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Barak Cohen

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Barak Cohen represents two kinds of clients: companies and individuals facing government enforcement actions and investigations in highly regulated industries, particularly the healthcare and government contracting industries, and companies that need strategic business advice regarding compliance and regulatory matters in the cannabis industry.

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Earlier today, May 4, 2022, the FDA issued warning letters to five companies selling products that contain delta-8 tetrahydrocannabinol (Delta-8 THC). Several of the companies also manufactured products containing hemp-derived cannabidiol (CBD). Significantly, today’s actions represent the first time the FDA has issued warning letters for products containing Delta-8 THC. According to the agency, “Delta-8 THC has psychoactive and intoxicating effects and may be dangerous to consumers,” and the FDA has received reports of adverse events after individuals consumed products containing Delta-8 THC.

Delta-8 THC is one of many cannabinoids produced in the cannabis plant, and it can have psychoactive and intoxicating effects. Products containing Delta-8 are available in numerous forms, such as edibles, extracts, and tinctures. Today’s five warning letters allege the companies violated federal law in the marketing of unapproved Delta-8 THC products as treatments for various medical conditions or for therapeutic use. The letters further claimed violations regarding drug misbranding and the addition of Delta-8 THC in food, such as gummies, chocolate, caramels, and chewing gum.…

Continue Reading FDA Issues New Warning Letters For Delta-8 and CBD Products

By a 50-46 vote, the Senate today confirmed Dr. Robert Califf as commissioner of the Food and Drug Administration (FDA). The narrow decision reflected opposition to the nomination by several Democratic senators, notably Joe Manchin, D-W.Va., who co-wrote a recent op-ed against Califf’s nomination. Six Republicans, including Susan Collins, R-Me., and Richard Burr, R-N.C., voted…

In July 2021, three Democratic senators—Cory Booker, Ron Wyden, and Majority Leader Chuck Schumer—distributed a discussion draft of the Cannabis Administration and Opportunity Act, a major bill promising sweeping reforms of cannabis regulation at the federal level, notably descheduling the substance under the Controlled Substances Act. The senators’ offices invited public comment from stakeholders. On…

Sheri Orlowitz

The discussion about federal regulation for the cannabis industry is complex. The Council for Federal Cannabis Regulation wants to ensure that federal regulations are informed by and grounded in science, best business practices, sound public policy, and social justice principles. Sheri Orlowitz, founder and chairman of the board of the Council for Federal Cannabis Regulation,…

Given that technology shapes, enhances, and intersects with nearly every aspect of our lives, it is unsurprising that e-commerce is emerging as a key component of the cannabis industry. Dutchie, a leading e-commerce platform with a particular focus on financial technology, is at the vanguard of this phenomenon. Dutchie General Counsel Lauren Thomas joins Perkins…

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

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…

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

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