In a sudden and unexplained transfer, Brazil’s well being company this week suspended the method to control the cultivation of commercial hemp, ignoring a deadline set by the nation’s highest courtroom.

The Nationwide Well being Surveillance Company (Anvisa) on Wednesday faraway from its agenda a long-anticipated proposal to control the planting and processing of hemp varieties with lower than 0.3% THC for medicinal and pharmaceutical functions solely. This comes regardless of a Might 19 deadline imposed by the Superior Court docket of Justice (STJ), which final yr ordered the federal authorities to implement the foundations.

The choice has left stakeholders surprised and created recent uncertainty round Brazil stakeholders’ try to ascertain a hemp sector simply days earlier than the authorized clock runs out.

Sudden suspension

The hemp regulation merchandise was pulled throughout Anvisa’s Might 14 public assembly, throughout which Director Daniel Pereira cited a imprecise “want for alignment” as the explanation for the withdrawal. The merchandise had been scheduled for formal dialogue, however the session as a substitute proceeded with routine votes on unrelated technical issues.

Thus far, neither Anvisa nor the Ministry of Agriculture (MAPA) has issued a public clarification. The silence is fueling hypothesis about whether or not the federal government intends to adjust to the courtroom’s order or search a brand new extension. Sources advised El Planteo that MAPA might quickly launch a strict decision allowing hemp solely below managed indoor situations, or else request extra time to develop a regulatory framework.

The suspension instantly contradicts a unanimous ruling by the STJ in November 2024, which granted six months—ending Might 19—for Anvisa and federal authorities to implement a regulatory pathway for industrial hemp.

‘Industrial’ potential ignored

The STJ’s ruling authorizes hemp cultivation particularly for “medicinal and pharmaceutical functions,” a distinction that carries regulatory weight. “Pharmaceutical” refers narrowly to clinically examined, government-approved medication—akin to prescription CBD remedies manufactured below pharmaceutical requirements. “Medicinal,” in contrast, can embody a broader vary of therapeutic makes use of, together with over-the-counter or plant-based merchandise not labeled as formal medicines. Whereas each phrases relate to well being, the twin framing might permit for some flexibility in product varieties.

The STJ’s resolution, nevertheless, doesn’t deal with broader agricultural or industrial makes use of of hemp, and the slender health-focused interpretation has pissed off advocates who argue that Brazil is lacking a significant alternative to foster a home provide chain for hemp-based supplies akin to textiles, constructing elements, and bioplastics.

Regulatory odyssey

The present state of affairs stems from a authorized case introduced by a biotechnology agency searching for to import and domesticate low-THC hashish for well being and industrial makes use of. Though a federal courtroom initially rejected the request, the STJ overturned that ruling, declaring that hemp doesn’t fall below Brazil’s Narcotics Act because of its non-psychoactive profile.

Justice Regina Helena Costa, who led the opinion, emphasised the urgency of regulation to make sure entry to hemp-derived well being merchandise, citing the constitutional proper to well being. The courtroom’s resolution obligated Anvisa to behave inside six months and explicitly denied a authorities request to increase the deadline to 12 months.

Market potential stymied

Regardless of regulatory inertia, curiosity in Brazil’s potential hemp economic system stays excessive. The Ficus Institute, a home coverage group, just lately submitted a technical be aware urging Anvisa to authorize hemp for fiber and grain manufacturing. The doc warned that limiting hemp to pharmaceutical use would damage Brazil’s world competitiveness.

Brazil’s sheer dimension and rising medical hashish market—projected to achieve $185 million in 2024—make it a main goal for worldwide CBD producers. GW Prescription drugs, part of drugmaker Jazz Prescription drugs, which markets Epidiolex, high-concentration CBD for epilepsy, has operated in Brazil since 2019 below present rules. A broader framework might set off funding in native farming, extraction, and manufacturing.

However the future is unclear. With no formal response from Anvisa or MAPA, and with simply days remaining earlier than the STJ’s deadline, Brazil’s hemp debate stands at a authorized and political crossroads. Observers now wait to see whether or not regulators will comply, stall additional, or transfer to limit hemp’s scope much more narrowly than initially feared.