September 28, 2022, was a busy day for those interested in food law and policy. Not only did the Biden Administration host the White House Conference Hunger, Nutrition, and Health, but the Food and Drug Administration (FDA) published a proposed rule that, if finalized, would amend the definition of “healthy” as it is used on food labels. This article primarily focuses on FDA’s proposed “healthy” rule, but also briefly talks about the White House conference.
The Proposed “Healthy” Rule
In response to the Nutrition Labeling and Education Act of 1990, FDA first defined the term “healthy” through a final rule in 1994, which is still in effect today. Currently, food labels can bare the term “healthy”, or a related term, only if the food contains less than a certain amount of total fat, saturated fat, cholesterol, and sodium, and contains above certain amounts for specific vitamins and nutrients. However, not all food types must meet the vitamin and nutrient minimums. For example, a raw fruit or vegetable may bare the “healthy” claim if its fat and sodium levels are below the regulatory limits but does not need to contain a minimum of any specific nutrient. 21 C.F.R. § 101.65(d)(2)(i)(A). On the other hand, a single-ingredient seafood product labeled as “healthy” must be below the fat and sodium limits AND exceed certain minimums for vitamins A and C, calcium, iron, protein, and fiber. 21 C.F.R. § 101.65(d)(2)(i)(D).
However, since 1994 nutrition science has developed and has changed what it recommends as a healthy American diet. As the proposed rule states, under the current “healthy” label, “foods that are encouraged by the Dietary Guidelines, 2020-2025 for inclusion in a healthy dietary pattern are sometimes not able to meet the nutrient criteria under § 101.65(d) for use of the claim ‘healthy’.” 87 Fed. Reg. 59172. The proposed rule further explains that “the current definition permits manufacturers to use the claim ‘healthy’ on some foods that, based on the most up-to-date nutrition science and Federal dietary guidance, contain levels of nutrients that would not help consumers maintain healthy dietary practices (e.g., certain ready-to-eat cereals that may be high in added sugars).” 87 Fed. Reg. 59172.
One of the key components of the proposed rule is that it focuses on food groups. FDA states that “instead of including a limited set of nutrients for which consumption is encouraged in the definition as surrogates for recommended food groups and subgroups, we proposed to directly incorporate food groups as criteria in the definition of the claim ‘healthy’.” 87 Fed. Reg. 59177. To do this, the proposed rule defines “food group equivalents” for five different food groups—vegetables, fruits, grains, dairy, and protein foods. The proposed rule defines “food group equivalent” as the minimum amount of a food group that a food must contain for it to bear the “healthy” claim. 87 Fed. Reg. 59200. The proposed rule explains that “food products would need to contain a certain amount of food (a “food group equivalent”) from at least one of these recommended food groups or subgroups (e.g., ½ cup of fruit or ¾ cup of dairy) to be labeled ‘healthy.” 87 Fed. Reg. 59176. Although most manufacturers of “healthy” food will need to pay attention to “food group equivalent” calculations, certain types of food, such as raw whole fruits and vegetables, are not required to meet any “food group equivalent” thresholds to bear the “healthy” claim.
Ultimately, FDA is proposing to allow food manufacturers to include a “healthy” claim on a food label if the food meets one of the following six criteria:
- The food is a raw, whole fruit or vegetable.
- The food is a vegetable product, fruit product, grain product, dairy product, protein food (which includes game meats; seafood; egg; beans, peas, and soy products; and nuts and seeds), or oil, and does not exceed certain limits on added sugar, sodium, and saturated fat per reference amount customarily consumed (RACC). As an example, the preamble to the proposed rule states that “a ‘fruit product’ would need to contain ½ c-eq of fruit per RACC (in addition to other requirements) to meet the proposed criteria for ‘healthy’.” 87 Fed. Regs. 59178.
- The food is a mixed product that contains at least half a food group equivalent of two different food groups and does not exceed certain limits on added sugar, sodium, and saturated fat per RACC. For example, a mixed product that contains half a food group equivalent of both dairy and whole grain can bare the “healthy” label if it contains less than 5% of the daily value of added sugar, 10% of the daily value of sodium, and 7.5% of the daily value of saturated fat. 87 Fed. Reg. 59200.
