Tetrahydrocannabinol (THC)

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

  • Election Round-up: Two States Approve, Three Reject Adult-Use Cannabis Referendums
  • Northern District of New York Rules on Dormant Commerce Clause and Adult-Use Retail Licenses in New York
  • Kansas Federal Court Dismisses Hemp Seizure Suit
  • Federal Court Dismisses Florida Lawsuit Seeking Gun Rights for Medical Cannabis Patients

Continue Reading Cannabis Legal Report – Week of November 14, 2022

Cannabis: In Focus

  • Cannabis Testing Companies Facing State Regulatory Scrutiny in Nevada and Florida
  • FDA Appoints Former State Cannabis Policy Regulator as New Cannabis Advisor
  • DOJ Responds to Florida Lawsuit Challenging Federal Regulations Regarding Firearm Purchases by Medical Cannabis Patients

Continue Reading Cannabis Legal Report­­ – Week of October 3, 2022

A class-action lawsuit was filed on July 12 in the U.S. District Court for the Eastern District of Arkansas alleging that cannabis testing companies inflated the amount of THC found in cannabis flower. Plaintiffs are a putative class of medical cannabis patients in Arkansas and bring suit under the Racketeer Influenced and Corrupt Organizations (RICO)

On July 8, California’s Department of Cannabis Control (“DCC”) issued draft regulations looking to standardize cannabis testing across the state. According to a statement, the DCC issued the proposed regulations in reaction to concerns about cannabis potency inflation and “laboratory shopping,” by cannabis businesses looking to secure THC levels that may be higher than what is actually contained in the cannabis flower or product. These new regulations would standardize the ways in which licensed cannabis labs in California can conduct their cannabinoid testing.Continue Reading California Proposes New Cannabis Lab Testing Regulations

More than 20 state attorneys general (AGs) authored an open letter to congressional leaders calling for legislation that would regulate tetrahydrocannabinol (THC) edibles that mimic the packaging and names of popular product. In their June 22 letter, the state AGs voiced their concern, particularly for children, writing that “copycat THC edibles pose a grave risk to the health, safety, and welfare of our children.” Specifically, the state AGs asked Congress to “immediately enact legislation authorizing trademark holders of well-known and trusted consumer packaged goods to hold accountable those malicious actors who are using those marks to market illicit copycat THC edibles to children.”Continue Reading State AGs Call for Congressional Action on Copycat THC Edibles

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