Quick takeaway: Brazil has no legal market for recreational or adult-use THC gummies. ANVISA's 2026 regulatory package treats cannabis products as industrialized pharmaceutical products for medical use, built around CBD or CBD-dominant extracts, and food products are excluded from that framework. Products reach patients through three regulated routes: Sanitary Authorization under RDC 1.015/2026 (with a Brazilian pharmaceutical partner), individual patient import under RDC 660/2022 (with a prescription), and newly authorized domestic cultivation and research.

For Brazilian companies building in those channels, custom CBD-dominant tinctures are the most practical product, and documentation matters as much as the formula.

Over the past several months, a growing share of the inquiries reaching our Plantation, Florida facility have come from Brazil — brands, distributors, clinics, and patient-service companies asking about hemp-derived THC gummies, CBD tinctures, and custom formulations.

The demand is real. Brazil's medical cannabis market reached an estimated R$970.9 million in revenue in 2025, and the patient base now numbers in the hundreds of thousands. But Brazil is not a copy of the US hemp market, and the rules changed significantly in 2026.

This guide is what we walk through with every Brazilian company that contacts us: what's allowed, how products legally reach patients, what the labeling rules require, and where a US contract manufacturer fits.

Brazil Market Access at a Glance

RDC 1.015/2026 Sanitary Authorization — Serves pharmacies and prescribing physicians nationwide. Requires a Brazilian pharmaceutical company holding the authorization, an import quota, and ANVISA-compliant labeling. Best fit for established brands building a long-term Brazil presence.
RDC 660/2022 patient import — Serves individual patients with a prescription. Requires patient registration on gov.br and ANVISA import authorization; personal use only. Best fit for companies facilitating patient access.
RDC 1.013/2026 cultivation & RDC 1.014/2026 sandbox — Serves Brazilian manufacturers, researchers, and patient associations. Requires Special Authorization from ANVISA. Best fit for Brazilian companies building domestic supply.
Adult-use / recreational THC products — No legal route. Not available.

These routes reflect the framework as of September 2026. ANVISA continues to issue supplementary rules, so confirm current requirements with Brazilian regulatory counsel before committing to a product plan.

First, the Honest Answer on THC Gummies

This is the question we hear most, so we'll answer it directly.

Brazil has not legalized adult-use cannabis, and ANVISA has been explicit that recreational use remains prohibited under the new framework. Under RDC 1.015/2026, a "cannabis product" is an industrialized pharmaceutical product for medical use whose active ingredient is the CBD phytopharmaceutical or an extract from a CBD-dominant chemotype of the plant. Cosmetics and foodstuffs are excluded from that definition.

THC content is tightly limited. Products containing more than 0.2% THC are restricted to patients with serious conditions.

What that means for brand owners:

A THC gummy marketed as a treat, supplement, or wellness product has no legal pathway into Brazil
A US "Farm Bill–compliant" label doesn't carry over — Brazil applies its own definitions, not US hemp law
The opportunity is in the regulated medical channel, where products are prescribed, dispensed, and tracked

If a supplier tells you otherwise, treat that as a red flag about how they'll handle the rest of your compliance.

How Cannabis Products Legally Reach Brazilian Patients

Route 1: Sanitary Authorization Under RDC 1.015/2026

RDC 1.015/2026 took effect on May 4, 2026 and fully replaced RDC 327/2019, which had governed cannabis products since 2019. It covers manufacturing, importing, distribution, commercialization, prescription, dispensing, and post-market monitoring.

Key points for foreign brands:

You need a Brazilian partner. Foreign companies can participate, but through a Brazilian pharmaceutical entity that holds the authorization
Import quotas apply. ANVISA sets import quotas based on estimated use and distribution over the first three years of commercialization
Imports can include finished products and inputs. The framework covers plant extracts, the CBD phytopharmaceutical, and intermediate or bulk product
Manufacturing standards are pharmaceutical-grade. Your Brazilian partner will confirm what certifications and documentation ANVISA requires for your supply chain

This is the route for brands planning a durable, nationwide presence. It's slower and more expensive to enter, but it's the most stable.

Route 2: Individual Patient Import Under RDC 660/2022

RDC 660/2022 was not revoked by the 2026 overhaul and remains in force. Under this route:

Patients (or their legal representatives) register through the gov.br portal
They upload a valid prescription and receive an import authorization valid for up to two years
Roughly 47% of Brazilian medical cannabis patients still rely on this route

Two important limits for B2B buyers:

Resale is prohibited. Products imported under RDC 660 are for the patient's personal use only. This is not a wholesale or distribution channel
The route may change. ANVISA has signaled in official documents that it views the RDC 660 model as a regulatory distortion needing review, so build plans that don't depend on it indefinitely

Companies that facilitate patient access (telehealth platforms, patient-support services) are the natural fit here.

