arachidonic acid [ARA], probiotics, prebiotics, beta-carotene, lutein, and lycopene) added to foods for infants, children, and adults to determine how USDA-FNS

might approach the inclusion of foods containing these ingredients in the WIC food packages.

Regulatory Framework for Functional Ingredients

At the time this report was written, the FDA had not established a definition for functional foods or ingredients. Functional ingredients are permitted in foods if evidence indicates the ingredients are safe at estimated national levels of consumption, but efficacy of these ingredients is not evaluated or regulated by the FDA. Broadly, functional foods and ingredients are thought to provide a “health benefit beyond basic nutrition,” and may be beneficial to long-term health (Crowe and Francis, 2013). At present, no nationally agreed-upon framework exists for determining the levels of substances in foods that can be linked to health benefits, although development of such a framework is under discussion in the nutrition community. Global organizations use various criteria to evaluate benefits (e.g., level of evidence supporting the beneficial outcome, level of exposure to the component, forms and sources of the component) (Crowe and Francis, 2013).

A functional ingredient can be a nutrient or non-nutrient component, while functional foods are generally regarded as having properties—taste, aroma, and/or nutritive value—of conventional foods. These characteristics set functional nutrients and functional foods apart from supplements (GAO, 2000). The position of AND is that “functional foods” can be whole, fortified, enriched, or enhanced foods (Crowe and Francis, 2013).

Findings on Health Benefits

Functional ingredients that have been systematically evaluated for outcomes within WIC’s target population are listed in Table 9-4 (see Chapter 3 for a summary of how the functional ingredients and studies listed in this table were selected). Two characteristics of the table should be noted. First, aside from statements related to formula-fed infants, the reviews and positions listed in the table are largely evaluations of the ingredient administered as a supplement and not in a food form. However, while these statements may not accurately represent the health effects that occur when the ingredient is consumed as part of a food matrix (Jeffery, 2005; Crowe and Francis, 2013), the relationships and strength of evidence provide insight into the current understanding of the biological role of the component. Second, diseases or conditions that are atypical in the WIC population (e.g., gout) or that may not be affected by the short-term, supplemental nature of the WIC program (e.g., cancer, heart disease) were not included in this evaluation.

Data that support a link between functional components and health

TABLE 9-4 Functional Ingredients and Health Benefits—Summary of the Evidence

NOTE: DHA = docosahexaenoic acid; LCPUFA = long-chain polyunsaturated fatty acids; PUFA = polyunsaturated fatty acids.

outcomes are generally insufficient or inconclusive. Probiotics appear to have the most consistent data indicating a beneficial effect (i.e., in relation to diarrheal conditions). However, with regard to the inclusion of probiotics in routine formulas, the German Federal Institute for Risk Assessment has recently released an opinion stating there is currently insufficient data to make a judgment on the safety and health benefits of probiotics for healthy infants (BfR, 2015). For other functional ingredients listed in Table 9-4, evidence for health effects may be apparent for specific subpopulations or health conditions of less relevance to the general WIC population. For example, the 2015 DGAC report noted that evidence for effects of EPA and DHA on neuropsychological health is substantial, and combined supplementation is now considered a complementary therapy for major depressive disorder (USDA/HHS, 2015). Note that the 2015 DGAC report did not review probiotics or prebiotics and that lutein, lycopene, and beta-carotene are all considered collectively as “carotenoids” (USDA/HHS, 2015).

In addition to health outcomes, cost is another important factor to consider when determining if foods with functional ingredients should be added to WIC food packages. Functional foods may have higher prices than their conventional counterparts, but may be cost-effective in the long run if a health impact were to offset medical costs (Schmier et al., 2014). Following their designation as being “generally recognized as safe” (GRAS) by the FDA, DHA and ARA were added to infant formulas sold in the United States starting in 2002. At present, as explained in detail in the next section in this chapter, nearly all nonexempt standard formulas distributed through the WIC program contain both DHA and ARA.

