Academy Comments to FDA re Nutrition Innovation Strategy

October 11, 2018

Scott Gottlieb, MD
Commissioner of Food and Drugs
c/o Division of Dockets Management (HFA-305)
Food and Drug Administration
Room 1061
5630 Fishers Lane
Rockville, MD 20852

Re: The Food and Drug Administration’s Comprehensive, Multi-Year Nutrition Innovation Strategy; Public Meeting; Request for Comments (Docket. No. FDA-2018-N-2381)

Dear Dr. Gottlieb,

The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to offer the following comments on the "Food and Drug Administration's (FDA's) Comprehensive, Multi-Year Nutrition Innovation Strategy" as originally outlined in your speech of March 29, 2018 at the National Food Policy Conference in Washington, DC and as requested in the June 27, 2018 and August 22, 2018 Federal Registers (Docket. No. FDA-2018-N-2381). Representing over 104,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals and is committed to a vision of the world where all people thrive through the transformative power of food and nutrition. Wherever Academy members work—in a variety of clinical and community settings preventing and treating chronic disease, in industry that is developing more healthful, reformulated food choices people want to eat, or providing consumers with the tools to make better food choices through nutrition education or public health campaigns—it is our singular mission to accelerate improvements in global health and well-being through food and nutrition.

A. Overarching Support for the FDA's Goals and Strategies

The Academy enthusiastically shares the goal the FDA's Nutrition Innovation Strategy is designed to attain; we wholeheartedly agree that "improvements in diet and nutrition offer us one of our greatest opportunities to have a profound and generational impact on human health."2 We support the FDA using its powers to harness market forces to incentivize the formulation of healthy products and better enable industry to effectively and truthfully promote them by aligning food labels and claims with validated, scientific dietary recommendations. Fostering innovation and sparking competition among industry has significant potential to reduce preventable death and disease related to poor nutrition.

The Academy also supports (1) robust consumer education initiatives that provide Americans with the knowledge and tools necessary to improve their dietary choices and (2) concomitant, aggressive consumer protection initiatives that shield Americans from false and misleading claims with potential to frustrate progress toward our shared goal. Recognizing, as the FDA does, that the "[Nutrition Innovation Strategy] is still in the early stages of development," we believe its framework manifests the Academy’s ongoing commitment to partnering with government, industry, consumer, and scientific organizations in the hope of creating a balanced and effective regulatory structure.

B. Academy's Labeling Principles

In 2014, the Academy adopted the following nine principles for labeling to guide development of our regulatory comments and policy stances, and we apply them to aspects of the Nutrition Innovation Strategy related to on-package communications, information, or marketing.

  1. Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
  2. The label must be truthful and not misleading.
  3. Content on the label should help consumers make informed decisions to build a healthy diet.
  4. Labels should help to provide understanding about the nutrient density and overall healthfulness of overall food rather than a focus on particular nutrients.
  5. Label content should have consistent type and format so products can be read and consumers can make product comparisons.
  6. Labeling should enhance consistency among the various government nutrition recommendations.
  7. All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
  8. Consumer research is imperative before making changes to the label.
  9. The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.

C. General Principles that Connect Sound Labeling Policy to Public Health Goals

Contrary to the sound recommendations of the 2015 Dietary Guidelines for Americans, Americans under-consume healthful foods including fruits and vegetables, low-fat dairy, and whole grains. Americans also over-consume certain designated nutrients of concern such as added sugars, saturated fats, and sodium. Labeling transparency is a valuable tool for encouraging and empowering consumers to make more healthful choices and should assist consumers in following dietary advice, as the Nutrition Labeling Education Act directs.

We are not presently a particularly healthy population. The commissioner notes that, "Today, chronic diseases are the leading causes of death and disability in the U.S., and both chronic diseases and weight-related conditions raise health care costs, reduce productivity, and shorten lifespans." Given these challenges, the American people and our government should expect and demand an all-hands-on-deck approach to finding effective, efficient, science-based solutions; there is no place for products or product marketing that intentionally or unintentionally mislead consumers. Consumers should be confident that foods marketed as 'good for them' or 'better for them' are indeed not simply more healthful choices, but are also objectively healthful choices. The stakes are high: 70 percent of adults and 33 percent of children and teens are now overweight or have obesity.4,5 Approximately 45 percent of adults have diabetes or prediabetes.6 Every time a consumer seeking healthier food is sold a food or beverage that undermines their health, there is another missed opportunity to reduce diet-related disease.

