Hemp Regulation in Brazil: STJ Reiterates Anvisa’s Obligation to Regulate the Topic by May 2025
A decision by the Superior Court of Justice (STJ) determined that the Brazilian Health Regulatory Agency (Anvisa) must issue regulations regarding the importation, planting, cultivation, industrialization, and commercialization of hemp for medicinal, pharmaceutical, and industrial purposes.
For those less familiar, hemp is a plant from the botanical class of Cannabis sativa cultivars. As recognized in the STJ decision, it is unsuitable for producing psychotropic substances if it contains less than 0.3% tetrahydrocannabinol (THC).Therefore, it cannot be considered proscribed under the Narcotics Law, making activities involving hemp lawful.
What happened?
On February 12, 2025, the STJ upheld its decision, within the context of a motion for clarification, requiring Anvisa to regulate and create the necessary rules for hemp-related activities by May 19, 2025.
Anvisa and the Attorney General’s Office (AGU) requested a deadline extension of 12 months, citing the need for more time to meet all the requirements of the regulatory process.
What was decided?
In November 2024, the STJ issued a historic decision clearly differentiating psychoactive cannabis from hemp, allowing the economic exploitation of hemp for exclusively medicinal and pharmaceutical purposes. The main points of the decision include:
- With a THC content of less than 0.3%, hemp cannot be considered proscribed by the Narcotics Law, as it is unsuitable for producing psychotropic substances.
- In the absence of legal provision for the industrial use of hemp, the Brazilian State must establish public policies for its management.
- Anvisa’s rules prohibiting the importation of seeds and the domestic handling of Cannabis (in general) must be interpreted in accordance with the Narcotics Law, not encompassing hemp.
- It is lawful to grant health authorization for the planting, cultivation, industrialization, and commercialization of hemp by legal entities for exclusively medicinal and pharmaceutical purposes, with regulations to be issued by Anvisa and the federal government within six months from the STJ decision.
- Anvisa and the Federal Government are responsible for adopting guidelines to prevent the diversion or misuse of seeds and plants, ensuring the suitability of the legal entities involved.
Why is this important?
The STJ decision is a significant milestone, as it stipulates that Anvisa regulates hemp-related activities, providing the sector with more legal certainty to operate in Brazil and allowing the development of economic activities related to hemp in the country.
Who needs to know?
This is relevant to all those who may have activities related to hemp, such as farmers, breeders, agronomists, seed companies, fertilizer companies, agricultural pesticide companies, and other inputs, researchers, scientists, doctors, and the industry as a whole, especially pharmaceutical industries.
What are the next steps?
With the deadline set for May 19, 2025, it is expected that the hemp regulation will be discussed in the upcoming public ordinary meetings (ROPs) of Anvisa’s Collegiate Board (DICOL) in the coming months. The regulated Cannabis sector should stay informed about these discussions and prepare for the forthcoming regulations.
Finally, it is important to clarify and distinguish that the activities related to hemp should not be confused with the June 2024 decision by the Supreme Federal Court (STF) regarding the presumption that individuals with up to 40 grams of marijuana or up to six plants are users, not drug dealers. In this case, “marijuana” is suitable for producing psychotropic substances and will not be addressed here.
Our Life Sciences & Healthcare team at Souto Correa is available for any questions about these topics and their possible developments through the email: lifesciences@soutocorrea.com.br.