YOUR GUIDE TO THE LEGAL PRESENT AND FUTURE OF THE CANNABIS INDUSTRY
Cannabis: In Focus
DEA Classifies Two Lab-Derived Cannabinoids as Schedule I
The U.S. Drug Enforcement Administration (DEA) determined that two lab-derived cannabinoids— delta-8 THC acetate ester (delta-8 THCO) and delta-9 acetate ester (delta-9 THCO)—do not meet the federal definition…
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
…
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
Cannabis: In Focus
…
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
…
Continue Reading Cannabis Legal Report – Week of October 3, 2022
Cannabis: In Focus
…
Continue Reading Cannabis Legal Report—Week of June 5, 2022
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