Many consumers who dutifully try to follow dietary advice nonetheless struggle with excess weight gain, high blood pressure, prediabetes, and other preventable diet-related health problems. Data from the International Food Information Council show that health and weight loss are core considerations for most consumers in making food choices. Consumers pay attention to labels even if they do not always understand or utilize them fully or accurately: more than half of consumers look at the Nutrition Facts Panel or ingredient list "often" or "always" when making a purchasing decision, and approximately 40% say they consider other labeling statements about health or nutrition benefits.7

Labels thus provide actionable information at the point of decision, connecting dietary choices to health. Yet products across the marketplace attempt "permission" marketing, in which a health halo is intentionally created to make food and beverages appear more healthful than they are. Specifically, consumers should not be misled that processed foods touting images of fruits and vegetables are actually adequate dietary substitutes for fresh fruits and vegetables. For this reason, it is critical that the FDA's initiative should seek to correct misleading or inaccurate labeling claims and should not enable unhealthy foods to unfairly compete with fresh fruits and vegetables, which occupy too little space in Americans' diets.

As the FDA fleshes out the details of its Nutrition Innovation Strategy, the agency should consider the extent to which its labeling policies and new strategies encourage the promotion of products that are substantively better than an unhealthful substitute but remain suboptimal in its nutrient density or other relevant characteristics. In addition, the FDA should ascertain whether labeling initiatives may drive consumers not only towards more healthful products labeled as such and away from less healthful products, but also unintentionally away from optimally healthful whole foods such that lack labels, such as fresh fruits and vegetables. For these reasons, we believe that the FDA should focus on the following initiatives as part of the Nutrition Innovation Strategy:

  • If defined with rigorous scientific substantiation and in a manner readily and accurately understood by the vast majority of consumers, the FDA should strengthen the definition of "healthy" and review a full range of options for front-of-package nutrition labeling programs.
  • The FDA should improve labeling of whole grains to enhance transparency and clarity for consumers and encourage healthful reformulation of grain-containing foods.
  • The FDA should have flexibility in prioritizing applications for health claims with rigorous scientific substantiation that have broad health benefits.
  • The FDA should support health and enhance transparency by addressing deceptive labeling.
  • The FDA should modernize and improve standards of identity and ingredient lists and continue its efforts on sodium reduction.
  • The FDA should continue and even redouble its critical work on nutrition education.

We address each of these in turn below. The FDA's initiative will be most effective if the agency limits misleading claims and undertakes other reforms in the service of a clear and powerful vision of a better marketplace for consumers and companies alike.

1. Improve "Healthy" Claims and Front of Package Programs

As part of its interest in "modernizing claims," the FDA seeks public comment on the possibility of using an easy-to-find symbol to denote the claim "healthy" on food labels. We support an effort to create a national standardized, front-of-package symbol system to help consumers quickly identify healthier foods. At the same time, the Academy reiterates its significant concerns about current and proposed use and definition of the "healthy" claim and questions whether it retains or could be instilled with sufficient meaning and cache that consumers would seek it out on products to purchase.

The potential public health benefit to defining the term "healthy" is a positive, visual, point of purchase education tool for consumers who are trying to make good choices among similar products, i.e., foods from the same groups. However, front of pack claims such as "healthy" are merely one piece of what must be a larger, comprehensive effort to educate consumers about what constitutes healthful food and eating patterns.

Without a business case for a "healthy" food product, the "healthy" claim is likely to be relegated to a virtually meaningless label for fresh fruits and vegetables, which consumers already know are healthy and which are still woefully underconsumed. The Academy is hopeful that stakeholders can find a mutually acceptable—even if imperfect—new definition for "healthy" that will help consumers shift to more nutrient-dense food and beverage choices and limit their intake of added sugars, sodium, and other nutrients to discourage. There is no benefit to the consumer and no positive impact on health from a nutrient content claim unless the label is widely disseminated, understood, and used.

The Academy previously declared that it supports the Food and Drug Administration-approved health claims on food labels "when based on rigorous scientific substantiation."8 In addition, "Tools designed to help individuals choose and consume nutrient-dense foods should be grounded in science, validated against objective measures of diet quality, and most importantly, be able to effectively translate recommendations into actionable strategies."9 We are optimistic that if the term "healthy" meets the scientific standards and its meaning is properly and sufficiently understood by the public, it could be an effective tool for enhancing consumers' ability to make improved eating choices.

While an FDA-defined healthy logo may hold potential value for consumers, we are concerned that a standardized "healthy" symbol, available to manufacturers for voluntary use, would be less helpful than a more comprehensive symbol system that conveys information about both the healthier and unhealthier attributes of foods, providing the all-important context for a particular food item. While a "healthy" logo may guide consumers to a few healthier choices within a food category, it would not allow them to discern which foods should be avoided or eaten less often —information that is critical to people’s ability to follow the advice in the Dietary Guidelines for Americans. Moreover, a "healthy" symbol that is primarily available for packaged foods would have the potential to make these foods appear more attractive relative to unpackaged alternatives, such as fresh fruits and vegetables, which are significantly under-consumed.