INFANT FORMULA: FUNCTIONAL INGREDIENTS AND THE MARKET LANDSCAPE

Infant formula is legally defined as a food that “purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk” (FDA, 2012 [section 201(z)]). USDA-FNS requested that the committee evaluate three specific aspects of infant formulas as a component of the food packages. Two of these aspects were addressed in Chapter 4, namely the maximum monthly allowances for infant formula and iron concentration. The third aspect was the nutritional and health effects of functional ingredients in infant formulas. A summary of the committee’s review of the science related to the nutritional and health impact of functional ingredients in infant formulas is provided here. Since the 2009 food package changes, the variety of infant formula products available in the marketplace has expanded substantially. As a foundation for this task,

the committee reviewed changes in the infant formula market landscape over the past decade, including but not limited to functional ingredients.

The Regulatory Process Governing Infant Formula

During the first several months of life, infants are unique in that all their nutrient requirements must be met by a single food source, namely either human milk or formulas. In recognition of the importance of a single food source for infant health, the U.S. Congress passed the Infant Formula Act of 1980, later amended in 1986, as section 412 of the Federal Food, Drug, and Cosmetic Act (NARA, 2014c). The associated regulations (NARA, 2014d) set standards for safety and nutrient sufficiency; establish premarket submission, registration, and records retention requirements; specify infant formula adulterant; grant the FDA mandatory recall authority; and mandate that formula meet “quality factors” (i.e., supporting normal growth, biological quality of protein). Formulas currently sold in the United States must contain minimum concentrations of 29 nutrients⁶ (3 of which are specifically required for all non-milk-based formulas) and not exceed the maximum concentrations for 9 of these nutrients. At least 90 days before introducing a new or a reformulated product (see 21 C.F.R. § 106.3 for definition of a “major change”), a manufacturer must submit a notification to the FDA that includes the product composition, processing, and packaging information, and required assurances that it meets the quality factors. After first production of the formula and before it is introduced to the market, the manufacturer must submit to the FDA a summary of test results assessing the levels of each of the required nutrients in the formula and must certify good manufacturing practices were established, in accordance with 21 C.F.R. § 106 regulations. Additionally, because the infant formula market is continually evolving and to ensure suitability of new or reformulated infant formulas, manufacturers are required to test and document that products are safe, support healthy growth when provided as the sole source of nutrition, and contain protein of biological quality (NARA, 2014c).

Manufacturers may add ingredients that are not required but may have health benefits to formulas in ways that will set their products apart from their competitors (Aggett et al., 2001; AAP, 2014, p. 63). These additions and reformulations are permissible only when included in the premarket submission to the FDA. Each ingredient must be an approved food additive, be generally recognized as safe (GRAS) under the conditions of intended use, or be used in accordance with a prior sanction (21 C.F.R. § 140(a)).

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⁶ Selenium was recently added as the 30th nutrient to be regulated in infant formulas, with the mandate specifying both minimum and maximum levels. The effective date of this final rule is June 22, 2016.

To ensure the formula matrix meets the quality factor of supporting normal physical growth (21 C.F.R. § 106.96), manufacturers must demonstrate that the added ingredients do not interfere with the bioavailability of the required nutrients.

WIC Formulas

As discussed in Chapter 7, WIC encourages exclusive breastfeeding during an infant’s first months of life and continued breastfeeding thereafter. In instances where an infant is partially breastfed or fully formula-fed, WIC aims to provide enough formula supplementation to meet, but not exceed, an infant’s nutritional needs. As such, WIC does not function as a “supplemental nutrition program” in its provision of infant formula. The formulas provided by WIC must comply with the federal definition of and nutrient requirements for infant formulas. In particular, they must provide at least 1.5 mg iron per 100 kilocalories at standard dilution; provide approximately 20 kilocalories per 100 milliliters at standard dilution; be able to be delivered orally or via tube feeding; and require nothing but water to be added for them to be in a liquid, ready-to-drink state (USDA/FNS, 2014).

Partially or fully formula-fed infants can receive selected milk-based and soy-based formulas through the WIC program. Formulas intended for healthy full-term infants (“nonexempt” formulas) are generally provided in powdered or concentrate form, unless living conditions require use of a prepared formulation. In an effort to contain costs, manufacturers must bid to be the sole supplier of a state’s standard formula. The manufacturer, in return for exclusivity, provides the agency with a significant rebate on each container of contract formula purchased with the WIC benefit ($1.7 billion in 2012 [USDA/ERS, 2013]).

