Standardized service

FDA Food Label Review

A line-by-line review of your label against FDA food labeling rules (21 CFR 101 and related requirements): mandatory declarations, Nutrition Facts, ingredients, and claims — with an action-points document and annotated correction suggestions so the label is compliant before it goes to market.

RegulatorU.S. FDA

Review basis21 CFR Part 101

Initial review10-14 business days

Follow-up review~3 business days

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What this service is

FDA does not approve food labels before marketing, but products are checked at random once on the U.S. market. Non-compliant labeling is treated as misbranding, leading to detention, warning letters, and public listing on the FDA website.

Food labeling is governed mainly by 21 CFR Part 101. Mandatory elements include the statement of identity, net quantity of contents, the ingredient statement, Nutrition Facts, allergen declarations, the name and address of the responsible firm, and country of origin — with specific rules on type size, format, and the order of declarations.

21 CFR Part 101FD&C Act §403FALCPA (2004)

Who needs it

Food, beverage, and dietary supplement companies entering the U.S. market for the first time

Businesses that changed a formula, pack size, or marketing claim and need the label re-checked

Companies asked by U.S. customers or platforms for evidence of a label compliance review

Prerequisites and sequence

A final or near-final label file (an editable version is recommended)
The complete ingredient information is finalized
Intended claims and marketing copy are defined
The target pack size is fixed, as it affects type size and layout compliance

Who holds regulatory responsibility

Responsibility for label compliance rests with the product's manufacturer and distributor. This service provides a regulatory review and correction recommendations; you implement the changes before printing and launch.

Materials we need from you

Label artwork (editable file preferred; plain text in a document is acceptable if no artwork exists yet)

Complete ingredient list

Nutrition data or its calculation basis

Name and address of the manufacturer or distributor

Intended product claims

Process

01
Check mandatory declarations: statement of identity, net contents, ingredient statement, business address, country of origin, serving size, and more
02
Review ingredient compliance, claim wording, and applicable warning statements
03
Check the Nutrition Facts format and declaration logic
04
Issue an action-points document marking each non-compliance with its regulatory basis
05
Annotate corrections on the existing label and provide a suggested revised draft
06
Confirm the corrections in a follow-up review after you implement them

Deliverables

An action-points document with regulatory references

An annotated version of your label

A suggested revised label draft

A follow-up review confirmation

Timeline

The initial review takes about 10-14 business days; a follow-up review after your corrections takes about 3 business days. The overall timeline depends mainly on how quickly corrections are implemented.

Scope

What we provide

Item-by-item check of mandatory declarations
Ingredient and claim compliance review
Nutrition Facts format check
Action-points document and suggested revised draft
One round of follow-up review

What is not included

Graphic design and artwork production
Laboratory nutrition testing
Repeated review rounds beyond the agreed scope (negotiated separately)
Label compliance for markets outside the U.S. (e.g., the EU)

What usually follows

FSVP Importer Verification Report FSVP Importer Agent

Common pitfalls

Disease treatment or prevention claims on the labelDisease claims cause a food to be regulated as a drug, followed by detention and warning letters. Even structure/function claims have strict wording boundaries — check every claim before launch.

Reusing one review conclusion across pack sizesNet contents and servings per container change with pack size, and the required declarations change with them. Carrying one conclusion over to a new size invites misbranding findings during FDA's random checks.

Assuming FDA approves labels before marketingFDA does not pre-approve food labels; it checks them at random after marketing. Non-compliance is treated as misbranding — detention, warning letters, and public listing — so compliance must be achieved before the product ships.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

Request a quote

FAQ

Does a passed review guarantee FDA will not detain the product?

No absolute guarantee is possible. FDA checks labels on a random basis after marketing; the point of a review is to eliminate every known non-compliance under current rules. If regulations change, a reviewed label may need to be checked again.

Can you design the label for us?

We do not provide graphic design. If you supply an editable file, we can produce a compliant corrected version ready for print; the overall visual design remains with your designer.

Same product, different pack sizes — separate reviews?

Recommended, yes. Net contents change with pack size, and declarations such as servings per container change with them, so one conclusion cannot simply be carried over.

Can the label carry claims about treating or preventing disease?

No. Disease treatment or prevention claims cause a food to be regulated as a drug. Structure/function claims have strict wording boundaries; during the review we check each claim and propose compliant alternatives.

Related services

Food Facility RegistrationAny facility that manufactures, processes, packs, or holds food for the U.S. market must register with the FDA. We prepare the registration, arrange the U.S. agent appointment, and obtain the registration number; a D-U-N-S Number is required before registration.Food U.S. AgentForeign food facilities must designate a U.S.-based agent when registering with the FDA, serving as the point of contact between FDA and the facility. We provide an annual U.S. agent service covering registration support, renewals, and day-to-day FDA correspondence.FSVP Verification ReportBuild your Foreign Supplier Verification Program file under FSMA (21 CFR Part 1, Subpart L) and receive a per-product verification report covering hazard analysis, supplier evaluation, and verification activity records. Priced per product.

Disclaimer

This service provides a regulatory review opinion, not legal advice, and does not represent FDA acceptance of the label. Final responsibility for label compliance rests with the manufacturer and distributor.