- The product is a main dish that contains at least one full food group equivalent of two different food groups and does not exceed certain limits on added sugar, sodium, and saturated fat per serving. For example, a main dish that contains a full food group equivalent for both dairy and whole grain can bare the “healthy” label if it contains less than 10% of the daily value of added sugar, 20% of the daily value of sodium, and 15% of the daily value of saturated fat. 87 Fed. Reg. 59200.
- The product is a meal product that that contains at least one full food group equivalent of three different food groups and does not exceed certain limits on added sugar, sodium, and saturated fat per serving. For example, a meal product that contains a full food group equivalent of dairy, whole grain, and vegetables can bare the “healthy” label if it contains less than 10% of the daily value of sugar, 30% of the daily value of sodium, and 20% of the daily value of saturated fat. 87 Fed. Reg. 59200.
- The product is plain or carbonated water without flavoring or additional ingredients.
Finally, the proposed rule includes a provision that requires food manufacturers to take and maintain records for up to two years after certain products are labeled with the “healthy” claim. The preamble to the rule explains that, for some foods, “it will be apparent from the Nutrition Facts Label whether a food meets the applicable criteria for saturated fat, sodium, and added sugars content, and thus no additional records are required.” 87 Fed. Reg. 59194. However, FDA recognizes that “the label will not provide sufficient information for FDA to verify that certain foods containing multiple components (such as most grain products and all combination foods) meet the food group equivalent requirements to bear the claim.” 87 Fed. Reg. 59194. Therefore, the proposed rule would require food manufacturers to take and maintain records indicating a product meets the requirements if compliance is not readily apparent from the label.
FDA is hosting a webinar on October 21, 2022, to discuss the rule. Those interested must register via the FDA website. Those interested in submitting a comment have until December 28, 2022, to do so. Comments can be submitted through the either the federal register website or regulations.gov. It is important to note that this proposed definition of “healthy” will only apply to FDA regulated food. Meat, poultry, and egg products with a “healthy” claim are regulated by the Food Safety and Inspection Service who has its own rules and guidance regarding the “healthy” claim.
White House Conference on Hunger, Nutrition, and Health
Also on Wednesday, September 28, the White House hosted its conference on hunger, nutrition, and health. As explained in a previous NALC article, this conference was modeled after a conference held in 1969 by the Nixon administration. Prior to the 1969 conference, President Nixon posed five questions to conference attendees. Similarly, the day before the 2022 conference, the Biden administration published a national strategy that outlines the five pillars that conference presenters discussed. The five pillars of the national strategy are:
- Improve food access and affordability: end hunger by making it easier for everyone—including individuals in urban, suburban, rural, and Tribal communities, and territories—to access and afford food.
- Integrate nutrition and health: prioritize the role of nutrition and food security in overall health—including disease prevention and management—and ensure that our health care system addresses the nutrition needs of all people.
- Empower all consumers to make and have access to healthy choices: foster environments that enable all people to easily make informed, healthy choices, increase access to healthy food, encourage healthy workplace and school policies, and invest in public education campaigns that are culturally appropriate and resonate with specific communities.
- Support physical activity for all: make it easier for people to be more physically active—in part by ensuring that everyone has access to safe places to be active—increase awareness of the benefits of physical activity, and conduct research on and measure physical activity.
- Enhance nutrition and food security research: improve nutrition metrics, data collection, and research to inform nutrition and food security policy, particularly on issues of equity, access, and disparities.
Although the conference is past, the goal of the conference was to inform hunger, nutrition, and health policy for years to come. Although there will likely be many occasions where the discussions held at the conference will inform policy, the proposed “healthy” rule offers a timely opportunity for stakeholders to evaluate a proposed regulatory action against the issues highlighted at the conference.
September 28, 2022, was a busy day for the food law and policy community. Both the proposed “healthy” rule and the White House conference have left food law and policy stakeholders with a lot to think and talk about. Both will also likely help shape the future of food law.
To read the proposed “healthy” rule, click here.
To watch the plenary and panel discussions that took place at the White House conference, click here.
To listen to the Ag Law in the Field podcast episode on the White House conference, click here.
To learn more about nutrient content claims, read the NALC’s article on the topic, here.
To learn more about food labeling generally, visit the NALC’s food labeling reading room, here.
To learn more about the federal nutrition programs, visits the NALC’s Nutrition Programs reading room, here.