As discussed in Chapter 8, in instances of medically documented qualifying conditions, infants may be eligible to receive nonstandard products. Given these infants’ unique dietary needs, exempt formulas can deviate from the federal nutrient requirements if the FDA is provided with substantiated medical, nutritional, scientific, or technological justification (NARA, 2014e). Some exempt formulas are available at retail outlets, while others are only available with a physician’s prescription (NARA, 2014e). At present, three infant formula manufacturers participate in the bidding process and each currently holds WIC contracts.

Infant Formula Developments

This section outlines advances and differences in the content of infant formulas available through the WIC program. The nutrition and ingredient lists, along with nutrient, health, and structure-function claims, were

compiled from the websites of the manufacturers holding state WIC contracts. Components that differentiate the products or are not part of the FDA nutrient requirements are highlighted. Products included in this analysis were primarily nonexempt formulas. Extensively hydrolyzed formulas, which are exempt formulas, were also included for comparison to their partially hydrolyzed, nonexempt counterparts. Formulas intended for medical use were not included in this evaluation.

Docosahexaenoic Acid (DHA) and Arachidonic Acid (ARA)

DHA and ARA, long-chain polyunsaturated fatty acids found in breastmilk (Lauritzen and Carlson, 2011), have been linked to brain and eye development due to their concentrations in those tissues (Martinez, 1992; van Kuijk and Buck, 1992; Uauy et al., 2001). Manufacturers began adding DHA and ARA to infant formulas sold in the United States in 2002 after they were designated as GRAS (FDA, 2001a,b). The majority of nonexempt infant formulas currently contain DHA and ARA from Crypthecodinium cohnii oil (an algae source) and Mortierella alpina oil (a fungal source), respectively. The AAP does not have an official position on supplementing full-term infants with long-chain polyunsaturated fatty acids like DHA and ARA (AAP, 2014).

Prebiotics

Prebiotics are selectively fermented ingredients that increase the activity or growth of gut bacteria. Based on the committee’s survey of the market (see Chapter 3 for details), all of the major infant formula manufacturers produce formulas with one or more of the following prebiotics: galactooligosaccharide, fructo-oligosaccharides, and polydextrose. However, these compounds are not in every formula product. The AAP does not believe the available evidence demonstrates health benefits of probiotics in infant formulas at this time (Thomas and Greer, 2010; AAP, 2014).

Probiotics

Probiotics are live microorganisms that can alter composition of bacteria in the gut. Although probiotics have been investigated for their effects on a range of conditions, the primary health benefit appears to be in preventing and potentially shortening the duration of diarrhea (see Table 9-4) (Allen et al., 2010; Johnston et al., 2011; Bernaola Aponte et al., 2013; Goldenberg et al., 2013). Based on the committee’s survey of the market, three different types of probiotics are currently being added to infant formulas by two of the major manufacturers: Lactobacillus reuteri, Bifidobacterium lactis,

and Lactobacillus rhamnosus GG. The AAP believes the evidence to support routinely adding probiotics to infant formulas is currently insufficient (Thomas and Greer, 2010; AAP, 2014).

Age-Specific Formulas

A conventional infant formula is typically indicated for use from birth through the first year of life. Although these 0–12 month formulas are standard for term infants, age-specific formulations are now available. Each of the major manufacturers has developed products for older infants, which are marketed for use beginning at 6 or 9 months through 12, 18, 24, or 36⁷ months of age (Gerber, 2015a,b,c; Mead Johnson, 2015a,b,c,d; Ross Abbott, 2015). There is also a product marketed just for the newborn period (0–3 months; Mead Johnson, 2015c). These age-specific formulations must still comply with federal nutrient specification requirements for infant formulas (NARA, 2014c) and, as such, vary only slightly in terms of composition from the standard 0–12 month formulations. The AAP states that there are no obvious benefits to these “follow-on” or “follow-up” formulas compared to standard formulas during the first year of life, although they have the potential to be advantageous for toddlers with iron-deficient and imbalanced diets (AAP, 2014).

