DEA Reschedules CBD to Schedule 5

Posted by Margolin & Lawrence on September 28, 2018

By Raza Lawrence and Allison Margolin

On September 28, 2018, the DEA issued a rule announcing that drugs including CBD with THC content below 0.1%  will be taken off of Schedule 1 of the controlled substances schedules, and moved to Schedule 5, which allows CBD products to be sold through traditional pharmacies with a doctor’s prescription, so long as the particular product is first approved by the FDA.  The order also disallows any importing or exporting of CBD products without a permit. 

It is important to note that the ruling is narrow in that it only applies to CBD products with less than 0.1% THC.  However, products with higher THC content could continue to be sold under state law and without federal FDA or DOJ regulation under the Rohrabacher–Farr amendment.  Ironically, the new federal policy is to tolerate sales of CBD products with high levels of THC, but to restrict sales of CBD products with low levels of THC by requiring FDA approval, a huge task in itself. Some sources indicate that it can cost more than $1 billion to bring one FDA-approved product to the market, including approximately $50-840 million to bring treatments through the stages of Basic Research/Drug Development and Pre-Clinical/Translational Research, and approximately $50-970 million to complete the Clinical Trials (Phases 1, 2, and 3).

The new ruling is bad news for anyone hoping to sell CBD with no or low levels of THC and without FDA approval.  Already, in July 2018, the California Department of Public Health ruled that hemp-derived CBD would not be allowed in food or drinks for humans or pets in California. 

CBD products could potentially be sold as edible cannabis products under California state law if the producers obtain commercial cannabis manufacturing licenses from the state and local government, and the products are distributed and sold through outlets with state and local commercial cannabis licenses.  Even if everyone involved complied with California state cannabis laws, they would still be subject to enforcement, punishment and being shut down by the FDA, unless they contain over 0.1% THC, in which case they could be sold under state law with no federal interference.

The Rohrabacher–Farr Amendment would not protect any low- or no-THC CBD distributors, even those who strictly complied with state law, from enforcement actions from the FDA, as Rohrabacher–Farr only restricts the DOJ from interfering with state regulation of medical marijuana.  The FDA is part of the Department of Health and Human Services, not the DOJ, and thus retains the ability to regulate CBD – its regulations trump any state laws relating to CBD under the supremacy clause of the US Constitution. 

It is possible that today’s DEA ruling could later lead to reclassification of all cannabis from a Schedule 1 to Schedule 5 substance, which would mean that all cannabis could fall under the jurisdiction of the FDA and could only be sold through pharmacies with doctor’s prescriptions and must be produced by companies with FDA approval (i.e., large drug companies). 

Since 2009, the FDA has had the authority to regulate tobacco products, which are now controlled by only a few large corporations, as are many other drugs regulated by the FDA.  The same could happen to cannabis.  Individuals and organizations in the cannabis community should lobby the government to prevent this monopolization by ensuring that cannabis is descheduled as a controlled substance.

Earlier this year, the FDA's parent agency stated that CBD has little potential for abuse – hopefully the government's future approach to CBD will follow this lead and remove CBD's schedule 1 classification.

Massachusetts Cannabis Regulators: 36 Watts will be the limit for cannabis cultivators

Posted by Margolin & Lawrence on May 8, 2018

Compared to the farming of most other crops, commercial cannabis cultivation’s impact on the environment is minimal – except when it comes to power use. A large proportion of cannabis cultivation takes place on indoor grow sites, using man-made lighting arrays as a substitute for daylight. These setups and their accessories, including the fans and HVAC systems that prevent the plants from overheating in proximity to the lights, can demand large amounts of power. Unsurprisingly, areas which have legalized cannabis cultivation have seen corresponding increases in energy use: In Colorado, cannabis grow facilities used 200 million kilowatt hours of electricity in 2014, with cannabis cultivation accounting for almost half of Denver’s yearly increase in energy use. For cities and states planning to legalize cannabis while still limiting their use of electricity, regulating the power used by cannabis cultivation is a must.

The History of Cannabis by Margolin & Lawrence

Posted by Margolin & Lawrence on April 20, 2018

News: Ninth Circuit Hears Medical Cannabis Case

Posted by Margolin & Lawrence on April 17, 2018

Just last week, on March 29th, a three-judge panel for the Ninth Circuit Court of Appeals held a special setting at the University of Idaho College of Law. Judges Richard Tallman, N. Randy Smith, and Morgan Christen considered the case of Michael Assenberg v. Whitman County (Case No. 15-35757). Assenberg was appealing the district court’s summary judgment in an action against Whitman County, the Sheriff’s Office, Sheriff Brett Myers, and the Quad Cities Drug Task Force. Assenberg alleged that the search of his Colfax home for marijuana and his subsequent arrest violated his rights under the Fourth Amendment of the U.S. Constitution.

In 2011, law enforcement conducted a raid on his home, where Assenberg was running a medical marijuana dispensary. According to Assenberg, the raid came about after a confidential informant posing as a medical marijuana patient visited his dispensary. The Whitman County sheriff and Quad Cities Task Force seized approximately one hundred marijuana plants and Assenberg was charged with four felonies. However, the charges were later dropped in Whitman County Superior Court after it became clear the marijuana was stored incorrectly by the county.

1

Categories

This blog is not intended as legal advice and should not be taken as such. The possession, use, and/or sale of marijuana is illegal under federal law.