21 CFR Part 101
For US food brands and packaging teams working out what FDA labeling rules expect, from nutrition facts to health claims. This page covers what you need to know and ways to avoid running into issues.
What we've seen reported
The FDA food labeling rules in 21 CFR Part 101 set out what US food labels carry, from the statement of identity and ingredient list to Nutrition Facts, and when nutrient content and health claims appear, according to their text.1
Last updated October 2026 · General information only, not legal advice. Sources.
What the rules cover
These are the kinds of label content the FDA food labeling rules in 21 CFR Part 101 describe, according to their text and the 2024 "healthy" final rule, and where each is described as applying.1,3
| Requirement | Where it applies |
|---|---|
| Statement of identity | On the principal display panel, as the common or usual name of the food. |
| Net quantity of contents | In the bottom 30% of the principal display panel, in US and metric units. |
| Ingredient list | Each ingredient by its common or usual name, in descending order of predominance by weight. |
| Name and place of business | The manufacturer, packer or distributor, qualified where the food was made by someone else. |
| Nutrition Facts | Calories, added sugars and other nutrients, in the format FDA updated in 2016. |
| The information panel | Required details on the principal display panel or the panel immediately to its right. |
| Nutrient content claims ("low fat", "high fiber") | Terms used under the definitions set out in subpart D of Part 101. |
| "Healthy" claims | Updated criteria: food group equivalents plus limits on added sugars, saturated fat and sodium. |
Where it goes wrong
One approved set of product information ends up in many channels, markets and languages. Along the way it gets shortened, translated and reworded, and some versions end up without the warnings or details these rules require.
Heldan oat granola: Nutrition Facts, ingredients (oats, honey, almonds), "Good source of fiber"
How Arbitr helps
Manually review everything? Or do what modern teams do and use AI to check that what you publish matches what you approved.
FAQ
More than the pack itself. The FDA food labeling rules place identity, ingredients and Nutrition Facts on the principal display and information panels,1 and we usually find the same details copied into:
Treat the recipe as the approved record and every pack, listing and feed as a version of it. When an ingredient or supplier changes, list everywhere that product is described and update them together, including stock already printed. Our packaging and labels page shows how teams track this.
Keep one record per product: the approved ingredient list, the Nutrition Facts values and the recipe version behind them, any claims with their supporting data, who approved each, and every pack and listing they appear on. When a recipe changes, the record shows which versions still carry the old details.
How it applies to a specific label is a question for your legal adviser. Where that label appears across your markets and languages is a question Arbitr answers.
Regulatory and R&D teams usually own the label, but brand, packaging, e-commerce and sales teams all publish it, and retailers repeat it from your feeds. A short briefing for each, using your own packs, helps. Related rules, such as California Prop 65 warnings, are on our product labeling hub.
FDA published the final rule on December 27, 2024, and gives February 25, 2028 as its compliance date. It replaces the earlier criteria with food group equivalents and limits on added sugars, saturated fat and sodium, according to the rule.3
From January 1, 2020, for manufacturers with $10 million or more in annual food sales, and January 1, 2021, for smaller ones, according to FDA, which extended the dates set by its 2016 rules.2
They're connected but separate. Part 101 is FDA's food labeling regulation, and the authority it lists includes sections of the Fair Packaging and Labeling Act alongside the Federal Food, Drug, and Cosmetic Act, according to its text.1
No. Your reviewers stop reading everything and read only what has been flagged, with the rule and the reason attached.
