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Label rules › United States

US label requirements: FDA food labeling, FPLA and MoCRA

Packaged food sold in the United States follows the Federal Food, Drug, and Cosmetic Act and the FDA’s labeling rules in 21 CFR Part 101; consumer goods follow the Fair Packaging and Labeling Act (FTC, 16 CFR 500); cosmetics follow the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Labels are in English, and imports name their country of origin.

Checked: 29 October 2026

Mandatory items

On the labelMeans
Statement of identityThe common name of the product, on the principal display panel
Net Wt · Net ContentsNet quantity in US customary and metric units, in the bottom 30% of the PDP
Nutrition FactsThe Nutrition Facts panel (21 CFR 101.9), in the 2016 format
IngredientsIngredients by common name, heaviest first
Contains: …The nine major allergens, sesame included since 2023
Manufactured for / Distributed byName and place of business of the maker, packer or distributor
Product of …Country of origin, for imported goods (CBP)
Cosmetics: US contactA US address, phone or website for adverse-event reports (MoCRA)

The principal display panel

The front shows the statement of identity and the net quantity, in both US customary (oz, fl oz, lb) and metric units, placed in the bottom 30% of the panel and parallel to its base. The net quantity’s minimum type height grows with the panel’s area, from 1/16 inch on the smallest.

The information panel

To the right of the front, or on the back: Nutrition Facts, the ingredient list, the allergen statement (“Contains: milk, wheat…”, or the allergen named in the list) and the name and place of business of the maker, packer or distributor, with “Manufactured for” or “Distributed by” when it is not the maker. Imported goods are marked with their country of origin in English (“Product of …”, “Made in …”).

What is changing

The FDA proposed a front-of-package “Nutrition Info” box in January 2025, rating saturated fat, sodium and added sugars as low, medium or high; it was still not final in mid-2026, so do not print it until the final rule is out. The updated definition of the “healthy” claim applies by February 2028. Cosmetics must carry a US contact for adverse-event reports since MoCRA’s label rule took effect.

Why the rules look like this

American label law grows by reaction — to illness, to lawsuits, to new science:

  1. 1990 — the Nutrition Labeling and Education Act makes the Nutrition Facts panel mandatory; its black box becomes the most copied label design in the world.
  2. 2004 — FALCPA requires the major allergens in plain words (“milk”, not “casein”) from 2006, after studies found parents could not spot them.
  3. 2016 — the panel is redesigned: calories in large type, added sugars declared, serving sizes nearer to what people eat. Old 2016-era artwork with no added sugars line is out of date.
  4. 2023 — sesame becomes the ninth major allergen. Some bakers chose to add sesame to every product rather than clean their lines — so “Contains: sesame” can appear where you do not expect it; take the client’s list, never guess.
  5. 2022–2025 — MoCRA, the first major cosmetics law since 1938, adds a US contact to every cosmetic pack; in 2025 the FDA proposes a front-of-pack nutrition box, still pending.

Seasons that sell packs

Halloween is the largest candy season of the year, so fun-size packs with full labels on each piece ship from August; Thanksgiving, Black Friday and Christmas follow with gift sets, where every item in a box keeps its own label and the outer box adds the contents and net quantity of the set. Valentine’s Day and Easter close the confectionery calendar.

Who answers for the label

Anyone who introduces misbranded food into commerce — maker, packer, distributor, importer — and, under the “responsible corporate officer” doctrine, executives who could have prevented it, even without intent.

The designer and the printer are not named by these laws — but a contract can make them pay for the reprint. Keep the client’s written approval of the final copy; Drint’s review link records it.

If the label is wrong

A food or cosmetic with a wrong label is “misbranded” under the Federal Food, Drug, and Cosmetic Act: the FDA sends warning letters, places imports on Import Alert so they are detained at the border, and can seize goods. Undeclared allergens are the leading cause of food recalls in the United States. Beyond the FDA, class actions over words like “natural” or “Made in USA” cost brands millions, the FTC fines unqualified “Made in USA” claims per violation, and California’s Proposition 65 lets private enforcers sue over missing warnings.

Who else loses, beyond the fine

A wrong label costs more than its fine, and the cost travels down the chain:

  1. The shopper — an undeclared allergen can put someone in hospital; that is why recalls for allergens move fastest.
  2. The brand — a recall notice with its name stays online for years, and retailers may delist the product.
  3. The importer and distributor — stock held at the port or in a warehouse, storage fees, relabelling labour, sometimes a whole container sent back.
  4. The shop — products immobilised or pulled from shelves in the middle of a season.
  5. The printer — a reprint at its own cost if the contract says so, and a lost client either way.
  6. The designer — the reprint blamed on the artwork, unless the client’s approval is on record.

