FDA Food Label and Ingredient Review for Compliant Labels
FDA does not pre-approve food labels, so the brand owner carries the risk if a label is wrong. We review your label against FDA rules: the name of the food, net quantity, ingredient list, allergens, Nutrition Facts, name and address, claims and English requirements. You get clear findings and corrections for $250 per label, usually in 2 to 3 business days.
$250 per label, results in about 2 to 3 business days. Send your artwork and formula. We check every required element and claim and tell you exactly what to change.
Request a Label ReviewEvery Required Element on Your Label
| Element | Rule | What we check |
|---|---|---|
| Statement of identity | 21 CFR 101.3 | Common or usual name, not a brand name alone |
| Net quantity | 21 CFR 101.105 | Placement, metric and U.S. units, type size |
| Ingredient list | 21 CFR 101.4 | Order by weight, common names, sub-ingredients |
| Major allergens | FD&C Act 403(w) | All nine, in the list or a Contains statement |
| Nutrition Facts | 21 CFR 101.9 | Format, serving size, values, exemptions |
| Name and place of business | 21 CFR 101.5 | "Manufactured for" or "Distributed by" and address |
| Language | 21 CFR 101.15 | Mandatory information in English |
| Claims | 21 CFR 101.13 | Nutrient content, health and "healthy" claims |
For the full rules, see our FDA food labeling requirements guide.
Food Label Review Cost: $250 per Label
| What you get | Included in $250 |
|---|---|
| Review of all required elements | Statement of identity, net quantity, ingredients, allergens, Nutrition Facts format, name and address, English |
| Claims check | Nutrient content, health, "healthy," gluten-free and similar claims on the label |
| Written findings | Each issue, the FDA rule behind it and the corrected wording |
| Revised artwork check | We confirm the corrections on your updated artwork |
| Turnaround | About 2 to 3 business days after complete files |
Quoted separately only when needed: nutrition analysis or lab testing, translation, substantial reformulation, multiple distinct package formats or specialized categories. Several flavors with different formulas count as separate labels. We confirm the total before starting.
Ingredient and Allergen Labeling
Order and names
Ingredients go in descending order of predominance by weight, using common or usual names, not supplier trade names.
Compound ingredients
Ingredients such as chocolate chips or sauces need their own sub-ingredients listed.
Allergens
Milk, egg, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added January 1, 2023 (FDA food allergies page).
"May contain" statements are voluntary and never replace declaring an allergen that is an ingredient.
Name and Place of Business Under 21 CFR 101.5
Every packaged food must show the name and place of business of the manufacturer, packer or distributor (21 CFR 101.5). If the company named is not the manufacturer, the name must be qualified with a phrase such as "Manufactured for," "Distributed by" or "Packed for." The address must include the city, state and ZIP code. The street address can be left off only if the business is listed in a current city or telephone directory.
For imported foods, we check whether the foreign manufacturer, the brand owner or the U.S. importer should be named and how the address should read.
Claims We Review
Labeling Changes Coming Up
| Change | Status | Date |
|---|---|---|
| Front-of-package Nutrition Info box | Proposed rule; final rule on the agenda | Final rule listed for December 2026 (Unified Agenda entry) |
| Updated "healthy" claim | Final rule | Comply by February 25, 2028 (FDA "healthy" claim guide) |
| Labeling rules published 2025 to 2026 | Uniform compliance date | January 1, 2028 (uniform compliance date of January 1, 2028) |
How Our Label Review Works
Other Labeling and Import Help
Supplements
Supplement Facts labels follow different rules. See supplement label review.
Quick questions
Importing food
Labels are separate from food facility registration, Prior Notice and FSVP.
Get Your Food Label Reviewed
Send your label artwork and formula. We check every required element, allergens and claims against FDA rules and give you clear corrections, usually in 2 to 3 business days.
- $250 per label, flat fee.
- Ingredient, allergen, Nutrition Facts and claims review.
- Findings in about 2 to 3 business days.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Pricing · FDA food services.
Request a Label ReviewFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — FDA Food Label and Ingredient Review
What is an FDA food label review?
A food label review is a professional evaluation of a conventional food label and the product information supporting it. The review can cover the statement of identity, net quantity, ingredient declaration, major allergens, Nutrition Facts, serving size, manufacturer/packer/distributor information, claims, warnings, and other product-specific requirements.
