In a sudden and unexplained move, Brazil’s health agency this week suspended the process to regulate the cultivation of industrial hemp, ignoring a deadline set by the country’s highest court.
The National Health Surveillance Agency (Anvisa) on Wednesday removed from its agenda a long-anticipated proposal to regulate the planting and processing of hemp varieties with less than 0.3% THC for medicinal and pharmaceutical purposes only. This comes despite a May 19 deadline imposed by the Superior Court of Justice (STJ), which last year ordered the federal government to implement rules allowing hemp cultivation.
The decision has left stakeholders stunned and created fresh uncertainty around Brazil stakeholders’ attempt to establish a hemp sector just days before the legal clock runs out.
Sudden suspension
The hemp regulation item was pulled during Anvisa’s May 14 public meeting, during which Director Daniel Pereira cited a vague “need for alignment” as the reason for the withdrawal. The item had been scheduled for formal discussion, but the session instead proceeded with routine votes on unrelated technical matters.
So far, neither Anvisa nor the Ministry of Agriculture (MAPA) has issued a public explanation. The silence is fueling speculation about whether the government intends to comply with the court’s order or seek a new extension. Sources told El Planteo that MAPA may soon release a strict resolution permitting hemp only under controlled indoor conditions, or else request more time to develop a regulatory framework.
The suspension directly contradicts a unanimous ruling by the STJ in November 2024, which granted six months—ending May 19—for Anvisa and federal authorities to implement a regulatory pathway for industrial hemp.
‘Industrial’ potential ignored
The STJ’s ruling authorizes hemp cultivation specifically for “medicinal and pharmaceutical purposes,” a distinction that carries regulatory weight. “Pharmaceutical” refers narrowly to clinically tested, government-approved drugs—such as prescription CBD treatments manufactured under pharmaceutical standards. “Medicinal,” by contrast, can encompass a broader range of therapeutic uses, including over-the-counter or plant-based products not classified as formal medications. While both terms relate to health, the dual framing may allow for some flexibility in product types.
The STJ’s decision, however, does not address broader agricultural or industrial uses of hemp, and the narrow health-focused interpretation has frustrated advocates who argue that Brazil is missing a vital opportunity to foster a domestic supply chain for hemp-based materials such as textiles, building components, and bioplastics.
Regulatory odyssey
The current situation stems from a legal case brought by a biotechnology firm seeking to import and cultivate low-THC cannabis for health and industrial uses. Although a federal court initially rejected the request, the STJ overturned that ruling, declaring that hemp does not fall under Brazil’s Narcotics Act due to its non-psychoactive profile.
Justice Regina Helena Costa, who led the opinion, emphasized the urgency of regulation to ensure access to hemp-derived health products, citing the constitutional right to health. The court’s decision obligated Anvisa to act within six months and explicitly denied a government request to extend the deadline to 12 months.
Market potential stymied
Despite regulatory inertia, interest in Brazil’s potential hemp economy remains high. The Ficus Institute, a domestic policy group, recently submitted a technical note urging Anvisa to authorize hemp for fiber and grain production. The document warned that limiting hemp to pharmaceutical use would hurt Brazil’s global competitiveness.
Brazil’s sheer size and growing medical cannabis market—projected to reach $185 million in 2024—make it a prime target for international CBD producers. GW Pharmaceuticals, a part of drugmaker Jazz Pharmaceuticals, which markets Epidiolex, high-concentration CBD for epilepsy, has operated in Brazil since 2019 under existing regulations. A broader framework could trigger investment in local farming, extraction, and manufacturing.
But the future is unclear. Without a formal response from Anvisa or MAPA, and with just days remaining before the STJ’s deadline, Brazil’s hemp debate stands at a legal and political crossroads. Observers now wait to see whether regulators will comply, stall further, or move to restrict hemp’s scope even more narrowly than originally feared.
The decision has left stakeholders stunned and created fresh uncertainty around Brazil’s emerging hemp sector. Read More
