For consumers, the widespread availability of products containing cannabidiol (CBD) is old news. But for those in the cannabis industry—and in particular, those monitoring applicable regulatory developments—the state of CBD remains largely in flux and continues to be marred by uncertainty.
Under the 2018 Farm Bill, the U.S. Food and Drug Administration (FDA) retained its regulatory authority over products derived from hemp, including CBD incorporated into products it traditionally regulates, such as food, dietary supplements, and cosmetics. Unfortunately for the industry, FDA has yet to propose or issue formal regulations concerning the manufacture, distribution, or sale of such products. At the same time, FDA has issued numerous warning letters to producers and retailers incorporating CBD into products operating in the complex gray area between state and federal law. Nevertheless, recent events occurring across all three federal branches of government may reflect an impetus for change in FDA’s approach to CBD products.
Gretchen L. Temeles authored the article, “The Next Cannabis? Patent Protection for Psychedelic Therapeutics,” for The Legal Intelligencer.
Dr. Temeles writes:
Along with cannabis, the Controlled Substances Act of 1970 designated many psychedelic compounds as Schedule I controlled substances. Schedule I controlled substances are considered to have no legitimate medical use and their possession and sale is illegal under U.S. federal law. Recent efforts to legalize psychedelics have followed in the wake of legalization of medical and recreational cannabis by multiple states. In the last two years, Denver, Colorado, and Oakland and Santa Cruz, California, decriminalized possession of psilocybin-containing mushrooms and/or plants having psychedelic properties. In February 2020, the Washington, D.C., Board of Elections decided to advance an initiative to decriminalize possession of any plant or fungus containing psilocybin and other psychedelic compounds. At the same time, scientific researchers have been looking at old research in a new light. The FDA has even shown willingness to support approval of psychedelic therapeutics. The renewed interest in psychedelics has spawned an increase in commercial activity and an increase in the number of patent applications and granted patents covering psychedelics.
Although the cannabis reform movement has made incredible strides over the past 25 years, our industry and the medicinal potential of the plant are still not recognized at the federal level. The COVID-19 pandemic is drastically altering our lives but difficult times are able to expose many truths, including the understanding that legalization and safe access to cannabis is critical, especially during a crisis.
Thankfully, many states already have come to the realization that cannabis, especially medicinal use, is not a luxury but a necessity. Although states are restricting access to public places and prohibiting gatherings, many governors have designated cannabis dispensaries as an “essential service.” […]
“Opponents of federal legalization are likely to argue the categorization was merely a natural extension of the law in states that have already legalized medical marijuana to treat certain conditions, and that the uniqueness of the COVID-19 situation limits the ‘essential’ designation to that very urgent and unprecedented fact pattern,” Seth Goldberg, attorney and partner at Duane Morris LLP told mg.
[…] With so many out of work and many more likely joining them in the coming weeks, Americans are looking to Washington D.C. to provide a lifeline. One bill, the Families First Coronavirus Response Act (FFCRA), has already been signed into law by President Trump. This provides $1 billion in additional funds for states to direct toward bolstering their unemployment insurance programs.
Lawmakers on Capitol Hill have been working to pass additional relief legislation—but when it comes to the federal government and the cannabis industry, the relationship is not usually cozy. Will those relief funds find their way to cannabis workers who are out of work due to the coronavirus pandemic?
“Given that marijuana remains an unlawful substance under Schedule I of the Controlled Substances Act, there has been concern that the relief under the FFCRA would not be available to cannabis businesses and, therefore, would not be available to support cannabis workers,” Linda Hollinshead, an attorney and Partner at Duane Morris LLP told mg.
“The law provides that any administrative grants transferred to the account of a state may be used ‘by such State only for the administration of its unemployment compensation law,’ suggesting that the money is being provided to support a state’s program, and that the federal government will not dictate how it is spent or what industries will be recipients of those grants,” Hollinshead said. “As a result, it does not appear that the additional availability of these federal funds under the FFCRA jeopardizes an individual’s ability to have access to state unemployment benefits.”
Over the last decade, there has been a remarkably swift rise in the popularity of vaporizers and vaping products. As reported by the BBC, the number of people using vaporizers increased from 7 million in 2011 to over 41 million in 2018. But in 2019, consumers began suffering from a rash of vaping-related lung injuries—according to the Centers for Disease Control and Prevention, as of February 18, 2020, there have been approximately 2,807 vaping-related injuries in the United States, occurring in all 50 states.
Highly publicized reports of these injuries raised serious concerns among the public and policymakers and threatened to halt the explosive growth of the vaping industry. State governments across the country issued emergency rules and executive orders to ban some, or all, vaporizer products. Even as courts issued injunctions prohibiting these bans from taking effect, more states moved forward with bans of their own. Within a few months states as diverse as Washington, Oregon, Montana, Michigan, Rhode Island, Massachusetts and New York had instituted some version of a vaporizer ban, mostly targeted at the highly popular flavored e-liquids.
