Unlike hemp, marijuana still is subject to state statutes and the federal Controlled Substances Act. The legal distinction between hemp and marijuana is too subtle for the human eye, or a trained K-9’s impressive nose, and it has created a quandary for interstate hemp shippers. Until federal law clarifies interstate commerce laws pertaining to hemp, producers should reconsider transporting hemp through less-receptive states.
On May 31, 2019, the Food and Drug Administration (FDA) will hold a public hearing on cannabis products. The hearing seeks to obtain scientific data on cannabis and cannabis-derived compounds, along with additional information regarding health and safety risks, manufacturing and product quality, marketing, labeling and the sale of such products.
The FDA’s notice announcing the hearing recognizes that the regulatory landscape surrounding cannabis continues to evolve at both the federal and state levels. At the state level, 33 states and Washington, DC, allow for the medical use of marijuana and 14 additional states have medical programs limited to cannabidiol (a/k/a CBD) products. Moreover, 10 states and Washington, DC have legalized marijuana for recreational use, while 13 additional states have decriminalized recreational marijuana possession in some form.
At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334 (often called the 2018 Farm Bill), removed hemp and its derivatives from the Controlled Substances Act, so they are no longer classified as controlled substances under federal law. This has prompted an avalanche of businesses marketing products containing hemp-derived compounds – most notably CBD – in ways that the FDA views as violations of the federal Food, Drug, and Cosmetic Act. According to the FDA, many questions remain concerning the safety implications of the widespread use of these products. Therefore, the FDA seeks relevant information to inform its position in regulating the development and marketing of cannabis products. (more…)
As beverage manufacturers mull the creation and distribution of cannabidiol (CBD)-infused products, the US Drug Enforcement Administration’s (DEA) recent actions regarding an approved CBD drug merit exploration. CBD is one of many chemicals in the cannabis plant, and the US Food and Drug Administration (FDA) has stated that CBD does not produce the same euphoric effect as tetrahydrocannabinol (THC), marijuana’s psychoactive component.
In June, FDA approved the first drug comprised of an active ingredient (CBD) derived from marijuana, Epidiolex. FDA approved the CBD oral solution for patients two years of age and older who have seizures associated with two forms of severe epilepsy. According to DEA and FDA, the CBD in Epidiolex is extracted from the cannabis plant and is a purified drug substance. Though it is derived from the cannabis plant, the FDA-approved drug has no more than 0.1 percent residual THC.
Last week, DEA announced an order scheduling Epidiolex under the least restrictive schedule of the Controlled Substances Act (CSA), schedule V. Notably, DEA still considers marijuana (which includes industrial hemp) and marijuana compounds other than Epidiolex to be schedule I controlled substances under the CSA. As a result, beverage manufacturers should carefully consider all legal implications prior to developing products that contain CBD. (more…)
Today, Attorney General Jefferson B. Sessions announced, in a memorandum to all US Attorneys, the immediate revocation of five Obama Administration policies on federal marijuana enforcement, including Guidance Regarding the Ogden Memo in Jurisdictions Seeking to Authorize Marijuana for Medical Use, Guidance Regarding Marijuana Enforcement and Guidance Regarding Marijuana Related Financial Crimes. These three Obama-era guidance documents were drafted by then Deputy Attorney General James M. Cole in response to state legalization initiatives. (more…)
In the past three years, TTB has approved an increasing number of certificate of label approvals (“COLA”) for hemp-flavored vodka, from Mill Six’s hemp, white tea and ginger flavored vodka to Olde Imperial Mystic’s hemp infused vodka. Distillers have designed labels with green smoke-like images and psychedelic sixties-style lettering to hint at their cultural connection to marijuana. As more states have legalized recreational cannabis, distillers have been thinking more ambitiously about combining their distilling business with one or more aspects of the emerging marijuana business.
Originally published in Artisan Spirit: Winter 2017.
To follow up on our prediction last month that the Trump Administration may take a more aggressive stance toward the legalization of marijuana, White House Press Secretary Sean Spicer stated during the February 23 daily briefing that he anticipates greater federal enforcement of marijuana laws. Spicer emphasized the distinction between medical marijuana (the legalization of which President Trump does not oppose) and recreational marijuana. In discussing the latter, Spicer invoked the country’s opioid addiction crisis, suggesting a link between recreational marijuana use and such other drugs.
