Key Considerations for Evaluating FDA’s Proposed Rule Redefining “Healthy” in the US and the EU

Introduction

On September 29, 2022, the US Food and Drug Administration (FDA or the Agency) published a proposed rule, Food Labeling: Nutrient Content Claims; Definition of Term “Healthy” (the Proposed Rule).¹ The Proposed Rule would revise the existing regulatory criteria for when advertisers may use the term “healthy” as an implied nutrient content claim in the labeling of human food products. FDA believes that the definition of “healthy” when used as a nutrient content claim should be updated to reflect the evolution of nutrition science and changes to other federal dietary guidelines since FDA first established the definition for the claim in 1994. This Advisory provides a brief overview of the history surrounding “healthy” claims on food labels, key updates to the definition in the Proposed Rule, and considerations for companies considering use of “healthy” in food labeling or advertising. We also provide a brief summary of the European Union’s regulation of this issue.

History and Background

FDA permits the use of nutrient content claims (NCCs) (i.e, claims that characterize the level of a nutrient in a food) in food labeling only if such claims adhere to all applicable FDA regulations. NCCs can be express (directly stating the level of a nutrient in a food) or implied (suggesting the food contains or lacks certain nutrients or is useful in maintaining a healthy diet).² NCCs that do not adhere to FDA regulations are prohibited from use in labeling and can render a food product misbranded under the Federal Food Drug & Cosmetic Act. Misbranding may lead to enforcement actions such as warning letters, recalls, or seizures of relevant products.³ Alleged misbranding has also been tied to piggyback litigation by private litigants under state law alleging that misbranding the product violates the states unfair and deceptive advertising practices statute.

FDA has long taken the position that “healthy,” when used in food labeling, is an implied nutrient content claim. FDA originally defined “healthy” when used as an NCC in 1994, when the Agency published in the Federal Register a final rule entitled Food Labeling: Nutrient Content Claims, Definition of Term: Healthy.⁴ The original definition provided specific criteria for individual nutrients, including limits on some nutrients (e.g., total fat and sodium) and minimum requirements for others (e.g., calcium and dietary fiber). As noted in the preamble to the Proposed Rule, FDA believes this original definition now allows use of the claim “healthy” on some foods that, based on current nutrition science and federal dietary guidelines, would not help consumers maintain healthy dietary practices, and disallows the use of the claim on some foods that are key elements of a healthy diet. In determining current nutrition science, FDA relies heavily on the federal dietary guidance established in the Dietary Guidelines for Americans (Guidelines).⁵

The Guidelines are developed jointly by the US Department of Agriculture (USDA) and the US Department of Health and Human Services (HHS) and provide recommendations on healthy eating. The Guidelines are published every five years and are designed to inform policymakers implementing policies and programs related to food, nutrition and health. FDA has previously relied on the Dietary Guidelines in promulgating rules governing the food labeling. For example, in 2016 FDA issued two final rules, Food Labeling: Revision of the Nutrition and Supplement Facts Labels (NFL Final Rule) and Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (Serving Size Final Rule), to update the nutrition facts label to better reflect the nutrition science in the 2015-2020 Guidelines, among other information.⁶

The most recent Guidelines publication, Dietary Guidelines, 2020-2025, recommends consumption of nutrient-dense foods to meet nutritional needs within calorie limits, rather than focusing on individual nutrients.⁷ Because FDA criteria for use of the “healthy” claim continues to focus on individual nutrients, foods encouraged by the Guidelines for inclusion in a healthy diet do not meet FDA criteria for use of the “healthy” claim; for example, some oils are recommended by the Guidelines as healthy sources of fat in place of alternative sources high in saturated fat, but do not meet the criteria for use of the “healthy” claim because they do not provide sufficient amounts of individual nutrients like vitamin A or protein. FDA’s Proposed Rule seeks to align the Agency’s definition of “healthy” for use as an NCC with the Dietary Guidelines to avoid such inconsistencies in federal guidance on healthy dietary practices.