Hydrolyzed Protein

The protein in hydrolyzed formulas has been broken down into mixture of peptides and amino acids. When a formula has been partially hydrolyzed, intact proteins may still be present and could elicit an allergenic response (AAP, 2014). As such, these formulas are often marketed as a means of managing feeding-related issues of healthy full-term infants (e.g., discomfort, fussiness) and potentially reducing the risk of atopic dermatitis (FDA, 2011), rather than as a way to avoid cow milk protein allergy (AAP, 2014). Completely or extensively hydrolyzed formulas, in contrast, are indicated for infants who have an allergy to cow-milk protein or soy (AAP, 2014).

Carotenoids

The term carotenoids encompasses a broad group of natural pigments, including provitamin A molecules. Selected carotenoids have been investigated for their antioxidant properties and potential health benefits related

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⁷ The formula indicated for use up to 36 months is a hypoallergenic, lactose-free formulation used for children with cow’s milk allergy and is suggested by the manufacturer to be a milk alternative.

to morbidity, mortality, and cancers (see Table 9-4). Although all infant formulas are required to contain vitamin A (NARA, 2014c), there are currently no standards for individual carotenoids. Only one manufacturer currently adds a blend of beta-carotene, lutein, and lycopene to all of its standard milk- and soy-based formulas, and promotes lutein through a structure-function claim (“Lutein: Found in areas of the brain related to learning and development” [Abbott Nutrition, 2015b]). The AAP nutrition handbook does not have specific recommendations on the inclusion of carotenoids in infant formulas (AAP, 2014).

Soy Formulas

Soy formulas have long been available on the market as an alternative to cow milk-based formulas. The AAP recommends the use of soy formulas when a term infant has galactosemia, hereditary lactase deficiency, transient lactase deficiency, or immunoglobulin E-associated allergy to cow milk, or if a vegetarian-based diet is sought (AAP, 2014). Soy formulas, however, cannot be recommended for the prevention of milk allergy or intolerance in high-risk infants with a history of allergy in a first-degree relative (Osborn and Sinn, 2006).

Nucleotides

Found in human milk, nucleotides (monomers for nucleic acids) are currently added to standard milk-based formulas by the major manufacturers. Nucleotides are believed to play a role in proper immune function and intestinal development. An international workgroup has recommended a maximum of 10.8 mg/100 kcal for follow-up formulas for children 6–36 months old (Koletzko et al., 2013). The AAP recognizes that nucleotides may have beneficial health effects, but recommends a better understanding of the mechanism, the clinical impact, and long-term outcomes (AAP, 2014).

Lactose-Reduced or Lactose-Free Formulas

Cow milk-based, lactose-reduced, or lactose-free formulas are available as formulations typically intended to manage an infant behavior such as fussiness (e.g., colic, gas, spit-up). Reduced-lactose or lactose-free formulas may transiently help with the management of acute diarrhea in young children (MacGillivray et al., 2013).

Formulas for Managing Feeding Issues

A range of formulas is available on the U.S. market for the management of feeding issues commonly experienced by infants. Partially hydrolyzed protein-containing formulas, for instance, are marketed as being soothing, providing comfort, and promoting regularity. Various formulas are advertised as managing colic, gas, fussiness, and spit-ups because some of the ingredients (e.g., lactose, protein source, or composition) have been modified. Partially hydrolyzed formulas may also be indicated in infants at risk of allergy (see Chapter 8 for additional detail). In accordance with the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)), any statement or claim on the label must be truthful and not misleading. Most label claims fall under the structure/function claim category, referring to an effect “derived from nutritive value” (FDA, 2014a). As such, the relationship describes a nutrient or a compound in the food rather than the food as a whole. The only type of infant formulas with a qualified health claim are those that are 100 percent whey-protein partially hydrolyzed, but the claim includes a statement of the relative dearth of data supporting it (e.g., “Little scientific evidence suggests that . . . ”) (FDA, 2011).

