FDA Labeling Requirements

FDA label review is a critical step to ensure that product labels meet all regulatory requirements set by the U.S. Food and Drug Administration. At RAPS, our technical experts conduct comprehensive label assessments to ensure accuracy, compliance, and clarity across all product categories—including cosmetics, food, drugs, and medical devices.

Labeling requirements can be complex, as they must address multiple audiences such as consumers, healthcare professionals, and regulators. A compliant label must present clear and accurate information regarding ingredients, safety data, directions for use, and potential adverse effects.

Our FDA label review service includes:

Verification of label content and product claims
Review of ingredient declarations and order
Assessment of label format, layout, and font size
Compliance checks based on FDA guidelines for specific product categories

Non-compliant labels are considered misbranded under FDA law and can result in product detention, regulatory action, or denial of market entry.

FDA Label Review Process and Timeline

At RAPS, we offer a thorough, compliance-focused FDA label review service tailored to drugs, cosmetics, and food products. Our standard timeline includes:

Initial Review: Completed within 2 weeks
Follow-up Reviews: Minimum 3 working days, depending on responsiveness to our recommendations
Total Duration: Depends on how promptly corrections are implemented and how closely our feedback is followed

Drug Label Review Process

Our drug label review is conducted in full alignment with FDA labeling requirements, and includes the following steps:

Verification of Active Ingredients: Checked against the applicable FDA monograph. If non-compliant, the customer is advised to reformulate before proceeding.
Label Compliance Checklist: A detailed review against FDA drug labeling standards, covering mandatory elements, font sizes, formatting, and sequence of information.
Action Points Document: Lists all non-compliant elements with corresponding FDA requirements and suggested corrections.
Commented Label Review: Comments and corrections are directly marked on the original label.
Suggested Draft Label: A revised draft label is provided to assist with accurate implementation of corrections.

Cosmetic Label Review Process

Cosmetic label reviews are conducted in accordance with FDA cosmetic regulations, with key focus areas including:

Claims Analysis: Review for drug-like claims, which are prohibited on cosmetic labels. FDA warning letters may be shared for similar past violations.
Ingredient Review: Ingredients are checked against FDA-approved references and the Cosmetic Ingredient Dictionary. Prohibited ingredients are flagged.
Compliance Checklist: A full review of labeling format, font, content, and declaration order, as per FDA cosmetic regulations.
Action Points Document: Detailed summary of labeling gaps and necessary corrections.
Commented Label Review: Annotations made on the existing label.
Suggested Draft Label: A proposed revised version is provided for easy correction.

Food Label Review Process

Our food label review process is structured to meet all applicable FDA food labeling standards:

Initial Compliance Check: Verification of Statement of Identity, Net Content, Ingredients, Business Address, Country of Origin, Product Category, Foreign Language usage, and Serving Size.
Detailed Label Review: Includes Standard of Identity, Ingredient Assessment, Claims Analysis, Warnings, and Nutrition Facts Panel.
Action Points Document: Lists non-compliant areas with corresponding FDA regulations and correction suggestions.
Commented Label Review: Corrections are marked on the current label.
Suggested Draft Label: A draft version is shared to simplify implementation.

FDA Label Review Pricing

We offer flexible pricing to suit various review needs:

Basic Review – $350 USD (3 working days)
Standard Review – $650 USD (10 working days)
Premium Review – $950 USD (14 working days)

Let RAPS Help You Label with Confidence

At RAPS, we combine regulatory expertise with precision and efficiency. Our FDA label review service helps you avoid costly delays, reduce compliance risks, and ensure your product is market-ready. Whether you're launching a new product or correcting an existing label, our team delivers trusted guidance every step of the way.

Simplify Compliance with Expert Label Reviews from RAPS

Your product label is more than just packaging—it's a regulatory document that speaks directly to the FDA. With RAPS, you gain a trusted partner committed to ensuring your labels meet all FDA requirements with accuracy and efficiency. Whether you're in the food, cosmetic, or pharmaceutical industry, our structured review process, expert insights, and fast turnaround times help you stay compliant, avoid costly setbacks, and confidently enter or stay in the U.S. market.