Comprehensive Regulatory Support for Food and Supplement Companies
Whether you're entering the U.S. market or scaling your product line, NX Food Consulting provides the compliance expertise to help you stay FDA-ready.
NX Food Consulting offers a complete suite of services tailored to the needs of food and supplement brands looking to meet U.S. regulatory requirements. Our solutions include:
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FSVP Importer
U.S.-based FSVP Importer services to ensure FDA-compliant food and supplement imports
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FDA Registration / U.S. Agent
Facility registration and U.S. Agent services to keep your company FDA-connected and compliant
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FSVP Evaluation
Expert review of your FSVP program to ensure FDA compliance and inspection readiness
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Export Certificates
Export documentation support to help your products move smoothly across borders
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Nutrition Labels & Ingredient Analysis
FDA-compliant labels and ingredient reviews for packaging and regulatory accuracy
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Prior Notice
Timely filing of FDA Prior Notice to keep your shipments moving without delays
FSVP Importer
Under the FDA’s Foreign Supplier Verification Program (FSVP), all foreign food and supplement suppliers must designate a U.S.-based FSVP Importer. NX Food Consulting serves in this role to ensure your shipments meet FDA requirements for documentation, verification, and safety.
What’s Included:
- Designation as your FSVP Importer for U.S. shipments
- Review and management of supplier documentation
- Risk-based evaluation of products and facilities
- Ongoing compliance support and inspection readiness
Why It Matters:
- Required for most foreign food and supplement manufacturers
- Ensures FDA compliance before and after shipment
- Helps prevent import holds, rejections, or penalties
FDA Registration / U.S. Agent
All foreign food and supplement facilities must register with the FDA and appoint a U.S. Agent. We take care of the registration process and serve as your U.S.-based representative to handle FDA communications and ensure timely responses.
What’s Included:
- FDA facility registration and biennial renewal
- DUNS number support and FDA account setup
- Designation as your official U.S. Agent
- 24/7 availability for FDA inquiries
Why It Matters:
- Required for foreign facilities to legally ship into the U.S.
- Keeps your registration active and compliant
- Provides a reliable U.S. contact for FDA updates or inspections
FSVP Evaluation
We provide expert evaluation of your FSVP program to ensure it meets FDA expectations. From supplier risk analysis to verification activities, we help you stay compliant and ready for inspection.
What’s Included:
- Full FSVP plan review and gap analysis
- Risk assessment of imported products
- Verification activity guidance
- Document and record readiness
Why It Matters:
- FSVP compliance is subject to FDA inspection
- A strong program reduces risk of enforcement
- Confidence in your supply chain builds trust with buyers
Export Certificates
We assist in obtaining Export Certificates (Certificate to a Foreign Government, Certificate of Exportability, Certificate of Free Sale, and USDA Certificates) for your products, which are often required for export or regulatory approval in other countries.
What’s Included:
- Certificate application preparation
- U.S. agent coordination (if needed)
- Follow-up with FDA or local health departments
- Fast processing and electronic delivery
Why It Matters:
- Many countries require certificates for customs clearance
- Ensures your exports move smoothly
- Proves product is approved for sale in the U.S.
Nutrition Labels & Ingredient Analysis
We provide FDA-compliant nutrition labeling and ingredient analysis for food and dietary supplement products. Whether you’re launching a new item or updating an existing label, our team ensures every element meets federal standards.
What’s Included:
- Standard or dual-column nutrition facts panels
- Ingredient and allergen statements
- Review of ingredient compliance and formatting
- Label formatting for packaging and marketing use
- Guidance for FDA submission and audit readiness
Why It Matters:
- Accurate labeling is required for most retail and e-commerce sales
- Ingredient errors can trigger recalls or enforcement action
- Clear, compliant labels build trust with consumers and regulators
Prior Notice
The FDA requires advance notice for all food, beverage, and dietary supplement shipments entering the United States. We handle the prior notice process on your behalf to help you avoid delays and stay compliant with federal import requirements.
What’s Included:
- Filing of FDA Prior Notice for incoming shipments
- Coordination with importers, brokers, or suppliers
- Review of shipment details to ensure accuracy
- Timely submission to prevent border holds
Why It Matters:
- Required for all food and supplement imports into the U.S.
- Prevents costly customs delays or rejections
- Keeps your supply chain running smoothly and on schedule
