US FDA sets up cannabis working group to clarify regulation

The US Food & Drug Administration (FDA) has set up a cannabis working group to work out how to regulate the sale and marketing of cannabis-infused food and drinks, and is asking for feedback from stake-holders.

The FDA said it remained “committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products”.

It has announced a public hearing on 31 May that will allow stakeholders to share their experience and challenges with products containing cannabis and compounds derived from it as well as provide feedback on the existing regulation, in order to move forward on regulation, marketing and labelling.

According to CNBC, the FDA has already been searching for a solution, following calls from Congress.

In a statement on the FDA website, outgoing FDA Commissioner Scott Gottlieb said it was “critical” to address unanswered questions about CBD and other cannabis and cannabis-derived products in order to inform its regulation on these products.

He confirmed that the high-level working group will “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed; including a consideration of what statutory or regulatory changes might be needed and what the impact of such marketing would be on the public health.”

He said stakeholders were looking to the FDA for clarity, particularly after Congress passed the Agriculture Improvement Act (Farm Bill), which removed hemp (an almost identical plant that does not contain the psychoactive compound Tetrahydrocannabinol or THC) from the schedule 1 of controlled substances Act, but maintained the FDA  should still regulate products containing cannabis or cannabis-derived compounds.

“We recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” he said.

“This is a complicated topic and we expect that it could take some time to resolve fully. Nevertheless, we’re deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward.”

The working group is expected to share its findings as early as this summer, Gottlieb said.

The US cannabis drinks industry was worth around $86 million last year, according to the CBD Drinks Report, which was published by drinks experts Zenith Global and Beverage Digest in February, but sales are likely to pass the $1 billion barrier in 2023.

It comes off the back of loosening regulation which has increased the rate of innovation in cannabis-infused drinks with companies such as Constellation Brands, investing in cannabis start-ups and developing products infused with the drug.