FDA requirements for labeling and selling hot sauce and salsa

Checked on 2026-10-31 · SupportMates LLC

Many bottled sauces (chile, habanero, salsa verde) are acidified foods under FDA rules. Before you design the label, check whether your process has to be registered.

1. Is your sauce an acidified food?

FDA defines acidified foods as low-acid foods to which acids or acid foods are added, with a water activity greater than 0.85 and a finished equilibrium pH of 4.6 or below (21 CFR 114.3). Many chile sauces made with vinegar or lime fall here. Fermented or naturally acidic sauces may be treated differently, so confirm with a process authority.

2. FCE registration and process filing

Commercial processors of acidified foods, including processors abroad who export to the US, must register the establishment (Form FDA 2541) and file a scheduled process for each product and container size (Form 2541e) under 21 CFR 108.25. Importers and distributors do not file, but must make sure the processors they represent comply. This is in addition to general food facility registration.

3. The label

• Nutrition Facts (21 CFR 101.9) unless exempt. Sauces often have small servings (for example 1 tsp), and rounded sodium is the number buyers check most.
• Ingredients in descending order of weight (101.4).
• Major allergens declared (for example soy or sesame).
• Net quantity in both metric and US units (101.105), such as “5 fl oz (148 mL)”.
• Everything in English; if you add Spanish, all required information must also be in Spanish (101.15).

Selling the same sauce in Mexico? Check the NOM-051 seals; excess sodium is common in sauces.

Official sources (checked on 2026-10-31)

1. 21 CFR Part 114 — Acidified foods (eCFR)
2. 21 CFR 108.25 — Acidified foods: registration and process filing (eCFR)
3. FDA — Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods
4. 21 CFR 101.9 — Nutrition labeling of food (eCFR)
5. 21 CFR 101.4 — Food; designation of ingredients (eCFR)
6. 21 CFR 101.105 — Declaration of net quantity of contents (eCFR)
7. FDA — Food Allergies (major food allergens)
8. 21 CFR 101.15 — Food; prominence of required statements, incl. foreign language (eCFR)

Guides

• How to make an FDA Nutrition Facts label to export food to the US
• Mexico NOM-051 warning seals: sizes, order and phases
• Nutrition Facts label template for small food brands
• 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