Cannabis: In Focus

  • New Mexico class action calls for insurance coverage for medical cannabis
  • Bicameral attempt to legislate bipartisan cannabis omnibus package
  • Oregon ban on “artificially derived cannabinoids” in cannabis products set to take effect July 1, 2022


Continue Reading Cannabis Legal Report—Week of June 19, 2022

As the cannabis industry and its associated sectors have gained increasing social and legal acceptance, these businesses have started to face an issue that has been plaguing traditional Consumer Packaged Goods companies in the state of California for decades—Proposition 65 claims.

Proposition 65 is a California initiative approved by voters in 1986 and enacted into law as the Safe Drinking Water and Toxic Enforcement Act. The law requires California to publish a list of substances that are known to the state of California to cause cancer or reproductive harm. The law prohibits “knowingly and intentionally” causing exposure to one of the substances on the list without first providing a “clear and reasonable” warning. To comply with Proposition 65, businesses must provide consumers with a Proposition 65 compliant warning unless they can ensure that their product does not expose consumers to a listed substance at levels that may cause cancer or reproductive harm.

Continue Reading Prop 65 Plaintiffs Set Their Sights on Cannabis Industry

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

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

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

Today, the U.S. Federal Trade Commission (FTC) announced a settlement in its most recent law enforcement action in its ongoing efforts to monitor the marketplace regarding misleading cannabidiol (CBD) product claims. The action targets Kushly Industries LLC (Kushly) and the company’s sole officer for allegedly making false or unsupported health benefit claims about Kushly’s CBD product.
Continue Reading FTC Continues Crackdown on Unsupported CBD Marketing