FDA Label Review Services
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FDA Food Label Compliance – Label Review Fees
The food manufacturer or distributor is responsible for ensuring their food product labeling complies with FDA regulations. Unlike meat and poultry products regulated by the USDA, food labels are not reviewed or pre-approved by the FDA before they go to market. This means the legal responsibility for an accurate, compliant label rests entirely with your company.
If your labels do not comply with FDA requirements — such as an incorrect Nutrition Facts panel, missing allergen declarations, an inaccurate net quantity statement, or unauthorized health claims — the FDA will consider the product misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act. Distributing a misbranded product is a prohibited act, and the FDA may take regulatory action, including detention at the U.S. port of entry, refusal of the shipment, warning letters, or product seizure. For imported food, non-compliant labels are a common reason shipments are held at the border, leading to costly delays.
Because there is no pre-market approval, these problems often surface only after a product is already in commerce or detained on import, when they are far more expensive to fix. A professional label review before you print and ship is the most effective way to catch issues early and keep your products moving.
LMG’s food label review service will help you confirm your product labels comply with FDA requirements before they reach the market. We have designed three types of label review services, so you can choose the option that best fits your products and your budget.
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Basic Food Label Review – Fees USD 249
A basic label review includes a review of
- Statement of Identity
- Net Content
- Ingredient Statement Present or Not
- Business Address
- Country of Origin
- Product Category
- Foreign Language
- Serving Size
- Nutrition Facts Present or Not
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Standard Food Label Review – Fees USD 649
Standard label review includes basic label review + Detailed Review of the below sections along with the action points document and the suggested draft label.
- Standard of Identity
- Ingredient Review
- Claim Interpretation
- Product-Related Warning Letters
- Nutrition Facts
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Advanced Food Label Review – Fees USD 949
Advanced label review includes a Standard label review + a comments file that marks the corrections to be done on the existing label that makes easy for you to understand the changes and correct the label at your end.
Drug Label Review
Review of OTC and prescription drug labels for compliance with 21 CFR — Drug Facts panel, monograph compliance, and marketing claims.
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Medical Device Label Review
Review of device labels for 21 CFR Part 801 compliance — intended use, warnings, UDI, IFU, and ISO symbols.
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Food & Supplement Label Review
Review of food and supplement labels for 21 CFR Parts 101 & 102 — nutrition facts, allergens, ingredients, and claims.
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Cosmetic Label Review
Review of cosmetic labels for FD&C Act, FPLA, and MoCRA 2022 compliance — INCI naming, claims, and formatting.
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Frequently Asked Questions
Why is FDA label review important?
Does FDA pre-approve product labels?
How long does label review take?
What is the outcome of the label review?
Ready to Review Your Product Label?
Select the appropriate label review service below or contact us for guidance.
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