INTERNATIONAL TRADE LAW
FDA Food Labeling & Packaging Checklist
An FDA-compliant food label must carry five required elements: a statement of identity, the net quantity of contents, an ingredient list, an allergen declaration, and the Nutrition Facts panel — plus the name and address of the responsible party. Get any one wrong and the product is “misbranded,” which is one of the most common reasons imported food is detained. This checklist covers what each label needs and the packaging and origin rules that ride alongside it.
The Five Required Label Elements
| Element | What it requires | Where it goes |
|---|---|---|
| Statement of identity | The common or usual name of the food | Principal display panel |
| Net quantity of contents | Amount in U.S. and metric units | Bottom of the principal display panel |
| Ingredient list | All ingredients in descending order by weight | Information panel |
| Allergen declaration | Major allergens, by “Contains” statement or in-list | With or near the ingredient list |
| Nutrition Facts | The standardized nutrition panel | Information panel |
| Name and address | Manufacturer, packer, or distributor | Information panel |
The principal display panel is the part the consumer sees first; the information panel is usually the area immediately to its right. Required type sizes and placement are set by FDA regulation, not by design preference.
Allergen Labeling: Nine Major Allergens
U.S. law requires plain-language declaration of the major food allergens. There are now nine, after sesame was added effective January 1, 2023 under the FASTER Act:
milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
The allergen must be named in everyday terms — “milk,” not just “casein.” Declare it either in a “Contains” statement after the ingredient list or by parenthetical naming within the list. This is the single highest-risk area on the label: an undeclared allergen is a leading cause of recalls and import refusals.
Nutrition Facts
Most packaged foods need the standardized Nutrition Facts panel, with the current format that emphasizes calories, lists added sugars, and uses updated serving sizes. Some small businesses and low-volume products qualify for exemptions, but the default expectation is a complete, correctly formatted panel.
Country-of-Origin Marking (Imported Goods)
Separate from FDA labeling, imported products must be marked with their country of origin under CBP rules (19 U.S.C. 1304). The mark must be legible, permanent enough to reach the ultimate purchaser, and conspicuous. Origin marking is a CBP requirement, while the food-content label is an FDA requirement — an imported food has to satisfy both, and they are assessed by different agencies.
Packaging Considerations
- Food-contact materials must be safe for their intended use under FDA rules.
- Packaging must protect the product through shipping, holding, and the cold chain where applicable.
- Claims on the package — “healthy,” “organic,” “gluten-free,” structure/function claims — are regulated and must be substantiated; an unauthorized claim is itself a misbranding.
The Compliance Checklist
- Statement of identity on the principal display panel
- Net quantity in U.S. and metric units
- Ingredients listed in descending order by weight
- All nine major allergens declared in plain language
- Nutrition Facts panel in the current format
- Responsible party’s name and address
- Country-of-origin marking (for imports), legible and permanent
- Any claims authorized and substantiated
- Type sizes and panel placement meet FDA spacing rules
Frequently Asked Questions
What are the required elements of a food label?
A statement of identity, net quantity of contents, ingredient list, allergen declaration, Nutrition Facts panel, and the name and address of the manufacturer, packer, or distributor. Missing any of these makes the product misbranded.
How many major food allergens must be labeled?
Nine. The original eight — milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, and soybeans — were joined by sesame, effective January 1, 2023, under the FASTER Act.
Is country-of-origin marking the same as the FDA food label?
No. The FDA food label covers content and nutrition; country-of-origin marking is a separate CBP requirement under 19 U.S.C. 1304 for imported goods. An imported food must comply with both.
What makes a food “misbranded”?
A label that is false or misleading, or that omits a required element — identity, net quantity, ingredients, allergens, or Nutrition Facts — or that makes an unauthorized claim. Misbranding is grounds for FDA detention and refusal.
A label is the cheapest place to get compliance right and the most expensive place to get it wrong. Reidel Law Firm reviews food labeling and import documentation for compliance, on flat-fee terms. Get an import compliance memo.
