The National Health Surveillance Agency (Anvisa) sent Official Letter No. 63/2025 to the Federation of Therapeutic Cannabis Associations (FACT), requesting contributions for the elaboration of regulations on the cultivation of Cannabis sativa L. in Brazil. The request stems directly from the decision of the Superior Court of Justice (Special Appeal No. 2024250/PR, representative of IAC 16), which determined that Anvisa, together with the Union, should issue rules to authorize the cultivation of hemp - varieties with a THC content equal to or less than 0.3%. 

According to the document, the future regulation should address everything from the exclusion of hemp from List E, which currently prohibits handling the plant, to strict control requirements to prevent diversion. The text states that cultivation will be allowed only for legal entities and exclusively for medicinal, pharmaceutical, veterinary, or research purposes.

In one passage, Anvisa mentions that the STJ decision obliges the agency to allow:
“the granting of health authorization for planting, cultivation, industrialization, and commercialization of industrial hemp - variety of Cannabis sativa L. with a THC content below 0.3% - by legal entities, exclusively for medicinal and/or pharmaceutical purposes, linked to the protection of the right to health.” 

Anvisa also details measures to mitigate risks, such as genetic traceability, controlled cultivation areas, continuous perimeter surveillance, and periodic laboratory monitoring to ensure that the THC content remains within the permitted limit. In addition, only certified seeds and seedlings may be used. 

The letter requests that FACT submit its contributions by November 19, 2025, mentioning Process No. 25351.914415/2025-70.