FDA Proposes New “Healthy” Definition Stemming from White House’s New Nutrition and Health Initiatives

Last week, as part of the historic White House Conference on Hunger, Nutrition, and Health, President Biden announced an ambitious goal of ending hunger and increasing healthy eating and physical activity by 2030 in America to help curb the negative impacts of diet-related diseases. The notable package of new actions, which includes recommendations from business, civic, academic, and philanthropic leaders, identifies actions to be taken across five guiding pillars including: 

1. Improving food access and affordability;
2. Integrating nutrition and health;
3. Empowering all consumers to make and have access to healthy choices;
4. Supporting physical activity for all; and
5. Enhancing nutrition and food security research.  

As a means to achieve the ambitious goal set out in third pillar, President Biden proposes to 1) develop a front-of-packaging labeling scheme for food packages, 2) facilitate sodium reduction in the food supply by issuing longer-term, voluntary sodium targets for industry, and 3) update to the nutrition criteria for a “healthy” claim on food packages. 

Proposed Changes to Definition of “Healthy”

In response to the White House announcement, the federal Food and Drug Administration (FDA) released a proposed rule that would bring the requirements to use the word “healthy” in a marketing claim in-line with modern dietary guidelines proscribed by the Dietary Guidelines for Americans 2020-2025.

The FDA’s current definition of “healthy” includes limits for total fat, saturated fat, cholesterol and sodium to qualify; foods must also provide at least 10% of the Daily Value for one or more of the following nutrients: vitamin A, vitamin C, calcium, iron, protein, and fiber. Sugar (added or naturally-occurring) is not addressed. The newly proposed “healthy” definition uses a food group-based approach in addition to nutrients to limit (based on the understanding that each food group contributes an array of important nutrients to the diet).

The proposed definition requires the following: a food must contain a certain amount of food from at least one of the food groups (fruit, vegetables, grains, dairy, and protein foods, oils, mixed products, main dish, and meals); specific limits for added sugars, saturated fat, and sodium is based on a percentage of the Daily Value for these nutrients; raw and whole fruits and vegetables automatically qualify for the “healthy” claim. 

If adopted, a compliance date is set for three years after the effective date (20 days after final rules are published in the Federal Register). The delayed compliance date is intended to “provide industry time to revise labeling to come into compliance with the new labeling requirements while balancing the need for consumers to have the information in a timely manner.”

The FDA’s definition of “healthy” was last updated in 1994.

Why Agencies Should Care

While the FDA must finalize the formal notice and comment process, agencies and their clients now have visibility into FDA’s current thinking on what will be required of food brands for labeling and “healthy” claims in the future. Final rules may be tweaked, however, as a result of this public stakeholder process. 

Given the significant investment and production time required to update product labels and packaging, and the potential for false advertising litigation connected with labeling compliance in the future, agencies and brands will want to assess whether a “healthy” claim on a product remains an option; they may alternatively decide to pivot to a claim that is subject to a less stringent regulatory definition. Either way, brands and agencies will want to be cognizant of the “net impression” of a food or beverage label and evaluate not just technical label compliance, but how consumer plaintiff attorneys may interpret the labels claims.

Comments Process

Specific comments are requested by the FDA on the following topics:

• Whether “nutrients-to-encourage” should be included in addition to the food groups; 
• Whether the use of food groups would better help consumers identify foods with healthy nutrient content rather than a limited set of individual nutrients; 
• Whether their calculations for required amounts is appropriate; 
• The scope of nutritional context and information the rule should apply to; 
• Whether the rule should include the addition of the automatically healthy category;
• Whether the various ceilings for limited nutrients are correct;
•  What types of records should be kept;
• Whether or not water should be included as automatically “Healthy.”

Written comments on the proposed rule are due by December 28, 2022 COB to regulations.gov. 

For questions regarding FDA’s newly proposed “Healthy” Definition rule, contact Alison Pepper.