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On May 16, the Drug Enforcement Administration (“DEA“) published its 92-page notice of proposed rulemaking (“NPRM“) to move marijuana from schedule 1 on the Controlled Substances Act (“CSA”) to schedule 3 (ironically, the proposed rule itself only takes up a couple of paragraphs on the last two pages of the NPRM). On the same day, the DEA released an opinion from the Office of Legal Counsel (within the Department of Justice (“DOJ”), which prepares legal opinions of the U.S. Attorney General “and provides its own written opinions and other advice in response to requests from the Counsel to the President, the various agencies of the Executive Branch, and other components of the Department of Justice”) in response to questions from the U.S. Attorney General’s office about schedule 3 marijuana (the “Opinion”). While the NPRM represents the proposed DEA rule that moves marijuana from schedule 1 to schedule 3, the Opinion is essentially the OLC’s roadmap for fending off legal and administrative challenges to this historic move.

The biggest legal shift in the cannabis industry in decades just occurred on the heels of the Drug Enforcement Administration’s (DEA) proposal today for cannabis rescheduling. Specifically, as many anticipated, the DEA will exercise its authority to reschedule cannabis from a schedule I controlled substance to a schedule III controlled substance on the Controlled Substances Act (CSA). This cannabis rescheduling comes in part from the recommendation of the Department of Health and Human Services to reschedule cannabis from a I to a III on the CSA. The DEA’s proposal must now go before the White House Office of Management and Budget (OMB) for review and approval. The OMB’s primary functions relate to budget formulation and execution, legislative coordination and clearance, executive orders and proclamations, information and regulatory affairs, and mission-support areas and management initiatives. OMB will very likely review this DEA proposal for budget impact, regulatory impact, and legislative coordination.

In November of last year, we wrote about how Total Wine & More jumped into the cannabis drinks arena in Minnesota. Since then (and probably before that), there’s been an influx of “THC Beverages” hitting the marketplace, and I don’t mean the state-licensed cannabis marketplace either. At this point, you can buy these drinks online or in person at a number of retail outlets and locations that don’t have any kind of state cannabis licensing at all (here’s one in Alabama, for example). How, you may be asking, is this legally possible and why are these libations picking up great speed with consumers?

Between LinkedIn, Twitter, the media, and diehard marijuana investors, there is more noise and froth in the industry about a marijuana reschedule than I’ve seen since Washington and Colorado legalized it back in 2012. When speculation about the Feds starts to explode in the industry, I usually ignore most of it as fairly useless hearsay backed by a lot of hope, negativity, and/or hypotheticals.

This time, the tea leaves surround the number one question in the industry, will there be a 2024 marijuana reschedule from the Drug Enforcement Administration (DEA) on the back of the Department of Health and Human Services (HHS) schedule III recommendation? Namely, is a marijuana reschedule imminent that could change the entire course of success for the industry?

In October 2022, President Biden asked the Department of Health and Human Services (HHS) and the Attorney General to review how marijuana is scheduled under federal law. In August 2023, the HHS marijuana recommendation went to the Drug Enforcement Administration (DEA). In October 2023, HHS released a heavily redacted copy of its recommendation to DEA. And until last Friday, no one outside of Bloomberg News and choice government insiders had seen the totality of the HHS marijuana recommendation. However, thanks to a Freedom of Information Act legal battle by lawyer Matt Zorn, the public can now see all 252 pages of (and related to) HHS’s marijuana recommendation to DEA.

As the cannabis industry continues to navigate choppy economic and legal waters into 2024, some cannabis companies are pivoting to the smokable herbs market. And I do not mean to those hemp-derived intoxicating cannabinoids (HDIC) either (which are part of a legally precarious loophole anyway depending on who you ask). The smokable herbs to which cannabis companies and entrepreneurs are turning to are things like wormwood, valerian, tarragon, and mugwort (among others). Of course, these smokable herbs face a different set of legal and compliance issues altogether than hemp and/or cannabis do.

Many states with cannabis legalization have manufacturer and dispensary licensees that make and sell cannabis-infused beverages and even cannabis-infused drink mixes. What you don’t usually see is a major liquor retailer carrying any form of cannabis drink. Why? First, states with cannabis legalization on the whole ban alcohol and cannabis being mixed together in a single beverage, and, second, major liquor retailers won’t bother getting a state cannabis license due to a multitude of legal issues, including federal law and how it conflicts with cannabis negatively impacts alcohol licensing. However, Total Wine & More (“Total Wine”) is breaking the mold by offering cannabis drinks in Minnesota.

Creating further confusion and uncertainty in the hemp derived cannabidiol (CBD) markets, the FDA has determined that the existing regulatory frameworks for food and supplements are not appropriate for CBD. The FDA cited various safety concerns as the impetuous in making this determination.

“FDA has concluded that a new regulatory pathway for CBD is …

The Federal Trade Commission (“FTC”) has joined the U.S. Food and Drug Administration (“the “FDA”) in enforcing laws related to marketing CBD products. The FDA has historically issued warning letters and pursued companies that illegally market CBD products with claims the products may treat medical conditions.  The FTC has joined the FDA is this pursuit and announced settlements with six different CBD companies involves fines ranging between $20,000-$85,000 in addition to notifications provided to consumers.  Pursuant to these settlement agreements the respondent companies are also prohibited from similar marketing efforts in the future, any health claims must have scientific evidence to support them.

Industry actors making any health or therapeutic claims are vulnerable to action by agencies such as the FDA and FTC, however, they may also be subject to civil suits based on enforcement by those agencies. In April of 2020 Charlotte’s Web Holdings, Inc. (“CWB”) was served with yet another (its second) class action lawsuit due to how their products are labeled. Benson v. Charlotte’s Web Holdings, Inc., No. 1:20-cv-00418 (N.D. Ill.)  The suit based a significant portion of the allegations on FDA guidance:

 “Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement”

Companies facing enforcement actions by the FTC may similarly be subject to civil allegations.

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