Register your product with the FDA and export to the US.
Food, supplements, cosmetics and medical devices. We assign your U.S. Agent, register your facility and get your FFR Number: done in 10 business days.
What kind of product are you registering?
Each category has its own form, CFR code and official costs. We put you on the right path from minute one.
From label to FFR Number in 10 business days.
We never leave you alone with a PDF. A bilingual specialist walks you through every milestone: what is missing, what to sign and what to expect from the FDA.
-
01
Day 1
Product assessment
A 30-minute call. We review your label, spec sheet, ingredients and the correct FDA category.
-
02
Day 2-3
Document collection
We send you the checklist and you upload the information to your Sell-U portal. We validate every document.
-
03
Day 4-5
U.S. Agent assignment
We activate your registered US agent, authorized to receive FDA communications.
-
04
Day 6-9
Official filing
We submit your Facility Registration and Product Listing through the FDA’s FURLS portal.
-
05
Day 10
FFR Number delivery
You receive your FDA registration number, official certificate and a labeling guide for your first shipment.
Clear pricing. No hidden fees.
One-time payment for the filing. Official User Fees are billed separately when they apply.
Essential
For a single facility with one product.
- Facility registration (FFR)
- U.S. Agent · 1 year
- Basic Prior Notice (3 shipments)
- Email support
- Detailed Product Listing
- Bilingual labeling
- FSVP / MoCRA
Compliance
The package Latin American exporters choose most.
- Everything in Essential
- Product Listing (up to 5 SKUs)
- U.S. Agent · 2 years
- FDA label review
- Unlimited Prior Notice · 1 year
- 1:1 specialist
- On-site FSMA audit
Multi-SKU
For brands with a large catalog or several plants.
- Everything in Compliance
- Up to 25 SKUs listed
- Up to 3 facilities
- MoCRA / FSVP review
- 12 months of support
- Biennial renewal included
Need more than 25 SKUs or OTC drugs? Talk to sales →
Estimate your total investment.
Choose your category, number of SKUs and U.S. Agent term. We show you the full breakdown.
This category pays no official FDA User Fee in 2026.
Firm quote. Nothing is charged until you sign the contract.
Everything the FDA requires, in one place.
No need to decode the FDA website or hire three different providers.
Facility Registration
We register your facility in FURLS. You receive the official FFR Number.
Product Listing
Every SKU listed with the correct category, subcategory and code.
U.S. Agent
A registered US agent authorized by the FDA to receive notices on your behalf.
Prior Notice
Advance notice to CBP/FDA for every shipment into the US.
Label review
Audit against 21 CFR 101: Nutrition Facts, allergens, claims and language.
DUNS Number
We help you get your free DUNS number from Dun & Bradstreet.
Biennial renewal
Reminders and automatic renewal every even year (Oct–Dec).
Support in Spanish
A bilingual specialist on Latin American hours. Replies in under 24 hours.
Built for Latin American founders.
| Features | Sell-U | Do it yourself | Another US agency |
|---|---|---|---|
| FDA-authorized U.S. Agent | Pending | Pending | |
| Support in Spanish · Latin America | — | — | |
| Firm quote before you pay | — | ||
| Guaranteed timeline (10 business days) | — | — | |
| 21 CFR 101 label review | — | ||
| Automatic biennial renewal | — | — | |
| One platform, no juggling providers | — | — | |
| Bicultural team (LATAM + US) | — | — |
"We had spent 8 months trying to export our snacks to Whole Foods Texas. Sell-U registered our plant in 9 days, listed 14 SKUs and set us up with a U.S. Agent. Today we invoice in USD."
Documents to get started.
You don’t need everything to be perfect. We send you an editable checklist and help you fill in whatever is missing.
01Company details
- Legal name and physical address
- Local Tax ID (RFC, NIT, CUIT, etc.)
- Legal representative details
02Product information
- Spec sheet for each SKU
- Full ingredient list
- Current label (front and back photo)
- Tentative FDA category
03Operations and shipments
- Plants/facilities where it is made
- Countries you already export to (if any)
- Estimated first-year volume
What matters, straight up.
Don’t see your question? A specialist will answer in under 24 hours.
Do I need a US LLC to register with the FDA?
No. The FDA accepts foreign companies as long as they designate a U.S. Agent. Sell-U assigns that agent as part of the service. If you also want your LLC, we can run both processes in parallel.
How long does my FDA registration last?
Food Facility registration is renewed every 2 years (Oct–Dec of even years). Cosmetics (MoCRA) require an annual update. Devices and drugs pay an annual User Fee.
What are an FFR Number and a U.S. Agent?
The FFR Number is your official FDA identifier. The U.S. Agent is a person or company with a US address, authorized to receive FDA communications on your behalf. It is mandatory for foreign companies.
Can the FDA inspect my plant in Latin America?
Yes. Inspections are possible under FSMA for high-risk foods. We prepare you with documentation, translation and mock inspections before any visit.
Does Sell-U guarantee FDA approval?
We guarantee a correct and complete filing. In these categories the FDA does not "approve", it registers. What we guarantee is 100% registration acceptance and zero rejections caused by our mistakes.
What if my product is rejected at customs?
If the rejection is due to an error in our filing, we fix it at no cost and cover reshipment up to $5,000 USD.
Does it cover Health Canada or COFEPRIS?
No, it is exclusively for the FDA (US). We have partners in Canada and Mexico and can refer you at no cost.
Can I cancel the U.S. Agent if I switch providers?
Yes, with 30 days’ notice so we can coordinate a proper handover and keep your registration from going inactive.
Tell us about your product and we’ll send you a firm quote.
A specialist replies in under 24 hours. No commitment.
- Firm quote before you pay
- Free label assessment
- Dedicated bilingual specialist
Your product, registered with the FDA in 10 business days.
Secure payment · USD · firm quote before any charge.