In the context of increasingly active exports, FDA food registration has become a mandatory step for Vietnamese businesses seeking to enter the U.S. market. However, to execute this process effectively, companies must understand the stringent regulations set forth by the U.S. Food and Drug Administration (FDA). The following article will help you understand the registration process and key considerations for 2025.
Why is FDA food registration a mandatory requirement?
The U.S. market upholds some of the world’s most rigorous food safety standards. According to the Food Safety Modernization Act (FSMA), all facilities that manufacture, process, pack, or hold food—including foreign entities—are required to register with the FDA in order to export to the U.S.
FDA registration is not only a legal requirement but also brings many critical benefits:
- Confirms the legal status of your product.
- Increases trust with importers and consumers.
- Minimizes risks of rejection or recall at ports of entry.
FDA Food Registration Process for Export in 2025
Step 1: Identify whether your product is regulated by the FDA
Businesses must clearly determine whether their product falls under FDA’s jurisdiction to select the appropriate classification code.
Step 2: Register your production facility with the FDA
Businesses must:
- Provide full details of the manufacturing location and processing methods.
- Appoint a U.S. Agent — mandatory for foreign entities.
Step 3: Obtain the FDA Registration Number
You will receive a registration number valid for 2 years and must renew it on time.
Step 4: Comply with labeling and testing regulations
Your products must:
- Have FDA-compliant labels.
- Undergo testing at certified laboratories.
Step 5: Periodic renewal
FDA food facility registrations must be renewed every even-numbered year (biennially).
Important Notes When Registering Food with the FDA
Choose a reputable U.S. Agent
The U.S. Agent plays a key role in liaising with the FDA during inspections or emergencies.
Prepare complete and accurate documentation
Information must be consistent and transparent to avoid rejection or delays.
Conduct regular product testing
Businesses should regularly test products to ensure safety compliance.
Be cautious of fraudulent service providers
Avoid working with unqualified or fake consultants to reduce legal risks.
What’s new in FDA food registration in 2025?
Digital registration platforms
FDA is enhancing its online systems to streamline and accelerate the registration process.
Additional supply chain requirements
Companies must now provide detailed information about raw material sources and the product supply chain.
Tighter control on high-risk products
Items such as seafood, fresh produce, spices, and dietary supplements will face stricter oversight.
Metti FDA – Specialized Companion for Vietnamese Businesses
If your business is facing challenges in the FDA food registration process, choosing a reputable consulting partner can save time, reduce costs, and minimize risks.
Metti FDA – a subsidiary of MettiTech Group Holdings – is a specialist partner providing consulting and support services for FDA registration across food, pharmaceuticals, and medical devices. With a team of experienced professionals, Metti FDA is committed to:
- Providing comprehensive and detailed procedural guidance.
- Acting as your legal and secure U.S. Agent.
- Ensuring fast FDA registration at optimized costs.
- Guaranteeing FDA-compliant documentation and adherence to all regulations.
Metti FDA has already partnered with hundreds of food processors, agricultural exporters, and F&B startups in Vietnam, helping them successfully enter the U.S. market.
Conclusion
FDA food registration is not just a legal necessity—it is the “passport” that enables Vietnamese enterprises to conquer the U.S. market. To ensure your documents meet standards, your process is smooth, and your risks are minimized, partnering with a professional consultant like Metti FDA is a strategic move.
If you’re seeking the optimal solution for FDA food registration, contact Metti FDA today for detailed consultation and full support from A to Z on your journey to global markets.
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