Quick Answer
Brazil exports meat, poultry, orange juice, nuts, cosmetics, and pharmaceuticals to the US. FDA facility registration, US Agent designation, Prior Notice for food, and product-specific regulations are mandatory. Some Brazilian meat and poultry establishments must meet USDA equivalency. Use our requirement checker to confirm your obligations.
What Are the FDA Requirements for Brazilian Exporters?
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ImmutableBrazilian manufacturers exporting FDA-regulated products must meet the same core requirements as other foreign establishments:
- FDA Facility Registration: All manufacturing and processing facilities must be registered.
- US Agent Designation: A US-based representative must receive FDA communications.
- Product Listing: Drugs, devices, and cosmetics must be listed; food requires Prior Notice.
- cGMP & Labeling: Drug and device facilities need cGMP; all products need English labels.
Meat and Poultry: USDA + FDA
Brazilian meat and poultry establishments must be approved by USDA's FSIS for export to the US. FDA regulates processed foods containing meat; both FDA registration and Prior Notice apply to such shipments.
Do Brazilian Companies Need a US Agent?
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Yes. Every foreign facility must designate a US Agent in the United States. Brazil and the US share similar time zones (Eastern time is typically 1–2 hours behind São Paulo), which helps with communication, but the legal requirement is unchanged.
Professional US Agent services provide prompt FDA communication forwarding and regulatory expertise. Appoint a US Agent through Assurentry for reliable representation.
Key Product Categories Exported from Brazil
Food Products
Beef, poultry, orange juice, nuts, coffee, and processed foods. Food facility registration, FSMA, and Prior Notice required. Meat/poultry need USDA approval.
Cosmetics
Brazilian cosmetics brands are growing in the US. MoCRA requires facility registration and product listing.
Pharmaceuticals
APIs and finished dosage forms. Drug establishment registration, drug listing, and cGMP compliance required.
Medical Devices
Diagnostic equipment and surgical instruments. Device registration, listing, and premarket clearance required.
FDA Facility Registration Steps
FDA Observation
"Procedures for verifying supplier controls were not adequately established."
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Assurentry auto-generates a 15-day response plan with acceptable corrective actions.
Registration is completed through FURLS. Food facilities register biennially (October–December, even years); drug and device establishments register annually with fees. Use the requirement checker to determine which registrations apply.
Prior Notice and FSVP for Food Shipments
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Every food shipment requires a Prior Notice filing before US port arrival. US importers must conduct FSVP verification of Brazilian suppliers; maintain hazard analyses, preventive controls, and audit records.
Common Compliance Pitfalls
Lapsed food facility registration
Food facilities must renew biennially. Miss the October–December window and face refusal at the border.
Missing Prior Notice
Every food shipment requires Prior Notice. Incorrect or late filings cause automatic detention.
Meat/poultry without USDA approval
Meat and poultry establishments must be on USDA's eligible countries list. FDA registration alone is insufficient for these products.
Non-compliant labeling
Labels must be in English and follow FDA format. Nutrition Facts, allergen declarations, and ingredient lists must comply.
Invalid US Agent
Update FDA registration within 60 days if your US Agent changes. Operating without a valid agent can lead to cancellation.
Registration Costs Overview
| Product Type | FDA Fee | Assurentry Service | Renewal |
|---|---|---|---|
| Food Facility | No FDA fee | From $199 | Biennial |
| Drug Establishment | ~$7,600+/yr | From $349/yr | Annual |
| Medical Device | ~$8,000+/yr | From $449/yr | Annual |
| Cosmetics (MoCRA) | No FDA fee | From $249/yr | Annual |
| US Agent Only | No FDA fee | From $399/yr | Annual |
View our pricing page for complete details.
How Assurentry Helps Brazilian Exporters
- FDA Facility Registration: Guided workflows for food, drug, device, and cosmetics
- US Agent Services: Professional US Agent with prompt FDA communication forwarding
- Prior Notice Filing: Automated Prior Notice for every food shipment
- Requirement Checker: Free tool to confirm your FDA obligations
- Renewal Management: Automated deadline tracking for biennial and annual renewals
Ready to Export to the US from Brazil?
Assurentry helps Brazilian manufacturers navigate FDA compliance, file Prior Notice, and maintain registration. Get started today.
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