Organic and Non-GMO Formulas

Only one of the manufacturers holding WIC state contracts makes an organic infant formula (although other manufacturers make organic brands). In June 2015, this company launched a “non-genetically modified organism (GMO)” version of one of its infant formulas. The ingredients in this product are identical in nutritional composition to the original version, but come from sources that have not been genetically engineered (GE). In conjunction with the USDA and the Environmental Protection Agency, the FDA regulates foods from GE crops, which must meet the same safety standards as traditionally bred plants (FDA, 2015).

Lower-Energy Formulas

In 2014, a manufacturer introduced lower-energy infant formulas to the U.S. market. The new products were a modification of available products and provide one less kilocalorie per prepared fluid ounce (19 versus 20 kcal/fl oz). The rationale for transitioning to lower-energy formulas was that it better reflected the energy density of human milk (Abbott Nutrition, 2015a). Inasmuch as the standard WIC formulas must provide 20 kcal/fl oz (USDA/FNS, 2015c), states can choose to offer these lower-energy formulas in cases of medically documented qualifying conditions rather than as

standard issue.⁸ However, given the lower energy in these formulas, concern has been raised about effects on infant growth. Findings from a recent systematic review suggest that healthy full-term infants consuming formulas with lower protein and/or lower energy levels than standard formulas have adequate growth, comparable to breastfed infants, although the authors recommended additional long-term evaluations of these formulas (Abrams et al., 2015). One manufacturer that did not reformulate its products to be lower in energy, however, has challenged the need for lower-energy formulas and currently (at the time this report was being written) intends to maintain the caloric density of its formulas at 20 kcal/fl oz (Mead Johnson, 2014). A taskforce of the AAP submitted a letter to USDA-FNS requesting a reevaluation of the 20 kcal/fl oz criterion for WIC formulas (AAP, 2012).

CHOICE AND FLEXIBILITY

Public comments received by the committee indicated that both participants and WIC program staff are generally supportive of increasing options within the food packages. Each food category fulfills a need for specific nutrient or food group, and increasing options that support intake of key nutrients may promote redemption. See Chapter 2 for a detailed discussion of factors related to redemption. Low redemption implies that issued foods are not being consumed and that the goal of the WIC program to provide needed nutrients and foods is not being met.

Changes Made in the 2009 WIC Food Packages to Improve Flexibility

Given the racial and ethnic diversity of the WIC population described in Chapter 1, the 2006 Institute of Medicine (IOM) review of WIC food packages recommended that the WIC program provide more flexibility to state agencies and more variety and choice for WIC participants. Accordingly, in the 2009 revision of the WIC food packages, new food options were added. These included corn tortillas, brown rice, soy-based beverages as an alternative to milk, and a cash value voucher (CVV) for fruits and vegetables that allowed choice at the participant level (IOM, 2006).

Satisfaction with the 2009 WIC Food Package Changes

As discussed in Chapter 2, multiple studies have documented moderate to high satisfaction with the 2009 changes in the WIC food package, but

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⁸ More than one-third of states held contracts with this manufacturer when the formulation change occurred and had to modify their prescribing policies to accommodate the lower-energy formulas.

with some cultural variation in participants’ satisfaction with food items in the packages (Gleason and Pooler, 2011; Ritchie et al., 2014). Additionally, since 2009, the Altarum Institute has been conducting interview, survey, and focus group studies with WIC participants across sites. A key theme emerging from these studies is that participants are especially satisfied with the flexibility allowed in the food packages (e.g., being able to choose canned beans instead of dried beans or corn tortillas instead of bread) and want as much food and brand variety as possible (Phillips et al., 2014; Personal communication, S. Whaley, Public Health Foundation WIC Enterprises, June 4, 2015). In a study by Altarum of women who had left the WIC program, responses to the question “What could WIC do to encourage you to participate in the program again?” included negative comments about food selection (e.g., being allowed to acquire only store brands, not being able to acquire the type of milk or formula needed) (Phillips et al., 2014).

