Federal Deadlines Loom For Public Comments On Marijuana Research, Hemp, CBD And Drug Testing

Four federal agencies currently have public comment periods open for proposed cannabis and drug-related regulations—with the deadline for one closing on Monday. The Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) are each accepting input from stakeholders on separate proposed rules that they’ve published in recent weeks. FDA For FDA, the proposed regulations concern research guidance on developing cannabis-based drugs. The draft document was reviewed by the White House Office of Management and Budget and released in July. The deadline to submit feedback is September 21. Much of the guidance—which is “limited to the development of human drugs and does not cover other FDA-regulated products”—covers the basics of conducting federally authorized research for drug development purposes such as where researchers are allowed to obtain cannabis and the importance of demonstrating the ability to “consistently manufacture a quality product.” As of Friday, only 26 comments have been received. The director of the University of Mississippi’s National Center for Natural Products Research submitted a comment stating that while “the development of botanical drugs presents many challenges for the pharmaceutical industry and for researchers, the guidance from FDA on botanical drugs has paved the way for important new clinical research possibilities, and these certainly afford a solid basic platform for cannabis-derived botanical products.” However, he said that “the additional barriers imposed by the controlled substance regulatory environment are essentially paralyzing.” In particular, Ikhlas Khan said FDA’s draft guidance…

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Source : MJ moment
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