A food label compliance checklist isn't a substitute for regulatory expertise — but it is what keeps regulatory expertise from being the last line of defense. When compliance is enforced systematically, at each stage of the label development process, fewer issues reach the final review, and fewer issues get missed when the timeline is tight.
The following checklist covers the required elements and highest-risk compliance areas for packaged food labels regulated by FDA. Dietary supplements have additional requirements; that checklist is covered separately.
Section 1: Required Label Elements
Every FDA-regulated packaged food label must include all of the following. Missing any one is a misbranding violation under 21 U.S.C. 343.
Principal Display Panel (PDP)
Statement of identity (product name / common or usual name) — 21 CFR 101.3
Net quantity of contents declared in both metric and U.S. customary units, in the bottom 30% of the PDP — 21 CFR 101.7
Characterizing flavor statement if applicable (e.g., "artificially flavored," "natural and artificial flavor") — 21 CFR 101.22(i)
Information Panel
Nutrition Facts panel in correct format — 21 CFR 101.9
Ingredient list in descending order of predominance by weight — 21 CFR 101.4
Allergen declaration for all nine major allergens (milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soy, sesame) — FALCPA / FASTER Act
Name and place of business (manufacturer, packer, or distributor) — 21 CFR 101.5
Section 2: Nutrition Facts Panel
The Nutrition Facts panel is among the most technically detailed required label elements. Verify each of the following:
Serving size is based on the Reference Amount Customarily Consumed (RACC) for the product's food category — 21 CFR 101.12
Serving size is expressed in common household measures and metric
Calories per serving are correctly calculated and rounded per regulatory rounding rules
Total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, and vitamin/mineral declarations are present and correctly rounded
% Daily Value is calculated correctly for each nutrient
Footnote text is present: "The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice."
For single-serving containers where the entire container is typically consumed in one sitting: dual-column format or single-serving treatment is applied correctly — 21 CFR 101.9(b)(12)
Type size meets minimum requirements (6-point minimum for most elements) — 21 CFR 101.9(d)
Section 3: Ingredient List
All ingredients listed in descending order by weight
All sub-ingredients in compound ingredients declared parenthetically or the compound ingredient is broken out
"Natural flavors" and "artificial flavors" are correctly classified — verify with supplier documentation that flavor systems labeled "natural" don't contain any artificial components — 21 CFR 101.22
Certified color additives (FD&C dyes) are declared by their individual name, not grouped as "artificial color" or "coloring"
Spices may be grouped as "spices" only — paprika, turmeric, annatto, and saffron must be individually named when used primarily as colorants
Every ingredient has a recognized common or usual name
Section 4: Allergen Declaration
Allergen compliance is the leading cause of FDA food recalls. Verify at ingredient level, not just label level.
All nine major allergens reviewed across the full ingredient list, including sub-ingredients in compound ingredients and flavor systems: milk, eggs, fish, shellfish, tree nuts, wheat, peanuts, soy, sesame
Allergens declared either parenthetically in the ingredient list (e.g., "whey (milk)") or in a "Contains:" statement following the ingredient list
If a "Contains:" statement is used, it includes ALL allergens in the product — partial "Contains:" statements are prohibited
Sesame reviewed throughout all natural flavors, artificial flavors, spice blends, and compound ingredients — sesame became the ninth major allergen under the FASTER Act, effective January 1, 2023
Shared equipment or shared facility advisory language reviewed for accuracy — "may contain" statements must be based on actual risk, not added as a blanket disclaimer
Supplier specification sheets reviewed for accuracy and recently updated — ingredient reformulations by suppliers are a primary source of allergen introduction
Section 5: Nutrient Content Claims
Every nutrient content claim on the label must meet its specific regulatory threshold. Verify each claim against the applicable CFR section.
Protein claims:
"High protein" or "excellent source of protein": ≥20% DV (≥10g for adults) per serving — 21 CFR 101.54
"Good source of protein": 10–19% DV per serving
Fat claims:
"Fat free": <0.5g total fat per serving — 21 CFR 101.62
"Low fat": ≤3g per serving and per 50g
"Reduced fat": ≥25% less fat than the reference food, with comparison disclosed
Sodium claims:
"Sodium free": <5mg per serving — 21 CFR 101.61
"Very low sodium": ≤35mg per serving
"Low sodium": ≤140mg per serving
"No salt added": no salt added during processing; product normally contains salt
Calorie claims:
"Calorie free": <5 calories per serving — 21 CFR 101.60
"Low calorie": ≤40 calories per serving and per 50g
"Reduced calorie": ≥25% fewer calories than reference food
Sugar claims:
"Sugar free": <0.5g sugars per serving; required disclosure if not low calorie
"No sugar added": no sugars or ingredients containing sugars added during processing; calorie disclosure required if food is not low calorie
"Healthy" claim (if used):
Meets 2025 updated definition under 21 CFR 101.65: food group contribution requirement satisfied; added sugars, sodium, and saturated fat within category-specific limits
Section 6: Health Claims and Structure/Function Claims
Any FDA-authorized health claim (e.g., "diets low in sodium may reduce the risk of high blood pressure") is used only with products that qualify under the relevant petition — 21 CFR Part 101 Subpart E
No disease claims on food labels unless the food qualifies for an authorized or qualified health claim
Structure/function claims on dietary supplements are accompanied by the DSHEA disclaimer — 21 CFR 101.93
All health-related claims on the label, website, and marketing copy have been reviewed — FDA and FTC enforcement covers every channel where claims appear
Section 7: Required Warnings and Notices
Iron warning present on all iron-containing dietary supplements in solid oral dosage form — 21 CFR 101.17(e)
Phenylalanine notice present on all aspartame-containing products — 21 CFR 101.17(f)
"Not a low sodium food" disclosure included with any "light in sodium" or "lightly salted" claim where sodium exceeds 140mg per serving — 21 CFR 101.56
"Not a reduced calorie food" / "not a low calorie food" / "not for weight control" disclosure included with "sugar free" claims on non-low-calorie foods — 21 CFR 101.60
Juice percentage disclosure included for beverages that contain juice but are not 100% juice — 21 CFR 101.30
Section 8: Format and Placement
All required label elements appear on either the PDP or the information panel
Information panel elements are presented together without intervening material
Minimum type size requirements are met: generally 1/16 inch for small packages, 6-point minimum for Nutrition Facts elements
Nutrition Facts and ingredient list are in English (additional languages permitted but English is required)
Label is not false or misleading in any particular — this includes imagery and implied claims, not just text
Using This Checklist
A checklist is a starting point, not a compliance program. The checklist catches the elements you know to look for — it doesn't catch the allergen buried in a sub-ingredient that isn't in your specification sheet, or the "healthy" claim that qualified under the 2024 definition but doesn't under 2025's update. For those gaps, you need systems that integrate with formulation data and stay current with regulatory changes.
Truli's AI compliance platform runs this checklist automatically on every label you submit — verifying each element against current FDA regulations, flagging what's missing or incorrect, and citing the specific CFR reference for each finding. It also scans marketing copy, website content, and social channels for claims that extend beyond what the label says. Book a demo to see Truli in action.
