2025

The Urgency of Regulating Cannabis Vaporizers in Brazil: Between Institutional Omission and the Right to Health

Paulo Thiessen, lawyer and global activist in the cannabis sector, Administrative Director of ACURA, Legal Director of the International Movement Cannabis Sem Fronteiras, President of Santo Amor, human rights and drug policy consultant for ENCOD, legal advisor for NORML France, member of the Cannabis Embassy and Cannabis Sans Frontières.

Email: paulothiessen@gmail.com.

Konstantin Gerber, Ph.D. in Law from PUC-SP, lawyer with expertise in the third sector and regulatory law. Member of SBEC – Brazilian Association for Cannabis Studies.

Email: juristasabolicionistas@gmail.com

The regulatory progress of cannabis in Brazil has been drawing global attention. In this tropical country of continental dimensions, where at least 7.7% of the population (1) has reported having used cannabis, a vast network of activists, users, patients, doctors, and lawyers is actively shaping public policy around the plant through a range of strategies—both direct and indirect.

To the attentive observer, the recent advancements in securing individual and collective rights for patients—including the legal recognition of cultivation and use of cannabis for health and well-being—combined with the recent decision of the Supreme Federal Court (STF) decriminalizing possession and private adult use in Brazil, all point toward an unavoidable question:

When will the country advance toward clear, effective, and accessible regulation of cannabis vaporizers? After all, these are well-established tools for the treatment of certain clinical conditions and for harm reduction—validated by evidence, scientific literature, and comparative law.

The proposed revision of RDC 327/2019 (2), currently under public consultation No. 1316/2025, reignites a crucial debate. While it expands the routes of administration for cannabis-based medicinal products—now including oral, buccal, sublingual, inhalation, and dermatological routes—it expressly excludes medical devices from its scope. This exclusion disregards the real needs of patients who depend on vaporizers to consume cannabis flowers and concentrates, thus exposing a troubling regulatory gap.

According to the draft regulation, the inhalation route is defined as the administration “through the nasal or oral respiratory system simultaneously for local or systemic effect (3),” allowing for pharmacokinetic identification of cannabinoids(4). Still, despite this explicit inclusion, there remain significant and urgent restrictions on the use of vaporizers that must be addressed.

First, we must dispel the notion that regulating vaporizers in Brazil is impossible due to the current restrictions on the import of cannabis flowers by individuals for medicinal purposes—as stated in ANVISA’s Technical Note No. 35/2023, which argues a lack of sufficient scientific evidence.

This argument loses credibility when confronted with reality: the therapeutic use of cannabis flowers has already been recognized by the Judiciary, both through favorable rulings to patient associations—such as ACAFLOR(5)—and via habeas corpus granted to individual patients. Added to this is the recent Supreme Court decision decriminalizing the possession of up to 40 grams and the cultivation of up to 6 female plants for personal use.

In this context, a logical conclusion emerges: there is an urgent need to ensure safe and regulated access to devices that enable inhalation for therapeutic purposes—vaporizers.

It is worth noting that Brazil has recently made progress by incorporating the quality standards for cannabis flowers described in pharmacopoeial monographs and their reintegration into the Brazilian Pharmacopoeia through RDC No. 940/2024(6). This is a positive step, no doubt. However, this milestone pertains to pharmaceutical ingredient standardization, not to the raw plant drug itself, especially regarding its use via inhalation. This regulatory gap continues to generate considerable bureaucratic hurdles—hurdles that must be tackled with urgency.

Although the current draft regulation still prohibits “(…) the commercialization of Cannabis products in the form of raw Cannabis sativa L. plant material or its parts, even after stabilization and drying, or in shredded, ground, or pulverized form, even if provided in any pharmaceutical form(7),” this delay on ANVISA’s part cannot override the lived reality of patients—whether members of associations or fighting legal battles individually— nor ignore the private sphere of citizens, as recognized by the STF recent ruling.

It is essential to distinguish between cannabis flower vaporization, when performed with pharmaceutical-grade products, and conventional smoking methods such as cigarettes. Vaporization, by definition, does not involve combustion, which significantly reduces respiratory harm and the release of toxic substances. Internationally, it is widely recognized as a therapeutic tool for managing chronic pain.

