Scarinci Hollenbeck, LLC, LLCScarinci Hollenbeck, LLC, LLC

Firm Insights

Will DEA Proposal Put Psychedelics on the Map or Not?

Author: Daniel T. McKillop

Date: October 13, 2021

Key Contacts

Back

The DEA is proposing a massive increase in the production quotas of cannabis, psilocin, and psilocybin (“magic mushrooms”) for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications…

The Drug Enforcement Administration (DEA) is proposing a massive increase in the production quotas of cannabis, psilocin, and psilocybin (“magic mushrooms”) for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications. The proposal highlights the growing acceptance that Schedule I substances like marijuana and psilocybin may hold great medical promise as therapeutics.

What Is Psilocybin?

Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi. Psilocybin and other psychedelics are on Schedule 1 of the federal Controlled Substances Act (CSA), just like cannabis. The designation is given to substances having “no currently accepted medical use and a high potential for abuse.”

Nonetheless, studies have shown that psilocybin has the potential to treat a variety of psychiatric and behavioral disorders, including depression, obsessive-compulsive disorder, smoking cessation, alcohol and drug addiction, cluster headaches, and cancer-related or other end-of-life psychological distress. Cancer-related psilocybin therapy is widely regarded as the most promising areas of research for the drug.

Given its potential benefits, efforts are underway to decriminalize the drug and make it easier to pursue further medical research. Decriminalization of psychedelics via local/municipal legislation is already gaining momentum.  Notably, New Jersey Gov. Phil Murphy signed legislation in February reducing penalties for possession of up to an ounce of psilocybin mushrooms by reclassifying the infraction to a disorderly person’s offense.

DEA Proposed Adjustments to Aggregate Production Quotas

Section 306 of the CSA requires the Attorney General to establish aggregate production quotas (APQs) for each basic class of controlled substance listed in schedules I and II and for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The Attorney General has delegated this function to the Administrator of DEA.

The DEA’s recent proposal calls for significant increases to the APQs of the schedule I substances psilocybin, psilocin, marihuana, and marihuana extract. According to the DEA, the proposed increases are “directly related to increased interest by DEA registrants in the use of hallucinogenic controlled substances for research and clinical trial purposes.” The proposal further states: “DEA firmly believes in supporting regulated research of schedule I controlled substances. Therefore, the APQ increases reflect the need to fulfill research and development requirements in the production of new drug products, and the study of marijuana effects in particular, as necessary steps toward potential Food and Drug Administration (FDA) approval of new drug products.”

While the DEA regularly adjusts APQs, the language used by the DEA is notable, as it expressly highlights the prospect of new drug products using the substances. The extent of the increases is also significant. The DEA is proposing to increase production of marijuana to 2 million grams (approximately 4,400 pounds), which represents a 500,000-gram increase from its initial APQ for 2021. The DEA is also seeking to manufacture 500,000 grams of cannabis extract, which is more than twice its original APQ. With regard to psilocybin and psilocin, production will also expand significantly under the DEA proposal. The APQ for psilocybin would increase to 1,500 grams, which is a 2,900 percent increase. The DEA is proposing to produce 1,000 grams of psilocin, up from its initial 2021 proposal of 50 grams.

What’s Next?

The DEA proposal was published in the Federal Register on September 2, 2021, and interested parties had 30 days to submit comments. Based on comments received in response to the proposal, the DEA Administrator may hold a public hearing on one or more issues raised.

While cannabis legalization continues to dominate headlines, psychedelics have the potential to be cannabis 2.0 – not because of their recreational use, but for their increasingly confirmed efficacy in medical treatment of mental health issues like PTSD, depression, anxiety (including end-of-life anxiety), and addiction, which may result in inevitable legalization. Scarinci Hollenbeck’s Cannabis Law Group is closely monitoring this rapidly evolving area of law.

If you have questions, please contact us

If you have any questions or if you would like to discuss the matter further, please contact Dan McKillop or the Scarinci Hollenbeck attorney with whom you work, at 201-896-4100.

No Aspect of the advertisement has been approved by the Supreme Court. Results may vary depending on your particular facts and legal circumstances.

