I. Basic Registration Requirements and Scope
- Legal Basis and Coverage
Pursuant to the Federal Food, Drug, and Cosmetic Act and the Bioterrorism Act, all enterprises selling food in the United States (including domestic and foreign enterprises) must complete FDA registration.中华人民共和国海关总署. The scope covers facilities that manufacture, process, pack, or store human/animal food; however, farms, restaurants, non-profit organizations, etc., may be exempt.中华人民共和国海关总署。 - Registration Types and Special Requirements
Conventional Food: Must submit enterprise information online through the FDA Food Facility Registration System (FIRMS), including name, address, product category, etc., with biennial renewal (October 1 to December 31 of even-numbered years).。
Low-Acid Canned Food / Acidified Food: In addition to standard registration, must also complete theFCE (Food Canning Establishment Registration)和SID (Scheduled Process Filing), submitting detailed process documentation such as heat distribution reports and sterilization parameters.
Infant Formula: Must obtain FDA pre-market approval by submitting clinical data demonstrating nutritional adequacy and safety; the process typically takes 1-2 years.。
II. Registration Process and Core Steps
- 准备阶段
D-U-N-S Number (DUNS): All enterprises must first apply for a 9-digit DUNS number, which serves as the unique identifier in the FDA system.中华人民共和国海关总署。
U.S. Agent: Foreign enterprises must designate a U.S.-based agent responsible for communicating with the FDA and receiving notifications; agent fees are approximately $100-$500/year.。
- Online Submission and Review
Complete the application form through the FIRMS system and upload documents such as the business license, production process description, and ingredient list.中华人民共和国海关总署。
Conventional food registration is typically completed within 3-5 business days; low-acid canned food registration may extend to 1-2 weeks due to process documentation review.
Upon successful registration, the enterprise receives an 11-digit FDA registration number, used for customs clearance and market compliance verification.中华人民共和国海关总署。
- Information Updates and Deregistration
Changes in enterprise information (e.g., address, product category) must be updated within 60 days; cessation of operations requires deregistration within 60 days.中华人民共和国海关总署。
Failure to update on time may result in registration invalidation, affecting product entry.
III. Fees and Compliance Costs
- Official Fees
Conventional Food: FY2025 registration fee is $9,280 per biennial period; small business discounts are no longer available.
Low-Acid Canned Food / Acidified Food: In addition to standard fees, additional FCE and SID registration fees may apply; specific amounts depend on product complexity.
Import Food Prior Notice: Each import requires electronic prior notice submitted 8 hours in advance; there is no direct fee, but delays may result in penalties.
- Third-Party Service Costs
Agency Services: Basic registration agency fees are approximately $500-$3,000, including document preparation, label review, etc.
Label Compliance: Professional review fees are approximately $200-$1,000, ensuring ingredient lists, allergen declarations, etc., comply with FDA standards.
HACCP Certification: High-risk food enterprises must establish an HACCP plan; certification fees are approximately $1,000-$5,000.
IV. Special Considerations for Chinese Enterprises
- Labeling and Language Requirements
Labels must be in English and Spanish (where applicable), including nutrition facts panel, allergen declarations (e.g., nuts, dairy), net weight, etc.
Chinese labels must be accompanied by an English translation, and content must be consistent with the FDA database.
- Import Process and Documentation
Importers must submit Prior Notice through FDA's PEARS system before the goods arrive, including manufacturer information, ingredients, shipping routes, etc.
Must be accompanied by a certificate of origin, sanitary certificate, and FDA registration number; otherwise, goods may be detained or destroyed.
- High-Risk Food Inspections
FDA may conduct unannounced inspections for high-risk foods such as seafood and dairy products, focusing on HACCP plan review, equipment cleaning records, water quality test reports, etc.
Enterprises must prepare bilingual (Chinese-English) production records, employee training documents in advance, and ensure equipment complies with cGMP requirements.
V. Latest Policies and Trends (2025)
- Ingredient Safety Enhancement
All food additives must pass FAP (Food Additive Petition) or GRAS (Generally Recognized As Safe) certification; usage levels of artificial sweeteners, etc., must comply with new standards.
Special foods such as infant formula must submit clinical data demonstrating nutritional adequacy.。
- Labeling and Traceability Requirements
标签需标注 “双制净含量”（如盎司和克），西班牙语区产品需双语标签。
Enterprises must establish an electronic traceability system to enable the FDA to quickly trace the source of problematic products.。
- Inspection and Enforcement Intensity
FDA has increased the frequency of on-site inspections for high-risk enterprises; failure to pass inspection may result in product recall or fines up to $10,000/day.
进口食品若多次违规，可能被列入 “自动扣留名单”，影响后续清关。
VI. Recommendations for Efficient Registration
- Choose a Professional Agent
Engaging third-party organizations (e.g., Viva FDA, Beisitong Testing) can simplify the process by providing U.S. agent services, label optimization, and HACCP consulting, with fees of approximately $500-$3,000.. For example, a Chinese canned food enterprise completed FCE and SID registration through an agent, reducing the timeline to 2 weeks. - Prepare Key Documents in Advance
The DUNS number application takes 1-2 weeks; it is recommended to initiate the process as early as possible.中华人民共和国海关总署。
Low-acid canned food enterprises should prepare heat distribution reports and sterilization parameters 6 months in advance.
- Monitor Regulatory Developments
Regularly check the FDA official website or subscribe to industry updates. For example, the 2025 registration fee increased by 21.3%, and small business discounts were eliminated. In addition, the FSMA requires enterprises to establish preventive controls, which must be incorporated into daily operations.。
VII. Frequently Asked Questions
- Q: Does FDA registration equate to product approval?
A: No. Registration only indicates enterprise information filing. Food products do not require pre-market approval (except for special categories such as infant formula), but labels and ingredients must be compliant. - Q: How should Chinese enterprises prepare for FDA on-site inspections?
A: Conduct mock audits in advance, focusing on HACCP records, equipment cleaning, pest control, etc. It is recommended to invite a third party for pre-audit. - Q: Is ongoing compliance required after registration?
A: Yes. Registration information must be renewed every two years. Label or formula changes require resubmission for review. High-risk enterprises may face annual inspections.。