Yet, ANVISA still fails to recognize the medical justification for inhalation, even with high-quality vaporizers, citing supposed harm to the respiratory system and risks associated with thermal degradation byproducts(8)—despite internal technical responses indicating that these devices could be imported under RDC 81/2008(9). This contradiction exposes a lack of internal consistency in the agency’s approach.

Let us digress briefly to expose a regulatory contradiction: the same ANVISA that authorizes the commercialization of tobacco cigarettes—full of pesticides, carcinogenic chemical additives, and plastic filters that become toxic environmental waste (cigarette butts)—refuses to regulate even hemp-derived smoking products, a cannabis variety with minimal THC. This is blatant hypocrisy, with consequences that extend beyond public health and into the realm of social justice and institutional coherence. While this debate deserves further exploration, especially within harm reduction, the point remains: ANVISA cannot continue ignoring the safe use of cannabis vaporizers, which do not burn the material—unlike tobacco cigarettes.

To advance as a nation on this issue, we must confront a terminological problem: the overuse of the English term “vape” to describe all devices used for inhalation, which blurs the line between harmful electronic cigarettes and cannabis medical vaporizers designed for harm reduction.

Indeed, ANVISA’s own responses to its public ombudsman—dated September 25 and 30, 2024—illustrate its confusion. On the first date, the agency claimed vaporizers could not be imported due to the prohibition on electronic cigarettes under RDC 46/2009(10) by the time. On the second, it acknowledged that while the use of flowers is restricted, such devices could be imported under the medical regulation of RDC 81/2008(11). This inconsistency demonstrates the lack of conceptual clarity between electronic cigarettes and medicinal cannabis vaporizers.

If ANVISA itself cannot distinguish between different device types and their respective regulations—committing errors that reveal conceptual confusion—then the matter becomes even more urgent. At the end of the day, patients and citizens suffer the consequences, relying on these devices for treatment, and they cannot have their care confused with risk promotion, especially by the very authority meant to ensure health safety. It is ANVISA’s duty to expand access and protect patients and citizens, instead of creating regulatory barriers.

So, what is the global regulatory landscape for cannabis vaporizers?

In Canada(12), devices such as dab pens (for concentrates) are licensed, and healthcare professionals receive specific guidelines on cannabis use, including vaporization as a safer alternative to combustion. Vaporization is known to extract Delta-9 THC and CBD efficiently, without adverse effects, and is clinically recommended, especially for chronic pain(13).

Israel is a global leader in medicinal cannabis and was one of the first to regulate vaporizers. Since 2018, devices such as the VapePod(14) (for extracts) and Syqe Inhaler (for microdosed flowers) have been approved by the Ministry of Health as medical devices(15). Both allow precise, safe, and damage-reducing cannabis administration compared to smoking. Israeli policies include clinical guidelines that prioritize vaporization as a preferred medicinal route.

The European Union, through the European Medicines Agency, regulates medical devices, allowing vaporizers to be certified(16). In Germany, where medicinal cannabis has been legal since 2017, devices like the Volcano Medic 2 and the Mighty+ Medic, from the German company Storz & Bickel, are certified medical vaporizers used across Europe(17) and beyond(18), demonstrating regulatory harmonization.

Australia legalized medicinal cannabis in 2016 and maintains an official list of approved vaporization devices(19), ensuring safe and effective methods of administration for patients.

In the United States, although cannabis remains federally illegal, 39 states and the District of Columbia have legalized medicinal use, each with its own rules for prescription, dispensing, and cultivation. Cannabis vaporizer regulation also varies by state, resulting in a patchwork of approaches. As in Brazil, the term “vape” can refer to both cannabis vaporizers and electronic cigarettes, highlighting the need for regulatory clarity.

In Brazil, based on ANVISA’s second response mentioned earlier, vaporizers could theoretically be imported under RDC 81/2008(20) for medical devices. However, this procedure is far from proportional to patients’ real needs, nor does it fit for citizens who now have the legal right to grow and use cannabis for personal use. This inconsistency clearly reveals the need for a new, proportional regulatory framework to enable citizens to exercise their constitutional right to health via vaporization (Article 5, LXXI, of the Constitution)(21).