Net quantity: minimum type height by panel area (21 CFR 101.105)

The panel’s area is height × width of a box face, or 40% of height × circumference of a can or bottle.

The figures of the net quantity are at least:

  1. 1/16 inch on a principal display panel of 5 square inches or less;
  2. 1/8 inch over 5 and up to 25 square inches;
  3. 3/16 inch over 25 and up to 100 square inches;
  4. 1/4 inch over 100 and up to 400 square inches;
  5. 1/2 inch over 400 square inches.

Mistakes, and a check before printing

The usual problems: “Net Wt” on a liquid (use “Net Contents” with fl oz); the net quantity placed in the middle of the front instead of its bottom 30%; the allergen statement placed away from the ingredients; “Made in USA” on goods that are not “all or virtually all” made in the United States, which the FTC treats as deceptive.

  1. Measure the front panel and set the net quantity at the height above, in oz/fl oz and g/ml.
  2. Choose the Nutrition Facts format that fits: standard, tabular, linear or the simplified form for small packs.
  3. Write the ingredients and a “Contains:” line naming the nine major allergens present.
  4. Add “Manufactured for / Distributed by” and the address when the brand is not the maker.
  5. Mark imports “Product of …” in English, and add the US contact on cosmetics.

Worked example: a 200 g box of butter cookies

Made in Vietnam and sold in the United States, the pack reads, line by line (the client’s own names and numbers replace those in brackets):

  1. BUTTER COOKIES
  2. NET WT 7.05 OZ (200 g) — in the bottom 30% of the front, at least 1/8 inch high on a 5–25 sq in panel
  3. INGREDIENTS: WHEAT FLOUR, BUTTER (CREAM, SALT), SUGAR, EGGS, SALT, BAKING SODA.
  4. CONTAINS: WHEAT, MILK, EGG.
  5. DISTRIBUTED BY: [COMPANY], [CITY, STATE ZIP]
  6. PRODUCT OF VIETNAM
  7. Nutrition Facts: serving size 30 g (about [ ] cookies), about 7 servings per container

Why it reads this way

Cookies have a 30 g reference amount, so the panel is per 30 g serving; butter is listed with its own ingredients, and the US distributor’s address replaces the Vietnamese maker’s.

How Drint helps

Three kinds of people make packs for the United States with Drint, and each needs something different:

Free, no account: the barcode generator, the mm to inches converter and the paper sizes table.

  1. A business with its own brand — The label kit for the United States places every mandatory block and Check lists what is missing before you export. See the pack in 3D before it is printed, send the design to the person who must approve it with a review link, and hand the printer one CMYK PDF/X-4 with the die on its own layer, so nobody retypes the label.
  2. A household business — start from a ready dieline cut to your exact box or bag size instead of paying for a die drawing, use your own photos on 3D mockups for your online shop, and keep the mandatory text exactly as you wrote it: Drint never translates or rewords a client’s copy.
  3. A designer — lay out several markets from one design, each with its own language and items, keep every client’s approvals in one place, and show finished packs on a portfolio page at drint.io/your-name.

Laying it out in Drint

  1. In the studio, click Insert → Product label and choose the market United States and the goods group.
  2. Paste the client’s copy as they wrote it — Drint does not translate or reword it.
  3. Check in Export lists the items still missing; export the CMYK PDF/X-4 with the die on its own layer for your printer.

Official sources

  1. 21 CFR Part 101 — Food labeling (eCFR)
  2. FDA — Food labeling and nutrition
  3. FDA — Modernization of Cosmetics Regulation Act of 2022
  4. 19 CFR Part 134 — Country of origin marking (eCFR)

Drint checks this label while you design, for 47 countries: see how the label-law check works.

Lay out the label in Drint

Questions

Do I need both ounces and grams?

Yes. The FPLA asks for the net quantity in US customary and metric units, e.g. “Net Wt 12 oz (340 g)”.

Is the front-of-pack Nutrition Info box required?

Not yet. It is a proposed rule; once final, large companies would have three years to comply and smaller ones four.

Which allergens must be declared?

Milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and, since 1 January 2023, sesame.

Which Nutrition Facts format fits a small pack?

Packs with under 40 square inches of label space may use the tabular or linear format; under 12 square inches, an address or phone for nutrition information may replace the panel if no claims are made.

A summary written to design packs, not legal advice. Check 21 CFR 101, the FPLA rules, CBP’s country-of-origin rules and the FDA’s guidance for your product category before printing.