Archive

The Legality of Distributing and Dispensing Botanical Cannabis under Schedule III

By Shawn Hauser, Daniel Molina, Andrew Livingston, Will Woodlee, Helen Ryan
Dec 16, 2025

This analysis examines the federal implications of reclassifying cannabis from Schedule I to Schedule III and its potential integration into the Drug Enforcement Administration’s closed system of distribution. Drawing on regulatory expertise from Vicente LLP and Kleinfeld, Kaplan & Becker LLP, the article evaluates how rescheduling would intersect with the Controlled Substances Act, the Food, Drug, and Cosmetic Act, and existing state cannabis frameworks. The authors assess the legal and operational barriers to prescribing and dispensing botanical cannabis, the feasibility of pharmacist involvement, and the constraints posed by FDA oversight of unapproved drugs.

What Can We Learn from the FDA's Warning Letters for Hemp-Derived Products?

By Shawn Hauser, Angela George, Genevieve Meehan
Nov 24, 2025

The FDA maintains that hemp-derived cannabinoids are not lawful food additives and has intensified enforcement against products making unapproved therapeutic claims, using unsafe or high-risk formulations, containing delta-8 in food, appealing to children through “copycat” packaging, or targeting pets and livestock. Recent warning letters reflect a clear shift toward stricter oversight across the hemp and cannabinoid sector. These measures highlight the rapidly evolving regulatory landscape and the need for companies to understand key enforcement themes from 2024–2025 and maintain strict compliance with federal and state law.

Vicente LLP Federal and International Cannabis and Psychedelics Law and Policy Update: November 2023

Nov 10, 2023

Federal and international law and policy insights, news and events from Vicente LLP.

US Officially Recognizes Medical Use and Safety of Cannabis: The Top 6 Things to Know About Schedule III and the Process Ahead

By Shawn Hauser
Aug 31, 2023

The federal government formally acknowledged the medical use and low potential of abuse for cannabis, with the US Department of Health and Human Services recommending that cannabis be rescheduled to Schedule III under the Controlled Substances Act. While placement in Schedule III still criminalizes commercial cannabis activity at the federal level, it is a significant step on the path to ending prohibition. This rescheduling would eliminate the application of 280E tax penalties, reduce the level of criminal liability for cannabis-related activity, reduce barriers to research, legitimize the industry through gaining credibility and engagement by physicians and the medical community, and support a growing industry for the American economy.

[Webinar] Opportunities in the Functional Mushroom Industry

Jul 12, 2023

Mushrooms are having a moment! Watch this session to learn about current and future business opportunities in the growing world of adaptogenic and functional mushrooms.

Functional Mushrooms: The Difference Between Regulation as a Food, Food Additive, or Dietary Supplement

By Charles Alovisetti, Sahar Ayinehsazian
Mar 3, 2023

Given the wide variety of available functional/adaptogenic mushroom product forms, producers and consumers should be aware of the significant differences in regulations for food, food additives, and dietary supplements.

CBD Products Liability Lawsuits Could Be Revived After FDA Declines to Regulate Cannabidiol

By Catie Wightman
Feb 13, 2023

In recent years, several CBD companies faced product liability lawsuits brought by consumers. Many of these cases were dismissed without prejudice or stayed until the FDA takes action to regulate CBD products. Now that the FDA said it will not take action to regulate CBD, could these cases be revived?

[Webinar] FDA Punts CBD Regulation: What Does that Mean for Hemp Businesses?

Feb 9, 2023

The FDA decided not to regulate CBD, denied three citizen petitions requesting CBD rulemaking or other FDA action, and announced it is now up to Congress to step in. Watch this webinar and learn what this means for your hemp-derived cannabinoids business.

High-THC Hemp Edibles Are Dangerous and Potentially Deadly: A Cautionary Tale in Minnesota

By Andrea Golan
Jan 6, 2023

Minnesota hemp companies are being sued by the Minnesota Board of Pharmacy for selling high-THC hemp-derived edibles that allegedly contained 100 milligrams of hemp-derived THC per gummy bear and were intentionally marketed in a manner that is appealing to children. What standards may lower consumer safety risks for these products?

Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products

By Catie Wightman, Michelle Bodian
Nov 30, 2022

On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets.

