On November 12, President Biden announced his intention to nominate Dr. Robert Califf as Commissioner of the U.S. Food and Drug Administration (“FDA”). Dr. Califf, a cardiologist, previously served as FDA Commissioner in the Obama Administration between February 2016 and January 2017. Califf is currently a professor of medicine at Duke.

The FDA has been without a permanent head since January 2021. For the past 10 months, the agency has been helmed by Acting Commissioner Janet Woodcock, who joined the FDA in 1986. In announcing Califf’s nomination, President Biden applauded Acting Commissioner Woodcock and her staff’s dedication during a “busy and challenging” time for the agency and noted that the agency would continue “its science and data driven decision-making” during this “critical moment” under Califf.

If confirmed, Califf would join the FDA as it prepares for further work in the face of the pandemic and supply-chain issues. Califf’s confirmation hearings could provide insights on his views on cannabidiol (“CBD”) and other issues facing the food and beverage industry.

Earlier this month, the FDA released a seven-page plan to accelerate its research into the safety of cannabis-derived products. The plan follows two reports to Congress last year (which the Perkins Coie Cannabis Industry Group has previously written about here and here) on the safety and labeling of products containing cannabidiol (CBD) and a public statement from outgoing FDA leadership in early 2021 seeking better data for a better understanding of CBD safety. For those in the industry hoping that this latest FDA announcement is the agency’s long-awaited CBD enforcement guidance, the wait continues. Instead, the FDA recognizes that “the growth of the [cannabis-derived product] market continues to outpace the growth in the science and our understanding of the public health implications of these products.”

Before issuing new rulemaking and guidance, the FDA’s new data acceleration plan notes that the agency “needs a better understanding of the quality and safety systems that are currently in place across the overall supply chain from origin, manufacturing, and distribution to consumer usage” with regard to products derived from cannabis. According to the agency, the market for these products is “fragmented and dynamic” “with hundreds of small manufacturers selling products online,” and is “rife with potential quality and safety concerns.” Continue Reading FDA Releases Plan to Obtain Data Regarding Cannabis-Derived Product Usage & Safety


State Attorneys General (AGs) play a central role in enforcing cannabis laws and protecting consumers. As legalization continues to sweep the country, the interplay between state and federal law demands particular attention. In this edition of The 411 on 420, Perkins Coie senior counsel Andrew Kline discusses the role of the State AGs with Austin Bernstein, Director of the Cannabis Project at the AG Alliance and an Assistant AG in Colorado. Austin shares background on the bipartisan nature of the AG Alliance and how private sector groups can engage with AGs on cannabis issues.

Listen to “The Role of State AGs in Cannabis Policy and Regulation: A Conversation with Austin Bernstein – Episode 16” on Spreaker.

Note that all episodes are available on Apple, Google and Spotify.

To say that the United States has a complicated relationship with hemp is an understatement. In this edition of The 411 on 420, Perkins Coie partner Barak Cohen discusses hemp’s complicated past and promising future with Eric Steenstra, founding member of the Hemp Industries Association, Vice President of the California Hemp Council and President of Vote Hemp, the political advocacy organization that he co-founded in 2000. Eric shares insights on how the industry was able to self-regulate prior to the Farm Bill, how the passing of the Farm Bill resulted in a lawsuit against the DEA, and the future of the industry.

Listen to “Delta 8, CBD, 1% THC, and Other Issues Affecting the Hemp Industry: A Conversation with Eric Steenstra – Episode 15” on Spreaker.

Note that all episodes are available on Apple, Google and Spotify.

Late last evening, the U.S. House of Representatives passed SAFE Banking legislation by voice vote, offered as an amendment to the National Defense Authorization Act (NDAA/H.R. 4350). While SAFE Banking legislation previously passed in the House, it had stalled in the Senate due to Republicans’ demands for changes that would have transformed the bill from one offering protection to financial institutions in the cannabis industry, to one enacting additional guardrails on federal marijuana policy. SAFE Banking legislation’s inclusion in a must-pass bill this time around marks a critical step in the effort to enact this legislation this Congress.

What is SAFE Banking legislation?

