Cannabis: In Focus

  • FDA Rejects Citizen Petitions, Declines To Regulate CBD as a Dietary Supplement
  • Ninth Circuit Affirms Dismissal of Cannabis Company’s RICO Claims
  • Tenth Circuit Holds that 2018 Farm Bill Doesn’t Create Private Cause of Action for Hemp Farmers
  • US Virgin Islands Legalizes Recreational Cannabis


Continue Reading Cannabis Legal Report—Week of January 30, 2023

Cannabis: In Focus

  • New York City Attempts to Crack Down on Illicit Cannabis Market
  • Connecticut Launches Recreational Cannabis Sales, With More States Expected to Follow in 2023
  • Psilocybin State Updates
  • FDA Issues Three New Warning Letters to CBD Product Manufacturers Alleging COVID-19 Benefits
  • Congressional Research Service: Cannabis Banking and the Federal Reserve


Continue Reading Cannabis Legal Report—Week of January 23, 2023

As 2022 drew to a close, the Wall Street Journal reported that the FDA is finally considering releasing potential guidance regarding cannabidiol (“CBD”) in the coming year. While the exact timeline and scope of the FDA’s potential action is unclear, the Journal asserts that the agency will decide “within months” regarding the appropriate regulation of CBD and whether that regulation would require Congressional action or new agency rulemaking. Concurrently, the FDA continues to explore potential CBD safety risks.

The agency has generally pursued limited enforcement activity to-date regarding CBD, with a focus on products in foods and beverages that make unsubstantiated health claims, such as claims that CBD could treat or prevent cancer or Covid-19. Stopping short of taking aggressive action, the FDA has only issued warning letters on CBD, despite the widespread availability of largely-unregulated food and beverage products containing the hemp-derived cannabinoid.

Continue Reading Will The New Year Finally Bring FDA Guidance on CBD?

On November 16, 2022, the Food and Drug Administration (FDA) issued five new warning letters to various companies making edible products containing cannabidiol (CBD) and/or Delta-8-tetrahydrocannabinol (THC). The companies were directed by the FDA to respond within 15 days to defend how their products do not violate the Food, Drug, and Cosmetic Act (FDCA) and how they plan to bring their products into compliance with the FDCA. Failure to address the issue to the agency’s satisfaction could plausibly result in enforcement actions, including seizure and/or an injunction.

The FDA’s most recent set of warning letters builds upon warning letters sent earlier this year targeting CBD and Delta-8 THC products. Previously, FDA has largely focused on CBD products that made health claims. These new warning letters are not, however, limited to those prior concerns. The FDA now appears to be particularly concerned about CBD and Delta-8 THC products that appeal to children.

Continue Reading FDA Issues New Warning Letters to Companies Making CBD and Delta-8 THC Edibles

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