On May 26, the FDA issued warning letters to four companies alleging that the companies sold unapproved animal drugs containing cannabidiol (CBD). Specifically, these products were intended for use in food-producing animals. In announcing the warning letters, the agency stated it was “taking steps regarding these unapproved and potentially unsafe products now to help protect animals and the safety of the food supply.”

The FDA’s latest set of warning letters builds upon the letters the agency has issued in recent years that highlight that CBD products are not approved for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Just this year, the agency issued at least 14 such letters targeting consumer products. These warning letters are unique as they target companies selling products targeted for food-producing animals, rather than those focused on human consumption.  

Continue Reading FDA Issues New CBD Warning Letters for Animal Products

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 products were specifically designed to mimic popular, well-recognized foods that appeal to children via similar brand names, logos, or pictures.

The FDA’s public warning reports that the agency has received over 100 adverse event reports involving children and adults who consumed edible THC products. Reportedly, these adverse events involved hallucinations, increased heart rate, and vomiting, and many of the children involved required medical intervention or hospital admission. The agency specifically noted that several of the adverse event reports were prompted following the consumption of products intentionally made to be a “copycat” of a popular food product.

The FDA is working with federal and state partners to address these concerns and monitor this emerging market. The agency further advised that consumers and health professionals report complaints and cases of accidental ingestion to its MedWatch Safety Information and Adverse Event Reporting Program.

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

Regardless of the industry, education and training your workforce is important. In the cannabis industry, it is critical and can significantly impact how consumers purchase cannabis moving forward. Perkins Coie associate Juan Fonseca Angel is joined by Maureen McNamara, Founder and Chief Facilitator of Cannabis Trainers, and Danny Gold, Co-Founder and CEO of ZolTrain an industry like cannabis, to discuss the importance of training both the workforce and the consumer. Maureen and Danny discuss the evolving regulatory framework that cannabis operators are currently working in and what best practices look like when it comes to consistently training their workforce. Juan also has our guests dig into how we educate the consumers and the role that the cannabis industry plays in ensuring a good experience with the product.

Listen to “Educating the Cannabis Industry: A Conversation with Maureen McNamara and Danny Gold–Episode 19” on Spreaker.

Note that all episodes are available on AppleGoogle, and Spotify.

On February 2, 2022, Republican Governor Tate Reeves signed the Mississippi Medical Cannabis Act, which legalizes medical marijuana for the treatment of certain debilitating conditions. Those debilitating conditions include, among others, cancer, Parkinson’s disease, HIV/AIDs, sickle cell anemia, Alzheimer’s disease, post-traumatic stress disorder, and autism. The law became effective immediately, making Mississippi the 37th state to legalize medical marijuana.

Read the full article on our update page.

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 to confirm. In the run-up to the confirmation vote, Senator Burr urged his colleagues to confirm Califf, arguing that the agency had gone more than a year without a permanent head.

Dr. Califf previously served as FDA commissioner during the Obama administration. In contrast to his narrow confirmation in 2022, his 2016 nomination for the same position was approved by a vote of 89-4. Prior to his confirmation, Dr. Califf served as the FDA’s deputy commissioner of Medical Products and Tobacco and as a cardiologist and professor at Duke University.

Dr. Califf joins the FDA as it prepares for further work in the face of the pandemic and supply-chain issues. Now with a permanent agency head, the FDA also faces calls to action regarding cannabidiol (CBD) in food and beverage products. Additionally, Congress is debating multiple proposals to deschedule and regulate cannabis at the federal level. If these proposals are enacted, the FDA, and Dr. Califf, would play a vital role in shaping the regulatory landscape concerning cannabis. We will continue to monitor developments affecting the industry.

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 February 10, 2022, these senators announced they had received over 1,800 stakeholder comments and circulated a “Dear Colleague” letter soliciting other senators to provide input, guidance, and advice before the formal introduction of the bill, which is expected in April.

In their letter, the senators argued that “the federal government has an important role to play” regarding cannabis. According to the senators, the discrepancy between state and federal law can lead to “confusion and uncertainty and raises significant questions around criminal justice reform, economic development and small business growth, and public health and safety,” all of which requires “some type of federal answer.” The senators concluded that the Senate is “long overdue” in addressing the implications of cannabis, and invited their colleagues to share their states’ experiences as the bill continues to take shape.

The Cannabis Administration and Opportunity Act is expected to be introduced in April 2022. In the weeks ahead, the senators plan to incorporate the comments received from stakeholders and aim to make the bill “as reflective of as many relevant views and voices as possible.”

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, joins Perkins Coie partner Barak Cohen to discuss how additional regulatory oversight can benefit the cannabis industry. Sheri brings more than 30 years of experience as an entrepreneur, venture capitalist, turnaround expert, board director, corporate leader, attorney, and former federal prosecutor. Among other things, Barak and Sheri discuss the ongoing debate as to whether the U.S. Food and Drug Administration (FDA) or the Alcohol and Tobacco Tax and Trade Bureau ought to have primary oversight over cannabis and the potential benefits that could be available as a result of federal regulation.

Listen to “Research and Regulation for the Cannabis Industry: A Conversation With Sheri Orlowitz – Episode 18” on Spreaker.

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