Route 3: Domestic Cultivation, Research, and Patient Associations

Since August 4, 2026, authorized companies can cultivate hemp with up to 0.3% THC for medicinal and research purposes under RDC 1.013/2026. Research institutions have a separate pathway under RDC 1.012/2026, and RDC 1.014/2026 created a regulatory sandbox for non-profit patient associations.

Operators already cultivating under court orders have until August 5, 2027 to reach full compliance.

Over time, this builds a domestic supply chain. In the near term, Brazilian companies entering this space still need formulation expertise, finished-product development, and reliable manufacturing partners while their own operations mature.

Labeling and Marketing Rules Are Stricter Than the US

Brand owners used to US hemp marketing need to reset expectations. Under the new rules:

Banned packaging terms: "CBD oil," "full spectrum," "broad spectrum," and "full extract" can no longer appear on packaging
Mandatory warnings: Labels must carry standardized statements that the product has not undergone full ANVISA efficacy and safety evaluation
No consumer advertising: Advertising to the general public is prohibited; only technical information directed at healthcare professionals is permitted

Practical impact: If your US packaging leads with "full spectrum," you'll need Brazil-specific labels, inserts, and sales materials built from scratch. Plan for this in your timeline and budget — it's rarely a simple translation job.

The US Side Is Changing Too

Brazilian buyers sourcing from the US also need to understand what's happening on this end.

Federal law is redefining hemp in two stages:

November 12, 2026: Cannabinoids the plant cannot naturally produce lose federal hemp status
December 11, 2026: A total-THC standard (including THCA) and a 0.4 mg total THC per container cap take effect for finished hemp-derived cannabinoid products

Industry estimates suggest the large majority of intoxicating hemp products currently sold in the US won't meet the new standard.

What this means for Brazil-bound products: CBD-dominant formulations with trace or non-detectable THC are the most durable option on both sides of the supply chain. Building your Brazil line around them avoids having to reformulate twice.

Why Custom Tinctures Are the Strongest Fit

Given how Brazil's framework is structured, custom tinctures tend to be the most practical starting product for Brazilian partners:

Familiar dosage format for prescribers and pharmacists
Precise, adjustable concentrations to match your partner's product specifications
Controlled cannabinoid ratios — CBD-dominant, with THC held at or below the level your route allows
Flexible carrier oils and bottle sizes for different patient programs
Straightforward documentation for potency and purity testing

What about gummies? Pectin gummies travel well — they resist melting during long international transit and are fully vegan-capable. But because Brazil's framework is built around pharmaceutical products and excludes foods, confirm with your regulatory partner that a gummy format is accepted for your specific route before investing in development.

Where Ajax Creations Fits

We're a direct contract manufacturer, which means the team formulating your product is the same team producing, testing, and packaging it.

What we bring to Brazilian partners:

Custom tincture formulation to your partner's specifications: cannabinoid profile, concentration, carrier oil, flavor, and volume
Pectin-based gummy manufacturing where the format fits your regulatory route (see our Pectin vs. Gelatin Gummies guide)
Two-phase testing: active ingredients verified before production, then every finished batch tested by an ISO-certified third-party lab
A full Certificate of Analysis with every order — the documentation your regulatory team will ask for first
Flexible minimums so pilot batches and registration samples don't require a large first commitment
FDA-registered facility following GMP protocols

What we're not: We're not your Brazilian regulatory representative. Your Brazilian partner and counsel determine what ANVISA requires for your supply chain, including any manufacturing certifications. We share our documentation early so you can confirm fit before you commit.

For more on vetting any manufacturer, see our guide on How to Choose a CBD Gummy Manufacturer.

What to Bring to Your First Conversation

The fastest projects start with clear answers to these questions:

1. Which Regulatory Route Are You Using?

RDC 1.015 partnership, RDC 660 patient-access support, or research and sandbox work. The route shapes everything else.

2. Who Is Your Brazilian Partner?

If you already work with a Brazilian pharmaceutical company or importer, loop them in early. If you don't, that's the first gap to close.

3. What's Your Target Cannabinoid Profile?

CBD concentration, any minor cannabinoids, and the THC ceiling your route allows.

4. What Format and Package Size?

Tincture volume and dropper type, or gummy count and potency if your partner has confirmed the format.