For legal entities seeking to import such devices, the procedures outlined in the Manual for Importing Medical Devices and the Licensing Manual via LPCO (License, Permission, Certificate, and Other Documents) must be followed. It is essential to include the manufacturer’s instructions for use.

Moreover, the manufacturing of cannabis vaporizers in Brazil could be enabled through regulatory harmonization with international certifications. RDC No. 687/22(22) allows the use of foreign Good Manufacturing Practice Certificates (CBPF) issued by recognized health authorities, which facilitates the local installation of production lines originally based abroad.

Already-certified vaporizers could adapt their production processes to Brazil, provided they comply with the criteria set out in IN No. 292/2024(23) and RDC No. 741/2022(24), which govern the recognition of good practices and international manufacturer inspections. This presents a concrete opportunity to stimulate national production of cannabis-focused health technology, with regulatory security and technical rigor.

In any case, the absence of clear regulation for cannabis vaporizers in Brazil is a direct obstacle to the realization of the rights to health, freedom, dignity, and self-determination. It hampers safe access to proven, less harmful devices, discourages productive investment in the country, prevents the establishment of international companies, and deprives the state of tax revenue and innovation in a sector that already exists and will not disappear.

The conceptual confusion between electronic cigarettes and medical vaporizers—often reinforced by ANVISA’s contradictory positions—only deepens this issue. It is urgent to technically distinguish these devices and establish specific rules to ensure safe, responsible access for Brazilians.

In the face of regulatory omission, it is both legitimate and necessary for patients, associations, and companies to pursue administrative and judicial remedies—such as writs of injunction or collective legal actions—to secure the right to cannabis vaporization treatment.

To regulate is, above all, a choice between institutional omission and commitment to public health. In a constitutional democracy, public administration must act in accordance with the principles of legality, reasonableness, and efficiency (Art. 37, CF), upholding the health and dignity of its citizens (Art. 5 and Art. 6, CF).

Brazil has already taken important steps toward therapeutic freedom. What remains is to do the same for the devices that make this freedom possible.

Footnotes

(1) : CORRÊA, Douglas. Fiocruz: 7.7% of Brazilians have used cannabis at least once. August 9, 2019. Available at: https://agenciabrasil.ebc.com.br/saude/noticia/2019-08/fiocruz-77-dos-brasileiros-usaram-maconha-pelo-menos-uma-vez (Accessed: April 16, 2025).

(2) : ANVISA – Brazilian Health Regulatory Agency. Collegiate Board Resolution (RDC) No. 327/2019 regulates the manufacture, importation, commercialization, and prescription of cannabis-based products for medicinal purposes in Brazil. It establishes quality, labeling, safety, and control standards for these products, allowing their use with a medical prescription, but does not authorize the cultivation of the plant within national territory. Available at: https://www.in.gov.br/en/web/dou/-/resolucao-rdc-n-327-de-9-de-dezembro-de-2019-232669358 (Accessed: April 16, 2025).

(3) : BRAZIL. Controlled Vocabulary of Pharmaceutical Forms, Routes of Administration and Medicine Packaging. 1st Edition. Brasília: ANVISA, 2011, p. 34. Available at: https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/medicamentos/publicacoes-sobre-medicamentos/vocabulario-controlado.pdf (Accessed: April 11, 2025).

(4) : BRAZIL. Regulatory Impact Analysis Report on Cannabis Products for Medicinal Purposes. Brasília: ANVISA – National Health Surveillance Agency, 2024, p. 51.

(5) : Court of Justice of Paraíba (TJ-PB). Criminal Habeas Corpus, Case No. 0816072-35.2023.8.15.0000. Judgment on February 29, 2024.

(6) : BRAZIL. Public Consultation No. 1,316 of March 27, 2025. Available at: https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&link=S&tipo=CPB&numeroAto=00001316&seqAto=222&valorAno=2025&orgao=ANVISA/MS&cod_modulo=630&cod_menu=9373 (Accessed: April 11, 2025).

