Why FDA Registration is Important
The U.S. is a compliance-centric market for food and dietary supplements. Products are regulated under the Federal Register and Title 21 of the Code of Federal Regulations (CFR), enforced by the U.S. Food and Drug Administration (US FDA).
While pre-market approval is not mandatory for most food and dietary supplements, the US FDA enforces strict post-market surveillance through:
- Adverse event monitoring
- Scientific research
- Pre-market notifications for novel ingredients (GRAS & NDIN)
FDA Food Facility Registration (FFR)
Any facility involved in the manufacturing, processing, packing, or storage of food, beverages, or dietary supplements intended for U.S. consumption must register with the FDA’s Food Facility Registration (FFR) system.
Key requirements include:
- A valid FDA registration for the facility
- Appointment of a U.S. Agent with a local U.S. address for FDA communication
Why FDA Food Registration is Crucial for U.S. Market Access
- Avoid import refusals and detentions at U.S. ports.
- Ensure smoother inspections and recalls if necessary.
- Gain consumer trust with compliant labels and practices.
- Align with retailers’ and e-commerce platforms’ compliance requirements.
Required Documents for FDA Food Registration
Facility name and address
DUNS number
Contact information
and emergency contacts
Product categories
Owner/operator details
Appointed U.S. Agent
(for foreign facilities)
How Freyr can help In US FDA Food Compliance
We offer end-to-end Regulatory support, including but not limited to:
- FDA Food Labeling Requirements
- FDA Food Facility Registration (FFR) & Renewals
- GRAS notification for novel food ingredients US
- New Dietary Ingredient Notification (NDIN)
- Submission Identification Number (SID) for LACF & Acidified Foods
- Food Packaging & Label Review
- FDA Product Classification (Food & Dietary Supplements)
- Ingredients/Formula Assessment
- Nutrition & Supplement Facts Panel Review
- Prop 65 (California) Consulting
- Claims Review & Substantiation
- Prior Notice Submissions
- U.S. Agent Representation
- Regulatory Marketing Strategy & Intelligence Report
Why Choose Freyr?
- Extensive U.S. Market Experience
- In-house Toxicology and Clinical Experts
- Strong Global Partner Network
- Trusted Relationships with Health Authorities (e.g., USFDA)
- Proven Success with NDIN and GRAS submissions
- Flexible, cost-effective, and responsive solutions
- Expertise across categories like: Health & Dietary Supplements, Functional Foods & Beverages, Nutraceuticals, Foods for Special Dietary Use (FSDU)
FAQs – US FDA Food Facility Registration
1. What is FDA food facility registration?
It’s the mandatory registration of facilities that manufacture, process, pack, or store food for U.S. consumption.
2. Is product registration required with the FDA?
No, not for most foods. However, dietary supplements and additives may require additional notifications (e.g., GRAS or NDIN).
3. Who must register their facility?
All domestic and foreign facilities involved in food production, packaging, or storage for U.S. markets.
4. What info is needed for registration?
Facility name, address, DUNS number, emergency contact, food types, and a U.S. Agent (for foreign sites).
5. How often must registration be renewed?
Biennially—between October 1 and December 31 of every even-numbered year.
6. What’s the difference between facility and product registration?
Facility registration is mandatory; product registration is typically not required unless the product is a food additive or supplement.
7. What if a facility fails to register or renew?
Penalties include import refusal, suspension, detainment, or FDA enforcement actions.
8. Does each facility need separate registration?
Yes. Each physical location must be registered individually with a unique 11-digit FDA Food registration number.
9. Is there a fee for FDA Food Facility registration?
No. FDA facility registration and updates are free of charge.
10. Are FDA approvals needed before selling food in the U.S.?
Generally, no. Pre-approval applies to additives and certain supplements, not conventional foods.