Who is responsible for the FDA food registration of Taiwan brand food exported to the US? (2026 Latest)

introductory

According to the U.S. Food and Drug Administration (FDA(Statistics show that there are more than 50% per year.foodstuffsImporters face delays in customs clearance or penalties due to a lack of understanding of regulatory requirements. For manyTaiwan BrandsIn other words.Export to USAThe market is full of business opportunities, but FDA The certification process is often confusing for the industry - who is responsible for it? FDA Food Registration? Manufacturer, Exporter, or U.S. Importer? This article will give you a complete explanationTaiwan Brand Food Export to U.S. FDA Vesting of responsibilities for registration and introduction of professional cross-border e-commerce compliance platformsGreen CircleHow to help Taiwanese companies enter the U.S. market smoothly.

Summary of Core Points

• FDA Food Facility Registration is a Mandatory Requirement: All supplies to the U.S.foodstuffsThe foreign manufacturer, processor or packer of the product is required to FDA Register
• Responsible parties are clearly defined: Usually consists ofTaiwan BrandsThe manufacturer is responsible for registration, but a US Agent is required.
• The registration process consists of three major steps: Obtain a Dunn & Bradstreet (DUNS) code, designate a U.S. agent, and complete online registration.
• Different food categories have different requirements: Additional Registration Procedures for Low-Acid Canned Foods and Acidified Foods
• Professional platforms such as Green Circle provide one-stop services.: Dramatically reduce compliance risk from document preparation to registration completion.

FDA Food Registration Responsibility Analysis

Who must register with the FDA?

According toU.S. FDA official regulations(a) any manufacture, processing, packaging, or storage for human or animal consumption in the United States; andfoodstuffsAll foreign facilities are required to report to the FDA Register. ForTaiwan BrandsFor the purposes of this section, the responsible parties usually include:

Mandatory registration of the subject:

1. Food Manufacturing Factory: Actual productionfoodstuffsTaiwan Factory
2. Processing Facilities: Manufacturers of secondary processing and packaging
3. Warehouse Facilities: Long-term storage supplyExport to USAWarehousing of food (over 24 hours)

Exemptions from registration:

• Farm Direct Harvest (unprocessed)
• Restaurants, retail food establishments
• Transportation-only logistics providers
• Pure traders (no contact with the food itself)

important reminder: Even for OEM/ODM.Taiwan BrandsThey also need to ensure that the OEMs complete the FDA Registration is the compliance responsibility of the brand.

Role of the U.S. Agent (US Agent)

FDA Require all foreign food facilities to designate aU.S. AgentsThis is necessary to complete the registration. The duties of the U.S. Agent include:

Points of Attention: A U.S. Agent must be an individual or business physically located in the U.S. and cannot be a P.O. Box address. ManyTaiwan BrandsSelect byGreen CircleGet a reliable U.S. agent service on a professional platform.

FDA Food Registration Complete Process

Step 1: Obtain a Dunn & Bradstreet Global Code (DUNS Number)

According toDun & Bradstreet, Inc.Information.DUNS Number It is the unique identifier of the enterprise, applying for the FDA Must be obtained prior to registration.

Application:

• Online application: Free application through D&B website (processing time about 30 days)
• Expedited service: 1-3 business days for paid expedited service.
• ThroughGreen CircleAssistance: Professional team to ensure the correctness of information

Step 2: Prepare the required information for registration

List of basic information:

1. Legal name and English name of the company
2. Complete address (physical address of manufacturing, processing or packaging facility)
3. Contact Phone & Email
4. DUNS Number
5. U.S. Agent Information
6. Product Category Code (FDA Product Code)
7. ProjectedExport to USA(used form a nominal expression)foodstuffsCategory List

Step 3: Submit Registration Online

Through FDA (used form a nominal expression) Industry Systems The platform submits an application for registration:

1. Establishment of FDA Industry Systems Account
2. Select "Food Facility Registration
3. Fill in facility information and product categories
4. Appointment of U.S. Agent
5. Submit and obtain a Registration Number

Timing::

• General Registration: Effective immediately after submission, registration number will be issued automatically by the system.
• Duration: Registration is valid for a long period of time, subject to renewal every two years (October-December of even years)

Additional Requirements for Special Food Categories

Low Acid Canned Food (LACF) and Acidified Food (AF)

with respect toTaiwan BrandsIn addition to the basic registration of facilities, canned products need to meet special requirements:

Low Acid Canned Foods (LACF):

• Canned foods with pH > 4.6 and water activity > 0.85
• require a report to FDA Submit Process Filing
• Operators need to be trained by the Better Process Control School.