Considerations for Future Modifications to Improve Choice and Flexibility

As noted in the interim rule, substitution for a food in the WIC food categories “must be nutritionally equivalent or superior to the food it is intended to replace” (USDA/FNS, 2007, p. 69004). The implication of this statement is that the nutrient content of substitutions for WIC foods should be similar, components (i.e., protein) should be of similar quality, and nutrients should be similarly bioavailable. As an example of a substitution comparison, the 2015 DGAC report evaluated a number of milk alternatives and found that, while most contain potassium, the amounts of it vary. Additionally, although most are fortified with calcium, calorie amounts are higher in some alternatives for a similar intake of calcium and calcium absorption is lower in plant-based milk alternatives (USDA/HHS, 2015). Both the interim and final rules require that soy beverages (a currently allowed milk alternative) provide a minimum 8 g of protein, 100 IU for vitamin D and 500 IU for vitamin A, and 276 mg calcium per 8 ounces (USDA/FNS, 2007, 2014). The representative almond milk in the USDA’s standard reference database contains similar amounts of micronutrients, but only 1 g of protein per 8 ounces (USDA/ARS, 2014a). Therefore, almond milk would not be considered nutritionally equivalent to cow’s milk because of the notably lower protein content.

COST CONSIDERATIONS

As part of the task, USDA-FNS requested that modifications to the recommended food package be cost neutral to allow the WIC program to maintain the current average food package cost, adjusting for inflation and

allowing for no more than 10 percent variance in per-participant average monthly food costs. As was the case for the 2006 IOM review, the term cost neutrality means that the average cost per participant of the complete set of revised WIC food packages proposed by the committee (in phase II) does not exceed the cost of the current WIC food packages. Table 9-5 illustrates how costs were contained in the 2009 food package revisions. Creating the final recommendations in the IOM (2006) report involved determining the priority nutrients and food groups, then evaluating cost of addressing those gaps in an iterative process. Details of these considerations are presented in that report. The same approach will be taken in phase II of this review. The committee was tasked with determining whether any cost increases associated with the potential expansion of options or new substitutions for foods could be offset by other package modifications while maintaining the overall nutritional goals, other population needs, and administrative constraints of the food package.

WIC is not an entitlement program. As a result, it has a fixed budget, so funds may not be available to cover the cost of WIC foods for those who are eligible. Consequently, cost containment is an important concern. A primary cost-saving practice of the WIC program is the negotiation of rebate contracts with infant formula manufacturers, as described previously. These rebates have contributed to significant savings and permitted more participants to be served by WIC (USDA/ERS, 2015a). Additional cost-containment practices include limiting approved brands, package sizes, forms, or prices (e.g., least expensive brand requirements), and limiting authorized vendors to stores with lower food prices. Smaller vendors, often with higher operating and procurement costs, are more likely to charge (and be reimbursed for) higher prices for WIC products than larger vendors. A recent USDA-ERS report documented that policies intended to reduce maximum allowable WIC reimbursement rates would have little to no effect on most standard-size supermarkets, where the majority of WIC transactions take place (USDA/ERS, 2014).

On the one hand, containing costs is essential for maximizing program funds to serve as many WIC-eligible individuals as possible. Yet strategies that limit cost are often synonymous with strategies that limit choice. Cost-containment practices that restrict participant choice in such a way that some foods become undesirable for purchase undermine WIC’s goal to provide healthy and nutritious foods to low-income individuals. As a result, states attempt to balance containing cost with promoting enough variety and choice among healthy WIC foods that families will want to purchase those foods.

TABLE 9-5 2009 Food Package Changes That Achieved Cost Neutrality by Balancing Increases and Decreases in Cost: Public Comment Summary

NOTE: CVV = cash value voucher.

^a Personal communication, S. Whaley, Public Health Foundation WIC Enterprises, June 2, 2015.

^b Public comments; All public comments are accessible through the National Academies Public Access File. Email: paro@nas.edu.

SOURCE: Phillips et al., 2014, is a 2012 study of KY, NV, and MI redemption rates sponsored by USDA-FNS.

PUBLIC COMMENTS

Public comments were solicited through the IOM study website and in-person at three public comment sessions over the course of the phase I data-gathering period, which extended from September 2014 through August 31, 2015. A summary of common themes is presented in Appendix T, Table T-2. All comments were made available to committee members for consideration over the course of the study. The committee acknowledged that many suggestions for food package modifications fell outside of the task and therefore could not be addressed.

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