Spicer hinted that the Justice Department’s enforcement of federal drug laws would extend to the nine jurisdictions that have legalized recreational marijuana, potentially putting at risk the schemes many of these states have created–or are in the process of creating–to regulate marijuana. As of today, the recreational use of marijuana is legal in Alaska, California, Colorado, the District of Columbia, Maine, Massachusetts, Nevada, Oregon and Washington. (Note: Congress has blocked the DC government from using funds to actually implement a system to regulate recreational marijuana, so although technically legal, there is currently no “market” for recreational marijuana in DC.)
If President Trump’s Justice Department does begin to pursue more active enforcement of marijuana laws in states that have legalized marijuana, it may meet pushback from Congress. Just last week, four congressmen announced the formation of the Congressional Cannabis Caucus (the Caucus), a bipartisan organization seeking to change the federal government’s attitude toward legalized marijuana and, notably, to leave the legalization question to the states. In support of this mission, earlier this month Representative Dana Rohrabacher (R-CA), a member of the Caucus, introduced a bill (HR 975) in the House that would prevent federal enforcement of the Controlled Substances Act (the Act) in states that have legalized the recreational use of marijuana.
Likely by design, the bill’s introduction occurred just a day before the confirmation of Jeff Sessions, a vocal opponent of marijuana legalization, as Attorney General. The bill would add a new section to the Act expressly stating that the Act’s provisions concerning marijuana do not apply to persons acting in compliance with state law regarding the possession or sale of marijuana. The bill, titled the “Respect State Marijuana Laws Act of 2017,” has been referred to the House Judiciary and Energy and Commerce Committees.
Of course, whether the bill will gain enough support to pass in Congress and survive a potential Trump veto remains to be seen. Nevertheless, the timing of the bill’s introduction, the bipartisan support it has garnered to date (half of its current cosponsors are Republicans), and the announcement of the Caucus indicate a growing tension between Congress–including some members of President Trump’s own party–and the Administration with respect to the enforcement of federal marijuana laws.
On August 11, 2016, the Drug Enforcement Administration (DEA) formally declined to change its position on the medical or recreational use of marijuana, denying two petitions urging the federal government to change marijuana’s drug classification under the Controlled Substances Act. The petitions, filed in 2009 and 2011, urged the DEA to change marijuana’s status as a Schedule I drug—a drug without any accepted medical uses—to a Schedule II drug—a drug with potential medical value but high potential for abuse—or to a drug “in any schedule other than [S]chedule I.” Despite a trend towards decriminalization and legalization on the state level, the DEA’s denial of these petitions indicates the Obama administration has not changed its stance on marijuana.
Twenty-five states currently allow some form of marijuana to be used for medical purposes. Four state—Alaska, Washington, Oregon, and Colorado—and the District of Columbia allow the recreational use of marijuana for adults. Nevertheless, the DEA, citing an evaluation and scheduling recommendation from the Department of Health and Human Services (HHS), concluded that marijuana “has no accepted medical use in the United States, and lacks an acceptable level of safety for use even under medical supervision.” The Agency ultimately declined to remove marijuana from Schedule I because of its “high potential for abuse,” lack of “currently accepted medical use in treatment in the United States,” and lack of “accepted safety for use under medical supervision.”
The DEA’s Thursday announcements were not uniformly anti-marijuana. Most notably, the Agency also published a policy statement designed to increase the number of entities registered to grow marijuana to supply researchers in the United States. Currently the only registered facility is at the University of Mississippi, which has been the single grower registered to supply medical marijuana research for nearly 50 years. In its policy statement, the DEA gave its full support to expanding research into the “potential medical utility of marijuana.” Based on its discussions with the National Institute of Drug Abuse (NIDA) and the Food and Drug Administration (FDA), the DEA concluded that “the best way to satisfy the current researcher demand” of marijuana “is to increase the number of federally authorized marijuana growers.” This new policy will allow more people to register with the DEA as marijuana growers.
The DEA on Thursday also signed onto a Statement of Principles on Industrial Hemp published by the Department of Agriculture and the FDA. The Agricultural Act of 2014 legalized the growing and cultivating of industrial hemp for research purposes in states where such activities are legal under state law. Growing and cultivation is limited to institutions of higher education or state departments of agriculture for purposes of agricultural or other academic research. The three federal agencies published the Statement of Principles “to inform the public regarding how Federal law applies to activities involving industrial hemp” so that those hoping to participate in industrial hemp agricultural pilot programs can do so in accordance with federal law.
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