Does FDA approve food labels before products are sold?
FDA generally does not pre-approve conventional food labels before marketing. The responsible company must ensure that the food and its labeling comply with applicable law. A professional review is a compliance service, not FDA approval or certification.
What information do you need to review my label?
For a meaningful review, we normally need the current label artwork, complete formulation/ingredient information, sub-ingredient information when applicable, package/net quantity, nutrition data or source data, serving-size information, product specifications, claims, and any special product-category details relevant to the label.
How much does a food label review cost?
The standard professional fee is $250 per label. Nutrition analysis, laboratory testing, translation, substantial reformulation, multiple distinct package formats or specialized category work may need a separate or expanded quote.
How long does a food label review take?
A typical standard review is targeted for approximately 2–3 business days after complete artwork and product information are received. Complex formulations, missing specifications, nutrition-data questions, or extensive claims can extend the timeline.
What are the main required elements on a conventional packaged-food label?
Common required elements are the statement of identity, net quantity of contents, ingredient list, major food allergen declaration when applicable, Nutrition Facts unless an exemption applies, and the name and place of business of the manufacturer, packer or distributor (21 CFR Part 101).
What is the statement of identity?
The statement of identity is the name of the food. Depending on the product, it may be a name required by law/regulation, a common or usual name, or an appropriately descriptive name. A brand name alone does not necessarily satisfy the statement-of-identity requirement.
Where does the net quantity statement go?
For most packaged foods subject to FDA's rule, the net quantity of contents statement appears on the principal display panel and is subject to placement, prominence, unit, and type-size requirements tied to the package/PDP size.
How should ingredients be listed?
Ingredients are generally listed by their common or usual names in descending order of predominance by weight, subject to exceptions and special rules. Compound ingredients can also require declaration of their sub-ingredients.
How many major food allergens are there?
Federal law recognizes nine major food allergens: milk, egg, fish, Crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame (FDA food allergies page).
When did sesame become a major food allergen?
Sesame became the ninth major food allergen effective January 1, 2023. FDA-regulated packaged foods using sesame as an ingredient must meet the applicable allergen-labeling requirements.
How can major allergens be declared on the label?
Depending on the ingredient naming, allergen sources can be identified in the ingredient list or through a properly formatted Contains statement immediately after or adjacent to the ingredient list. If a Contains statement is used, it must identify all applicable major food allergens used as ingredients.
Is a 'may contain' allergen statement required?
Advisory statements such as 'may contain' are voluntary. They should not be used as a substitute for good manufacturing practices or for proper declaration of major allergens that are intentionally used as ingredients.
Does every packaged food need Nutrition Facts?
Most packaged foods subject to FDA nutrition-labeling requirements need Nutrition Facts, but exemptions and special provisions exist. A product should not omit Nutrition Facts unless it actually qualifies under the applicable exemption or rule.
What is the small-business nutrition-labeling exemption?
One low-volume exemption can apply when the person claiming it meets the employee and unit-sales thresholds and files the required notice annually. Other sales-based exemptions also exist. These exemptions address nutrition labeling only and do not remove other mandatory label information. Nutrition/health claims can also make certain exemptions unavailable.
Can a small business use nutrition claims and still rely on the low-volume exemption?
Generally not for the low-volume/small-business nutrition-labeling exemptions that are conditioned on the absence of nutrient content claims, health claims, or other nutrition information. The specific exemption and product facts should be checked before relying on it.
Can you create or review a Nutrition Facts panel?
We can review a Nutrition Facts panel and the supporting serving-size/nutrition information included in the service scope. If nutrient values must be generated from formulation databases, laboratory analysis, or other source data, that work should be identified separately from a basic artwork review.
How is serving size determined?
Serving sizes for many foods are based on FDA Reference Amounts Customarily Consumed (RACCs), together with package size and product-specific rules. Serving size should not simply be chosen for marketing preference.
What are nutrient content claims?
Nutrient content claims characterize the level of a nutrient in a food, such as 'low sodium,' 'sugar free,' or 'high fiber.' The claim must meet the applicable FDA criteria and related labeling conditions.
What is a health claim?
A health claim describes a relationship between a food or food substance and reduced risk of a disease or health-related condition. FDA has specific pathways and requirements for authorized or qualified health claims.