As increasing numbers of U.S. states have legalized both medical and adult-use cannabis, another set of Schedule 1 controlled substances – psychedelics – has begun to emerge from the shadows. Psychedelics such as psilocybin, lysergic acid diethylamide (LSD), mescaline, and ayahuasca were designated along with cannabis as Schedule I controlled substances under the Controlled Substances Act of 1970. Recently, several U.S. cities, including Denver, Colorado and Oakland, California, have decriminalized possession of psilocybin-containing mushrooms and plants having psychedelic properties. In February 2020, the Washington D.C. Board of Elections voted to advance an initiative to decriminalize possession of plants and fungi containing psilocybin and other psychedelic agents. As was the case for cannabis, biomedical research into psychedelics ground nearly to a halt following the Schedule 1 designation. But, over the past 10 to 15 years, researchers at both universities and in the private sector have turned back to both cannabis and psychedelics as possible therapies for disorders that are intractable to standard pharmaceutical treatments. In 2019, FDA approved esketamine, a compound from a family of compounds known to have hallucinogenic effects, for treatment-resistant depression. As has been the case for cannabis, the renewed interest in psychedelics has brought with it an increase in patenting activity. Even though legalization of psychedelics has lagged behind that of cannabis, legal wrangling over patents covering psychedelics has not, as demonstrated by recent developments in the area of psilocybin-based therapeutics.
Psilocybin is a tryptamine alkaloid found in a number of fungal species, also known as “magic mushrooms.” The psychoactive and hallucinogenic properties of such fungi have been a part of traditional religious rituals of indigenous cultures in Central and South America for centuries. In the 1950s, scientists at Sandoz Ltd., isolated psilocybin from fungi. The first US patents covering psilocybin issued to Sandoz Ltd. in 1965: U.S. Patent No. 3,183,172, “Obtaining Psilocybin and Psilocin from Fungal Material” and U.S. Patent No. 3,192,111, “Method of Inducing Therapeutic Tranquilization with Psilocybin and Psilocin.” Continue reading Patent protection of psychedelic therapeutics: a page from the cannabis playbook?→
On February 26, 2020, the United States Department of Agriculture (USDA) took a significant step toward allaying industry concerns by announcing that it delaying enforcement of the interim final rule (IFR) requirement that hemp producers only use testing laboratories registered with the Drug Enforcement Administration (DEA).
When the IFR was published in late October of 2019, it faced near-immediate criticism from industry participants and stakeholders who, among other things, voiced concerns that the DEA registration requirement would create a bottleneck given capacity issues. Appearing to respond to those critiques, the USDA explained that its enforcement discretion “will allow additional time to increase DEA registered analytical lab capacity.”
Notwithstanding other applicable provisions of law, the requirement that hemp testing labs be DEA-registered largely foreclosed the potential for a single laboratory facility to test both hemp and marijuana, as the DEA, which is a division of the U.S. Department of Justice, continues to treat marijuana as an illegal, Schedule I controlled substance. While this delay may provide an opportunity for labs that currently test medical and recreational marijuana pursuant to state law to also test hemp for compliance with the 2018 Farm Bill, it is not certain that the DEA registration requirement will not be reinstated. It is also not clear what further requirements states may impose.
Under the USDA’s guidance, hemp testing may be “conducted by labs that are not yet DEA registered until the final rule is published, or Oct. 31, 2021, whichever comes first.” Until that time, labs conducting hemp testing are still subject to the other compliance requirements of the IFR, including those related to methods of testing.
On January 1, 2020, Illinois became the 11th state to legalize adult-use cannabis. The Cannabis Regulation and Tax Act is comprehensive and impacts employers in many ways. Following Illinois’ legalization of medical cannabis in 2014, marijuana is now available for recreational use by all adults age 21 and older, while remaining an unlawful controlled substance under federal law. As a result, Illinois employers must ensure that they have considered their organization’s philosophy for dealing with marijuana in the application and disciplinary process for all positions and employees. Continue reading Key Cannabis Issues for Illinois Employers in 2020→
In this second article of his Cannabis Patent Review series, Duane Morris partner Vince Capuano reports on recently granted U.S. patents in various areas of cannabis technology.
There are plenty of reports and testimonials on the medical benefits of cannabis. Time, and better data, will determine whether these benefits are realized, and whether some are overblown, and the U.S. FDA will decide when the therapeutic uses of cannabinoids are safe and effective, and approvable for human use in the U.S. The FDA has approved CBD (cannabidiol), the principal non-psychoactive constituent in cannabis, for the treatment of certain types of seizures. The approval of Epidiolex (NDA Approval Holder: GW Research Ltd.) brings the therapeutic use of CBD as an active drug substance within the jurisdiction of the FDA. Thus, because CBD is the active drug substance in an FDA-approved pharmaceutical (Epidiolex), the FDA is currently considering regulations for the testing and approval for all drug products containing CBD.