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01 · Route the review
Confirm scope and current files
A label review is only as reliable as the product version and records supplied with it.
Evidence to compare
Product classification, formula, artwork filename, nutrition source, package dimensions, target market, claims list.
The product category and regulator are confirmed. Document why the product follows the conventional FDA food-labeling path. Stop if FDA versus USDA FSIS or another jurisdiction is unresolved. The final formula and ingredient information are current. Include ingredient specifications or supplier documents that show subingredients, allergens, colors, flavors, preservatives, and processing aids. The nutrition basis matches the product version. Identify the laboratory report, database calculation, recipe calculation, or other source used for the Nutrition Facts label. The artwork includes every consumer-facing panel at final size. Record the artwork filename or version, principal display panel area, total available label space, and package dimensions. Claims, certifications, markets, and requested changes are listed. Include statements in product names, callouts, seals, symbols, romance copy, websites referenced on-pack, and outer packaging.
Hold the artwork: the formula, nutrition source, artwork, or intended market refers to a different product version.
02 · Principal display panel
Check product identity and net quantity
The front panel should tell the consumer what the food is and how much is in the package.
Official rules
21 CFR 101.1 , 101.3 , and 101.7
The statement of identity accurately names the food. Use the required name when a standard of identity applies. Otherwise confirm the common or usual name, or an appropriately descriptive name. Any applicable standard of identity was checked against the formula. Do not use a standardized food name unless the formulation and product meet the applicable standard. The statement of identity is on the principal display panel and is prominent. Review its placement, orientation, type size, and relationship to brand names or other wording on the front panel. The net quantity statement uses the correct amount, units, placement, and type size. Compare the declared quantity with the package fill or count and calculate the applicable principal display panel area before checking type size.
Hold the artwork: the product name does not match the formula or a standardized name, or the net quantity has not been confirmed from the finished package.
04 · Ingredient statement
Match the ingredient statement to the formula
Review the final formula line by line. Supplier names, shorthand, and internal material codes are not substitutes for label names.
An ingredient statement is present when the food has two or more ingredients. Confirm the heading and placement with the other required information. Ingredients follow the required order of predominance. Compare the statement with the formulation weights at the point required by the rule. Investigate ties, grouped ingredients, and ingredients added through components. Each ingredient uses its common or usual label name. Replace supplier trade names, material codes, and unexplained abbreviations with appropriate label terminology. Subingredients are declared using an allowed presentation. Compare each multi-component ingredient with its current specification. Do not assume a shortened supplier statement is complete. Colors, flavors, chemical preservatives, incidental additives, and processing aids were evaluated. Document why an ingredient is declared, grouped, described by a permitted term, or omitted under an applicable provision.
Hold the artwork: the ingredient statement and current formula do not match, or a supplier has not provided the subingredient information needed to finish the review.
05 · Major food allergens
Trace allergens through every ingredient and subingredient
The 9 major food allergens are milk, egg, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame.
Current FDA guidance
Food Allergen Labeling, Edition 5 (January 2025)
Every intentionally added major allergen is identified from current source documents. Review compound ingredients, flavors, colors, processing aids, and other inputs rather than relying only on the supplier's front-page allergen summary. Allergen source names are sufficiently specific. Confirm the species for fish and Crustacean shellfish and the type of tree nut, along with the correct source name for other major allergens. Major allergens are declared through an allowed ingredient-list or “Contains” presentation. Check the exact declaration location and wording. Sesame must be handled as a major allergen for applicable products. If a “Contains” statement is used, it includes every intentionally added major allergen in the food. Compare the statement with the complete ingredient and subingredient review, not with a previous artwork version. Cross-contact wording is treated separately from the declaration of intentionally added allergens. Do not use advisory wording as a substitute for supplier review, allergen controls, or the required declaration of an intentionally added major allergen.
Hold the artwork: any ingredient or subingredient has unresolved allergen information, or the ingredient statement and “Contains” statement disagree.
06 · Nutrition labeling
Verify the Nutrition Facts basis, serving, values, and format
Use the current regulation and FDA's current Nutrition Facts resources. FDA states that the nutrition chapter of its older Food Labeling Guide does not reflect all current requirements.
Official rules and current help
21 CFR 101.9 , 101.12 , and FDA industry resources
The requirement or exemption basis is documented for this product. Do not assume a small business is automatically exempt. Low-volume exemptions are conditional, may require an annual FDA notice, and can be lost when nutrition claims or other nutrition information appear. The serving size and servings per container use the applicable current basis. Identify the product's reference amount customarily consumed and document the household measure and metric amount. Single-serving and dual-column requirements were evaluated for the package. Use the amount in the full container and the applicable reference amount to determine which presentation rules apply. Declared nutrient values and rounding match the current product data. Reconcile the source calculation or analysis with the label, including added sugars, voluntary nutrients, and nutrients mentioned in claims. The panel uses an allowed current format for the available label space. Check nutrient order, units, Daily Values, footnotes, type sizes, rules, indentation, and any aggregate, tabular, linear, simplified, or bilingual format used.
Hold the artwork: the serving basis, exemption, underlying nutrient data, or label format cannot be supported from a current source.