Scarinci Hollenbeck, LLC, LLC

Related Posts

See all
The Current Administration's Proposals for the Financial Services and Banking Industries Will Affect Your Business post image

The Current Administration's Proposals for the Financial Services and Banking Industries Will Affect Your Business

Since his inauguration two months ago, Donald Trump’s administration and the Congress it controls have indicated important upcoming policy changes. These changes will impact financial services policies and priorities. The changes will particularly affect cryptocurrency, as well as banking rules and regulations. Key Regulatory Changes in Cryptocurrency For example, in the burgeoning cryptocurrency business environment, […]

Author: Dan Brecher

Link to post with title - "The Current Administration's Proposals for the Financial Services and Banking Industries Will Affect Your Business"
Tips for Commercial Landlords Impacted by Wave of Retailer Bankruptcies Part 1 post image

Tips for Commercial Landlords Impacted by Wave of Retailer Bankruptcies Part 1

The retail sector has experienced a wave of bankruptcy filings over the last year. Brick-and-mortar businesses in financial distress include big-name brands like Big Lots, Party City, The Container Store, and Vitamin Shoppe. When large retailers seek bankruptcy protection, they are not the only businesses impacted. Landlords can be particularly hard hit. While commercial landlords […]

Author: Brian D. Spector

Link to post with title - "Tips for Commercial Landlords Impacted by Wave of Retailer Bankruptcies Part 1"
How Understanding Bankruptcy Trends Can Benefit Your Business post image

How Understanding Bankruptcy Trends Can Benefit Your Business

The bankruptcy legal landscape presents both challenges and opportunities for businesses navigating financial distress. Understanding current bankruptcy trends can help businesses make more informed and strategic decisions. Corporate Bankruptcy Filings Trending Upwards Bankruptcy filings continued to trend upwards in 2024. According to statistics released by the Administrative Office of the U.S. Courts, personal and business […]

Author: Brian D. Spector

Link to post with title - "How Understanding Bankruptcy Trends Can Benefit Your Business"
SEC Takes Actions Against Issuers for Failure to File Form D post image

SEC Takes Actions Against Issuers for Failure to File Form D

In December, the U.S. Securities and Exchange Commission (SEC) announced charges against two privately held companies for failing to file a Form D notice, which is generally utilized for exempt securities offerings. Here, the SEC’s enforcement sends a strong message: compliance with regulatory requirements is not optional and failure to comply can have significant consequences. […]

Author: Kenneth C. Oh

Link to post with title - "SEC Takes Actions Against Issuers for Failure to File Form D"
Redefining Labor Relations: NLRB's Pivot from Abruzzo’s Memoranda post image

Redefining Labor Relations: NLRB's Pivot from Abruzzo’s Memoranda

On February 14, 2025, the Office of General Counsel (OGC) of the National Labor Relations Board (NLRB) under Acting General Counsel William B. Cowen issued Memorandum 25-05, “New Process for More Efficient, Effective, Accessible and Transparent Case handling.” The Memorandum rescinds nearly all of the Memoranda issued by his direct predecessor, Jennifer Abruzzo, setting the […]

Author: Matthew F. Mimnaugh

Link to post with title - "Redefining Labor Relations: NLRB's Pivot from Abruzzo’s Memoranda"
What Are FIRPTA Withholding Requirements? post image

What Are FIRPTA Withholding Requirements?

If you purchase real property from a foreign person or entity, you may be required to withhold taxes from your payment to the seller under the Foreign Investment in Real Property Tax Act (FIRPTA). The federal tax law is designed to ensure that foreign sellers pay any applicable capital gains tax on profits realized from […]

Author: Jesse M. Dimitro

Link to post with title - "What Are FIRPTA Withholding Requirements?"

No Aspect of the advertisement has been approved by the Supreme Court. Results may vary depending on your particular facts and legal circumstances.

Sign up to get the latest from our attorneys!

Explore What Matters Most to You.

Consider subscribing to our Firm Insights mailing list by clicking the button below so you can keep up to date with the firm`s latest articles covering various legal topics.

Stay informed and inspired with the latest updates, insights, and events from Scarinci Hollenbeck. Our resource library provides valuable content across a range of categories to keep you connected and ahead of the curve.

Let`s get in touch!

* The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

Sign up to get the latest from the Scarinci Hollenbeck, LLC attorneys!

Please select a category(s) below: