Tetrahydrocannabinol (THC)

On January 12, 2024, a 252-page memorandum from the U.S. Department of Health & Human Services (“HHS”) was publicly released. This memorandum, dated August 29, 2023, portends a potential monumental shift in the regulation of marijuana under federal law and recommends that marijuana be regulated under schedule III of the Controlled Substances Act (“CSA”). The

Cannabis: In Focus

  • VA Continues to Prohibit Doctors from Prescribing Cannabis to Veteran Patients
  • NY Judge Issues Court Order to Halt Cannabis Business Licensing
  • DEA Email Suggests DEA Considers Delta-8 THC a Controlled Substance
  • THC Testing Class Action Claims Proceed against Cannabis Company

Continue Reading Cannabis Legal Report – Week of August 14, 2023

On July 12, 2023, the U.S. Food and Drug Administration (FDA) released a public inventory of certain food ingredients that the agency has determined are unsafe because they are unapproved food additives that are not Generally Recognized as Safe (GRAS) when used as intended. FDA developed this inventory as part of its post-market surveillance of

Cannabis: In Focus

  • DEA Announces New Guidance for Synthetic Cannabinoids
  • Oregon To Hold Landowners Responsible for Illegal Cannabis Grow Operations
  • States Provide State-Level Tax Relief to Cannabis Businesses
  • D.C. Superior Court Rules Cannabis Odor Constituted a Nuisance
  • New Suit Alleges Illicit Cannabis Operations Harm State-Legal Retailers

Continue Reading Cannabis Legal Report—Week of June 19, 2023

Cannabis: In Focus

  • Coalition Forms To Influence Scheduling Review Process
  • FDA Holds Stakeholder Call on CBD Regulation
  • New York Cannabis Regulators Settle Cannabis Licensing Suit
  • Minnesota Legalizes Adult-Use Cannabis
  • Maryland Releases Adult-Use Cannabis Regulations

Continue Reading Cannabis Legal Report—Week of June 5, 2023

Cannabis: In Focus

  • Attorney General Garland Testifies Before Senate Judiciary Committee
  • Ninth Circuit Affirms Ruling that California County May Deny Licenses to Cultivate Cannabis
  • Oklahoma Recreational Cannabis Measure Fails
  • Medical Cannabis Patient Sues Arkansas Company for Inflating THC Levels

Continue Reading Cannabis Legal Report—Week of March 20, 2023

The U.S. Food and Drug Administration (FDA) recently released new guidance on sourcing and product quality to companies conducting clinical research related to the development of human drugs involving cannabis or cannabis-derived compounds. The agency’s nonbinding recommendations highlight potential opportunities for clinical researchers and sponsors of investigational new drugs after the 2018 Farm Bill significantly altered the regulatory landscape applicable to cannabis products.Continue Reading FDA Releases Guidance on Clinical Research into Cannabis-Derived Drugs

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

Earlier this month, the medical journal Pediatrics published a new study analyzing reports of accidental child exposure to cannabis edibles from 2017 – 2022, finding that the number of young children accidentally ingesting cannabis in the United States has increased consistently and significantly over the past five years. According to the study, children, especially those under age five, are at particular risk as they may not be able to distinguish between copycat tetrahydrocannabinol (THC) products and the well-known treats they resemble.

As we’ve written elsewhere, states impose strict restrictions on underage access to cannabis products in the licensed marketplace and generally prohibit marketing cannabis products to minors. The study’s findings emphasize the risks posed by copycat THC products and echo concerns raised by the U.S. Food and Drug Administration (FDA) in a 2022 consumer alert. The agency noted many “edible products are designed to mimic the appearance of well-known branded foods by using similar brand names, logos, or pictures on their packaging. These copycats are easily mistaken for popular, well-recognized foods that appeal to children.” As the FDA detailed, “accidental ingestion of these products can lead to serious adverse events, especially in children.”Continue Reading Preventing Accidental Exposure of Illicit Cannabis Products to Underage Consumers

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