The company DNA Soluções em Biotecnologia filed a petition to the Superior Court of Justice (STJ) requesting urgent actions against the "repeated non-compliance" with the schedule for the regulation of industrial hemp in Brazil.

In the document, DNA requests the immediate release of its activities under supervision. Alternatively, it asks for the creation of a "regulatory sandbox" (a controlled testing environment created by regulatory agencies for companies to experiment with innovations without violating current regulations). exclusively for the company.

According to the company, the goal is to overcome the inertia of the Union and the National Health Surveillance Agency (ANVISA) in the process.

Delay in regulation prompts request

DNA's petition comes after the federal government and ANVISA missed a second deadline, established by themselves for September 30, 2025. The agencies requested a new extension for the delivery of the regulation of industrial hemp determined by the STJ in the Incident of Assumption of Competence (IAC-16). Minister Regina Helena Costa has not yet cast her vote.

The company argues that the delay is "unjustifiable." DNA proposes the regulatory sandbox as a "practical and effective measure" to advance the issue. According to the petition, "there is a clear adherence between the application of this model, the decision-making command object of this IAC, and the alleged difficulties presented by the UNION and ANVISA to try to justify their – unjustifiable – delay".

The proposal of the Regulatory Sandbox in practice

DNA's central proposal is that, if immediate release is not granted, the STJ should determine the creation of an experimental regulatory environment. This pilot project would be exclusively conducted by DNA, under strict control and supervision of ANVISA.

The suggested model would operate under Level I biosafety parameters, similar to those used by CTNBio and the Ministry of Agriculture (MAPA) for transgenic plants. The company would adopt risk mitigation plans, genetic traceability, and digital monitoring.

DNA proposes to conduct experimental crops with different THC ranges, aiming to "address the Agency's doubts about the appropriate concentration". The goal is to base the final regulation on "real evidence and under direct control".

The company emphasizes that the measure would not require legal innovation, as it is already provided for in Complementary Law 182/2021 (Startup Legal Framework) and the Economic Freedom Law.

According to lawyer Natan Duek, who is following the case, DNA's initiative presents an innovative legal solution to the impasse. "DNA's proposal shows that delay and omission can be faced. The idea is to turn this delay into an experimental project, a regulatory sandbox supervised by Anvisa itself and overseen by the STJ," he analyzes.

Duek explains that, while the definitive norm is being developed, the company would operate in a controlled environment. "This would allow the State to learn from the experience and for the regulation to be based on concrete data, not abstractions," he points out.

What is a Regulatory Sandbox?

The regulatory sandbox, or experimental regulatory environment, is a mechanism that allows companies to test innovations—such as new products or business models—in a real but controlled environment supervised by a regulatory body.

During the test, the company receives temporary authorizations and can operate with relaxed rules. The goal is to allow the regulator (in this case, ANVISA) to assess risks and benefits, gather practical data, and decide on a more modern definitive regulation.

The history of waiting for hemp regulation

The legal dispute over hemp cultivation in Brazil reached a decisive point in November 2024. At that time, the STJ (in the IAC-16 trial) granted DNA's appeal and ordered the federal government to regulate the matter.

The original deadline expired on May 19, 2025 without the delivery of the regulation. Faced with non-compliance, the Union and ANVISA presented an "Action Plan" with a new deadline of September 30, 2025. The STJ approved the plan but warned of sanctions in case of a new failure.

Recently, the government admitted to not meeting its own schedule and requested a new extension to February 2026.