Compliance Library

20 automated checks.
FDA to barcode.

Every rule below is run against your packaging artwork on every submission. Each check is grounded in federal regulation — not just style preferences.

12 blockers 7 warnings 2 info 21 total
Jump to: FDA Nutrition Facts FDA Allergens FDA/USDA Labeling Organic & Claims FTC Barcode

FDA Nutrition Facts

6 checks
Serving size format blocker

Serving size must use household measures (cup, tbsp, tsp, oz) followed by metric equivalent in parentheses. Font must be equal or larger than the amount in cups — not smaller. Numeric amount must fall within realistic ranges for the product type.

21 CFR 101.9(b)(1)-(2); 2020 FDA rule
Calories prominence blocker

Calories must be declared in a type size at least 60% larger than the serving size font. Total calories per serving must be bold or highlighted to stand out from other nutrient rows.

21 CFR 101.9(d)(1); 2020 FDA rule
% Daily Value calculation sanity blocker

The % Daily Value (%DV) for each nutrient must be correctly calculated using FDA reference values. Common errors: saturated fat DV = 20g, dietary fiber DV = 25g, sodium DV = 2300mg, potassium DV = 4700mg. Values must round to the nearest 1% for amounts ≥1% DV and to the nearest 2% for amounts <1% DV.

21 CFR 101.9(d)(7); 2020 FDA rule
Dual-column for >1 serving blocker

Containers with ≥2 servings must display a dual-column nutrition facts table: "Per serving" and "Per package" columns, unless the serving size is the entire container (single-serving declarable). Missing dual-column on multi-serving products is a critical FDA violation.

21 CFR 101.9(e)(14); 2020 FDA rule
Vitamin D and potassium required blocker

Post-2020 FDA rule requires mandatory declaration of vitamin D and potassium in the nutrition facts panel. Calcium and iron remain mandatory. If vitamin D or potassium is absent from the label entirely, it must be included even if the amount is 0 mcg / 0 mg.

21 CFR 101.9(d)(3),(d)(7); 2020 FDA rule
Calories "must be" / "greatly exceed" qualifier check warning

Calories value must not be preceded by qualifying language like "only" or "just" which could understate the caloric content. The calorie amount must be the most prominent number in the serving size row.

21 CFR 101.9(d)(1); 2020 FDA rule

FDA Allergens

4 checks
All 9 major allergens declared blocker

All 9 major food allergens must be identified by their common name: milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame (added January 2023). Allergen must appear in the ingredient list AND in a "Contains:" statement. Missing any of the 9 is a critical FDA violation.

FASTER Act 2019 (Public Law 116-128); 21 CFR 101.4(a)(1)
"Contains:" statement format blocker

"Contains:" statement must immediately follow or be adjacent to the ingredients list. Must list allergens by their common names (not scientific names), separated by commas, in the exact order they appear in the ingredient list. Statement must not be hidden, truncated, or in smaller font than the ingredients.

21 CFR 101.4(a)(1); 21 CFR 101.22(h)
"May contain" / "Made in" placement warning

"May contain" statements for allergen cross-contact must appear after the "Contains:" statement. "Made in a facility that processes X" advisory statements must not be the primary allergen declaration — they do not satisfy FDA allergen labeling requirements. Advisory statements alone do not protect against allergen liability.

FDA Guidance for Industry: Food Allergen Labeling (2006); 21 CFR 101.4(a)(1)
Fish / Crustacean species specificity info

"Fish" allergen requires declaration of the specific species if used (e.g., "cod", "salmon", "anchovy"). "Crustacean shellfish" requires the specific species (e.g., "crab", "lobster", "shrimp"). Generic "fish" or "shellfish" without species is acceptable but species-specific declarations improve compliance documentation.

21 CFR 101.4(a)(1); FDA Allergen Guidance 2006

FDA/USDA Labeling

3 checks
Net weight in metric and US units blocker

Net quantity of contents must be stated in both US customary units (oz, lb) and metric (g, kg) on the same label. For FDA-regulated products the metric statement may follow the US statement in parentheses. USDA has separate net weight requirements for meat and poultry.