07 · Claims and marketing copy
Review every claim, not only the front-panel callouts
A claim can appear in the product name, a badge, a comparison, romance copy, a certification mark, or other words and graphics that communicate a product benefit.
Official rules and current help
21 CFR 101.13 , 101.14 , and FDA label claims
Every express and implied claim on every panel is listed. Include nutrient, health-related, structure/function, ingredient, processing, absence, comparative, environmental, origin, certification, and quality claims. Each regulated nutrition or health-related claim is classified before it is approved. Determine whether the wording is a nutrient content claim, health claim, qualified health claim, structure/function claim, dietary guidance, or another type of statement. The product meets the applicable conditions and uses the required wording and disclosures. Compare the claim with the formula, serving size, declared nutrition values, and the specific regulation, authorization, or enforcement-discretion conditions. Support is current, specific to the product, and retained with the approved artwork. Verify certification status, test results, supplier statements, comparative data, and other evidence instead of relying on a claim used by a similar product. The effect of each claim on other label requirements was checked. A claim can change nutrition-labeling obligations or require additional declarations, disclosures, or referral to another regulatory pathway.
Hold the artwork: a claim lacks product-specific support, depends on an expired certification, conflicts with the formula or Nutrition Facts, or has not been classified.
08 · Product-specific triggers
Check requirements triggered by the formula, product, or claim
These are review branches, not statements required on every food. Mark an item only after deciding whether it applies and documenting the reason.
Selected official rules
101.17 , 101.22 , 101.30 , 101.91 , and 101.100
Warnings and special statements under 21 CFR 101.17 were evaluated. Check the formula and product form for ingredients or conditions that trigger specific statements. Do not add a warning by analogy to another product. Flavor, color, and chemical-preservative declarations were evaluated. Review the product name, characterizing flavors, ingredient statement, and any special labeling tied to the type of flavor, color, or preservative. Percentage-juice labeling was evaluated for a beverage that contains fruit or vegetable juice. Confirm whether the rule applies, how the percentage is determined, and where the declaration belongs. Any “gluten-free” claim was checked against the applicable definition and conditions. Retain the product and supplier evidence used to support the claim and review related wording throughout the package. Incidental additives, processing aids, and sulfites were evaluated under the applicable provisions. Keep the basis for any omission. Do not treat a supplier's omission from a statement as proof that the ingredient can be omitted from the finished label. Other product-specific requirements were identified from the product category and intended use. Check applicable standards, imitation or substitute status, preparation directions, storage statements, package-specific rules, state requirements, and other triggered provisions.
Hold the artwork: a formula component, product category, or claim may trigger additional wording and the team has not finished that review.
09 · Final artwork proof
Review the assembled package at actual size
A correct source document can still become an incorrect label through copy changes, scaling, dieline movement, or an outdated art file.
Evidence to compare
Approved copy, actual-size proof, dieline, formula version, nutrition source, claim support, printer proof.
Required information is complete and consistent across all panels and package levels. Compare the front, information panel, lid, bottom, neck, outer carton, individual units, inserts, and other consumer-facing pieces that apply. Legibility and placement were checked on an actual-size proof. Review type size, contrast, line breaks, curved surfaces, seals, folds, trim, adhesive zones, and areas blocked after filling or closing. Codes and production elements do not obscure required information. Check anticipated placement for lot and date codes, UPCs, QR codes, price labels, case labels, and print registration movement. No unresolved placeholder, old revision, or contradictory copy remains. Search the final file for “TBD,” “FPO,” notes to the printer, hidden layers, duplicate statements, old barcodes, and superseded claims. The last artwork change was reviewed against the supporting product files. A late copy edit, claim change, formula change, package-size change, or panel move should trigger the affected checks again.
Hold the artwork: the file reviewed is not the file being printed, any required statement is unreadable at actual size, or a late change has not been rechecked.
10 · Review record
Record the decision and keep the evidence together
The approval record should identify exactly what was reviewed, which sources were used, what remains open, and which file is approved for print.
Keep with the final label
Artwork version, formula, nutrition support, claim evidence, certifications, review notes, approvals, and superseded-file history.
The record identifies the product, SKU, package size, market, and exact artwork version. Use a filename or version identifier that lets another reviewer find the same file without guessing. The reviewer, review date, source versions, and supporting files are listed. Record the current eCFR or agency source used for each substantive finding and retain dated evidence that may later change. Every open item has an owner, required evidence, and next review date. Do not convert “waiting for supplier,” “confirm with marketing,” or “verify at printer” into a silent approval. Required changes were verified on the revised artwork before approval. Check the corrected page and the surrounding copy. Do not close a finding only because a designer said it was addressed. The authorized internal approver recorded the print decision and any conditions. State “approved for print,” “hold,” or another defined internal status. This is a company decision, not FDA approval or a general compliance determination.
Hold the artwork: an open item can affect required label information, the revised artwork was not verified, or the approval does not identify the exact print file.
Worksheet
Open items and review notes
Write the missing evidence, mismatch, or decision needed. Add an owner and date before the artwork moves forward.
Product, SKU, package size, and artwork version
Reviewer, review date, and decision
Open item 1: issue, evidence needed, owner, and due date
Open item 2: issue, evidence needed, owner, and due date