These two initiatives are part of the agency’s nutrition-related regulatory agenda and continued focus on increasing consumer access to information to facilitate healthier food choices and increasing the availability of healthier foods.¹

FDA Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling

The draft guidance outlines the agency’s current thinking the use of dietary guidance statements in food labeling, with the stated purpose of ensuring that such statements promote nutritious dietary practices.² FDA states that the draft guidance is based on the recommendations in the Dietary Guidelines for Americans 2020-2025³(DGA) related to nutrients to limit and food group intake.

Background

Dietary guidance (DG) statements are used in food labeling to represent or suggest that a food or food group may contribute to or help maintain a nutritious dietary pattern (e.g., “make half your grains whole” or “The Dietary Guidelines for Americans recommends eating fruits and vegetables as part of a balanced diet. This food has ½ cup of broccoli per serving.”). DG statements may be written statements or graphic material, including symbols or vignettes such as the MyPlate logo.⁴ DG statements differ from nutrient content claims⁵ and health claims.⁶ According to the draft guidance, unlike nutrient content claims, DG statements do not characterize the nutrient level of the food; and unlike health claims, they do not describe the relationship between a food and a disease or health-related condition. DG statements refer to a food or food group, rather than a specific food or component of food, and are not required to undergo review by the agency prior to their use. Notably, the draft guidance would deviate from earlier agency positions on dietary guidance statements. In FDA’s 2013 Food Labeling Guide, for example, the agency indicated that dietary guidance statements could reference either a substance or a disease, but should not reference both and identified as an appropriate dietary guidance statement a statement such as, “consuming at least 3 or more ounce-equivalents of whole grains per day can reduce the risk of several chronic diseases.”⁷ Similarly, in a 2003 advance notice of proposed rulemaking (ANPR) FDA identified the statement, “Diets rich in fruits and vegetables may reduce the risk of some types of cancer and other chronic diseases,” as an example of an appropriate dietary guidance statement.⁸

This marks the first time FDA has provided significant guidance on the parameters of DG statements and a departure from earlier statements recognizing it is appropriate for a dietary guidance statement to reference reduced risk of developing certain diseases. The agency has long signaled that DG statements presented a unique category of claims distinct from nutrient content or health claims.⁹ FDA notes the 2003 ANPR in the draft guidance and states some comments it received are no longer relevant given the evolution of nutrition science.

Key Provisions of the Draft Guidance

The draft guidance contains a number of recommendations related to dietary guidance statements.

1. Recommendations on How to Use Dietary Guidance Statements in Food Labeling

FDA encourages manufacturers to “convey healthful attributes of their products” to consumers by using dietary guidance statements on labeling, but notes that dietary guidance statements should not be made on dietary supplements. FDA also indicates that the draft guidance only applies to statements for individuals aged 2 and older, although the agency may consider in the future how to apply the recommendations to products specifically intended for infants and children under 2.

2. Recommendations on the Source of the Dietary Guidance Statement

The draft guidance provides that DG statements should be based only on “key or principal” recommendations of a consensus report, which FDA defines as “a report that represents the consensus produced by a group of qualified experts whose bias and conflicts of interest have been minimized and that are convened to study a specific issue.”¹⁰ Examples of consensus reports are reports published by U.S. government agencies, such as the Centers for Disease Control and Prevention (CDC), or reports published by private scientific or health organizations whose work directly relates to human nutrition and whose views are neutral and objective. Although DG statements do not need to use the precise wording found in the consensus report, the statement should be truthful and non-misleading.

3. Recommendations for Meaningful Amounts of Recommended Foods or Food Groups a Product Should Contain When Making a Dietary Guidance Statement

FDA states it would consider a DG statement about a food group to be misleading if the product bearing the claim contained little or no amount of that food group. Accordingly, the agency provides “food group equivalent” recommendations to calculate the meaningful amount of the food or food group that is the subject of the DG statement, based on the DGA and a 2,000-calorie dietary pattern.

