FDAbasics Offers Complete FDA Compliance and Registration Services for the Food Industry
If your facility manufactures, processes, packs, or holds food for the US market, FDA compliance starts with facility registration but does not stop there. FDAbasics handles registration, US Agent appointment, biennial renewal, Prior Notice filing, FSVP compliance for importers, and labeling support for foreign and domestic food companies of all sizes. We have served clients in 100+ countries since 1995 and will have your registration number to you within 2 business days.
The FDA does not issue a Certificate of Registration. FDAbasics provides one at no extra charge with every completed registration, so you have documentation ready for buyers, importers, and customs brokers.
Ready to Register? We Make It Simple.
Complete the registration form below to receive your FDA registration number within two business days. We will also issue your Certificate of Registration, ensuring you are prepared for buyers, importers, and customs brokers.
FDA Food Compliance Requirements: Step-by-Step for Foreign and Domestic Food Facilities
Registration follows the same basic process for all food facilities. The steps below apply to everyone. FDAbasics can help you at each step along the way.
Step 1: Obtain a DUNS Number / Unique Facility Identifier (UFI) All facilities, foreign and domestic, must have a valid DUNS number or UFI before registering. If you do not have one, FDABasics can assist.
Step 2: Designate a US FDA Agent Foreign facilities only. If your facility is located outside the United States, you must designate a US FDA Agent before completing registration. Your US Agent serves as your official point of contact with the FDA, receives inspection notices and regulatory correspondence on your behalf, and must be physically located in the US and available during US business hours. Domestic facilities do not require a US Agent.
Step 3: Complete FDA Food Facility Registration Registration is submitted through FDA Industry Systems (FIS). FDABasics handles the entire submission on your behalf. Your registration number is confirmed within 2 business days. We will also issue your Certificate of Registration, ensuring you are prepared for buyers, importers, and customs brokers.
Step 4: Implement Your FSMA Preventive Controls Plan All registered food facilities must have a written food safety plan and documented hazard analysis under the FSMA Preventive Controls rule. Animal food facilities comply under 21 CFR Part 507 rather than the human food rule, but the requirement is the same: a written plan is required.
Step 5: Review Your Food and Dietary Supplement Labels for FDA Compliance All food and dietary supplement labels sold in the US market must comply with FDA labeling requirements, including Nutrition Facts panels, ingredient lists, allergen declarations, net quantity statements, and any health or nutrient content claims. Dietary supplement labels have additional requirements, including Supplement Facts panels and structure/function claim notifications. FDABasics offers label compliance review for food and dietary supplement products to confirm your labels meet FDA requirements before your products reach the US market.
Step 6: File Prior Notice Per Shipment Foreign facilities only. Every food shipment entering the United States requires a Prior Notice filing before arrival. Domestic facilities are not subject to this requirement.
Step 7: FCE and SID Registration (if applicable) Facilities that produce low-acid canned food or acidified food, including animal food, must also complete FCE and SID registration. This applies to both foreign and domestic facilities that meet the definition.
Step 8: Renew Every Two Years All food facility registrations must be renewed between October 1 and December 31 of every even-numbered year (2024, 2026, 2028, and so on). FDAbasics tracks your renewal deadline and contacts you before each window opens. You do not need to track it yourself.
If a registration lapses, you must re-register from scratch and will receive a new registration number. Shipments that arrive at US ports without a valid registration are subject to detention. FDABasics keeps this from happening.
A Note for US Food Importers
If you are a US company importing food from foreign suppliers, you have one additional obligation that is separate from facility registration. Under FSMA, you are the FSVP Importer and are required to maintain a written Foreign Supplier Verification Program plan for each foreign supplier you use. The plan must document hazard analysis, supplier approval, and ongoing verification, and records must be kept for a minimum of two years. You must also file Prior Notice for every incoming shipment and identify yourself as the FSVP Importer at Customs entry.
If you store, repack, or process food at a facility you control, that facility may also require its own FDA registration.
Who Must Register
Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA under Section 415 of the FD&C Act, as amended by FSMA. This includes both foreign and domestic facilities.
Facilities generally exempt from registration include farms, restaurants, retail food establishments, and nonprofit food establishments. If you are unsure whether your facility is required to register, contact us before your first shipment.