(7) : BRAZIL. Op. cit., 2024, p. 128.

(8) : ANVISA – Brazilian Health Regulatory Agency. RDC No. 81/2008: Resolution establishing technical regulations for goods and products subject to health surveillance during importation. It defines the procedures and requirements for the entry of medicines, health products, food, cosmetics, and others into national territory.

(9) : ANVISA. RDC No. 46/2009: Resolution prohibiting the commercialization, importation, and advertising of electronic smoking devices (e-cigarettes), aiming to protect public health in light of the lack of scientific evidence on their safety and efficacy. This resolution was later repealed and updated by RDC No. 855/2024.

(10) : ANVISA – Brazilian Health Regulatory Agency. RDC No. 940/2024. Resolution that reintegrates Cannabis sativa L. into the Brazilian Pharmacopoeia, establishing official quality standards for the plant’s dried flowers, without modifying cultivation rules in the country.

(11) : Ibid. 7.

(12) : CANADA. Cannabis accessories for inhalation: minimizing your risk when smoking, vaping and dabbing. Available at: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/personal-use/accessories-inhalation.html (Accessed: April 11, 2025).

(13) : CANADA. Information for health care professionals: cannabis (marihuana, marijuana) and the cannabinoids. Available at: https://www.canada.ca/en/health-canada/services/drugs-medication/cannabis/information-medical-practitioners/information-health-care-professionals-cannabis-cannabinoids.html#a2.2.1.2 (Accessed: April 11, 2025).

(14) : LEICHMAN, Abigail Klein. Israel first country to approve medical cannabis vaporizer. Israel21c, March 13, 2018. Available at: https://www.israel21c.org/israel-first-country-to-approve-medical-cannabis-vaporizer/ (Accessed: April 14, 2025).

(15) : KRESH, Daniela. Israel aposta em maconha com fim medicinal. Folha de São Paulo, February 17, 2018. Available at: https://www1.folha.uol.com.br/mundo/2018/02/israel-aposta-em-maconha-com-fim-medicinal.shtml (Accessed: April 14, 2025).

(16) : EUROPEAN UNION. Medical Devices. European Medicines Agency. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/medical-devices (Accessed: April 11, 2025).

(17) : VENTURA, Gregorio. Cannabis vaporizers receive EU certification. Cannabis & Saúde, July 25, 2023. Available at: https://www.cannabisesaude.com.br/vaporizadores-storz-bickel-certificados/ (Accessed: April 14, 2025).

(18) : SCHULER, Frank. Storz and Bickel announces certification of medical vaporizers. International Cannabis Business Conference, July 23, 2023. Available at: https://internationalcbc.com/storz-and-bickel-announces-certification-of-medical-vaporizers/ (Accessed: April 14, 2025).

(19) : AUSTRALIA. Medicinal cannabis vaping devices that are approved in Australia. Available at: https://www.tga.gov.au/products/unapproved-therapeutic-goods/medicinal-cannabis-hub/medicinal-cannabis-vaping-devices-are-approved-australia (Accessed: April 11, 2025).

(20) : Ibid. 7.

(21) : In cases where the lack of regulation prevents the exercise of a fundamental right, the constitutional remedy of writ of injunction (mandado de injunção) is guaranteed.

(22) : ANVISA. RDC No. 687/2022: Resolution establishing the criteria for granting and renewing the Certificate of Good Manufacturing Practices (CBPF) for Class III and IV medical devices. Applies to both national and international manufacturers, including units that produce final devices, conduct final product release, or manufacture software as medical devices (SaMD).

(23) : ANVISA. IN No. 292/2024: Normative Instruction outlining criteria and procedures for recognizing foreign regulatory authorities regarding good manufacturing practices for medical devices. Establishes a list of countries and organizations whose certifications may be accepted as equivalent in Brazil, facilitating registration, importation, or local production.

(24) : ANVISA. RDC No. 741/2022: Resolution regulating procedures for certifying good manufacturing practices for medical devices. Allows the use of audit reports conducted by foreign health authorities or recognized organizations, provided they comply with applicable regulations and are included in Brazil’s regulatory convergence agreements.

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