When the subject of the DG statement is an individual food or food group, the agency recommends that the product provide ¼ of the DGA daily recommended amount of the food or food group per reference amount customarily consumed (RACC). The table below summarizes the recommended amounts of a food or food group that FDA recommends be present per RACC when it is the subject of a DG statement, which closely track the food group equivalent criteria for individual foods under FDA’s proposed “healthy” rule.

Table 2. Food Group Equivalents for Individual Foods or Food Groups¹¹

For mixed products that contain significant amounts of food from more than one food group, if a DG statement is about the entire mixed product (e.g., “Trail mix can be part of a well-balanced diet”), the agency recommends that the product contain at least half of one food group equivalent from two different food groups (e.g., ¼ cup-equivalent of fruit and ½ ounce-equivalent of nuts). If the subject of the DG statement, however, is more than one food or food group (e.g., a statement about fruits and vegetables) that are ingredients of the overall food product, the agency recommends that the product contain at least one food group equivalent from each of the different foods or food groups that are the subject of the statement.

With regard to main dishes and meals, if the subject of the DG statement is a main dish product (e.g., baked chicken), FDA recommends the product contain at least one food group equivalent each from at least two different food groups. If the subject of the DG statement is the entire meal product (e.g., frozen dinner), FDA recommends the product contain at least one food group equivalent each from at least three different food groups.

The agency notes that raw, whole fruits and vegetables may bear DG statements even if they do not conform to the food group equivalent criteria above (e.g., an apple may bear a DG statement even though it may not always contain ½ cup equivalent of fruit). Additionally, for the purposes of the recommendations, FDA considers all plant-based milk and yogurt alternatives that have been fortified to meet the USDA’s fluid milk substitutes criteria – i.e., not just soy-based milks and yogurts – to be included in the dairy category.¹²

The draft guidance notes that, as an option, a product may include a statement on its label near or adjacent to the dietary guidance statement that indicates the amount of the food or food group that is present in one serving of the product (e.g., “This food has ½ cup of vegetables per serving.”).

4. Recommendations for Nutrient Levels When a Product Bearing a Dietary Guidance Statement

The draft guidance establishes recommended thresholds for saturated fat sodium, and added sugars when a product bears a DG statement. The agency indicates that these recommended nutrient levels provide greater flexibility than the “healthy” claim nutrient requirements.¹³

• For saturated fat, FDA recommends that individual foods and mixed foods bearing dietary guidance statements should not contain more than 10 percent of the daily value (DV) (2 grams) per RACC. However, when considering whether a product exceeds the recommended saturated fat level for dietary guidance statements, the saturated fat content of nuts and seeds in the product should not contribute toward the overall recommended saturated fat level.
• For sodium, FDA recommends that individual foods and mixed foods bearing dietary guidance statements should not contain more than 15 percent of the DV (345 milligrams) per RACC.
• For added sugars, FDA recommends that individual foods and mixed foods bearing dietary guidance statements should not contain more than 10 percent of the DV 5 grams) per RACC.

FDA will consider whether a food is below the nutrient levels outlined in the draft guidance when evaluating whether a dietary guidance statement is truthful and non-misleading. However, the agency also states that there may be some instances where a food is recommended by a consensus report as part of a nutritious dietary pattern but the food exceeds these recommended nutrient levels. For example, FDA states that fat-free and low-fat yogurt often contains added sugar because it may help increase consumption of the food, which is recommended as part of nutritious dietary pattern. In those instances, FDA states that a dietary guidance statement is still appropriate, but recommends the addition of a disclosure statement about the recommended nutrient levels the product exceeds (e.g., “This product contains 10g (20% Daily Value) of Added Sugars per serving” or “See nutrition information for added sugar content.”).

