MMJ International Holdings Corp is preparing a lawsuit against the Drug Enforcement Administration (DEA) claiming the agency is violating the law by not responding to its application to grow pharmaceutical cannabis to support its research. MMJ, which has two Food and Drug Administration (FDA) investigational drug applications to research its developed soft gelatin capsule in clinical trials for multiple sclerosis and Huntington’s disease, filed its application nearly five years ago.
MMJ alleges that the DEA’s inaction on its application is in violation of the Controlled Substance Act (CSA) and the Marijuana and Cannabidiol Research Expansion Act (MCREA), which was signed into law in December 2022.
Late last month, Megan Sheehan of Sheehan & Associates, representing MMJ, sent a warning letter to DEA Deputy Assistant Administrator Matthew Strait, and DEA regulatory chief Ricardo Quintero, informing them that they were in violation of the law.
In the letter, Sheehan argued that DEA’s failure to process MMJ’s bulk manufacturing application for almost five years was a violation of both the CSA and the MCREA. She also argued that DEA’s attitude toward the application, which was reported that they “would get to it when they get to it,” was in violation of DEA policies and procedures, MMJ said in a press release.
In general, the consequences for violating federal laws and regulations can include fines, penalties, and other legal sanctions. In this case, if the DEA is found to have violated the CSA or the MCREA, it is possible that the agency could face fines or court-ordered injunctions, or the court could order the DEA to process MMJ’s bulk manufacturing application and take other actions to address the agency’s failure to comply with federal law.
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