Across states, lawmakers often embrace “medical” marijuana as a precursor to establishing a “recreational” marijuana market. Although marijuana remains illegal at the federal level — and would remain illegal even under the...more
The United States Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking to reschedule marijuana from schedule I of the Federal Controlled Substance Act (“CSA”) to schedule III. As a reminder,...more
The Drug Enforcement Administration (DEA) will call for cannabis to be rescheduled according to a report by the Associated Press. The anticipated rescheduling follows the Department of Health & Human Services’ (HHS) August...more
In an industry full of buzzwords, “adaptogens” and “nootropics” are current stand outs within the beverage industry. The beverage industry experienced a significant shift in consumer preference following the COVID-19...more
On February 22, 2024, FDA released a final guidance detailing how foods derived from genome-edited plants fall into FDA’s existing food safety framework and outlining two voluntary consultation processes for developers. The...more
Attend ACI’s 8th Advanced Summit on Food Law – Regulation, Compliance and Litigation and obtain the tools and techniques you need to meet the legal and regulatory challenges which the food industry is now facing as well as...more
Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year....more
Psychedelics have the potential to treat chronic conditions such as post-traumatic stress disorder (PTSD), depression, obsessive-compulsive disorder (OCD), fibromyalgia, and various behavioral health conditions, yet...more
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...more
On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more
Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more
Much attention has recently been placed on hemp-derived products marketed in packaging that mimics popular snack foods. Originally published in Law360 - August 15, 2023....more
The Ninth Circuit Court of Appeals recently heard oral argument in the case of Aggarwal v. U.S. Drug Enforcement Administration over whether the DEA’s process to consider controlled substances reclassification was unlawful...more
A year ago today on October 6, 2022, President Joe Biden asked the U.S. Secretary of Health and Human Services (HHS) and the U.S. Attorney General to initiate an administrative process to review how marijuana is scheduled...more
According to a report from the Congressional Research Service (the Report), the Drug Enforcement Administration (DEA) is likely to follow the Department of Health and Human Services (HHS) and the Food and Drug...more
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post....more
On June 23, 2023 the U.S. Food and Drug Administration (FDA) published a draft guidance document with foundational considerations for researchers that are developing psychedelic drugs for the treatment of medical conditions....more
On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more
The Food and Drug Administration (FDA) held a stakeholder call on May 25, 2023 to provide additional information related to the agency’s January 26 announcement that it believes a new regulatory framework for cannabidiol...more
While the state of the U.S. Food and Drug Administration’s (FDA’s) regulation of Cannabidiol (CBD) remains gray, the agency now sees a path forward through federal legislation. Here’s what companies in the cannabis industry...more
The U.S. Food and Drug Administration (FDA) has written a letter to the manufacturers and developers of new plant varieties, urging them to fully consider the potential ramifications of transferring the genes of allergens to...more
In February, the U.S. Food and Drug Administration (FDA) issued draft guidance describing its "current view" of how companies should name plant-based foods marketed and sold as alternatives to milk. In this hotly contested...more
The FDA is catching up with the increase in demand for plant-based milks that has occurred throughout the last ten years. There is no established standard for the compositional requirements of plant-based milk alternatives...more