Why it Matters

The draft guidance represents the first time FDA has provided significant parameters on DG statements, and the recommended criteria are much stricter than any guidance FDA has provided in the past on DG statements. The draft criteria are quite similar to the “healthy” proposed rule criteria, though the “nutrients to limit” thresholds are not as strict. The draft guidance also takes a different approach in the treatment of plant-based milk and yogurt alternatives than in the “healthy” proposed rule by recognizing that these products can count toward the dairy group when fortified to be nutritionally equivalent to cow’s milk, a position that is also generally consistent with the agency’s recently issued draft guidance on the labeling of plant-based milks.¹⁴

FDA Proposed Rule on the Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods

On March 24, 2023, FDA announced a proposed rule on the Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods.¹⁵ The proposed rule would update the existing standards of identity that include salt as either a mandatory or optional ingredient to allow manufacturers to use a salt substitute. Importantly, FDA does not establish a minimum replacement level of salt or a minimum reduction in sodium content, but allows manufacturers to determine the level of salt replacement appropriate for the particular standardized foods. Any salt substitute added to a standardized food must be an approved food additive or generally recognized as safe (GRAS) for its intended use.

The proposed rule outlines a partly “horizontal approach” – i.e., an approach that applies to multiple standards of identity at the same time – to updating the standards of identity to allow for salt substitutes. The agency plans to do this in two ways. First, FDA proposes amending 21 CFR part 130 to create a new subpart C titled “Flexibility in Standardized Foods” and section 130.30 titled “Ingredient Flexibility in Standardized Foods” which would define “salt substitutes.” This represents the horizontal approach.

Second, FDA would individually update 80 standards of identity to permit salt substitutes. FDA asserts that amending the 80 identified standards using this “vertical approach” – i.e., amending each individual standard that is affected – is necessary to provide optimum flexibility. These amendments will take one four forms depending on the nature of salt in the food:

• Type 1: When salt is an optional ingredient, the standard would be amended to state “salt or salt substitute.”
• Type 2: When salt is a required ingredient, the standard would be amended to state “salt or salt substitute.”
• Type 3: When the current standard uses terms such as “salted,” “salted with dry salt or brine,” or “salting” to provide for use of salt in the food other than as an ingredient, the standard’s optional ingredient list would be amended to add “salt substitute.”
• Type 4: When the current standard uses terms such as “salted” or “salted in brine” but does not include a list of optional ingredients, the standard would be amended to state “during the cheesemaking process, where the curd is salted, salt substitute may be used.”

Note that types 3 and 4 would only apply to the standards of identity for cheeses listed in 21 CFR part 133. Although the proposed rule states that the agency will adopt a “horizonal approach” to efficiently update the standards, the addition of the 80 specific amendments represents a “vertical approach” to making these changes as well.

Why it Matters

The proposed rule represents the first “horizontal” change aimed at modernizing multiple food standards at the same time. (The other key provision that applies horizontally across numerous standards is the regulation allowing for nutritionally modified standardized foods such as “low fat milk.”¹⁶) The food industry has long advocated that due to the sheer number of standards and common issues across them, the agency should pursue a horizontal approach to standards modernization.¹⁷ By proposing to utilize a partly horizontal approach in making these updates, FDA has created precedent for more efficiently updating standards of identity going forward.

Additionally, the proposed rule is part of the agency’s efforts to facilitate reduced sodium intake among Americans. The amendments to the standards would allow manufacturers to reduce the use of salt in foods without needing to meet the requirements for, or label the food using a “low-sodium” or “reduced sodium” claim. FDA hopes that by removing a barrier to sodium reduction in standardized foods, this flexibility will lead to lower sodium consumption by Americans.

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Next Steps

Comments on FDA’s Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling are due June 26, 2023.¹⁸ FDA is seeking comment on whether to include recommendations for the use of DG statements on “bottles or containers of plain water and other calorie-free beverages (e.g., flavored carbonated water, coffee, and tea).”

Comments on FDA’s Proposed Rule on the Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods will be due 120 days after the date of publication in the Federal Register. FDA is particularly interested in comments on the number of companies that will likely reformulate their products if the proposed rule is enacted and the potential salt substitutes that may be used in these formulations.