Acidified Foods (AF):

• Foods originally low in acid but acidified to pH ≤ 4.6
• Process reporting and operator training are also required.

Professional Advice: The compliance process for this type of product is complex and it is recommended that this be done through theGreen CircleProfessional consultants will assist to ensure that the process documentation complies with the requirements of the FDA Standard.

Infant Formula and Dietary Supplements

According toU.S. Federal Regulations (CFR)In addition, there are more stringent requirements for these products:

Infant formula:

• Requires prior notification to FDA Formulation and Labeling
• Conducting nutrient analysis and stability testing
• Implementation of CGMP (Good Manufacturing Practice)

Dietary supplement:

• NDI (New Dietary Ingredient) assessment is required prior to product launch.
• Compliance with CGMP for Dietary Supplements
• Strict labeling requirements (no claims of efficacy)

Green Circle: The Best Partner for Taiwan Brands Exporting to the U.S.

One-stop cross-border e-commerce compliance solution

Green CircleAs a professional cross-border e-commerce compliance service platform in Taiwan, we provide completeTaiwan Brand Food Export to U.S. FDA Registration Service:

Core Services:

1. FDA Registration
   • DUNS Number Application Assistance
   • U.S. Agent Services
   • Preparation and Submission of Registration Documents
   • Automatically updated reminder every two years
2. Product Label Audit
   • Nutrition Label Compliance Check
   • Verification of the correctness of ingredient expression
   • Allergen Labeling Review
   • Multi-language label design
3. Testing and Certification Assistance
   • Recommended ISO 17025 Accredited Laboratories
   • Coordinate product safety testing
   • Microbiology Testing Arrangements
   • Heavy Metal and Pesticide Residue Testing
4. Cross-border logistics integration
   • Preparation of Customs Clearance Documents
   • HS Code Classification Proposal
   • Warehouse Logistics Planning
   • Amazon FBA Matching

Successful Cases

Case: Taiwan Tea Drinks Brand Successfully Enters U.S. Market

A famous tea drink in TaiwanbrandingPlans to bottle tea beveragesExport to USAAmazon platform throughGreen CircleThe assistance of the

• Week 1: Completing the DUNS Number Application and U.S. Agent Designation
• Week 2: Submission FDA Facility registration, obtain registration number
• Week 3Completed Product Labeling Compliance Audit and Amendments
• Week 4: Arranging third party laboratory testing and obtaining qualified reports
• Week 6Product: Clearing Customs on Amazon U.S.A.

efficacy::

• Sales exceeded $100,000 in the first month
• Zero compliance issues or customer complaints
• Establishment of a long-term stable supply chain system

Common Mistakes and Ways to Avoid Them

Mistake #1: Starting to Export Without Designating a U.S. Agent

RisksThe products may be detained by the Customs or even returned in one shipment.

Proper Practice::Export to USAFormerly ensured to be completed FDA Register and appoint a qualified U.S. agent.

Mistake 2: Labeling does not meet FDA requirements

According toFDA Labeling GuidanceThe common labeling problems include:

• Incorrectly formatted nutrition label
• Major allergens not labeled
• Incorrect unit of net content (both metric and imperial should be labeled)
• Claims of violation

Solutions: ThroughGreen CircleWe provide professional auditing services to complete labeling compliance checks before printing.