21 CFR 101.105; NIST Handbook 130 (Weights and Measures)
Country of origin present blocker

Country of origin (COO) or place of last substantial transformation must appear on the label for all food products. Required wording: "Product of USA", "Made in USA", "Packed in USA", or similar. Misleading COO claims can trigger both FDA and FTC enforcement.

COOL Act 2002; 19 CFR 134.11; 21 CFR 101.25
Manufacturer name and address blocker

The label must include the name and address (city, state, zip code) of the manufacturer, distributor, or packer. "For more information contact:" lines are acceptable but must include a full address. P.O. Box alone is insufficient.

21 CFR 101.5; 21 CFR 101.9(a)

Organic & Claims

3 checks
USDA Organic seal only when certified blocker

The USDA Organic seal may only be used by certified organic operations. Using the seal without valid organic certification violates federal law. The ingredient list must also reflect organic sourcing when the seal is present.

7 CFR 205.300; OFPA 1990
"Natural" claim restrictions warning

"Natural", "All Natural", "100% Natural" claims must not contain artificial or synthetic ingredients. "Natural" does NOT mean organic (no synthetic pesticides/fertilizers) and does NOT mean "no additives." Products making natural claims must not have artificial flavors, colors, or synthetic processing aids.

FDA Policy Guide (2016); 21 CFR 101.22(f)
"0g trans fat" requires <0.5g actual blocker

"0g Trans Fat", "Trans Fat Free", or similar claims may only be used when the product contains less than 0.5g of trans fat per serving. If the label claims 0g trans fat but the actual amount is ≥0.5g, the claim is illegal regardless of rounding rules.

21 CFR 101.9(d)(2); 2020 FDA labeling rule

FTC

2 checks
Made in USA substantiation blocker

"Made in USA" or "USA made" unqualified claims require that the product be "all or virtually all" made in the US. Marketers must maintain substantiation for such claims. "Assembled in USA" or "Designed in USA" from foreign components does NOT qualify as "Made in USA."

FTC "Made in USA" Policy Statement (2021); 16 CFR Part 255
"Eco-friendly" / "Biodegradable" qualifications warning

Environmental marketing claims must be qualified and substantiated. "Eco-friendly" without specifics is too vague and potentially deceptive. "Biodegradable" claims require proof of complete decomposition under typical disposal conditions. "Recyclable" claims require qualification if only part of the package is recyclable.

FTC Green Guides (2012, updated 2023); 16 CFR Part 260

Barcode

3 checks
UPC-A / EAN-13 check digit validation blocker

UPC-A barcodes must be 12 digits; EAN-13 must be 13 digits. The final digit is a calculated check digit — if it does not match the calculated value, the barcode will not scan correctly. All leading zeros must be preserved; truncation at the barcode text field is a common error.

GS1 General Specification §7.4; ANSI/UCC1-1995
GS1 prefix sanity check high

The barcode prefix (first 7-10 digits for a GTIN) must not start with 0 for EAN-13, and must use valid GS1 assigned prefixes. If the first digits match known invalid prefixes or reserved ranges (e.g., 000-009), the barcode is malformed. The company prefix must be registered with GS1.

GS1 General Specification §4.1; GS1 Prefix List
Barcode quiet zone minimum warning

Barcodes require a minimum clear zone (quiet zone) of 10x the narrow bar width on both left and right sides. If the label design crops or positions the barcode too close to text, graphics, or the label edge, the scanner may fail to decode it in retail or warehouse environments.

GS1 General Specification §5.3; ANSI/GS1-1-2018

How we keep this updated

ProofRun's compliance library tracks federal rule changes as they happen — FDA nutrition labeling updates, the FASTER Act sesame allergen mandate (January 2023), FTC Green Guides revisions, and GS1 barcode specification updates. When regulations change, our engineering team updates the rule definitions and pushes them live. You don't need to re-upload or re-configure anything.

This library reflects the full set of checks the AI agent is prompted to evaluate. Not all checks apply to every product — the agent identifies only relevant issues for your specific label.

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