Controlled Substances Act Archives

Controlled Substances Act

DOJ Proposes to Reschedule Marijuana (Cannabis) to Schedule III

by James R. Ravitz, Alva C. Mather, Paul S. Gadiock, Deepika Raj, Marissa Hill Daley and Karis Jackson | Jun 3, 2024 | Cannabis, Food Safety and FDA, Hemp-Derived Beverages, THC Beverages

On May 21, 2024, the US Department of Justice (DOJ) published the highly anticipated notice of proposed rulemaking (NPRM) to reschedule marijuana (cannabis) from a Schedule I controlled substance to Schedule III, taking the first step to easing federal restrictions on cannabis and potentially opening up the door for further cannabis research and development. This regulatory change could have far-reaching implications for the cannabis, pharmaceutical and banking industries if promulgated in a final rule. Stakeholders interested in submitting comments to the DOJ must do so by July 22, 2024.

Navigating Hemp THC Beverages

by Alva C. Mather and Christine Dower | Mar 4, 2024 | Cannabis, Food Safety and FDA

Nonalcoholic beverages infused with delta-9 tetrahydrocannabinol (THC) derived from hemp (aka intoxicating hemp beverages) are becoming increasingly popular for consumers looking for an alternative to alcohol.

With major alcohol retailers like Total Wine entering the cannabis space, alcohol beverage producers may be looking for opportunities to leverage their existing experience in manufacturing, marketing and distributing alcohol beverages towards the emerging intoxicating hemp beverage market. While intoxicating hemp beverages are arguably legal pursuant to the Agriculture Improvement Act of 2018 (2018 Farm Bill), risks remain under federal and state food and drug laws. Accordingly, beverage producers looking to enter this emerging market should become familiar with the ambiguities involved.

Federal Treatment of Intoxicating Hemp Beverages

The 2018 Farm Bill removed hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of delta-9 THC (specifically, no more than 0.3 percent THC on a dry weight basis), from the definition of “marijuana” in the Controlled Substances Act. The federal government defines hemp as “the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” Accordingly, products that meet the definition of “hemp” may be marketed and sold in the United States and are no longer classified under federal law as illegal drugs.

How Is Hemp Regulated?

Under the 2018 Farm Bill, the US Department of Agriculture (USDA) has been assigned to regulate hemp production.

However, any hemp-derived foods, including beverages, are subject to regulation by the US Food & Drug Administration (FDA) under the Food, Drug, and Cosmetics Act (FDCA). While the FDA has largely avoided enforcement actions against such products, focusing most of its efforts on products making unsubstantiated medical and therapeutic claims, it has clearly concluded that it is a prohibited act under federal law to introduce any food in the market to which THC or cannabidiol (CBD) has been added. Therefore, the risk of federal enforcement remains until the agency changes its stance towards THC as a beverage additive.

State Regulation

While the federal government has been inactive in this space, the legal status of intoxicating hemp beverage products varies significantly by state. On the one hand, several states, including Minnesota, have expressly legalized the inclusion of hemp-derived cannabinoids in beverage products, with clear regulations regarding testing, labeling, advertising and more. On the other hand, some states have legalized hemp beverage products but lack a robust regulatory framework – leading to a mostly unregulated, laissez-faire market.

Further, many states fall into a grey area when it comes to the legality of such products. Some of these states have legalized hemp along the lines of the 2018 Farm Bill but have not officially opined on whether it can be added to beverage products, while others do not mention hemp products at all. A subset of states has expressly legalized hemp [...]

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EPA Approves Use of 10 Pesticide Products on Hemp

by Alva C. Mather and Noah Feldman Greene | Dec 20, 2019 | Cannabis, Food Safety and FDA

Yesterday, the Environmental Protection Agency (EPA) announced its approval of 10 new pesticides for use on hemp products. EPA’s approval of nine biopesticides and one conventional pesticide provides greater certainty to hemp farmers in time for the 2020 planting season.

The hemp industry awaits further guidance from other federal regulatory agencies.

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Congressional Committee Takes Historic Step Toward Decriminalizing Marijuana

by Robert M. Kline | Nov 25, 2019 | Cannabis, Legislation

For the first time in American history, a congressional committee approved a marijuana legalization bill. On November 20, 2019, after more than two hours of debate, the House Judiciary Committee approved the Marijuana Opportunity Reinvestment and Expungement (MORE) Act of 2019 (H.R. 3884) in a 24 to 10 vote. If the MORE Act becomes law, it would effectively end the federal prohibition of cannabis in the United States.

Currently, marijuana remains a Schedule I drug, alongside heroin and LSD, under the Controlled Substances Act. Schedule I drugs are those that the federal government considers to have no proven or acceptable medical use and a high abuse potential. The MORE Act, if passed into law, would remove marijuana from Schedule I.