FDA’s Proposed Rule also aims to respond to stakeholder input. Notably, in March 2015, FDA issued a warning letter informing a food producer, KIND, that the company was violating agency regulations by labeling as “healthy” products that did not meet the regulatory definition.⁸ KIND responded to the letter by filing a citizen petition that mustered evidence and expert signatories against the wisdom of FDA’s definition.⁹ The petition included evidence from the 2015 Dietary Guidelines Advisory Committee’s scientific report, which counseled a shift from emphasizing the importance of attaining particular nutrient levels to emphasizing the importance of eating particular foods, and urged FDA to adopt a definition of “healthy” highlighting particular recommended foods and to revise FDA regulations to restrict foods high in certain nutrients.¹⁰

Based on this evolution of nutrition science, changing federal dietary guidelines and stakeholder input, FDA has previously taken steps to harmonize the requirements for the “healthy” claim with current nutrition science. In 2016, FDA published a final guidance, Use of the Term ‘Healthy’ in the Labeling of Human Food Products: Guidance for Industry, describing the Agency’s intent to reevaluate the existing criteria for “healthy” and to exercise enforcement discretion where a product uses the “healthy” claim despite lacking a low total fat content, so long as the product contains predominately mono- and polyunsaturated fats.¹¹ FDA also issued a request for comment regarding the definition of “healthy” in 2016 and held a public meeting on the same subject in 2017 following the initial comment period.¹² The Proposed Rule and the changes to existing regulations it will produce once finalized reflect FDA’s conclusions following this period of reevaluation.

Changes in Proposed Rule

Definition of “Healthy” Application

FDA proposes to continue to define “healthy” as an NCC only when used in a nutritional context (e.g., on a label or in labeling alongside other information about the nutrition content of the food). However, FDA believes the existing language may be too narrow and, accordingly, proposes to revise the existing text to broaden the description of what a nutritional context entails. Under the proposed revision, the regulations would no longer require that an implied NCC be used “in connection with an explicit or implicit claim or statement about a nutrient.” Instead, the term “healthy” would constitute an NCC where the term is used to characterize the food itself and where there is also implied or explicit information about the nutrition content of the food. The proposed revision would also no longer require that the material accompanying the claim be “a claim or statement about a nutrient.” Instead, it would require that the material be “information about the nutrition content of the food.”

Shift to Food Groups

FDA has concluded that using food groups as the criteria for “healthy,” rather than focusing on a limited set of nutrients, would better identify foods with the nutrient content to help consumers maintain healthy dietary practices consistent with current nutrition science. The most current iteration of the Guidelines acknowledges that foods are not consumed in isolation, but in combinations over time as components of a larger dietary pattern. The principal message of the Guidelines is to follow a healthy dietary pattern that focuses on meeting food group needs while staying within calorie limits. The Guidelines show that a healthy dietary pattern is associated with beneficial health outcomes. The Guidelines identify that common characteristics of healthy dietary patterns include higher consumption of vegetables, fruits, whole grains, lean meats, seafood, nuts, and unsaturated vegetable oils, along with lower consumption of red meats, sugar-sweetened foods and refined grains.

FDA proposes to require that food products contain a certain amount of food from one of six food groups—vegetables, fruits, grains, dairy, protein, and oils—recommended by the Guidelines. FDA proposes to refer to the amount of a food from a particular food group that must be contained in a food product for it to bear the “healthy” claim as a “food group equivalent.” FDA further proposes to define a “food group equivalent” as equal to different amounts for five of the different food groups, with further subgroups for protein products. FDA has not proposed a food group equivalent for oils, as only certain oils meet the criteria for inclusion in a healthy dietary pattern.

Nutrients to Limit

FDA also proposes to retain certain nutrients to limit as criteria for bearing the claim “healthy.” FDA notes that current nutrition science continues to recommend limiting certain nutrients as a component of a healthy dietary pattern, and that the Guidelines define nutrient dense foods in part as those prepared with no or little added sugars, saturated fat and sodium. Accordingly, FDA proposes to retain baseline nutrient limits for these three nutrients as a part of the criteria for use of the claim “healthy,” while adjusting the limits applicable to different food groups to account for instances where a food’s relatively high content of a limited nutrient is naturally occurring and offset by high content of other, beneficial nutrients (e.g., some dairy products are relatively high in saturated fat, but also high in vitamin D and calcium).

In contrast, FDA proposes removing the limits for total fat, trans fat and dietary cholesterol.