We will continue to monitor FDA’s nutrition initiatives and related rulemaking.

References

1 See, e.g., FDA’s Nutrition Initiatives, https://www.fda.gov/food/food-labeling-nutrition/fdas-nutrition-initiatives; The White House, Executive Summary: Biden-⁠Harris Administration National Strategy on Hunger, Nutrition, and Health (Sept. 27, 2022), https://www.whitehouse.gov/briefing-room/statements-releases/2022/09/27/executive-summary-biden-harris-administration-national-strategy-on-hunger-nutrition-and-health/.

2 U.S. Food & Drug Administration, Draft Guidance for Industry: Questions and Answers About Dietary Guidance Statements in Food Labeling (March 2023), available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-questions-and-answers-about-dietary-guidance-statements-food-labeling.

3 Dietary Guidelines for Americans, 2020-2025, available at: https://www.dietaryguidelines.gov/.

4 U.S. Department of Agriculture, MyPlate, available at: https://www.myplate.gov/.

5 Nutrient content claims expressly or implicitly characterize the level of a nutrient in a food (e.g., “high in Vitamin D”) and must be made in accordance with an FDA nutrient content regulation. 21 CFR § 101.13(b).

6 Health claims describe a relationship between a food substance and reduced risk of a disease or health-related condition and undergo review by FDA (e.g., “Diets low in sodium may reduce the risk of high blood pressure, a disease associated with many factors.”). 21 CFR § 101.14(a)(1).

7 U.S. Food & Drug Administration, Guidance for Industry: Food Labeling Guide (Jan. 2013), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-food-labeling-guide.

8 Food Labeling: Health Claims; Dietary Guidance, 68 Fed. Reg. 66040, 66046 (Nov. 25, 2003)

9 See 21 CFR 101.13(q)(5)(iii); 58 Fed. Reg. 2302 (Jan. 6, 1993).

10 The draft guidance provides that this approach is consistent with the Federal Food, Drug, and Cosmetic Act’s (FFDCA’s) requirements for the use of certain health claims and nutrient content claims that are based on an “authoritative statement” from U.S. scientific bodies with public health and nutrition expertise under sections 403(r)(2)(G) and 403(r)(3)(C).

11 The draft guidance provides additional recommendations for the amount of food that should be present in a food per RACC for the different forms that foods take within each food group (e.g., cooked vs. raw) when the product bears a dietary guidance statement.

12 U.S. Department of Agriculture, Nutrition Requirements for Fluid Milk and Fluid Milk Substitutions in the CACFP, Q&As (Jul. 14, 2016), https://www.fns.usda.gov/cacfp/nutrition-requirements-fluid-milk-and-fluid-milk-substitutions-cacfp-qas.

13 HL Engage, FDA proposes updated criteria for "healthy" claims in labeling (Sept. 28, 2022), https://www.engage.hoganlovells.com/knowledgeservices/news/fda-proposes-updated-criteria-for-healthy-claims-in-labeling; 87 Fed. Reg. 59168 (Sept. 29, 2022).

14 U.S. Food & Drug Administration, Draft Guidance for Industry: Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements (Feb. 2023), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-labeling-plant-based-milk-alternatives-and-voluntary-nutrient-statements; HL Engage, FDA issues draft guidance on labeling of plant-based milk alternatives (Feb. 23, 2023), https://www.engage.hoganlovells.com/knowledgeservices/news/fda-issues-draft-guidance-on-labeling-of-plant-based-milk-alternatives

15 U.S. Food & Drug Administration, Use of Salt Substitutes to Reduce the Sodium Content in Standardized Foods, FDA.gov (Mar. 24, 2023), https://www.fda.gov/media/166473/download.

16 See 21 CFR 130.10.

17 See Grocery Manufacturers Association, Citizen Petition to Modernize Food Standards, Regulations.gov (Oct. 25, 2006), https://www.regulations.gov/document/FDA-2007-P-0463-0367.

18 88 Fed. Reg. 18149 (Mar. 27, 2023).