This problem would be exacerbated if the standard for "healthy" is too lax, allowing products high in refined grains or added sugars to be mislabeled as healthy. Such a "healthy" logo must not appear on sugary cereals and desserts, fruit snacks, potato chips, pretzels and crackers high in refined grains, and other unhealthy or merely "not-unhealthy" foods and beverages.

Should the FDA proceed with a healthy logo, we encourage the agency to consider ways to integrate the effort with existing labeling systems and provide additional information to consumers about the nutrition content of foods. This could include guidance on integrating the healthy logo with additional front-of-package elements, such as the information about calories, saturated fat, sodium, and added sugars, which are provided through the industry’s "Facts Up Front" initiative.

We note that the Healthy Star Rating in use in Australia and New Zealand combines normative advice (a star rating score) with nutrition information for calories, saturated fat, sodium, and sugars (the same macronutrients used for the industry’s Facts Up Front program in the United States). The FDA should consider whether a healthy logo could similarly combine both normative advice and nutrition information into one standardized logo. Presenting both types of elements in combination may also help to distinguish the logo from other packaging symbols and clarify its connection to nutrition. Consumer testing of a range of systems, as well as existing research and labeling rules on front-of-package systems around the globe, should guide the FDA's review, and should include an evaluation of their impact on both consumer choices and reformulation.

If the FDA makes additional changes as to the healthful ingredients permitted on labels using the term "healthy," it should consider only the foods that make up the core of a healthy eating pattern in their nutrient-dense forms. For example, should the agency consider exempting certain fruits and vegetables from the minimum requirements that apply to certain beneficial nutrients, any such exemption should only apply to fruits and vegetables that are present in a food in a whole or cut-up form, and not when they are merely a concentrate, powder, paste, isolate, juice, or puree. We are concerned that if "healthy" is not carefully defined, the claim could encourage consumers to select unhealthy foods rather than under-consumed whole fruits and vegetables.

2. Improve Labeling of Whole Grains to Enhance Transparency and Encourage Healthful Reformulation

Virtually everyone eats packaged bread, crackers, pasta, and cereals, rather than preparing them from scratch at home, which means improved labeling of grains on processed foods is an important and promising area with added clarity for consumers and revitalized incentives to improve the healthfulness of these foods. Driving Americans to consume food patterns consistent with recommendations of the Dietary Guidelines is the heart of the FDA's Nutrition Innovation Strategy, and making these patterns affordable, and appealing, the commissioner notes, is also a priority to fight social inequalities in health.

Despite the Dietary Guidelines' whole grains recommendation that Americans "make at least half of your grains whole"10> we know that Americans in every age group are not following this advice, and are instead under-consuming whole grains and over-consuming refined grains.11 Auspiciously, consumers are increasingly seeking to increase their intake of whole grains. The International Food Information Council 2018 Food and Health Survey shows whole grains near the top the list of components considered to be healthful by consumers (following only vitamin D and fiber).12 The marketplace is responding: market analysts predict the global market for whole grain and high fiber foods will expand by nearly 50% over the next five years, reaching $46.2 billion by 2022.13,14

Labeling on grain-containing products remains afflicted by a lack of clarity. A study published in 2016 by the FDA in collaboration with several academic institutions showed that older adults are confused by package information about whole grain products. The study used a structured interview protocol to determine whether older adults (n = 89, age ≥ 65 years) are able to accurately identify whether three common food items were whole grain. The study found that approximately 35 percent of participants were not able to correctly identify the two whole grain products tested (cereal and crackers) as whole grain, and 80 percent of participants could not correctly identify that the refined grain product (bread) was not whole grain; nearly half of participants misidentified the refined grain bread as whole grain. Participants also did not know where to look on labels for information about whole grains and consulted the Nutrition Facts label almost as often as they did ingredient lists.

These results accord with those of a national online survey commissioned by the Center for Science in the Public Interest in 2011 that included more than 1,000 participants. The survey, which was sent to the FDA in 2012, showed that consumers overestimated the amount of whole wheat in a product when shown the front of product packages that emphasized the word "wheat," including when "wheat" was accompanied by depictions of dark-colored crackers, heads of wheat, or the term "stone ground."

A result of this confusion is that while some companies are innovating in the ovens and the marketplace to offer products with whole grains that appeal to consumers, incentives for these innovations are blunted by the fact that consumers often cannot tell which grain products are whole grain, and which are refined grains. Hearty-looking (and sometimes artificially colored) "wheat" breads and "multigrain" breads add to the confusion by containing labeling claims and images that suggest they contain whole grains when they may include none or negligible amounts. Whole grain content is not disclosed in the Nutrition Facts panel, and even the ingredient list may not be informative if it contains confusing names, fails to specify which grains are whole grains, or lists multiple refined grains after whole grain, which together could add up to make refined grain the predominant ingredient.

