What Is Required on a US Food Label

A US food label can look finished and still be missing something a retailer or FDA will catch. The reason is that a compliant label is not one rule. It is six separate required elements, each governed by its own part of the regulations, each with its own format and placement requirements.

This guide is the overview: the six things that generally must appear on a packaged food label sold at retail in the US, where each one is governed, and the most common ways each gets missed. It links down to the detailed guides for the parts that have the most rules. Treat it as a map, not a substitute for a compliance review. Almost every rule below has exceptions, and several of the exceptions have exceptions.

The short answer: six required elements

Most FDA-regulated packaged foods offered for retail sale must carry these six things:

1. A statement of identity (the product’s common or usual name) on the principal display panel
2. A net quantity of contents statement (how much is in the package)
3. An ingredient list, in descending order by weight
4. A major food allergen declaration
5. A Nutrition Facts panel
6. The name and place of business of the manufacturer, packer, or distributor

These requirements come primarily from the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act, with the specifics spelled out in 21 CFR Part 101. If any required element is missing, wrong, or formatted incorrectly, the product is considered “misbranded,” and a misbranded product can be refused by a retailer or pulled after it is already printed.

That last scenario is the expensive one. A single non-compliant reprint run can run from a few thousand dollars to tens of thousands, depending on quantity and substrate, and it tends to surface right before a launch, when you have the least room to fix it. The exact figure varies, but the pattern does not: the point of a checklist is to catch all six before anything reaches a printer.

A note on scope: most packaged foods are regulated by FDA, but meat, poultry, and certain egg products fall under USDA, which has its own labeling requirements that overlap with but are not identical to FDA’s. If your product contains those, assume a second set of rules applies and confirm which agency governs your label.

1. Statement of identity

The statement of identity is the name of the food. It has to be the product’s common or usual name, or an appropriate descriptive name if there is no common one, and it must appear on the principal display panel, the part of the package a shopper most likely sees first. The rules are in 21 CFR 101.3.

This sounds trivial and usually is, but two things trip people up. First, your brand name is not the statement of identity. “Aurora’s” is a brand; “roasted almond butter” is the statement of identity, and both generally need to appear. Second, the statement of identity has to be prominent, in bold type, and reasonably related in size to the most prominent printing on the panel. A tiny product name under a large logo can be a finding on its own.

For some foods, a “standard of identity” defines what the name legally means and what the product must contain to use it. Calling something “mayonnaise,” “milk chocolate,” or “fruit juice” carries defined requirements. If your product does not meet the standard, you cannot use the name.

2. Net quantity of contents

The net quantity statement tells the buyer how much food is in the package, by weight, measure, or count, and it has to appear in the bottom 30% of the principal display panel. The general food requirement lives in 21 CFR 101.7.

There is a second piece that founders often miss the source of. The dual declaration in both US customary and metric units does not come from that FDA section. For retail consumer commodities, the dual statement is required under the Fair Packaging and Labeling Act and the rules built on it, not under 21 CFR Part 101, where a separate metric statement is treated as supplemental rather than mandatory. The practical takeaway is the same: your label generally needs both unit systems, so confirm both are present.

The common errors here are mechanical: missing the metric equivalent, putting the statement in the wrong location on the panel, or using the wrong unit basis for the product type (a solid food declared by fluid measure, for example). None of these are conceptually hard. They are just easy to get slightly wrong, and “slightly wrong” is still misbranded.

3. Ingredient list

Every ingredient has to be listed by its common or usual name, in descending order of predominance by weight. The ingredient present in the largest amount comes first, and so on down the line. This is governed by 21 CFR 101.4.

The order is the part that gets miscalculated. It is by weight as the ingredients go into the product, not by how prominent they feel in the recipe, and certain ingredients have sub-listing rules. Components of a compound ingredient (a sauce that is itself made of several things) often have to be broken out. Color additives, spices, and flavorings have their own naming conventions. Chemical preservatives have to be declared with their function.