FDA notes in the Proposed Rule that current nutrition science has shifted away from recommending low intake of total fat to instead emphasize intake of unsaturated fats in place of saturated fats. Thus, while retaining the nutrient limits for saturated fat, FDA has concluded that both trans fat and dietary cholesterol are unnecessary because both are already sufficiently limited by the proposed limits for saturated fat, as both natural trans fat and dietary cholesterol are found primarily in foods that are also sources of saturated fat. Further, FDA no longer thinks the limit on trans fat currently included in the criteria for use of a “healthy” claim is necessary following the Agency’s determination in 2015 that partially hydrogenated oils, the primary dietary source of industrially produced trans fat, are no longer generally recognized as safe for use in food and have accordingly been largely removed from the food supply.

Covered Products

FDA proposes to limit the foods that may bear the “healthy” NCC to several enumerated categories: (1) raw, whole fruits and vegetables; (2) individual food products; (3) combination foods, which encompasses mixed products, main dish products, and meal products; and (4) plain water. Foods falling into one of these categories would be eligible for description as “healthy” where they contain a food group equivalent and adhere to nutrient-to-limit requirements.

FDA proposes a narrow exception to the food group equivalent and nutrient-to-limit requirements for raw, whole fruits and vegetables. Under this exception, such foods would not need to contain certain amounts of any food group equivalent to qualify for the “healthy” claim, (e.g., one strawberry could be labeled “healthy”), nor would they need to meet the nutrient-to-limit requirements.

Recordkeeping Requirements

For some foods, the label will not provide FDA sufficient information to verify whether the foods meet the requirements for “healthy,” specifically whether certain foods containing multiple components meet the food group equivalent requirements. Where the “healthy” claim is used for such foods, FDA proposes to require the manufacturer to make and keep records verifying that the food meets the food group equivalent requirements. This requirement would not apply to water or to raw, whole fruits and vegetables. Such records could include recipes or formulations, batch records providing data on the weight of certain ingredient contributions to the total batch, certificates of analysis from ingredient suppliers, or other appropriate verification documentation.

Additional Details

Preemption

FDA has issued the Proposed Rule under the Agency’s authority under section 403(r) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).¹³ Section 403A(a) of the FD&C Act is an express preemption provision and provides that no state or political subdivision thereof may directly or indirectly establish or continue in effect any requirement for nutrition labeling that is not identical to requirements established under section 403(r) of the FD&C Act.¹⁴

European Union Considerations

FDA’s proposed removal of the requirement that an implied NCC be used “in connection with an explicit or implicit claim or statement about a nutrient” would, if finalized, be in contrast to the position in the EU.

Like the US, the EU places strict controls on the use of nutrition and health claims on food labeling. Most claims require prior approval (under Regulation (EC) No. 1924/2006) either as (1) nutritional claims, which state, suggest, or imply that a food has particular beneficial nutritional properties due to the energy and/or nutrients or other substances it provides or contains (e.g., “low fat” or “source of fiber”) or (2) health claims, which state, suggest or imply that a relationship exists between a food category, a food, or one of its constituents and health (e.g., “calcium is needed for the maintenance of normal teeth”).

However, the term “healthy” is considered a general, non-specific health claim which may be used without prior approval, provided it is accompanied by an authorized, specific health claim (i.e., a claim falling into group (2) above). The Court of Justice of the EU has considered this requirement and held that the accompanying specific health claim is required to appear next to the term “healthy” or, where it appears elsewhere on the packaging, an asterisk must clearly link the two.

Key Considerations

The Proposed Rule, once finalized, will harmonize FDA’s regulations governing use of the term “healthy” in promotional materials as a nutrient content claim with current nutritional science and with the dietary recommendations made by other federal government institutions. FDA’s position can also serve as a benchmark for companies considering use of the term in food advertising. Companies that manufacture and market food products should become familiar with FDA’s updated requirements to ensure that their promotional practices continue to align with federal regulation, avoid the potential consequences of noncompliance, and protect against efforts to challenge non-compliant products by private litigants seeking recovery under state law.

FDA intends that any final rule resulting from this proposed rulemaking becomes effective 60 days after the date of the final rule’s publication in the Federal Register, with a compliance date three years after the effective date. FDA is accepting comments to the Proposed Rule until December 28, 2022. Interested companies or other stakeholders should consider submitting comments 

© Arnold & Porter Kaye Scholer LLP 2022 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.