We therefore urge the agency to prioritize the issue of whole grain labeling. To prevent misleading claims and encourage healthful innovation, we request that the FDA:

  • Define "whole grain claims" to clearly include use of the terms "whole wheat," "whole grain," "made with whole grain," "multigrain," a declaration of the whole grain content by weight; the term "wheat" on a wheat-based bread, pasta, or other product that is typically made from wheat, use of depictions of wheat or grains, or any similar descriptive phrases, terms, or representations suggesting the product contains whole grains; and
  • Require that foods making such whole grain claims prominently and uniformly disclose either the percentage of whole grains and refined grains or the grams of both refined and whole grains per serving (for example, "Contains 8 g whole grain and 16 g refined grain"). The form of the disclosure should be based on the results of consumer testing.

3. Provide Flexibility to Prioritize Applications for Health Claims with Rigorous Scientific Substantiation that Produce Broad Health Benefits

The FDA expressed an interest in reviewing the process for approving new health claims.15 We do not perceive this interest as seeking to weaken in any way the standards for reviewing these claims, and we urge the FDA not to do so, as this category represents a very narrow subset of claims related directly to disease risk and should be subject to the highest review standards by the agency.

However, we appreciate the appeal of triaging petitions for qualified health claims, and we note the FDA's longstanding practice of prioritizing various petitions for them since at least its 2003 "Guidance for Industry: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements." Recognizing the FDA has not identified all the factors it will use in streamlining or prioritizing its review of claims, we offer tentative support the concept of Pareto-efficient, more effective prioritization.

4. Support Health and Transparency by Addressing Deceptive Labeling

A vast majority of health-related food label claims are not health claims at all, but are categorized as structure/function claims, nutrient content claims, or have no regulatory definition at all.16 Many consumers will presumably fail to draw meaningful distinctions between a structure/function claim like "calcium helps build strong bones" and a health claim like "calcium helps prevent osteoporosis." Moreover, similar "health halo" effects can come from nutrient content claims ("contains calcium"), or claims for high-value ingredients that imply a health or nutrient benefit ("made with real yogurt").

We urge the FDA to focus its reform efforts primarily on ensuring that healthful-sounding claims cannot be made on unhealthy products. Food stores are filled with sugary cereals, frozen novelties, and pastries carrying claims that they are "good" or "excellent" sources of vitamins and minerals. Cereals, candy, and salty snacks tout healthful ingredients like berries, fruit, or kale, even when they contain minuscule amounts of these healthful ingredients. When consumers purchase and consume these generally unhealthy products based on misleading claims, producers of truly healthy foods lose market share, undermining healthful innovation.

Existing rules to prevent such abuses are weak: health claims may not be made on products high in total fat, saturated fat, cholesterol, and sodium, but can be made on products made primarily of refined grain or high in added sugars.17 Regulation of nutrient content and structure/function claims is weaker still, as these claims generally can be made on unhealthy products with no more than a weak disclosure ("See nutrition information for __ content") provided for nutrient content claims on foods high in total fat, saturated fat, cholesterol, or sodium (but there is no disclosure for products high in added sugars).

Moreover, structure/function claims do not require FDA approval, although for consumers such claims are often indistinguishable from health claims. The FDA has the authority to regulate structure-function claims under its general authority to prevent misleading labeling. Alternatively, the agency could deem at least some of these claims to be implied health claims, as it has done in the instance of labeling claims related to maintaining heart health.18

The FDA currently lacks a framework to prevent claims for healthy ingredients from being made on unhealthy products, such as claims that a product is "made with” whole grains, fruits, vegetables, nuts, and dairy made on products high in saturated fat, added sugars, and sodium. In addition to its general authority to prevent misleading claims, the agency has the authority to deem such claims to be implied nutrient content claims to the extent that they are known to contain a particular nutrient (e.g., "contains oat bran" = "a good source of dietary fiber").19 However, we are not aware of the FDA applying this authority to whole grains, fruits, vegetables, or other nutrient-dense ingredients associated with health benefits and for which the Dietary Guidelines encourage increased consumption.

The FDA expressed an interest in exploring claims for products that offer fruits, vegetables, low-fat dairy, and healthy oils, for which American diets typically fall short of recommendations.20 The FDA also has sought how claims could or should signal that a product contains a "meaningful amount" of these food groups.21 To create more clarity for consumers, we encourage the FDA to consider requiring clear, transparent declarations on foods making fruit and vegetable claims that would allow consumers to understand how these products do, or do not, contribute to a healthy dietary pattern.

