mitigate risk while conducting business

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FDA Regulatory Counsel has been advising clients on the full risk spectrum of cannabusiness since 2015. We maintain up-to-date state and federal databases pertinent to manufacturing, distributing and marketing cannabis products, and track the enforcement priorities that should guide all business operations.  At the current time, operating within state law and avoiding FDA is the steady course. 

 

Federal vs. State

Regulation of marijuana cannabis in the U.S. is a Gordian Knot of law, with a multitude of federal and state agencies, and even international authorities providing the threads. The FDA, DEA, USDA, DOJ, FTC and International Treaties - some preempting state law and some not - are all involved.

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Separately, state cannabis commissions promulgate and enforce regulations on growing, processing, dispensing and consuming cannabis. Medical marijuana (a technical misnomer in FDA terms) is authorized (but not 'legalized') by state law in more than half the country, each with its own licensing and restriction protocols. Recreational marijuana (also incongruent with current FDA framework) is likewise authorized through various paradigms on the state level in about a quarter of the country.

 

While the Cole Memorandum, the continued existence of which is not a certainty, pledged enforcement discretion as to federal criminal law where marijuana activity is conducted within the legal framework of a state's laws and does not promote crime, illegal drug, or violence, the FDA has explicitly stated that it has no such official policy of enforcement discretion. And Attorney General Barr, who would prefer a uniform federal rule against marijuana, has conceded that DOJ would nonetheless support an act encouraging states to make their own laws in line with the Tenth Amendment and supporting immunity from federal action.

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Scientific Considerations

DEA and HHS have considered several Citizens Petitions requesting the rescheduling of marijuana from Schedule 1 of the CSA. At that time, HHS concluded marijuana had no accepted medical use in the U.S., and for that reason DEA denied the petitions. However, new FDA approvals of THC- and CBD-related drugs has suddenly shifted the landscape. Scientific innovation and scientific advancements now make it possible to provide the specificity needed for rescheduling; for example, rescheduling specific strains or standardized doses, safety and efficacy data, expert opinions on medical utility, specific disorders and medical conditions for which clinical trials could be run, and the collection of data to address chemistry, toxicology and effectiveness under controlled conditions.

 

International, Political & Market Considerations

While on the one hand international treaties like the single Convention on Narcotic Drugs (1961) require U.S. comportment with stringent requirements on marijuana, the proliferation of other nations allowing access to quality-controlled, regulated marijuana - most notably Canada in 2018 - makes it all but inevitable that the global trend will cross U.S. borders. In addition, the massive potential market combined with consumer pressure on both business and politicians historically trend in the same direction of inevitability. The question is only which paradigm will be chosen.

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At FDA Regulatory Counsel we understand the pathways, stakeholders, and real world considerations for businesses operating during this evolution. Our clients hail from all sectors of the cannabis industry and we counsel them on all facets of coloring inside the most up-to-date lines. We represent clients looking to establish themselves as leaders in shaping marijuana dialogue and regulatory standards, as well as those who prefer to focus on maintaining compliant operations while others pave the road.  We invite all businesses that participate or invest in this booming industry to learn how we can support your goals through transactional diligence, compliance guidance, and regulatory advocacy.