Tag: Medical marijuana

The federal government has decided to move toward marijuana rescheduling.  So what’s next and how long until it done?

The Drug Enforcement Agency (DEA) has agreed with Health and Human Service’s (HHS) recommendation for cannabis to be rescheduled to Schedule III, with Schedule III drugs defined as having a moderate to low potential for physical and psychological dependence (Schedule III drugs include ketamine, anabolic steroids, and testosterone). This rescheduling will have a significant impact on state-legal cannabis businesses, but some uncertainty remains. Once the DEA publishes its proposed rule, it will be reviewed by the White House Office of Management and Budget (“White House”) and if approved, it would then proceed to a public comment period. Notably, the DEA could reschedule cannabis by issuing a final order and bypass the notice and comment period which would allow the change to become effective 30 days after publication in the Federal Register.

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However, it seems certain that the DEA will elect to do so by proposed rule, which is followed by a comment period of between 30-90 days. This comment period will be followed by a formal administrative hearing if requested, which rescheduling opponents will most certainly want, along with a flood of comments ranging from why cannabis should remain in Schedule I to why it should not be rescheduled lower than Schedule II. While rescheduling to Schedule III is almost certain, it is critical that proponents submit comments as well in order to ensure a robust record supporting marijuana’s reclassification.

Once the comment period and administrative hearing have concluded, the DEA will review the entire record and issue its final rule based on its analysis, HHS’ analysis, the comments submitted, and the administrative hearing record. The timeframe for issuing a final rule is uncertain and not statutorily defined, but since the DEA is required to review and respond to every comment submitted during the notice period, it could take some time.

Whether the DEA goes straight to issuing a final order or allows notice and comment, after the final decision/order is issued, it will not become effective until 30 days after it is published in the Federal Register. During this time, an aggrieved party that participated in the notice and comment period has 30 days to file a lawsuit to seek judicial review of the agency’s decision. In the event of a lawsuit, it is possible the effective date of the reclassification is delayed by a court order.

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Federal Regulations

Cannabis rescheduling is likely to inspire further federal regulations, but the nature of said regulations is uncertain. Since 2009, during the Obama administration, the federal government has declined to enforce federal law against the overwhelming majority of state compliant marijuana businesses. The federal government’s reluctance since the 2013 Cole Memorandum continued despite the DOJs enforcement guidance being rescinded during the Trump administration. It is possible we will see the DOJ reissue another enforcement memo. While it is still uncertain, enforcement action may follow cannabis rescheduling in an attempt to form a more cohesive national industry. For example, rescheduling cannabis to Schedule III may push the FDA to enforce against false and misleading drug claims as it has for hemp products. The DEA would continue to regulate cannabis as it had under Schedule I, however, they could now require dispensaries to conform to pharmacy regulations and the significant requirements associated with such. It is unclear but unlikely that the DEA will enforce pharmacy requirements upon state-legal dispensaries, since the difficulties and required resources associated with such enforcement will likely be too burdensome for the DEA immediately following rescheduling.

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The FDA may also become more involved in the regulation of cannabis, particularly concerning cannabis products’ dietary supplements and conventional food claims. While regulatory clarity would be welcome, we must be careful as to over-regulating the various cannabinoids (or compounds found in cannabis). It is likely that the FDA receives an influx of new drug applications following cannabis rescheduling, as FDA approval of any specific cannabinoids as drugs may be quite valuable. However, since FDA-approved medications cannot typically be legally added to conventional foods or dietary supplements, FDA approval of certain cannabinoids would create a complicated regulatory environment and spur subsequent consumer confusion (similar to the FDA’s approval of CBD in the form of Epidiolex).

Timeline

As for the timing of the rescheduling process, it will not happen overnight. Following approval by the White House, the DEA will likely initiate a public comment period. While this comment period itself will likely last from 30 to 90 days, the overall rescheduling process may take much longer. A previous drug rescheduling via rulemaking, for Hydrocodone Combination Products, took years to fully reschedule (though the timeline from HHS’ recommendation to the new rule taking effect was within one year). Following the quick turnaround by HHS to recommend cannabis rescheduling, it is possible that the DEA publishes its final rule as early as 2024.

Terran Cooper is a regular contributor to The Fresh Toast.  He is part of Falcon Rappaport & Berkman LLP. This article was developed in part with the help of Andrew Cooper and Matthew Foreman.

The Cannabis world is going through another big change with the potential of rescheduling – but what does it really mean?”

The Fresh Toast – The cannabis world is going through another major change, so what is the future of cannabis after rescheduling?

The Drug Enforcement Administration (DEA) is moving for cannabis to be rescheduled. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August 2023 recommendation, based on scientific support for the rescheduling from the FDA, that cannabis be rescheduled under Schedule III of the Controlled Substances Act. Cannabis has remained a Schedule I substance since it was originally “temporarily” classified as such by the Controlled Substances Act of 1970. Schedule I drugs are defined as having no currently accepted medical use and a high potential for abuse, with other Schedule I drugs including heroin and LSD (despite cocaine, fentanyl, and other potentially dangerous drugs being in less restrictive drug schedules). The status of cannabis as a Schedule I drug has long been criticized, particularly as more and more U.S. states legalized cannabis for medical and recreational use.