The Dietary Guidelines recommend that consumers eat a variety of vegetables and increase their consumption of fruits, with a focus on whole fruit.22 Despite such advice, Americans in every age group consistently fail to consume the amount of fruit and vegetables recommended in the DGA.23 The Centers for Disease Control found that only one in ten adults meet the federal fruit or vegetable recommendations.24 More than half of consumers in the IFIC 2018 Food and Health Survey report eating less fruits and vegetables than what they believe experts recommend.25

We therefore urge the FDA to review the most frequently utilized deceptive labeling claims with implications for public health, including "made with" and "contains real fruit" claims, the use of misleading images of whole fruits and vegetables when only minuscule amounts are in a serving, the use of misleading titles for categories of foods that are unhealthy or are minimally nutritious foods (i.e., "Veggie Sticks," "Fruit Snacks"). The agency should consider whether, taken as a whole, such labels, images or claims are misleading or deceptive, and should use its full range of regulatory options, including enforcement, as well as developing new clarifying guidance or regulations where needed.

The FDA should proceed with caution, as creating a new definition for a "meaningful amount" of fruits, vegetables, or other healthful yet under-consumed ingredients on packaged foods is unlikely to result in appreciably better choices for consumers unless the term is defined very narrowly to include only those foods made of whole, largely unprocessed ingredients. The definition should not allow claims based on powders, juices, purees, pastes, and concentrates, which are not as nutritious as whole fruits or fruit pieces because they lack the low-calorie density, cell structure, intact fiber, and other factors that contribute to the healthfulness and satiety of whole or cut up fruit. Permitting "meaningful amount" claims for these ingredients could appear to inflate the minimal nutritional value of options that are less nutritious than real fruits and vegetables, and therefore undermine Americans' efforts to eat more healthful foods.

Instead, we urge the FDA to address this issue by:

  • Requiring that foods making fruit and vegetable claims (through words or depictions) disclose the quantity of fruits and vegetables per serving in household measures (e.g., "contains 1/8 teaspoon of strawberries per 1-cup serving"). The declaration should be specific to the type of fruit or vegetable depicted or mentioned in claims, to avoid creating a lack of transparency that unfairly depicts that more desirable or expensive ingredients (e.g., "spinach" or "strawberries") predominate in a food when they do not.
  • Foods that contain fruit or vegetables that are not in their whole or cut form (without added sugar or sodium) should not be counted towards the amount of fruit in the declaration (for example, powers, concentrated fruit juice, or purees). A required disclosure should additionally indicate that the "The Dietary Guidelines for Americans recommends that at least half of your daily amount of fruit intake should be from whole fruits."
  • If a food is lacking in fruits and vegetables and contains only fruit or vegetable flavoring, it should bear a disclosure: "Contains no real fruits/vegetables."

There are a number of specific additional steps that the FDA should take to update labeling requirements and address deceptions in the marketplace that currently impede healthful choices. The FDA currently lacks a framework to prevent claims for healthy ingredients from being made on unhealthy products, such as claims that a product is "made with" whole grains, fruits, vegetables, nuts, and dairy made on products high in saturated fat, added sugars, and sodium. For example, caramel popcorn can currently be labeled "whole grain," despite containing 30 percent of the Daily Value for added sugars per serving.

In addition to its general authority to prevent misleading claims, the FDA has authority to deem such claims to be implied nutrient content claims to the extent that they are known to contain a particular nutrient (e.g., "contains oat bran" = "a good source of dietary fiber").26 We urge the FDA to strengthen the rules for health, nutrient content, structure-function, and other “health halo,” claims to ensure these claims are not made on unhealthy products, by:

  • Updating 21 CFR § 101.14 to include a disqualifying level of added sugars for health claims that comport with its Daily Value for added sugars, as the FDA indicated that it plans to do in its Nutrition Facts Panel Final Rule.
  • Updating nutrient content claim disclosures for unhealthful nutrients, at 21 CFR § 101.13, to require a comparable disclosure for foods high in added sugars.
  • Preventing claims for healthful ingredients like fruits, vegetables, and whole grains from misleading consumers into believing products high in saturated fat, added sugars, or sodium are healthy. This can be done either by initiating a rulemaking under the FDA's general authority to prevent misleading claims, or by deeming such claims to be implied nutrient content claims.
  • Issue regulations or take enforcement actions to define use of the term “low sugar” as a nutrient content claim. Because the FDA has not defined "low sugar" by regulation, the use of this term (or similar phrases like "lightly sweetened," "just a tad sweet," "sorta sweet") that imply low sugar content should therefore be prohibited under 21 C.F.R. §101.13(b). A reasonable consumer would likely believe that a product labeled with any variation of the term 'lightly sweetened' contains a small amount of sugar and is a healthier option. Yet products labeled "lightly sweetened" sold today may contain as much as 20 grams of sugar, or 40 percent of the Daily Value for added sugars.
  • Relatedly, the FDA should require a specific disclosure if a product boasts "0 grams" or "no" trans fat but is above a certain threshold for saturated fat, added sugars, or sodium, as most artificial trans fat is now gone from foods and this can create an unwarranted health halo on some unhealthful foods.
  • IFIC consumer survey data indicate that "natural" is the most influential of all label claims and is used by nearly 40% of consumers when making purchasing decisions. The FDA should move forward to clarify the definition of "natural" and require a prominent disclosure defining the meaning of the term natural from a consumer perspective and clarifying what it does, and does not, mean in terms of ingredients and manufacturing processes.

