FDA Proposes New “Healthy” Definition As Part Of Comprehensive Biden Administration Nutrition And Health Initiatives – Food and Drugs Law

Earlier this week, as part of the White House Conference on
Hunger, Nutrition, and Health, President Biden announced a goal of ending hunger and
increasing healthy eating and physical activity by 2030 so fewer
Americans experience diet-related diseases. The strategy identifies
actions to be taken across five guiding pillars: first, improving
food access and affordability, second, integrating nutrition and
health, third, empowering all consumers to make and have access to
healthy choices, fourth, supporting physical activity for all, and
finally, enhancing nutrition and food security research. In order
to achieve the third pillar, President Biden proposes, among other
things, to develop a front-of-packaging labeling scheme for food
packages, facilitate sodium reduction in the food supply by issuing
longer-term, voluntary sodium targets for industry, and finally to
propose an update to the nutrition criteria for a
“healthy” claim on food packages. On the heels of this
announcement, FDA released a proposed rule that would bring the
requirements to use the word “healthy” in a claim in-line
with modern dietary guidance.

What Is Changing?

The proposed rule attempts to harmonize the definition of
“healthy” with the current recommendations published in
the Dietary Guidelines for Americans 2020-2025. Accordingly, the
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), which has changed since 1994,
when the current definition of “healthy” was promulgated.
The proposed rule would also require a food to contain a certain
amount from at least one of the food groups or subgroups
(vegetables, fruits, grains, dairy, and protein foods) recommended
by the Dietary Guidelines in order to use the “Healthy”
claim, e.g., there must be at least ½ cup of fruits or
vegetables, 3/4 cup of dairy, a range of 1-1 and 1/2 ounces of
protein depending on the type, or no less than 3/4 ounce whole
grain. Additionally, the new rule discards certain nutrient
requirement provisions as no longer relevant while prescribing
limits on three specific nutrients – sodium, saturated fat,
and added sugar. Required amounts and limits are all adjusted for
each specific food group, as well as the type of item (a mixed
product, a main dish, a meal) in question. Finally, the proposed
rule creates a group of foods, including raw and whole fruits and
vegetables, and water, that will be automatically considered
“healthy” and can use the claim without being subject to
requirements for food group equivalent amounts or the nutrients to
limit.

How Does The Proposed Rule Compare To The New Rule?

The 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 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.
These requirements and limitations are illustrated in the charts
below.

How Will the Proposed Rule Affect Labels?

Although FDA must finalize the notice and comment process,
industry now has the agency’s current thinking regarding what
will be required. Given the investment required to modify product
labels, and the potential for false advertising litigation
associated with labeling compliance in recent years, companies will
want to consider whether a “healthy” claim remains an
option or whether they want to pivot to a claim that is not limited
by a strict regulatory definition. Either way, manufacturers will
want to be mindful of the “net impression” of the label
and consider not just technical label compliance, but how the
watchful eye of the plaintiff’s bar may interpret the claims as
well.

Opportunity To Comment

Once the proposed rule is published in the Federal
Register, the FDA will consider comments submitted within the
following 90-days. Specifically, the FDA has requested comment on:
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; and
Whether or not water should be included as automatically
“Healthy.”

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