Brazil market entry for U.S. brands

A legal path into Brazil for U.S. hemp brands

Southbound helps U.S. hemp and wellness brands sell to Brazilian patients under Anvisa's import rule, from first diagnostic to first sale. Led by a Brazilian regulatory lawyer.

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Why now

The U.S. hemp window is narrowing. Brazil's market is opening.

United States

Dec 11, 2026

The new federal hemp definition (Section 781) is scheduled to take effect. It counts total THC including THCA and caps it at 0.4 mg per container. Many full-spectrum products fall outside it.

Brazil

A legal patient route

Under RDC 660, the rule of Anvisa (Brazil's FDA), a patient with a Brazilian prescription imports directly from abroad. The brand does not register the product in Brazil.

The Brazilian market

Large, growing, and already buying U.S. products

873kpatients in treatment in 2025, up 30% in a year
R$ 971Mmarket in 2025, about US$ 190M at R$ 5.1 per dollar
92%of 2025 import requests involved U.S.-made products

Sources: Kaya Mind annual report 2025; Anvisa data obtained through public-information requests, compiled by Cannabis & Saúde. The 92% counts import requests, not sales.

A first read on which of your products fit Brazil.

Request a 30-minute call or write to contact@southboundbr.com

How the route works

The patient imports. Your product ships directly from the U.S.

  1. A Brazilian doctor prescribes

    Your product, by name, in a prescription from a Brazilian physician.

  2. The patient gets Anvisa's authorization

    Individual and personal. Products listed in Anvisa's technical note are approved automatically.

  3. You ship to the patient's home

    From your U.S. warehouse, through an international courier.

Ground rules. Only individuals import. No company in Brazil may import, store or resell the product. Flower and smokables are not permitted. Advertising is tightly restricted. Southbound builds the plan inside these limits.

What Southbound does

One clear path, in three stages

Diagnostic

3 to 4 weeks, fixed scope

Which of your products can enter Brazil, through which channel, and what it takes. You receive a written report in English and a call to go through it.

  • Product-by-product screening against Anvisa's rules
  • Portfolio fit: where your formulas fill a gap in the Brazilian catalog
  • Map of Brazilian access platforms and marketplaces, and which fit your brand
  • Compliance frame for advertising, patient data (LGPD) and doctor engagement
  • A costed implementation plan

Implementation

4 to 6 months

A project led by Southbound until the first sale. You sign every contract; Southbound leads the work.

  • Structure and contracts with Brazilian partners
  • Introductions to access platforms and marketplaces
  • Education material for prescribers and for patients, within Anvisa's advertising limits
  • Coordination of logistics, payments and onboarding up to the first order

Ongoing

Monthly retainer

Rules change and campaigns need review. Southbound stays on as your regulatory arm in Brazil.

  • Regulatory monitoring
  • Review of campaigns and content before they go out
  • Patient-data compliance and responses to public bodies

Ready to see what it takes to enter Brazil?

Request a 30-minute call or write to contact@southboundbr.com

Who is behind it

A Brazilian regulatory lawyer who has run this route

Southbound is led by Tami Lima, a lawyer who has hands-on experience in every step Southbound now guides: regulatory approvals, contracts, advertising compliance and corporate structure.

Southbound exists so that a U.S. brand does not have to learn all of this by trial and error.

Meet Tami on LinkedIn →

What you get

  • One senior person, not a rotating team
  • Reports and calls in English
  • Fixed scope and price for the diagnostic
  • Any referral fee from a partner is disclosed in your contract

Questions brands ask

Before you write to us

Does my product need to be registered with Anvisa?

Not under the patient import route. Products on Anvisa's list of approved products are authorized automatically. Products that are not on it go through an online review, typically with no forms or extra interaction with the agency. Once a product is authorized, it joins the list, and later requests for it are approved automatically. Registering a product as a medicine in Brazil is a separate, slower path.

Do I need a company in Brazil?

Not to sell through patient import. Which parts of the operation need a local presence depends on how much of the patient relationship you want to control. The diagnostic answers this for your brand.

Which product formats can enter?

Brands bring oils and tinctures, capsules, edibles, topicals and cosmetics through the patient route. Products legally produced in the U.S. are accepted by Anvisa. Flower, other parts of the plant and smokables are not permitted. The diagnostic answers this for your portfolio.

Can I advertise in Brazil?

Only within limits. Brazilian rules treat cannabis products as medicines. Educational content, doctor engagement and social media each have their own constraints, and platforms such as Meta apply rules of their own. Our marketing playbook maps what your brand can do in each channel.

What if Anvisa changes the rule?

Regulation of this market keeps evolving. The monthly retainer includes regulatory monitoring, so you hear about changes early. If a change affects your operation, we can help you adapt your plan to the new rules.

Do you guarantee sales?

No. Southbound is responsible for the analysis, the structure, the contracts and the material it delivers. Sales depend on doctors, patients and platforms.

Next step

A 30-minute call to check which of your products fit Brazil

No cost, no commitment. You leave with a first read on your portfolio. Write to:

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