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House Judiciary Committee to Consider De-Scheduling Bill

by Anthony DeMaio | Nov 19, 2019 | Cannabis, Legislation

This Wednesday, November 20, the House Judiciary Committee will hold a markup of H.R. 3884, the Marijuana Opportunity Reinvestment and Expungement Act (MORE Act). The bill’s sponsors and advocates for cannabis normalization say the legislation is the most comprehensive ever considered by Congress. In fact, due to the bill’s sprawling reforms, it was referred to eight separate committees for consideration according to their discrete jurisdictions. The Judiciary Committee will be the first to consider the bill and the Committee members will have opportunities to amend it.

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Cannabis and Hemp Update

by Noah Feldman Greene and McDermott Will & Emery | Jul 29, 2019 | Cannabis, Distribution, Food Safety and FDA, TTB COLAs and Formulas

Cannabis legalization receives widespread popular support. According to opinion polls, more than two-thirds of Americans support full legalization—a steep rise in support considering that as recently as 2005, almost two-thirds of Americans opposed legalization. The country appears on the path to full cannabis legalization, but until that time, citizens and companies should be aware of the legal risks involved in entering the cannabis space.

Access the full article.

Originally published in The New Brewer, July/August 2019.

Courts Are Siding with Employees Who Use Medical Marijuana

by Robert M. Kline | Jun 19, 2019 | Cannabis, Legislation

Marijuana, a Schedule 1 drug under the federal Controlled Substances Act (CSA), is the most commonly detected illicit drug in employment drug testing. According to Quest Diagnostics, in 2018, approximately 3% of urine-based workplace drug screenings tested positive for marijuana. Notwithstanding marijuana’s illegality under federal law, 33 states and the District of Columbia have legalized marijuana for recreational or medicinal use. And it is big business. The Colorado Department of Revenue recently revealed that its tax, license and fee revenue from marijuana has reached $1.02 billion. Legal marijuana appears here to stay in the United States. (more…)

If the DEA Does Not Quickly Reexamine Marijuana’s Classification Under the Controlled Substance Act, the Second Circuit Might

by Robert M. Kline | Jun 10, 2019 | Cannabis

“Plaintiffs claim that marijuana has extended their lives, cured seizures and made pain manageable. If true, these are no small things.” So wrote Judge Calabresi on behalf of the United States Court of Appeals for the Second Circuit (Second Circuit) in Washington, et al. v. Barr, et al.

In Washington, a coalition of plaintiffs launched a broad attack on marijuana’s status as a Schedule I drug under the Controlled Substances Act (CSA). The plaintiffs include the parents of infants Alexis Bortell and Jagger Cotte. According to the plaintiffs’ allegations, Alexis Bortell suffers from chronic, intractable seizures, and Jagger Cotte suffers from Leigh’s disease, a progressive neurometabolic disorder characterized by necrotizing (dead or dying tissue) lesions on the brain. After exhausting traditional treatment options, the children found relief with medical marijuana. (more…)

USDA Issues Opinion on Several Hemp-Related Provisions of the 2018 Farm Bill

by MaryKathryn Hurd and McDermott Will & Emery | Jun 3, 2019 | Cannabis, Food Safety and FDA

On May 28, 2019, the United States Department of Agriculture (USDA) issued a legal opinion to address questions raised by several hemp-related provisions of the Agricultural Act of 2018, better known as the 2018 Farm Bill. The USDA opinion clarifies four areas of the 2018 Farm Bill:

the removal of hemp as a controlled substance and schedule I drug became effective upon enactment of the 2018 Farm Bill;
following the publication of implementing regulations, states and Indian tribes cannot prohibit interstate transportation and shipment of hemp and hemp-based products, and the USDA confirmed that this preemption also covers hemp produced under the 2014 Farm Bill;
pending certain exceptions, individuals with certain controlled substance felony convictions will be barred from producing hemp; and
following the enactment of the 2018 Farm Bill, states and Indian tribes still retain the ability to regulate hemp production, including the ability to grow or cultivate hemp in that state or territory.

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TTB’s Take on Alcohol Beverages Infused with Cannabidiol

by McDermott Will & Emery | Apr 29, 2019 | Cannabis, Food Safety and FDA

On April 25, 2019, TTB published Industry Circular 2019-1. It addresses the hot topic of alcohol beverages (especially beer) infused with hemp-derived ingredients–with cannabidiol (CBD) as the clear focus of industry interest. While hardly surprising, the Industry Circular takes or reiterates the following positions:

TTB will require a formula for any product containing a hemp-derived ingredient
TTB will not approve a formula for any product containing a Schedule I controlled substance under the Controlled Substances Act
TTB will not approve a formula for any product containing CBD until FDA changes its current position towards CBD as a food ingredient. FDA currently views interstate commerce in any food containing CBD as a violation of the federal Food, Drug & Cosmetic Act
TTB will continue to approve formulas for alcohol beverages containing ingredients derived from hemp seeds and hemp oil
TTB will not approve a formula for any product containing a hemp ingredient other than those derived from hemp seeds or oil unless it also receives adequate evidence that FDA deems the ingredient generally recognized as safe (GRAS) for food

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