Can I use the word 'healthy' on my food label?
Yes, if the food meets FDA's updated criteria. "Healthy" is an implied nutrient content claim, and FDA's final rule requires a meaningful amount from at least one food group plus limits on added sugars, sodium and saturated fat. Companies must meet the new criteria by February 25, 2028 (FDA "healthy" claim guide).
Is front-of-package nutrition labeling currently mandatory?
No. As of October 2026, FDA's front-of-package Nutrition Info box is still a proposed rule (published January 16, 2025), not a final requirement. The Unified Agenda entry lists a final rule for December 2026, so watch for it, but do not treat the proposal as law yet.
Can I use 'gluten-free' on the label?
A voluntary 'gluten-free' claim must meet FDA's applicable gluten-free definition and requirements. The claim should be reviewed against the product ingredients, manufacturing conditions, and any relevant testing or supplier information.
Can I use 'natural' on a food label?
Claims such as 'natural' require careful review because they can be misleading depending on the product and context. FDA has historically maintained a policy rather than a comprehensive formal definition for 'natural' in conventional foods, so the full claim context matters.
Does 'organic' fall under FDA labeling rules?
Organic certification and the USDA Organic seal are primarily governed by USDA's National Organic Program, while FDA food-labeling requirements still apply to the food. Organic status does not replace FDA labeling requirements.
Do imported foods need U.S.-compliant labels?
Yes. FDA-regulated foods offered for import into the United States must comply with applicable U.S. food-labeling requirements. Foreign-market artwork should be reviewed rather than assumed to be acceptable for U.S. sale.
Does FDA require labels to be in English?
FDA requires mandatory food-label information to appear in English unless an applicable exception applies. When a label contains a foreign-language representation, the regulations can require mandatory information to appear in that language as well.
Can I apply a corrective sticker to imported food packaging?
A sticker or supplemental label can sometimes be used when it produces labeling that is complete, accurate, legible, conspicuous, and compliant before the product is introduced or delivered for introduction into U.S. commerce. The exact correction and timing should be reviewed for the specific product and import situation.
Does the label need the U.S. importer's name?
The label must give the name and place of business of the manufacturer, packer or distributor (21 CFR 101.5). If the named company did not make the food, the name must be qualified, for example "Manufactured for" or "Distributed by." Whether a U.S. importer is the right named party depends on the business relationship.
Is country-of-origin marking part of FDA label review?
Country-of-origin marking is principally a U.S. Customs and Border Protection requirement rather than an FDA Part 101 requirement. A comprehensive import-label review can flag the issue, but FDA and CBP requirements should not be confused.
Can I copy the Nutrition Facts or ingredient list from a competitor?
No. A competitor's formulation, nutrient profile, serving size, process, package dimensions, claims, exemptions, and supplier ingredients may differ from yours. The label should be built from your own product data.
Can one label review cover multiple flavors?
Only when the labels and underlying formulations are sufficiently identical for the agreed scope. Different flavors can change ingredients, allergens, nutrient values, claims, statements of identity, colors, or other mandatory information, so each distinct label may require its own review.
Does a food label review replace FSVP?
No. Food labeling and FSVP are separate compliance programs. FSVP applies to the FDA-defined FSVP importer of covered imported food, subject to exemptions and modified requirements.
Does a food label review replace Food Facility Registration?
No. A label review does not register the manufacturing facility, and Food Facility Registration does not approve the label. Each requirement should be handled separately when applicable.
Does a food label review replace Prior Notice?
No. Prior Notice is a separate FDA import requirement for covered imported food shipments, subject to exemptions and timing rules.
Does FDA issue a label-compliance certificate after review?
FDA does not issue a general conventional-food label approval certificate. A private consultant may provide a review report or service documentation, but it should not be represented as FDA approval or certification.
What happens if a food label is wrong?
Depending on the issue and circumstances, a food can be considered misbranded and may face regulatory or import consequences. The appropriate correction can range from artwork revision to relabeling, claim removal, ingredient/allergen correction, or other product-specific action.
Should I review my label again after changing the formula?
Yes. A change in ingredients, supplier composition, allergen status, nutrient values, serving size, package size, product name, claims, or other material information can affect the label and should trigger a review of the affected sections.
Request a Food Label Review
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.