Cosmetic Label Regulatory Review Compliance Assessment
Initial U.S. Label Compliance Based on FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA),
21 CFR Parts 701 & 740, FTC Environmental Marketing Guidelines, and 19 CFR 134
This one-time regulatory assessment provides a comprehensive review of cosmetic product labeling to help manufacturers, brand owners, importers, exporters, labelers, and distributors comply with the U.S. requirements under the Modernization of Cosmetics Regulation Act (MoCRA). The review addresses FDA, FTC, and CBP standards, ensuring label content is accurate, legally compliant, and appropriately formatted for the U.S. cosmetics market.
Scope of Work
FDA Cosmetic Label Content Review
• Compliance with 21 CFR Part 701 and Part 740 for elements such as:
- ∘ Principal Display Panel (PDP)
- ∘ Information Panel
- ∘ Ingredient Declaration
- ∘ Warning Statements
- ∘ Business Name and Address
- ∘ Label Formatting
Allergen and Sensitivity Disclosure (If Applicable)
• Evaluation of voluntary allergen declarations and other disclosures based on industry best practices
Marketing and Environmental Claims Review
• Review of claims in line with Federal Trade Commission (FTC) guidelines, including:
- ∘ Health-related Claims
- ∘ Environmental Claims
- ∘ Claims Substantiation
- ∘ Use of Certification Seals or Logos and Accreditation Claims
Assessment of Other Additional Labeling Elements
- • UPC Barcode
- • Lot Number
- • Expiration or Period After Opening (PAO) Country of Origin (19 CFR §134.11)
Deliverables
Regulatory Compliance Assessment Report
- • Identification of compliant and non-compliant areas, with applicable recommendations
- • Actionable guidance with citations of relevant regulations
Certificate of Cosmetic Label Compliance
- • Issued after final review and implementation of corrections
- • Confirms the label complies with FDA and federal labeling regulations at the time of assessment
Fees and Subscriptions
First Label – One-Time Review
Comprehensive compliance review of the first cosmetic label
Fee: $750.00 USD
Additional Labels – One-Time Review
Review of each additional label submitted
Fee: $650.00 USD
First Label – Annual Reassessment
Annual label reassessment to reflect regulation updates or product revisions
Fee: $450.00 USD/year
Additional Labels – Annual Reassessment
Ongoing annual reviews for any additional labels
Fee: $350.00 USD/year
Customized Packages Available
For brands managing multiple SKUs, seasonal packaging updates, or frequent rebranding, we offer customized packages with bundled pricing, streamlined review processes, and coordinated regulatory planning.
Contact us to build a solution tailored to your cosmetic portfolio.
Ideal For:
- • Cosmetic companies entering or expanding into the U.S. market
- • Foreign exporters seeking FDA-compliant labeling for customs and U.S. Cosmetics Regulation (i.e., FDA MoCRA) requirements Brands launching new formulations or redesigning packaging with marketing claims
- • Importers, co-packers, and private labelers managing multi-brand label portfolios
Need help ensuring your cosmetic labels are compliant?
Reach out to us today to begin your regulatory review.