In a non-public letter sent earlier this week, the US Department of Health and Human Services (HHS) recommended to the US Drug Enforcement Administration (DEA) that marijuana be re-classified under the Controlled Substances Act (CSA) from Schedule I to Schedule III. The recommendation is a key first step to changing the legal status of marijuana
We’ve written previously about FDA’s denial of three petitions requesting that the agency issue a regulation that would allow cannabidiol (CBD) products to be marketed as dietary supplements. FDA also issued a call for a legislative fix to allow broader access to CBD products, stating that it did not consider existing dietary supplement and conventional
Section 201(ff) of the FD&C Act defines dietary supplements to exclude products that contain active drug ingredients (ie, ingredients that have been approved under section 505 of the FD&C Act or have been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such
The House has passed a revised version of the Medical Marijuana and Cannabidiol Research Expansion Act, HR 8454, sending it back to the Senate for action. With previous bipartisan approval, the legislation is expected to soon head to the President’s desk. The bill is a critical step forward in federal legalization and regulatory science of
At the federal level, multiple agencies have oversight over the marketing, sale, distribution, and transportation of hemp-derived CBD products. The chart below offers a high-level summary of these federal agencies’ current positions on products containing hemp-derived CBD.
Note that we intend this chart to provide general insights based on public commentary, enforcement actions and guidance
Interest in cannabis is at an all-time high. In 2020, Americans bought $18.3 billion in cannabis products, a $7.6 billion increase from 2019. The surging popularity of the plant is running parallel to the move towards legalized cannabis. With the removal of hemp from the CSA controlled substance list, and as ever more jurisdictions broadly
The Bankruptcy Court for the District of Colorado has issued another decision with ramifications for debtors in the cannabis industry by dismissing the chapter 11 cases of United Cannabis Corporation (UCANN) following assertions that UCANN was not merely a producer of hemp-CBD products but also involved in the marijuana industry. On January 12, 2021, Judge
The US Hemp Production Handbook offers a high-level, concise overview of the basic rules and regulations for producing hemp in the United States.
This handbook highlights commonalities and distinctions between State/Tribal Plans and the Federal Plan. Among other topics, the handbook addresses disclosing land information, sampling and testing hemp crops, and disposing of non-compliant plants.
In this inaugural article we will introduce each type of intellectual property protection and set out some preliminary questions raised by the legalization of hemp. In the series of posts which follow, we will explore the answers to those questions and continually update those answers as the hemp and CBD regulatory and legal landscape continues
The hemp industry is growing on a global scale with many private equity groups, investors, venture capitalists, industry leaders, and established corporations seeking to take advantage of consumer and commercial opportunities in this industry. However, many hemp producers, investors, and corporations alike worry about complying with the hemp regulations since there is an inconsistent patchwork