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From a consumer standpoint rescheduling will not actually legalize cannabis. At least not in a way forcing States in which cannabis is currently prohibited to immediately change course as a direct result of rescheduling. Instead, those States are likely to continue cannabis prohibition (though this momentous step may influence further states to legalize). Similarly, states with state-legal cannabis programs will likely not immediately change from a consumer perspective, although further regulation or even a reduction in product pricing due to cannabis no longer being subject to section 280E of the Internal Revenue Code (discussed in detail below) may soon follow.

There is more going on the business side with rescheduling. Falcon Rappaport & Berkman LLP has reviewed the process and outcomes.

Taxes

The most significant consequence of cannabis rescheduling will be the immediate removal of cannabis from the reach of I.R.C. Section 280E, which is arguably the greatest burden on state-legal cannabis operators. Section 280E prohibits cannabis businesses from writing off many business expenses when calculating their net profit, which has resulted in vastly higher taxes as compared to similar non-cannabis businesses. Instead, section 280E only permits a deduction for the Cost of Goods Sold (COGS) for any business trafficking in any controlled substances (i.e., drugs listed on Schedule I or Schedule II). Despite cannabis businesses operating under state-legal programs, they are considered “trafficking” and cannot take ordinary business deductions. Allowing cannabis businesses to deduct all ordinary and necessary business expenses, and not just COGS, will help to even the playing field with nearly every other legal business.

Federal Illegality

As discussed from a consumer standpoint, rescheduling cannabis does not affect the overall federal illegality of cannabis. This means that state-legal cannabis businesses will not automatically be federally legal, as their federal illegality will continue under Schedule III. While Schedule III drugs may be legally prescribed and sold under federal law, the various restrictions (such as requiring FDA approval of any such Schedule III drug and DEA registration of a distributor) mean that your average dispensary, even medical dispensaries, will still be federally non-compliant.  For these same reasons, the reclassification to Schedule III does not mean that marijuana grown pursuant to state programs can be sold in interstate commerce. Marijuana products, even under Schedule III, are only federally legal if they are federally approved and there are only three FDA-approved cannabis-based drugs developed to date (Marinol, Epdiolex, and Syndros).

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Intellectual Property & Cannabis Trademarks

The United States Patent and Trademark Office (USPTO), the agency tasked with examining federal trademark applications, has generally required use of a mark to be lawful under federal law in order to receive federal trademark registration under the U.S. Trademark Act (see Examination Guide 1-19). The federal illegality of cannabis has thus prevented trademark registration in connection with most cannabis products. Unfortunately, cannabis rescheduling will not remedy this issue. Even in Schedule III, cannabis products would have to be federally lawful, with lawful use of a Schedule III drug requiring FDA approval.

Entitlement to Federal Bankruptcy Protection 

Currently, plant-touching cannabis companies are not entitled to federal bankruptcy protection. That is because the U.S. Bankruptcy Code requires that bankruptcy plans are “proposed in good-faith and not by any means forbidden by law.” Since even state-regulated cannabis companies violate the federal Controlled Substances Act (CSA), they are disqualified. Unfortunately, rescheduling to Schedule III of the CSA alone will not likely solve that barrier to bankruptcy. While some have argued otherwise, the fact is that to manufacture, distribute, or dispense a Schedule III Controlled Substance, businesses must be registered with the Drug Enforcement Administration (“DEA”). Any business or person not registered with the DEA is not authorized to manufacture, distribute, or dispense it. Meaning that violations would likely constitute an unlawful act under the CSA. Consequently, an attempt by the non-complying business to commence a voluntary petition seeking federal bankruptcy protection will likely result in a motion to dismiss the case by the U.S. Trustee’s Office.

However, in light of a recent trend among bankruptcy court’s in allowing ‘one-step-removed’ distribution of cannabis-related assets, federal rescheduling may very well result in a more liberalized approach to administering bankruptcy cases so that bankruptcy judges will be more willing to look past the issue of marijuana’s federal illegality.

Status Quo

There are several aspects of the existing cannabis industry which would not be immediately changed by rescheduling cannabis to Schedule III. Ongoing banking issues including the lack of access to standard commercial bank loans and lines of credit would likely persist; difficulties in processing cannabis transactions due to the reality that major credit card companies like Visa, Mastercard and others will likely still not service marijuana businesses; general federal illegality; and the criminalization of cannabis (and continued incarceration of certain offenders) in prohibitive states would remain following rescheduling.

While many had hoped for the de-scheduling of cannabis, the change in stance of the DEA, a longstanding adversary of cannabis reform, is no small feat.

Terran Cooper is a regular contributor to The Fresh Toast.  He is part of Falcon Rappaport & Berkman LLP. This article was developed in part with the help of Andrew Cooper and Matthew Foreman.