5. Modernize and Improve Standards of Identity and Ingredient Lists and Continue its Efforts on Sodium Reduction

i. Modernizing Standards of Identity

We support modification of certain standards of identity in a manner that would benefit public health and urge the FDA to finalize its proposed rule from 2005 expressing general principles for modernizing standards of identity.27 In particular, we support principle #4, stating that the standards of identity "[m]ay be used as a vehicle to improve the overall nutritional quality of the food supply." FDA should focus its consideration of standards of identity on the ways in which individual standards may be revised to better reflect public health priorities. Specifically, we support efforts to modify the standards of identity to provide flexibility to manufacturers to implement modest reductions in saturated fat and sodium without changing the name of their products, such as:

  • Eliminating milkfat minimums where they appear as part of a standard of identity, including for certain cheeses (21 CFR Part 133), cacao products (21 CFR Part 163), frozen desserts (21 CFR Part 135), and milk and cream (21 CFR Part 131). In particular, consistent with any forthcoming 2020-2025 Dietary Guidelines recommendations regarding types of dietary fats, FDA should prioritize milkfat minimums for the most commonly consumed cheeses (mozzarella, cheddar, and American), as cheese is a major contributor of saturated fat to the American diet and a calorically dense food.

Other requests for modification of the standards of identity should be considered by the FDA on a case-by-case basis with considerable input from stakeholders who would be impacted by the modification, in a manner similar to that applied to the petition for potassium chloride use. In considering such petitions, the FDA should consider the principles laid out in its 2005 proposed rule. The agency should also consider evidence of consumer acceptance of the ingredient in the given product, and any likelihood of consumer confusion that might result from the changes. As it has for "low-sodium" cheeses and similar products, FDA should require disclosures when needed to facilitate consumer understanding of distinctions among products.

ii. Modernize and Simplify Ingredient Lists Without Losing or Obfuscating Material Information

The Academy supports efforts to modernize ingredients lists to make them more readable and consumer-friendly. We urge the agency to take regulatory and enforcement action to ensure the readability of ingredients lists. The FDA should establish a minimum type size and allowable type styles, require use of upper- and lower-case letters, and include contrast requirements similar to those required for the Nutrition Facts panel, and other conspicuity measures.

The Academy Labeling Principles 1 ("Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.") and 3 ("Content on the label should help consumers make informed decisions to build a healthy diet.") leads us to support a narrow carve out for dietary supplements to ensure the ingredients are labeled with the requisite detail to ensure consumers are able to identify subtle but important differences between versions of the same ingredient. We share the concerns expressed at the public meeting by Keith Nelson from SmartyPants Vitamins "that the proposal to change ingredient labels will be detrimental to consumer transparency and our industries, specifically, with regards to dietary supplement labels, and believe[d] it will negatively impact consumers' ability to make informed decisions about their health. For example, if companies only list B9 in their labels, versus listing folic acid or methyl folate, this could lead to uniformed health decisions and consumer distrust as these two versions of B9 impact populations mu[ch] differently."28

It is useful and convenient for consumers to have clear and understandable labels. Clarity leads to informed decisions, but truly obtaining this clarity may sometimes require the FDA to choose a somewhat less simple, but ultimately more clear and informative, set of rules for conveying material information about the label to consumers. In short, we agree with Mr. Nelson's assertion that the FDA should “continue providing the u[t]most transparency regarding dietary supplement ingredients so that consumers are able to supplement their diet with the specific nutrients they need."29>

iii. Continue Sodium Reduction Efforts

We strongly support inclusion of sodium reduction included in the FDA's Nutrition Innovation Strategy. As the FDA notes, "[r]educing sodium in the diet is the single most effective health action related to nutrition.”"30> The typical sodium intake—about 4,000 milligrams per day31—is a major cause of high blood pressure, or hypertension. An estimated 46 percent of U.S. adults32 suffer from that condition, which increases the risk of heart disease and stroke. Together, coronary heart disease and stroke kill about 500,000 people annually in the United States.33

Given successful population-wide sodium-reduction efforts in several other countries and the variation in sodium concentration within similar types of foods, the FDA's proposed sodium-reduction targets are feasible. The FDA should also continue its work toward finalizing the ten-year sodium-reduction targets, since far more significant reductions could be accomplished and ten years provides industry ample time to plan and reformulate its products.

