Within days of announcements by large pharmacies CVS and Walgreens concerning the addition of CBD-derived products to their in-store offerings, the FDA has announced that it will hold its first hearing on Cannabidiol (“CBD”). According to reports, the hearing is scheduled for May 31, 2019 and will focus on the efficacy of ingestible CBD (i.e., in beverages and foods), as well as designing the infrastructure to regulate the newly legalized cannabinoid. According to outgoing Commissioner Scott Gottleib:
"It's critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA's regulatory oversight of these products — especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods.” To date, the FDA has prohibited adding CBD to beverages or foods.
At the same time, the FDA fired warning shots to three companies (located in New Jersey, Florida, and Washington) that the Agency believes to be making unsubstantiated claims concerning the benefits of CBD. In light of such warnings, businesses engaging in CBD commerce should take caution. According to Commissioner Gottleib:
“The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today . . . . Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk . . . . These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”
The landscape of the Cannabis industry continues to evolving at a rapid pace. The FDA’s hearings on CBD in May, together with possible legalization initiatives in New Jersey and New York, should give rise to a busy Spring and Summer for industry participants – and those seeking to participate. All individuals and businesses looking to get involved should take a moment to consult with experienced counsel to evaluate their business and marketing plans – and should stay tuned to the ongoing legislative and regulatory debates that will soon shape this brand new industry.
The Cannabis Law Practice Group at Bressler consists of attorneys with the skills, experience, depth and flexibility needed to assist clients looking to capitalize on opportunities within the legal cannabis industry. Bressler’s expertise in a broad range of practice areas gives it the unique advantage of being able to provide its clients with full service legal counseling in a rapidly emerging industry faced with myriad challenges and complexities. Bressler professionals are available to discuss and assess the risks to your business, as well as potential solutions to make sure you are informed and prepared.
Disclaimer: Possessing, using, distributing and/or selling marijuana or marijuana-based products is illegal under federal law, regardless of any state law that may decriminalize such activity under certain circumstances. Although federal enforcement policy may at times defer to states’ laws and not enforce conflicting federal laws, interested businesses and individuals should be aware that compliance with state law in no way assures compliance with federal law, and there is a risk that conflicting federal laws may be enforced in the future. No legal advice we give is intended to provide any guidance or assistance in violating federal law.
Alert
04.03.2019