《2025 Latest! A Complete Interpretation of FDA Regulations for Cosmetics Exports to the United States (with a Guide to Avoiding Pitfalls)》

Foreword
As the global cosmetics market continues to expand, the United States, as one of the world’s largest cosmetics consumer markets, has attracted the attention of many international brands. However, the U.S. Food and Drug Administration (FDA) has strict regulatory requirements for cosmetics, and the implementation of the new regulations in 2025 has brought new challenges to exporters. This article will fully interpret the latest regulations and provide a practical guide to avoid pitfalls to help your products enter the U.S. market smoothly.

I. Core changes in the new FDA cosmetics regulations in 2025

1. Mandatory product registration system (fully implemented in 2025)
   All cosmetics companies must complete registration through the FDA electronic submission portal

Product list requirements include full ingredient disclosure (including the chemical name of fragrance ingredients)

Annual update requirements (even if there is no change, the information must be confirmed to be accurate)

2. New safety certification standards
   GMP compliance becomes a mandatory requirement (no longer just a recommendation)

Toxicological risk assessment must be completed by an FDA-approved laboratory

Microbial limit standards are fully updated (especially for water-based products)

3. Upgraded labeling requirements
   All ingredient labels must use INCI names (trade names are prohibited)

Standardized warning statement format (specific ingredients must use FDA-specified warning words)

QR code extended information is allowed but must comply with FDA data specifications

II. List of necessary compliance documents for export to the United States
Enterprise registration certificate (FEI number)

Product list filing confirmation letter

GMP compliance statement (with factory audit report)

Ingredient safety certification documents (including CAS number of each ingredient)

Stability test report (accelerated test data of at least 3 batches)

Microbiological test report (according to USP<61> and <62> methods)

Label compliance statement (Chinese and English version)

Avoidance tips: Starting in 2025, FDA will randomly require the provision of COA (Certificate of Analysis) and TDS (Technical Data Sheet) from raw material suppliers. It is recommended to prepare complete supply chain documents in advance.

III. List of key regulated ingredients in 2025
Ingredient category Restricted substances Allowed limits Special labeling requirements
Sunscreen Benzophenone-3 ≤6% “may cause allergic reactions” warning
Preservative Methylisothiazolinone Prohibited from use in leave-on products Rinse-off products must be labeled “limited use”
Whitening agent Hydroquinone Completely prohibited Not detectable (detection limit 0.1ppm)
Hair dye Containing phenylenediamines Allergenicity test data must be provided 48-hour skin test recommendation must be marked
Nanomaterial Titanium dioxide (nanoscale) Requires separate safety assessment Mark “nanoscale” and particle size range
IV. Common reasons for customs rejection and solutions

1. Document issues (accounting for 42% of customs rejections)
   Typical problems: translations are not notarized, test reports are expired, and ingredient lists are incomplete
   Solution: Use FDA-approved translation agencies, and test reports must be issued within 6 months before shipment
2. Unqualified labels (accounting for 31%)

High frequency errors: wrong order of ingredients, inconsistent font size, lack of necessary warnings

Compliance tips: Use FDA label design template (downloadable on the official website), note that the net content must be marked in both metric and US units

3. Ingredient violations (accounting for 19%)

Risk ingredients: Contains banned plant extracts (such as angelica root), unapproved colorants, excessive heavy metals

Preventive measures: Establish a raw material pre-screening system, with special attention to the hidden risk substances that “natural ingredients” may contain

4. Other issues (accounting for 8%)
   Including: unpaid annual fees, unupdated registration information, incorrect product classification, etc.

V. Step-by-step compliance operation guide
Step 1: Pre-compliance assessment (recommended 6 months in advance)
Screen product formula (recommended to use FDA’s Cosmetics Ingredient Database)

Determine product classification (common cosmetics/OTC drugs/medical device combination products)

Select a third-party testing agency approved by the FDA

Step 2: Document preparation stage
Complete enterprise registration (obtain FEI number)

Prepare product files (including complete technical documents)

Perform necessary safety and stability tests

Design compliance labels (it is recommended to make physical samples for verification)

Step 3: Customs clearance preparation
Submit a pre-notification 30 days in advance (PN system)

Prepare the “immediate response package” that may be required by the FDA inspection (including electronic versions of all documents)

Confirm that the freight forwarder is familiar with Familiar with FDA detention review process

VI. Compliance cost optimization strategy for 2025
Joint registration plan: similar products can submit safety assessment reports together (saving 30-50% testing costs)

Batch shipment strategy: first small trial orders to verify customs clearance process

Digital document management: Use FDA-approved eSubmitter software to reduce clerical errors

Pay attention to FDA exemption policy: small businesses (annual sales < $1 million) can apply for partial fee reductions

Conclusion
Although the 2025 FDA new regulations have raised the compliance threshold, they have also created a fairer competitive environment for companies that operate in a standardized manner. Recommended export companies:

Establish a full-time compliance team

Invest in a compliance management software system

Regularly attend FDA webinars (first Wednesday of each month)

Subscribe to FDA cosmetics compliance update emails (free service)

Additional resources:

FDA Cosmetics Compliance Manual (2025 version download link)

Contact information for US regulatory consultation window of China Institute of Inspection and Quarantine

White paper on analysis of common customs rejection cases (scan the code to obtain)

Through advance planning and systematic preparation, your products will be able to successfully enter the US market and win the trust of consumers!