Mistake 3: Ignoring the special requirements of product categories

not the samefoodstuffsThe categories have different degrees of supervision:

The Importance of Continuous Compliance Management

Regular updates and monitoring

FDA Registration is not a one-time exercise.Taiwan BrandsThere is a need to establish a continuous compliance mechanism:

Bi-annual registration renewal:

• Time: October 1 to December 31 of each even-numbered year
• What: Confirm or update facility information, product category, U.S. agent
• Fee: No fee required (but late renewal may result in registration lapse)

Daily monitoring program:

1. FDA Warning Letter Tracking: Check FDA Warning Letters regularly for common violations.
2. Regulatory Changes Updates: Concerns Federal Register Latest Statutory Notices
3. Supply Chain Audit: Ensure raw material suppliers are also FDA compliant
4. Staff Training: Regular training on food safety and CGMPs

Green Circle's Continuous Support Services

Green CircleProvides annual compliance consulting services including:

• Automatic registration update reminder
• Immediate notification of regulatory changes
• Quarterly Compliance Check
• 24/7 Chinese Customer Service Support
• Annual Training Program

Conclusion and Call to Action

Taiwan Brand Food Export to U.S. FDA Registration may seem complicated, but with the right process and professional assistance, compliance can be smooth. Key points include:Clarifying the Responsible Entity(usually the manufacturer),Get DUNS Number,Appointment of U.S. Agentas well asFulfillment of special requirements according to product typeThe

For those who want toExport to USA(used form a nominal expression)Taiwan BrandsThe most efficient option is to work with a professional platform.Green CircleAs Taiwan's leading cross-border e-commerce compliance service platform, we have assisted hundreds of Taiwanese companies to successfully enter the international market, offering services ranging from company registration,FDA One-stop solution for certification, product testing and customs clearance.

Take immediate action:

• Evaluate whether your product requires FDA Register
• ContactsGreen CircleFree compliance consultation by professional consultants
• Start preparing the required documents for registration
• Establishment of a long-term compliance management mechanism

Cross-border entrepreneurship starts from e-commerce; globalization of goods takes off from Taiwan.SelectionGreen CircleThe following is a list of the most popular ways to get the most out of yourTaiwan BrandsThe company has taken off in the U.S. market!

Frequently Asked Questions FAQ

Q1：Do I have to do FDA registration for exporting Taiwan brand food to the U.S.?

Yes, under the U.S. Bioterrorism Act and the Food Safety Modernization Act (FSMA), all products and services supplied to the U.S. are subject to a "no-go" requirement.foodstuffsAll foreign facilities are required to be FDA Registration. This is a mandatory requirement, and unregistered products will not be able to clear customs and enter the U.S. market.Taiwan Brandsif you wantExport to USAIt must be done. FDA Registration of food facilities.

Q2: Should exporters or manufacturers be responsible for FDA registration?

Often physically manufactured, processed or packagedfoodstuffsThe facilities are responsible for the registration of the If theTaiwan BrandsIn the case of OEM, the brand owner will register directly; in the case of OEM, the brand owner has the responsibility to ensure that the OEM completes the registration, even though the OEM is the subject of the registration. ByGreen CircleCan assist with attribution of responsibility and completing the registration process.

Q3: How long does it take to register with the FDA? How much does it cost?

The standard process takes about 2-4 weeks to complete, with the bulk of the time spent on obtaining the DUNS Number (30 days if you choose the free application option, 1-3 days if you pay for expedited processing).FDA There is no fee for the food facility registration itself, but fees that may be incurred include an expedited DUNS Number fee (approximately $220), a U.S. agent's service fee (approximately $200-$500 annually), and a professional consultant's fee.Green CircleProvide one-stop service with transparent pricing.

Q4：What else do I need to do after registration? How long is the validity period?

FDA Registrations are permanent, but need to be renewed every two years (October-December of every even-numbered year). In addition, companies are required to: maintain compliance with CGMP regulations, maintain product labeling compliance, cooperate with potential FDA plant inspections, and monitor for regulatory changes.Green CircleProvide annual compliance management services to assistTaiwan BrandsSustainability FDA Request.

Q5: Which Taiwanese food products require additional certification or testing?

In addition to the basic FDA Registration, additional procedures are required for certain products:Low-acid canned and acidified foodsProcess Filing is required;Seafood ProductsHACCP compliance is required;Infant FormulaPrior notification and recipe review is required;Dietary SupplementsNDI evaluation required;Organic ProductsUSDA Organic certification required.Green CircleWe can provide professional advice and representative services for different product categories.

Source:

• U.S. Food and Drug Administration (FDA) Official Website
• Electronic Compilation of U.S. Federal Regulations (eCFR)
• Dun & Bradstreet, Inc.
• Federal Register - U.S. Federal Register
• FDA Industry Systems

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