The ingredient list also has to be grouped correctly with the Nutrition Facts panel and the manufacturer information, which is a placement question, not just a content one. We cover how those pieces sit together in the FDA two-panel system and what must appear where.

4. Major food allergen declaration

The US currently recognizes nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame. Sesame became the ninth allergen under the FASTER Act, effective January 1, 2023. The declaration requirements come from the Food Allergen Labeling and Consumer Protection Act (FALCPA).

A major allergen has to be declared in plain language, either inside the ingredient list using its common name, or in a separate “Contains” statement placed immediately after or adjacent to the ingredient list. “Contains: milk, wheat, soy.” For tree nuts, fish, and crustacean shellfish, the specific type generally has to be named, not just the category.

This is one of the highest-stakes elements on the label, because an undeclared allergen is one of the leading causes of food recalls in the US. It is also subtler than it looks: allergens can hide in flavorings, in processing aids, and in compound ingredients you did not formulate yourself. We go through the full set of rules, including “Contains” formatting and the difference from voluntary “may contain” advisory statements, in the allergen labeling requirements guide.

5. Nutrition Facts panel

The Nutrition Facts panel is the most tightly regulated element on the label, specified down to the nutrients you list, the order they appear in, the type sizes, and how each number is rounded. The rules live in 21 CFR 101.9.

A few things make this element its own project. The serving size is not your choice; FDA sets it through the RACC system, and getting it wrong throws off every number below it. The panel has specific rounding rules per nutrient. There are multiple approved layouts, and which one you may use depends on your package size. And the current 2016 format is fully in force, so an older-style panel is not grandfathered in.

Because there is so much here, we wrote a dedicated pillar: the FDA Nutrition Facts panel requirements guide covers the required nutrients, format, rounding, and exemptions. For the serving-size piece specifically, see how the FDA RACC system sets your serving size. Some very small or low-volume businesses qualify for an exemption from the panel, but the moment you make a nutrient content or health claim, the exemption is gone.

6. Name and place of business

The label has to identify who is responsible for the food: the name and place of business of the manufacturer, packer, or distributor, per 21 CFR 101.5. If the named company is not the actual manufacturer, the statement has to qualify the relationship, for example “Manufactured for” or “Distributed by.”

The address generally needs the street address (unless the firm is listed in a current phone or city directory), city, state, and ZIP code. This is the element founders most often leave as a placeholder and forget to finalize. It is small, but a missing or incomplete address is still a compliance gap.

The quiet failures, and where they cluster

Labels rarely fail at review for one dramatic reason. They fail on the same handful of quiet ones: an outdated Nutrition Facts format, a rounding mistake, a serving-size error, a miscalculated ingredient order, or a missing allergen declaration. We pulled the most frequent ones together in five failure modes that kill a food label at review.

Use the six elements above as a literal checklist. For a deeper, line-by-line version you can run against your own artwork, see the food label requirements checklist.

If you are also selling in Canada

None of the six elements above carry over cleanly to Canada. Canadian labels follow the Safe Food for Canadians Regulations (SFCR) and the Food and Drug Regulations (FDR), use a different Nutrition Facts table, and require bilingual (English and French) labeling. Canada also recognizes a broader allergen list than the US, including mustard, molluscs, and added sulphites alongside the priority allergens that overlap with the US set. And as of January 2026, front-of-package nutrition symbols are mandatory on foods high in saturated fat, sugars, or sodium. If a second market is in your plans, start with selling food in Canada, and for a focused before-and-after, what your food label must change to sell in Canada.

The shortcut

You can learn all six of these. Founders do it every day, usually the hard way, one rejected proof at a time. The faster path is to hand it off.

That is what Complion does. You send us your recipe or product idea, and we build the whole label: the statement of identity and net quantity, the ingredient statement, the allergen declarations, the Nutrition Facts panel, and the print-ready artwork. Then our food-compliance experts verify the entire thing against FDA, USDA, Health Canada, and CFIA before it reaches you. Your only step is sharing what you have.

If you want a compliant, print-ready label without becoming an expert in 21 CFR Part 101, book a free call to start.