Common examples of food facility types that must register include:
- Dietary supplement and nutraceutical producers
- Beverage companies (juices, energy drinks, tea, coffee, bottled water)
- Snack food and confectionery producers
- Cereal and breakfast food companies
- Spice, flavoring, and condiment producers
- Frozen food and dairy producers
- Low-acid canned food (LACF) and acidified food (AF) facilities
- Organic food exporters
- Co-packers and contract food producers
- Cold storage warehouses holding food
- Private label food companies
- Pet food and animal feed producers
- Livestock and aquaculture feed producers
- Animal dietary supplement producers
Renewal Dates and Deadlines
| Registration Type | Renewal Frequency | Renewal Window | Deadline |
|---|---|---|---|
| Food Facility Registration (foreign, domestic, and animal food) | Every 2 years | Oct 1 to Dec 31, even years (2024, 2026, 2028...) | December 31 |
| FSVP Program Records | Ongoing | Maintain and update continuously | Ongoing |
| Prior Notice (per shipment) | Per shipment | Before each US shipment arrives | Before arrival |
Our Services and Fees
| Service | Fee | Need to Know |
|---|---|---|
| Registration and US Agent | ||
| US Agent Services (foreign food and animal food facilities) | $299/yr or $250/yr for 2 years | Mandatory for all foreign food and animal food facilities |
| FDA Food Facility Registration (foreign) | Included with US Agent | Completed within 2 business days |
| FDA Food Facility Registration (domestic) | $149/year | No US Agent required for domestic facilities |
| Biennial Registration Renewal | Included with US Agent (foreign) / $149/year (domestic) | We contact you proactively at renewal time |
| Labeling and Compliance | ||
| Food and Dietary Supplement Labeling Review | Starting at $299 | Nutrition Facts, allergens, claims, ingredient list |
| FSMA Preventive Controls Guidance | Contact us for pricing | Written food safety plan and hazard analysis support |
| FCE and SID Registration (LACF and acidified food) | FCE $199 / SID $399 | Foreign and domestic facilities producing low-acid canned or acidified food |
| Importers and Shipping | ||
| Prior Notice Filing | $15 (3 minimum) | Per shipment or bundled rate available |
| FSVP Program Setup and Management | Contact us for pricing | Includes written plan, supplier approvals, and verification |
| FSVP Importer Identification Assistance | Contact us for pricing | Port of entry identification requirements |
Why Food Companies Choose FDAbasics
FDAbasics has been helping foreign manufacturers navigate US FDA requirements since 1995, with over 30 years of regulatory experience serving clients across the food, drug, medical device, and cosmetics industries. We are headquartered in New York, USA and combine deep expertise with the most competitive fees in the industry.
30+ Years of Experience
Originally founded in 1995 as Tobias Systems, we have guided thousands of foreign companies through FDA registration, US Agent services, and full compliance across all four regulated industries.
5-Star Rated on Trustpilot and Google
Our clients consistently rate us 5 stars on both Trustpilot and Google for fast turnaround times, clear communication, and expert handling of their FDA compliance needs.
Strict Client Confidentiality
We believe in ethical business practices and maintain strict confidentiality for all clients. We do not share your information and we do not offer advice simply to sell services.
Lowest Fees, No Hidden Charges
Our fees are straightforward with no hidden charges. We guarantee a cost-effective solution for your business, whether you are a startup or an established manufacturer.
Fast Turnaround and Responsive Service
We know that FDA registration issues can hold up your shipments and delay your market entry. We work quickly and respond promptly so that your compliance is never a bottleneck for your business.
Global Clients, US-Based Team
We serve manufacturers from over 100+ countries and are physically located in the United States, which is a legal requirement for any company serving as your official US FDA Agent.
Frequently Asked Questions
Can I get a Certificate of Registration for my food facility?
The FDA does not issue a Certificate of Registration. FDAbasics provides a Certificate of Registration as part of every completed registration at no extra charge. It serves as documentation of your valid FDA registration for buyers, importers, and customs brokers.
Does my food company need to register with the FDA?
Yes, if your facility manufactures, processes, packs, or holds food for distribution in the United States. This applies to both foreign and domestic food facilities under Section 415 of the FD&C Act as amended by FSMA. Farms, restaurants, retail food establishments, and nonprofit food establishments are generally exempt. Dietary supplement producers, co-packers, private label companies, and cold storage warehouses holding food are typically required to register.
What is a US FDA Agent and why does my foreign food company need one?
A US FDA Agent is a person or company physically located in the United States who serves as the official point of contact between your foreign facility and the FDA. All foreign food facilities must designate a US Agent before completing their FDA registration. Without a valid US Agent, your registration cannot be completed or maintained. The US Agent receives FDA communications on your behalf including inspection notices, and must be available during regular US business hours.
When is the FDA food facility registration renewal deadline?
Food facility registrations must be renewed between October 1 and December 31 of every even-numbered year (2024, 2026, 2028, and so on). This applies to all food facilities, both foreign and domestic. If your registration is not renewed by December 31, it is cancelled and you must re-register from scratch. There is no government fee for food facility registration or renewal.
Do domestic US food companies need to register with the FDA?
Yes. Any US domestic facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA, regardless of whether the food crosses state lines. Domestic facilities do not need a US FDA Agent and can complete registration and renewal directly through their own FDA Industry Systems (FIS) account.
What is FSVP and does it apply to my food import business?
FSVP stands for the Foreign Supplier Verification Program. If you are a US company importing food from foreign suppliers, you are likely the FSVP Importer and are required to maintain a written FSVP plan for each foreign supplier. The plan must include hazard analysis, supplier approval, and ongoing verification activities. FSVP records must be kept for at least two years. You must also identify yourself as the FSVP Importer at each US port of entry.
Do pet food and animal feed companies need to register with the FDA?
Yes. Facilities that manufacture, process, pack, or hold food for animal consumption are subject to the same FDA registration requirements as human food facilities. This includes pet food producers, livestock feed companies, aquaculture feed producers, and animal dietary supplement facilities. Foreign animal food facilities must also appoint a US FDA Agent. Animal food facilities must also comply with FSMA Preventive Controls for Animal Food under 21 CFR Part 507.
What is the difference between foreign and domestic food facility registration?
The registration process is similar for both, but foreign facilities have two additional requirements. First, they must designate a US FDA Agent before completing registration. Second, they must file Prior Notice for every food shipment entering the United States. Domestic facilities do not need a US Agent and can renew directly through their own FDA Industry Systems account. The renewal deadline and biennial schedule are the same for both foreign and domestic facilities.
Get Started With Our Top Food Facility Forms
- US Agent Form (Foreign Food Facility)
- Foreign Food Facility Registration Form
- Domestic Food Facility Registration Form
- Prior Notice Form
- DUNS Number Assistance Form
- Foreign Supplier Verification (FSVP) Form