[Updated] U.S. FDA Unveils Two Notifications for Nutrition Content Claim and Food Allergen Labeling

Editor's note: This article was originally published on December 9, 2022, and was updated on December 25, 2024, as per the latest developments. 

On December 19, 2024, FDA issued a final rule, Finalizing updated "healthy" nutrient content claim. Manufacturers choosing to use this claim have three years to comply but may adopt the new criteria sooner. 

At the end of November 2022, The United States issued two notices in a row, intending to revise the requirement for nutrition content claim and food allergen labeling on food packaging. The details are as follows:

Nutrition Content Claim

On November 28, 2022, U.S. Food and Drug Administration (FDA) released a notification, extending the comment period for another 90 days for revising the definition of nutrition content claimed as "healthy". Stakeholders can summit their suggestions before February 16, 2023. The major revisions include:

1. Updated the definition of "healthy" nutrient content claims

The existing definition of “healthy” as a nutrient content claim on food packaging includes the minimum content thresholds for a limited number of nutrients whose consumption is encouraged. In the consultation document, FDA proposed a new criteria for “healthy” nutrient content claims, including that:

• The food shall contain a certain amount of a food group like fruits, vegetables, grains, proteins, and dairy.

• The food shall not contain too much saturated fat, sodium, or added sugars.

After implementing the new definition：

• Salmon, avocados, olive oil, etc., are allowed to use the “healthy” claim;

• Plain, non-carbonated water and plain, as well as carbonated water can also be labeled with "healthy".

• Sweetened cereals and yogurt that are high in sugars do not qualify for a "healthy" claim;

2. Written record

Each food manufacturer using the "healthy" nutrient content claim on their products shall keep written records and provide them in response to FDA inspection. However, raw and whole fruits/vegetables, water, as well as individual foods that provide sufficient information on the food label are excluded.

Food Allergen Labeling

On November 29, 2022, FDA issued the Notice 2022-26110 aimed at food allergen labeling requirements, seeking comments from the public within 60 days. The main contents include:

1. Expansion of the source range of allergens

2. Specific packing and labeling situations

Food allergen labeling requirements apply to bulk containers, such as reusable totes and containers of bulk food shipped for further processing, labeling, or repacking between manufacturers, repackers or distributors. Most mandatory food labeling may be exempted during a food shipment, but allergen labeling cannot be exempted.

Individual units within a multiunit package shall mark the "Contain" declaration when being added with an allergen substance. However, allergen labeling is allowed to be omitted when the individual unit is an unlabeled inner sleeve solely intended to protect the product, such as sleeves of crackers, and does not contain any written, printed, or graphic matter.