On January 16, 2025, the Food & Drug Administration (FDA or
the Agency) published a proposed rule requiring front-of-package
(FOP) nutrition labels on most foods that bear a Nutrition Facts
label. The rule follows the issuance of FDA's new final rule defining
"healthy" and the 2025 Dietary Guidelines Advisory
Committee (DGAC) Scientific Report to the Secretaries of the
U.S. Department of Health and Human Services (HHS) and the U.S.
Department of Agriculture recommending their updates to the U.S.
Dietary Guidelines for Americans.
The proposed FOP label will be a "compact informational box
containing certain nutrient information" regarding the
food's saturated fat, sodium, and added sugar content.
According to the proposed rule, FDA chose these nutrients due to
their "significance in building healthy dietary
patterns." FDA has also proposed amending the nutrient content
claim definition for the term low sodium (including derivatives
such as "low in sodium" and "little sodium")
and low saturated fat (including derivatives such as "low in
saturated fat" and "a little saturated fat").
FDA is accepting comments on the proposed rule until May 16, 2025
and the compliance date for the proposed rule would be three years
after the final rule's effective date for businesses with $10
million or more in annual food sales, and a compliance date of four
years for businesses with less than $10 million in annual food
sales.
An overview of the proposed rule and related considerations for
companies engaged in the labeling and promotion of food products in
the United States is provided below.
Background
Congress passed the Nutrition Labeling and Education Act in 1990
which granted the Secretary of HHS, and by delegation FDA, the
authority to require certain nutrition information for food product
so that consumers could make educated decisions regarding their
dietary habits. In 1993, FDA issued its first regulations relating
to Nutrition Labels and have since amended the regulations in 1995,
2003, and 2016. FDA believes that the addition of the FOP label
will provide "a more accessible description of the numerical
information contained in the Nutrition Facts label."
In support of the proposed rule, the Agency notes the increased
prevalence of diet-related chronic diseases and conditions, which
are the leading cause of death and disability in the United States.
The Agency also relies on the recommendations from the Dietary
Guidelines for Americans, 2020-2025, which recommends limiting the
intake of saturated fat, sodium, and added sugars. According to the
preamble to the proposed rule, "the proposed rule would
provide consumers, including those who have lower nutrition
knowledge, with interpretive nutrition information that can help
them to quickly and easily identify how foods can be part of a
healthy diet." FDA considers this proposal to be a part of a
"whole-government approach" to reduce the burden of
diet-related chronic diseases and believes that adding FOP labels
will help achieve that goal by providing consumers with greater and
more visible nutrition information.
The FOP Label Proposed Rule
The proposed rule would add a requirement for certain nutrition information regarding nutrients to limit in the diet to appear in a FOP compact informational box contained on the principal display panel or bulk food labelling for most foods that bear a Nutrition Facts label. In pertinent part, the proposed FOP label would describe the relative amount of these nutrients in a serving of food, by listing the serving size and the percentage of the recommended daily value for saturated fat, sodium, and added sugars contained in the food product. In addition to having the daily value percentages for these nutrients, the FOP label will also contain a "low, medium (abbreviated to "med"), and high" evaluation for each of these nutrients. An example of an FOP label published by the FDA in the proposed rule is below:
According to the proposed rule, a food is low for a certain nutrient if it is 5% or less of the daily recommended value for that nutrient; medium for the nutrient if the percentage is between 6% and 19%; and high for the nutrient if the food contains 20% or higher of the recommended daily value for that nutrient. A few other requirements include:
- The FOP label be "somewhere in the top third of the principal display panel, without specifying the exact location"
- A single, easy-to-read type style be used for the FOP label with the proposed style aligning with the Nutrition Fact label's type style requirements
- The font be in black and a minimum font size of at least eight point
- All the font used in the FOP label be in bold or extra-bold except the "Per Serving" heading with the "Nutrition Info" and "% Daily Value" subheading in extra bold
No other information would be allowed on the FOP label.
Packaged foods which contain two or more separately packed foods
that are intended to be eaten individually, would be able to use an
aggregate FOP for each of the product contained in the package as
long as they appear together in either horizontal or vertical
lines. For foods served in bulk containers, the FOP label would
need to be displayed plainly in view of the consumer at the point
of purchase.
Exceptions and Exclusions
The proposed rule will not apply to food marketed for children under four years old or for dietary supplements. Foods that have dual-column labeling (the display of multiple sets of nutrition information for multiple groups for which reference daily intakes are established) would require FOP labels for people ages four and older. Any food product that is currently exempted from displaying a Nutrition Facts label would similarly be exempted from adding an FOP label under the proposed rule. Food products that have a total surface area available of less than 12 inches are also exempted from adding an FOP label, though they would still be required to contain a Nutrition Facts label.
Amended Nutrient Claim Definition for Low Sodium and Low Saturated Fat
In the proposed rule, the Agency is also seeking to amend the
nutrient claim definition for low sodium and low saturated fat. Any
food manufacturer that wishes to voluntarily market its food
product as low (or derivatives of that phrase) in sodium or in
saturated fats must adhere to the definitions set in the proposed
rule. These definitions would be different than the "high,
medium, and low" framework used in the FOP label.
The proposed rule changes the low sodium thresholds to 115
milligrams or less sodium per reference amounts customarily
consumed (RACC) for food products that are not a meal product or a
main dish and 115 milligrams or less per 100 grams for food
products that are a meal product or a main dish. FDA notes that
this proposed definition aligns with the current daily reference
value of 2,300 milligrams of sodium, which was updated in the 2016
Nutrition Fact label final rule.
As for saturated fats, under the proposed rule, a food product is
low in saturated fats if it has one gram or less of saturated fatty
acid per RACC and not more than 15% of calories from saturated
fatty acids or if the product contains one gram or less of
saturated fatty acids per 100 grams and less than 10% of calories
from saturated fat.
Other Notable Observations
The preamble to the proposed rule discusses the results of
consumer research that echoes concerns expressed in the Scientific Report of the 2025 Dietary Guidelines
by the Dietary Guidelines Advisory Committee regarding
discrepancies in nutrition literacy and health outcomes across
racial/ethnic populations and socioeconomic levels. In particular,
FDA notes that while 87% of U.S. consumers report ever looking at
the Nutrition Facts label, "fewer people who ever look at the
Nutrition Facts label look at nutrients to limit (including sodium,
saturated fat, and added sugars) in that label," and
"regular use of the Nutrition Facts label is lower among men,
those with lower education levels, and those with lower
incomes." FDA also notes that use of the Nutrition Facts label
"differs by sex, race/ethnicity, education level, and
household income," drawing light to concerns about consumer
comprehension of nutrition information, generally.
Both FDA and the DGAC's discussion of consumer understanding of
nutrient information across subgroups of the population should be
on the radar of companies considering how to mitigate class-action
and other risks related to promotion of both products with
health-related claims and products that contain material amounts of
sodium, saturated fat, or added sugars.
Conclusion
FDA's proposed rule reflects the government's heightened focus on nutrition policy, as it aims to combat an increase in diet-related chronic diseases in the United States. We will continue to monitor these developments.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
