I. Mandatory Registration Requirements and Timelines
Establishment Registration：
All facilities manufacturing or processing cosmetic products (including overseas facilities) must complete registration through FDA's FURLS system. Non-U.S. companies must designate a U.S. Agent (providing a physical address and 24/7 contact information)。
The initial registration deadline was July 1, 2024; products from unregistered establishments may be detained by customs or denied entry.
The registration cycle typically takes 1 week (establishment registration) to 2 weeks (establishment + product listing), but may be extended near compliance deadlines; early application is recommended.
Product Listing：
The responsible person (e.g., brand owner, manufacturer) must submit each product's formulation, labeling, usage instructions, and other information through FDA's CPIS system, including INCI names and content ranking for all ingredients.
Product listing requires annual renewal (October 1 to December 31), while establishment registration requires biennial renewal。
II. Registration Process and Key Documents
Basic Information Preparation：
Companies must provide a DUNS number (Dun & Bradstreet identification number), U.S. Agent information, manufacturing facility address, and contact personGeneral Administration of Customs of the People's Republic of China。
Product information includes English label artwork, ingredient list (in descending order of concentration), and usage descriptions.
Submission and Review：
Submit registration applications through FDA's electronic system; upon approval, an FDA Registration Number and Product Listing Number are issued as compliance credentials.
After successful registration, company information is entered into the FDA database, significantly reducing the risk of customs inspections.
Legal Liability：
Companies must consent to FDA inspection of manufacturing facilities at any time and assume ultimate responsibility for product safetyfda.gov。
False declarations or failure to update information in a timely manner may result in product recalls, fines (up to $500,000 per violation), or placement on the FDA blacklist.
III. Strict Ingredient and Labeling Standards
Ingredient Safety and Prohibited Lists：
The use of ingredients explicitly prohibited by FDA (such as mercury, clobetasol) is forbidden, and all color additives must be FDA-certified (e.g., D&C Red 33 requires batch testing)fda.gov.ph。
Products containing sunscreen agents or anti-dandruff ingredients may be classified as drugs and must additionally comply with OTC monograph or New Drug Application (NDA) requirementsfda.gov。
Labeling Compliance Essentials：
Must include Net Contents (metric + imperial units), Ingredient List (in descending order of concentration), Manufacturer Address and Required Warnings (e.g., "Avoid contact with eyes")。
Starting in 2025, products containing fragrance allergens (such as linalool, geraniol) must be disclosed separately on labels, with the specific list to be published by FDA within 18 months of MoCRA's effective date.
Misleading claims such as "all-natural" or "additive-free" are prohibited unless supported by scientific evidencefda.gov。
IV. Import Process and Customs Compliance
Pre-Import Preparation：
Foreign establishments must submit product information including ingredients, labeling, and manufacturing processes through the FDA Prior Notice System, along with U.S. Agent contact information。
Cosmeceuticals (such as sunscreens) must undergo prior review by the Center for Drug Evaluation and Research (CDER), or they may be detainedfda.gov。
Customs Inspection Focus：
Customs will verify whether products comply with ingredient prohibition rules, labeling completeness, and whether FDA registration has been completedfda.gov。
Common detention reasons include use of non-FDA-certified color additives, labels lacking English ingredient listings, or false efficacy claimsfda.gov。
Non-Compliance Handling：
Non-compliant products must be rectified, destroyed, or re-exported within 30 days, or face fines or permanent entry denialfda.gov。
V. Good Manufacturing Practices and Quality Control
GMP Requirements：
While FDA does not mandate cGMP certification for cosmetic companies, manufacturing processes must comply with the Cosmetic Good Manufacturing Practice Guidelines, including equipment sanitation, personnel training, and recordkeeping.
Cosmeceuticals must strictly adhere to pharmaceutical cGMP standards, or they may be deemed adulterated products.
Safety Data Submission：
Companies must retain product stability testing, microbiological testing, and toxicological assessment data for at least 3 years for potential FDA inspection。
For high-risk products (such as those containing novel preservatives), proactively submitting safety assessment reports to FDA for filing is recommended。
VI. Special Considerations for Chinese Enterprises
U.S. Agent Selection：
The agent must have the capability to handle FDA inquiries and assist with inspections; selecting an experienced compliance service provider (such as Registrar Corp) is recommended。
U.S.-China Regulatory Differences：
Of the 2,000+ ingredients banned by the EU, only approximately 11 are prohibited by FDA; special attention must be paid to the compliance of ingredients such as parabens and formaldehyde-releasing agentsfda.gov.ph。
Certification and Testing：
It is recommended to conduct ingredient testing and label review through third-party laboratories (such as SGS) to ensure compliance with FDA and local requirements such as California Proposition 65.
VII. Compliance Tools and Resources
FDA Official Systems：
FURLS (Establishment Registration): https://www.access.fda.gov/
CPIS (Product Listing): accessible via FDA account linkage
Compliance Support：
Download the FDA Cosmetic Labeling Guide and MoCRA Implementation Rules, or contact the FDA Office of Cosmetics and Colors (Phone: 301-796-2632)fda.gov。
Professional service providers can assist with registration, label review, and mock inspections to reduce compliance risks.