Brazil’s Superior Court of Justice (STJ) has upheld a six-month deadline for the country’s food and drug agency to regulate the import, cultivation, and sale of hemp for medicinal, pharmaceutical, and industrial use. The deadline period started Nov. 19, 2024, and ends May 19.
The decision reinforces an earlier decision to bring clarity to the status of hemp that could reshape Brazil’s approach to low-THC cannabis.
In its session Wednesday, the STJ unanimously rejected a request from ANVISA (Brazil’s food and drug authority) and the attorney general’s office to extend the timeline for rulemaking to 12 months, citing the need for more time to comply with regulatory requirements.
Justice Regina Helena Costa emphasized that an earlier ruling by the court was clear, and resulted from an extensive debate. The legal action reflects Brazil’s ongoing struggle to reconcile regulatory caution with growing interest in hemp’s economic potential.
Regulatory odyssey
The case traces back to a legal challenge from a biotechnology company seeking to import and cultivate industrial hemp for medicinal and industrial uses. The Federal Regional Court of the Fourth Region initially denied the request, arguing that authorizing hemp imports was a matter of public policy beyond the judiciary’s scope. However, the STJ overruled this, mandating that ANVISA establish a regulatory framework under the May deadline.
Failure to meet this timeline could prompt renewed legal challenges or requests for extensions. However, Justice Costa noted that any future extension would require proof of concrete efforts by ANVISA to comply with the court’s rulings.
The overruling by the STJ underscored that industrial hemp, with a THC concentration below 0.3%, does not fall under the restrictions of Brazil’s Narcotics Act, as it cannot produce psychotropic effects or cause dependency. Nevertheless, the government retains authority over all cannabis varieties, including industrial hemp, under Brazilian and international narcotics laws.
The STJ ruling strictly applies to hemp used for medicinal and pharmaceutical purposes, emphasizing the “right to health” as a legal basis. Costa noted that the decision is limited to health-related applications, and does not address broader agricultural uses of industrial hemp.
This narrow interpretation has sparked disappointment among stakeholders who had hoped for a more expansive ruling to include industrial applications. The restriction leaves unresolved questions about hemp’s potential as an agricultural commodity in Brazil, despite growing interest in hemp for textiles, construction materials, and bioplastics – which the ruling does not explicitly address.
Market potential
Brazil’s decision is closely watched by international cannabis companies, given the country’s potential to become a significant player in the global medical CBD market. With a population exceeding 200 million and increasing acceptance of cannabis-based treatments, Brazil is positioned to be a lucrative market for CBD producers. According to Statista, Brazil’s demand for medical CBD and medical marijuana is projected to reach $185 million in 2024, with CBD accounting for up to 80% due to its wider range of uses and fewer regulatory hurdles compared to THC.
The STJ ruling, originally made in November 2024, could intensify competition for international firms, including Ireland-based Jazz Pharmaceuticals, which markets Epidiolex, the first FDA-approved prescription CBD medicine for epilepsy. Jazz Pharmaceuticals entered the Brazilian market in 2019 under strict regulatory guidelines. As Brazil’s regulatory framework evolves, domestic producers and multinational companies could vie for market share, driving growth in local cultivation, extraction, and processing industries.
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