5. What Labeling Does Your Route Require?

Portuguese labeling, mandatory warnings, and banned terms all affect packaging design.

6. What Volumes Are You Planning?

Pilot batch size, registration sample needs, and a realistic first-year forecast (especially relevant if you're working within an import quota).

Frequently Asked Questions

Can I import hemp-derived THC gummies into Brazil?

Not for recreational or general wellness sale. Brazil has no adult-use cannabis market. Under RDC 1.015/2026, cannabis products are pharmaceutical products for medical use based on CBD or CBD-dominant extracts, and foods are excluded. Products with more than 0.2% THC are restricted to patients with serious conditions.

Is CBD legal in Brazil?

CBD is available in Brazil through regulated medical channels. Products are dispensed with a prescription through pharmacies under RDC 1.015/2026, or imported by individual patients with a prescription and ANVISA authorization under RDC 660/2022. Over-the-counter consumer sales are not permitted.

What replaced RDC 327/2019?

RDC 1.015/2026 replaced RDC 327/2019 on May 4, 2026. It governs the manufacturing, import, commercialization, prescription, and dispensing of cannabis products for human medical use in Brazil.

Can a US company sell cannabis products directly in Brazil?

Foreign companies generally participate through a Brazilian pharmaceutical partner that holds ANVISA authorization. Import quotas and Brazilian labeling requirements also apply. Work with Brazilian regulatory counsel to structure the relationship.

Can I resell products imported under RDC 660/2022?

No. RDC 660/2022 allows individual patients to import cannabis products for personal use with a prescription. Resale of products imported under this route is prohibited.

Can labels for Brazil say "full spectrum" or "broad spectrum"?

No. Terms including "CBD oil," "full spectrum," "broad spectrum," and "full extract" are prohibited on cannabis product packaging in Brazil. Labels must also include standardized warnings, and advertising to the general public is not allowed.

Does the 2026 US federal hemp change affect Brazil-bound products?

It can. Federal law applies a total-THC standard and a 0.4 mg total THC per container cap to finished hemp-derived cannabinoid products starting December 11, 2026. CBD-dominant formulations with trace or non-detectable THC are the most durable choice for products made in the US and sold into Brazil.

Why are custom tinctures a good fit for the Brazilian market?

Tinctures are a familiar format for prescribers and pharmacists, allow precise and adjustable concentrations, and make it straightforward to control cannabinoid ratios and THC levels to match a specific regulatory route.

Are gummies allowed under Brazil's cannabis rules?

Brazil's framework is built around pharmaceutical products and excludes foods, so gummy acceptability depends on your regulatory route and how the product is classified. Confirm with your Brazilian regulatory partner before developing a gummy for Brazil.

What documentation does Ajax Creations provide?

Every order includes a full Certificate of Analysis from an ISO-certified third-party lab, and active ingredients are tested before production begins. We share documentation early so Brazilian partners and their counsel can evaluate fit.

Final Thoughts

Brazil is one of the most promising cannabis markets in Latin America, but it's a medical, pharmaceutical, CBD-dominant market — not a place to ship US-style THC gummies.

The brands that will win there are the ones that:

Choose a clear regulatory route from the start
Partner with an experienced Brazilian pharmaceutical company
Build products around CBD-dominant formulations that hold up under both Brazilian and US rules
Work with manufacturers who lead with documentation, not promises

If you're building a compliant cannabinoid line for Brazil, we'd be glad to talk through formulation, testing, and pilot production.

About the Author

Romas Marcin — Founder, Ajax Creations

Romas founded GoGreen Hemp in 2016 and leads Ajax Creations, the Plantation, Florida contract manufacturer behind GoGreen Hemp, Royal Remedies, and private label cannabinoid products for brands across the US and internationally. He has spent nearly a decade working with cannabinoid formulation, third-party testing, and hemp regulation, and focuses on helping brand owners build products that hold up to regulatory scrutiny in every market they sell into.

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This article provides general information for brand owners and industry professionals and is not legal or regulatory advice. Brazilian and US cannabis and hemp regulations are changing rapidly; consult qualified regulatory counsel in each jurisdiction before manufacturing, importing, or selling cannabinoid products. Ajax Creations is a contract manufacturer; brand owners are responsible for the compliance of finished products marketed under their brands. These statements have not been evaluated by the Food and Drug Administration. Hemp-derived products are not intended to diagnose, treat, cure, or prevent any disease.

Supplying Brazil's Cannabis Market: A Brand Owner's Guide to Hemp Gummies and Custom Tinctures