YOUR GUIDE TO THE LEGAL PRESENT AND FUTURE OF THE CANNABIS INDUSTRY
Cannabis: In Focus
DEA Classifies Two Lab-Derived Cannabinoids as Schedule I
The U.S. Drug Enforcement Administration (DEA) determined that two lab-derived cannabinoids— delta-8 THC acetate ester (delta-8 THCO) and delta-9 acetate ester (delta-9 THCO)—do not meet the federal definition…
The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or cannabis-derived compounds. The agency’s nonbinding recommendations highlight potential opportunities for clinical researchers and sponsors of investigational new drugs after the 2018 Farm Bill significantly altered the regulatory landscape applicable to cannabis products.…
Continue Reading FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs
The U.S. Department of Agriculture (USDA) published a final rule today, building off the interim final rule it issued in October 2019 and incorporating both public comments and the agency’s takeaways from the 2020 growing season. In general, the final rule makes modest adjustments to the interim final rule in order to make it less onerous for producers to grow hemp while imposing stricter requirements on how crop must be tested.
Most importantly, the final rule recognizes that growers may accidentally produce crop that contains more than 0.3 percent THC and raises the limit for negligently doing so from 0.5 percent to 1 percent, but requires that producers test for total THC levels in crop, rather than for delta-9 THC levels. Testing for total THC levels makes it more likely a crop could exceed the legal limit for THC in hemp.
Continue Reading USDA’s Final Rule Makes Hemp Easier to Grow, Harder to Test
On December 7, 2020, cannabis industry leaders, former federal government officials, and leading state regulators met for a Virtual Public Policy Summit, a policy discussion among key leaders in the cannabis industry that was co-hosted by the Marijuana Policy Project and the National Cannabis Industry Association (NCIA). Participating industry leaders discussed how to define and address key issues to help advance the cannabis industry in 2021 and beyond. To help facilitate candid discussion, the event was closed to the media (likewise, comments made and positions taken described below have not been ascribed to particular speakers).
Continue Reading Striving to Reach Consensus on a Regulatory Framework for the Emerging Cannabis Industry
A new rule from the U.S. Drug Enforcement Administration (DEA) has caused considerable concern within the cannabidiol (CBD) industry. The rule relates to the distinction made in the 2018 Farm Bill that removed certain cannabis products, such as industrial hemp and those containing hemp-derived CBD, with levels of THC not exceeding 0.3% by weight from the federal controlled substances list. THC is the psychoactive substances most associated with a marijuana “high.” DEA’s interim final rule appears straightforward at first glance: cannabis products containing more than 0.3% by weight are subject to DEA enforcement as controlled substances. The rule appears to mean, however, that THC levels can never exceed 0.3% at any point during the product’s manufacturing process, even if the final product offered for sale had THC at appropriate levels.
Continue Reading New DEA Rule May Threaten CBD Manufacturing
