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On May 19, 2022, the U.S. Circuit Court of Appeals for the Ninth Circuit issued an opinion holding that Delta-8 THC products are legal at the federal level and eligible for intellectual property protection. The Ninth Circuit held that the “2018 Farm Bill was silent with regard to Delta-8 THC,” writing that “regardless of the wisdom of legalizing delta-8 THC products, this Court will not substitute its own policy judgment for that of Congress.” According to the Court, if the bill “inadvertently created a loophole legalizing vaping products containing delta-8 THC, then it is for Congress to fix its mistake.”

 The case involved two companies selling products both labeled under “Cake” branding. Manufacturer AK Futures argued that a competitor was selling counterfeit “Cake” Delta-8 THC products. The competitor did not contest that it was selling counterfeit “Cake” products, but instead it argued that AK Futures could not hold a valid trademark because Delta-8 THC was illegal under federal law.…

Continue Reading Ninth Circuit Rules on Legality of Delta-8 THC Products

On May 13, the FDA issued a public warning regarding reports of accidental ingestion of food products containing tetrahydrocannabinol (THC) by children. The FDA warned that edible products containing THC “can be easily mistaken for commonly consumed foods such as breakfast cereal, candy, and cookies, and accidentally ingested.” The agency was particularly concerned as some…

California enacted statute AB 45 in October 2021, authorizing the use of hemp and hemp-derived cannabidiol (CBD) in food, beverages, dietary supplements, and cosmetics at the state level. Now, state regulators have proposed new regulations to govern the state’s hemp-derived CBD market. Comments on the proposed regulations are due by May 31, 2022.

California’s proposed regulations primarily address new registration requirements for in-state industrial hemp manufacturers and out-of-state industrial hemp extract manufacturers. In-state manufacturers of extract, human foods (including beverages and dietary supplements), cosmetics and processed pet food products containing industrial hemp will need the appropriate registration for their respective products. Manufactures may be required to hold multiple registrations for each type of product manufactured if the proposed rule is adopted.…

Continue Reading California Proposes New CBD Regulations & Registration Requirements

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…

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…

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

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