President Biden's Cannabis Scheduling Directive: Part 3

By Shane Pennington
Nov 9, 2022

What outcomes are possible from the impending administrative process to reconsider cannabis’s schedule I status? What are the implications of those various possible outcomes? And how should we all proceed in light of it all?

President Biden's Cannabis Scheduling Directive: Part 2

By Shane Pennington
Oct 21, 2022

To appreciate the gravity of the President’s scheduling directive and what could happen next, you need to understand (1) how the administrative process the President has set in motion will actually work and (2) how the agencies in charge have used it to affirm and reaffirm cannabis’s schedule I1 status repeatedly throughout the Comprehensive Drug Abuse Prevention and Control Act of 1970’s (“CSA”) history. Those topics are covered in this article. 

President Biden's Cannabis Scheduling Directive Is a Game Changer

By Shane Pennington
Oct 21, 2022

President Biden’s scheduling directive is enormously important. In fact, if permitted to run its course, it could revolutionize federal drug control law to a far greater degree than any of the many pending cannabis legalization bills.

FDA Enforcement Continues Against Companies Making CBD Product Claims

By Catie Wightman, Ariane Beckman
Aug 11, 2022

The FDA is cracking down on companies making unlawful drug or disease claims about their products relating to CBD by recently issuing several warning letters to address these compliance violations.

Vicente Sederberg LLP Hemp Update: July 2022

Jul 28, 2022

Update on hemp-related legislation and rulemaking, regulatory changes, and other noteworthy hemp news and events.

[Webinar] Intoxicating Cannabinoids: The Science and the Law

May 17, 2022

Watch this VS live session for a timely discussion exploring intoxicating hemp-derived products.

FDA Enforcement Action Targeted at Hemp-Derived Delta-8 Products

By Michelle Bodian, Shawn Hauser, Catie Wightman
May 5, 2022

For the first time ever, the FDA issued warning letters to companies selling products containing hemp-derived Delta-8 THC. Notably, this is the first time the FDA has specifically enforced against Delta-8 products. Read this for key takeaways from these warning letters.

Vicente Sederberg LLP Hemp Update: April 2022

Apr 4, 2022

Update on hemp-related legislation and rulemaking, regulatory changes, and other noteworthy hemp news and events.

FDA Warns CBD Companies Making COVID-19 Claims: 7 Key Takeaways from the Latest CBD Product Warning Letters

By Michelle Bodian, Jace Pohlman
Mar 30, 2022

The FDA and FTC are working together to target fraudulent COVID-19 claims made by CBD companies. Seven CBD product companies received warning letters. Read this article for a look into what to do—or not do—to avoid a warning.

SXSW 2022 Panelpicker is Open! Vote for 'Sue 'n the DEA: Breaking the 50-Year NIDA Monopoly'

Aug 25, 2021

Vote for the panel "Sue 'n the DEA: Breaking the 50-Year NIDA Monopoly," featuring Shane Pennington to be included in SXSW 2022!

sxsw

Aug 25, 2021

Vote for the panel "Sue 'n the DEA: Breaking the 50-Year NIDA Monopoly," featuring Shane Pennington to be included in SXSW 2022!

What is the FDA saying about Full Spectrum Hemp? Key Takeaways from Rejections of NDINs

By Shawn Hauser
Aug 25, 2021

Recent NDIN notification objections from the FDA give us more insight into the agency's factors differentiating "full spectrum" hemp from CBD.

Andrea Golan Featured in INCBA CLE: Hemp 201 — FDA and the Marketing of CBD Products

Aug 11, 2021

With a new Administration and Congress, changes in personnel at FDA, and new safety data being published, is 2021 the year when CBD will come out from under the FDA shadows to be legally marketed in all 50 states?

Understanding the Shifting Trends of State and Federal CBD Laws and Regulations

By Shawn Hauser
Jul 22, 2021

In this article, we’ll look at the history of CBD regulation in the United States, the trends that are dominating CBD regulation in 2021, and some of the state-specific regulations in the largest states.

Epidiolex Was Removed from the CSA. Now What?

By Corey Cox
May 28, 2020

The CBD-based medicine, Epidiolex, was descheduled by the DEA and is no longer a controlled substance. What are the implications of this change and what, if anything, does it mean for CBD products in general?