6. Implementing Education Campaigns for Menu Labeling and the Nutrition Facts Label Initiatives

The Academy notes with great pleasure the FDA's new nutrition education initiatives and the availability of funding that finally finances the "Education" component of the Nutrition Labeling and Education Act of 1990 (NLEA). We specifically support the agency conducting consumer-awareness education campaigns for menu labeling and the updated Nutrition Facts Panel and urge the agency to dedicate adequate funding and resources towards these efforts. Such campaigns will maximize these consumer education tools and assist consumers in making informed choices about what they eat, support healthier eating, and increase healthier food options. Registered dietitian nutritionist and nutrition and dietetic technicians, registered remain are uniquely skilled and trained to design, implement, and provide effective nutrition education programs and services.

For menu labeling, we were pleased that the FDA conducted focus groups and found the learnings helpful for developing consumer education materials. For instance, the FDA found that simple swaps are effective messages, such as "getting your sandwich with grilled chicken instead of fried helps cut the calories." We encourage the FDA to finalize and release its menu labeling materials. Other materials that would be useful could highlight the succinct statement on menus and menu boards providing context about calories in a daily diet as a way to educate the public on the ballpark target for 2,000 calories per day. The FDA should also highlight the additional nutrition information that is available upon request, which information can be of importance for people with diet-related diseases.

For both menu labeling and Nutrition Facts efforts, we encourage the agency to collaborate with major public health coalitions and organizations that represent constituencies such education, nutrition, and other health professionals. We encourage the FDA to hold a meeting with these stakeholders and present at key conferences and coalitions to widely disseminate its menu labeling materials.

For Nutrition Facts Panel public education efforts, we support the focus on calories, serving sizes, and added sugars, and we encourage the agency to include sodium. As the commissioner stated in his March 29, 2018, speech at the National Food Policy Conference: "[t]here remains no single more effective public health action related to nutrition than the reduction of sodium in the diet." As the agency works with food manufacturers to voluntarily reduce sodium levels in the food supply, it will be helpful for consumers to be able to evaluate whether a product is considered high in sodium; this is oftentimes not the case currently. We also encourage the FDA to conduct message testing through focus groups and/or polling to determine best practices for educating consumers about the updated Nutrition Facts label, as it has done with menu labeling. We recommend the designation of low-income mothers as a priority population given their influence regarding child and family health in purchasing decisions. Practices could also include incorporation of the Nutrition Facts Panel into math and science curricula, and working to incorporate lessons learned by the USDA Center for Nutrition Policy and Promotion related to dissemination of the MyPlate messaging.

In addition, given the agency's public health progress towards requiring a Daily Value for added sugars on the Nutrition Facts Panel, it is critical that consumers continue to account for the added sugars from single-ingredient sweeteners such as table sugar, honey and maple syrup as part of their overall daily "budget" for sugars. The declaration of added sugars on the Nutrition Facts label is of great public health importance: two out of three adults and one out of three children are overweight or have obesity, and one of three adults is diagnosed with prediabetes. Small amounts of single-ingredient sweeteners significantly contribute to daily added sugars intake. For example, a one-tablespoon serving of honey contains about one-third of a day’s worth of added sugars, and a two-tablespoon serving of maple syrup has half a day's added sugars.

We urge the FDA to ensure that the percentage "Daily Value" of sugars remains listed for these single-ingredient sweeteners regardless of whether the word "added" is retained on the label. To facilitate consumer understanding, we urge the FDA to issue guidance that maintains clear and specific labeling requirements that apply only to single-ingredient sweeteners. Such guidance should require that the percentage "Daily Value" for added sugars be provided as part of the current line for "Total Sugars" and permit substitution of the term "Sugars" in lieu of "Total Sugars" to alleviate any consumer confusion.

D. Conclusion

The Academy appreciates the opportunity to comment on the Nutrition Innovation Strategy and supports its promise to improve Americans' dietary choices by promoting healthful foods and preventing misleading labeling. We look forward to working closely with you as partners and as a resource whenever possible. Please contact either Jeanne Blankenship by telephone at 312-899-1730 or by email at jblankenship@eatright.org or Pepin Tuma by telephone at 202-775-8277 ext. 6001 or by email at ptuma@eatright.org with any questions or requests for additional information.

Sincerely,

Jeanne Blankenship, MS, RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, JD
Sr. Director, Government & Regulatory Affairs
Academy of Nutrition and Dietetics


1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.

2 Scott Gottlieb, MD, "Reducing the Burden of Chronic Disease" (speech, Washington, DC, March 29, 2018), U.S. Food and Drug Administration website.

3 FDA Nutrition Innovation Strategy. U.S. Food and Drug Administration website. Updated September 4, 2018. Accessed October 10, 2018.

4 Fryar CD, Carroll MD, Ogden CL. Prevalence of Overweight, Obesity, and Extreme Obesity Among Adults Aged 20 and Over: United States, 1960–1962 Through 2013–2014. National Center for Health Statistics, July 2016.

5 Fryar CD, Carroll MD, Ogden CL. Prevalence of Overweight and Obesity Among Children and Adolescents Aged 2–19 Years: United States, 1963–1965 Through 2013–2014. National Center for Health Statistics, July 2016.

6 National Center for Chronic Disease Prevention and Health Promotion. National Diabetes Statistics Report, 2017: Estimates of Diabetes and Its Burden in the United States. 2017.

7 International Food Information Council Foundation. 2018 Food and Health Survey. Washington, DC: International Food Information Council Foundation, 2018.

8 Crowe KM, Francis C. Position of the academy of nutrition and dietetics: functional foods. J Acad Nutr Diet. 2013;113(8):1096-103. (Emphasis added.)

9 Hingle MD, Kandiah J, Maggi A. Practice Paper of the Academy of Nutrition and Dietetics: Selecting Nutrient-Dense Foods for Good Health. J Acad Nutr Diet. 2016;116(9):1473-9.

10 2015–2020 Dietary Guidelines for Americans. 8th Edition. Washington, D.C.: U.S. Department of Health and Human Services and U.S. Department of Agriculture: December 2015.

11 2015–2020 Dietary Guidelines for Americans. 8th Edition. Washington, D.C.: U.S. Department of Health and Human Services and U.S. Department of Agriculture: December 2015; 2:41-43.

12 International Food Information Council Foundation. 2018 Food and Health Survey. Washington, DC: International Food Information Council Foundation, 2018.

13 WhaTech. Research Details Developments in the Whole Grain Foods Market to Grow at 6.71% CAGR by 2021. WhatTech, 2017.

14 Stratistics Market Research Report. Whole Grain and High Fiber - Global Market Outlook (2015-2022). Stratistics Market Research Consulting, 2016.

15 Scott Gottlieb, MD, "Reducing the Burden of Chronic Disease" (speech, Washington, DC, March 29, 2018), U.S. Food and Drug Administration website.

16 U.S. Government Accountability Office. FDA Needs to Reassess Its Approach to Protecting Consumers from False or Misleading Claims. GAO-11-102: Jan 14, 2011.

17 21 CFR § 101.14

18 U.S. Food and Drug Administration. Hampton Creek Foods 8/12/15. 2015.

19 21 CFR 101.65(c)(2).

20 U.S. Food and Drug Administration. FDA Nutrition Innovation Strategy. 2015.

21 Scott Gottlieb, MD, "Reducing the Burden of Chronic Disease" (speech, Washington, DC, March 29, 2018), U.S. Food and Drug Administration website.

22 2015–2020 Dietary Guidelines for Americans. 8th Edition. Washington, D.C.: U.S. Department of Health and Human Services and U.S. Department of Agriculture: December 2015.

23 2015–2020 Dietary Guidelines for Americans. 8th Edition. Washington, D.C.: U.S. Department of Health and Human Services and U.S. Department of Agriculture: December 2015; 2:41-43.

24 Lee-Kwan SH, Moore LV, Blanck HM, Harris DM, Galuska D. Disparities in State-Specific Adult Fruit and Vegetable Consumption – United States, 2015. MMWR Morb Mortal Wkly Rep. 2017; 66:1241–1247.

25 International Food Information Council Foundation. 2018 Food and Health Survey. Washington, D.C.: International Food Information Council Foundation, 2018.

26 21 CFR 101.65(c)(2).

27 Food Standards; "General Principles and Food Standards Modernization" 70 FR 29214 (May 20, 2005).

28 Transcript of Public Meeting re FDA's Comprehensive Multi-Year Nutrition Innovation Strategy. Page 80. U.S. Food and Drug Administration website. Accessed October 5, 2018.

29 Ibid.

30 U.S. Food and Drug Administration. FDA Nutrition Innovation Strategy. 2015.

31 Cogswell ME, Loria CM, Terry AL, Zhao L, Wang CY, Chen TC, Wright JD, Pfeiffer CM, Merritt R, Moy CS, Appel LJ. Estimated 24-Hour Urinary Sodium and Potassium Excretion in US Adults. JAMA. 2018; 319(12):1209–1220.

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33 Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JHY, Alger HM, Wong SS, Muntner P. Heart Disease and Stroke Statistics—2017 Update: A Report from the American Heart Association. Circulation. 2017; 135(10):e146-e603.