FR 2025-05277

The document in question is a notice from the Drug Enforcement Administration (DEA) regarding an application by Ohana Bio Pharma, LLC to be registered as a bulk manufacturer of marihuana, a schedule I controlled substance. The purpose of this application is to facilitate the production of marihuana for scientific and medical research. This regulatory step is part of a broader program overseen by the DEA to ensure that research involving controlled substances can proceed within legal and safe parameters. Comments or objections to this registration must be submitted by May 27, 2025.

Summary

The DEA is evaluating a proposal for Ohana Bio Pharma, LLC from Rhode Island to become a bulk manufacturer of marihuana. The goal is to contribute to scientific and medical exploration, expanding the understanding and potential therapeutic uses of marihuana. The DEA's notice is based on a regulatory framework designed to prevent misuse and diversion while permitting necessary advancements in research.

Significant Issues and Concerns

Several concerns arise from this document:

1. Lack of Specific Information: The notice does not detail the criteria that the DEA will use to assess Ohana Bio Pharma’s application. This lack of transparency might lead to uncertainties for both the applicant and other interested entities about how the decision will ultimately be made.

2. Scope and Scale: The document does not specify how much marihuana Ohana Bio Pharma intends to produce. This omission makes it difficult to evaluate the potential effects of the company’s operations at local, national, or international levels.

3. Safeguards Against Diversion: While the document mentions compliance checks, it does not elaborate on the exact measures that will be employed to ensure that marihuana is not diverted for illegal purposes. This could be a significant oversight, leading to potential concerns about efficacy in preventing illegal distribution.

4. Access and Inclusivity: Submissions of comments must be made electronically, potentially excluding individuals without internet access or those unfamiliar with digital processes, thus limiting public participation in the regulatory process.

5. Complex Legal References: The document includes multiple references to legal statutes and regulations without explaining them, which may be confusing for readers unfamiliar with these legal citations.

Public Impact

Broadly, the document underscores the DEA's ongoing management of controlled substances to support research. If successful, such registrations can promote scientific discoveries and the development of new medical treatments. Conversely, issues with oversight might raise public safety concerns about the risk of substance diversion.

Impact on Stakeholders

For research institutions and pharmaceutical companies, this document signals potentially increased access to marihuana necessary for exploring its medical benefits, thus potentially accelerating the pace of discovery and innovation in this field.

For the public and policy stakeholders, there could be both excitement about advancements in medical research and concern about regulatory rigors and the potential for misuse if there is insufficient oversight.

Interested members of the public, such as local communities and advocacy groups, might be impacted by this notice based on social, economic, and environmental considerations. Without detailed information, local stakeholders may feel unsure about how an increase in marihuana manufacturing might affect their community.

In summary, while the DEA's notice represents a step forward in the integration of marihuana into legitimate scientific inquiry, the document leaves many questions unanswered. Additional clarity and inclusivity in the commenting process could enhance understanding and participation from all affected parties.