How to make an FDA Nutrition Facts label to export food to the US

Checked on 2026-10-31 · SupportMates LLC

If you sell packaged food in the United States, FDA requires a Nutrition Facts panel (21 CFR 101.9) unless an exemption applies, and every required statement must be in English. Here is the short version for producers in Mexico, Guatemala and Central America.

1. Language: English is required, Spanish is optional but must be complete

All required label information must appear in English (21 CFR 101.15(c)(1)). If the label has any representation in another language, all required information must also appear in that language (101.15(c)(2)). The nutrition panel can be one label per language or a single bilingual panel with Spanish following English, for example “Protein/Proteínas 2 g” (101.9(d)(14)).

2. Serving size and servings per container

Declare the serving in a household measure plus grams or milliliters, such as “2/3 cup (55g)”. Servings per container round to the nearest whole number; between 2 and 5 they round to the nearest half serving with “about” (101.9(b)(8)).

3. Get defensible values and apply FDA rounding

• Calories: under 5 is declared as 0, up to 50 in 5-calorie steps, and above 50 in 10-calorie steps.
• Sodium: under 5 mg is declared as 0, 5–140 mg in 5 mg steps, and above 140 mg in 10 mg steps.
• Total fat: under 0.5 g is declared as 0, below 5 g in 0.5 g steps, and from 5 g in 1 g steps.

LabelKit applies these rules automatically from your unrounded values.

4. Pick the right format

• Standard vertical: the default.
• Tabular: when the package lacks the height for vertical.
• Linear: only for packages with under 12 sq in available for labeling, or up to 40 sq in when no panel fits a vertical or tabular display (101.9(j)(13)).
• Dual column: per serving and per package, for certain containers (101.9(e)).
• Bilingual: English and Spanish in one panel (101.9(d)(14)).

5. Check whether an exemption applies

There are narrow exemptions, for example for direct-to-consumer sellers with annual gross sales up to $500,000 or food sales to consumers up to $50,000, as long as the product makes no nutrition claims (101.9(j)(1)). The low-volume exemption requires fewer than 100 full-time-equivalent employees and fewer than 100,000 units sold in the US per year (101.9(j)(18)) and usually requires a notice to FDA. Importers must always file that notice; only non-importers with fewer than 10 FTEs selling fewer than 10,000 units are excused. Any nutrient claim such as “low fat” removes the exemption.

6. Beyond the label

Exporting usually also requires FDA food facility registration, Prior Notice for each shipment, and a US importer that meets FSVP. FDA does not pre-approve labels; compliance is the company's responsibility.

Also selling in Mexico? See NOM-051 warning seal sizes and phases.

Official sources (checked on 2026-10-31)

1. 21 CFR 101.9 — Nutrition labeling of food (eCFR)
2. 21 CFR 101.15 — Food; prominence of required statements, incl. foreign language (eCFR)
3. FDA — Changes to the Nutrition Facts Label
4. FDA — Guidance for Industry: Food Labeling Guide
5. FDA — Importing Food Products into the United States
6. FDA — Registration of Food Facilities and Other Submissions
7. FDA — FSMA Final Rule on Foreign Supplier Verification Programs (FSVP)

Guides

• Mexico NOM-051 warning seals: sizes, order and phases
• Nutrition Facts label template for small food brands
• FDA requirements for labeling and selling hot sauce and salsa
• How to label tortillas for sale in the US
• FDA labeling for coffee: do you need Nutrition Facts?
• Mexican candy in the US: labeling and lead
• Honey labels: how to declare added sugars
• NOM-051 for US brands exporting food to Mexico
• Nutrition Facts dual-column labels: when they are required
• How to calculate % Daily Value