The SAFE Banking amendment would enable financial institutions to support the cannabis industry by eliminating two major risks of adverse government action. The proposed law explicitly permits financial institutions to do business with cannabis companies and prohibits the government from terminating or limiting a financial institution’s deposit or share insurance solely because the institution works with a cannabis business. These changes would remove current federal restrictions that have resulted in only a limited number of financial institutions currently willing to take on the risk of banking cannabis companies. And those that do charge exorbitant fees and costs that foreclose the services to many—predominately impacting small and diversity-owned entities. As a result, the economic development of all cannabis industries, and especially small and diversity-owned entities, has been impeded through reduced liquidity, heightened entry barriers, and heightened security issues for some businesses forced to depend upon cash transactions. Continue Reading U.S. House Votes SAFE Banking Legislation into Defense Bill

Earlier this month, California legislators passed a law, AB 45, aimed at providing guardrails for an expanded consumer marketplace for products containing hemp and hemp-derived cannabidiol (CBD) in California. Given that the bill will take effect immediately following Governor Newsom’s signature, cannabis businesses, and businesses looking to add hemp to their products, should take note of the new law. With the new law’s passage, many hemp-derived CBD products will be able to enter the market legally in California.  Here are five key takeaways from AB 45 for the cannabis industry. Continue Reading Five Takeaways From California’s New State Industrial Hemp Bill

In this edition of The 411 on 420, Perkins Coie partner Megan Morrissey was joined by Nancy Whiteman (CEO of Wana Brands), Gail Rand (CEO and Founder of grand consulting), and Allison Pugina (Category Manager of Canopy Growth Corporation) to discuss product development and branding strategies within the cannabis industry.  As co-authors of the recently-released white paper series entitled “Building New Foundations in the Cannabis Industry: Creating Gender Parity through Ownership, Leadership, Boards, Pay Equality, Branding, and Capital”, the group specifically discusses how cannabis companies can thoughtfully market to the female consumer base and increase overall revenue.

Listen to “Actionable Insights for Winning Product Development and Branding Strategies – Episode 14” on Spreaker.

Note that all episodes are available on AppleGoogle and Spotify.

Millions of Americans are utilizing medical cannabis and psilocybin to treat specific medical conditions each day. However, scientific and medical research lags in the U.S. lags behind other nations. Dr. Stephen M. Dahmer, Chief Medical Officer at Vireo Health, and Betty Aldworth, Director of Communications and Events at the Multidisciplinary Association for Psychedelic Studies (MAPS) join Perkins Coie senior counsel Andrew Kline to discuss the current dilemma and a path forward. During the podcast, the group discusses the current state of cannabis and psilocybin research, the barriers faced by researchers, and why it is critically important to have people who understand the science involved in policymaking.

Listen to “The Future of Cannabis and Psilocybin as Plant-Based Medicine: A Conversation with Stephen Dahmer and Betty Aldworth – Episode 13” on Spreaker.

Note that all episodes are available on AppleGoogle and Spotify.

While most people are discussing federal legalization of cannabis these days, the industry operates at a local level and the role of state-level cannabis associations is crucial. Perkins Coie associate Michael Bleicher is joined by Truman Bradley, Executive Director of the Marijuana Industry Group (MIG), the oldest and largest trade association in Colorado for the legal cannabis industry. During the podcast, Michael and Truman discuss how cannabis regulation currently varies all the way down to the city level and whether a one-size-fits-all approach to federal legalization would be effective or if a more nuanced approach is needed. Truman also shares his thoughts on how the pandemic has impacted the cannabis industry in Colorado. Continue Reading The Role of State-Level Cannabis Associations: A Conversation with Truman Bradley

Last week, Senators Schumer (D-NY), Booker (D-NJ), and Wyden (D-OR) circulated a discussion draft of the Cannabis Administration and Opportunity Act, a legislative proposal to deschedule and legalize cannabis.  In related statements to the Senate, Senator Schumer emphasized that cannabis legislation will be prioritized during this Congress, stating “it’s time to end the federal prohibition on marijuana [a]nd as majority leader, I am going to push this issue forward and make it a priority.”

While there is much to explore in the bill’s 163 pages, here are five immediate takeaways for the cannabis industry. Continue Reading Senators Propose Cannabis Descheduling Plan: Five Takeaways for The Cannabis Industry