In the pilot episode of NBC’s Parks and Recreation, Leslie Knope, deputy director of the Pawnee Parks and Recreation Department, promises her constituents she will fill in “the pit” that has become a hazard to her community and will build a park in its place. Despite the roadblocks and red tape, Leslie delivers on her promise and turns the pit into a beautiful park. FDA’s most recent announcement regarding the agency’s CBD products regulatory framework is reminiscent of Leslie Knope’s “pit”: Both leave you feeling lost without any tools (i.e., regulations) to climb out. But our team, like Leslie Knope, is eager, determined, and prepared to tackle the issues presented by the FDA’s announcement.
On January 26, 2023, FDA announced that “existing regulatory frameworks for foods and supplements” are not “appropriate” for CBD products and a new pathway to regulate CBD products is required. In accordance with its vision for a new CBD product regulatory framework, FDA denied citizen petitions requesting that the agency “conduct rulemaking to allow the marketing of CBD products as dietary supplements.” FDA intends to work with Congress and initiate a “cross-agency strategy” to create the new regulatory framework for CBD products. This announcement previews indefinite waiting for new regulations, which would be enough to make Leslie Knope’s boss, Ron Swanson (ironically a major critic of government intervention), frown.
FDA’s announcement comes after a “high-level internal working” agency group met to review regulatory framework options for CBD products. The group reviewed studies (some of which were agency commissioned) and scientific literature to inform its decisions.
The agency’s announcement discussed the need to balance consumers’ desire to use CBD products against the need for a regulatory framework to mitigate risk. According to FDA, the agency cannot measure how much CBD or how long CBD may be consumed safely. As we discussed in a previous post, FDA maintains risks of “long-term” CBD use include harm to the liver and male reproductive system and “interactions with certain medications.” FDA noted CBD exposure is also “concerning” for “vulnerable” populations, including “children and those who are pregnant.” An additional FDA concern relates to CBD products for animals. Individuals who consume products from animals receiving CBD may be unwittingly exposed to CBD. FDA proposed potential CBD product regulations to mitigate the risks discussed above that could require “clear labels, prevention of contaminants, CBD content limits, . . . and minimum purchase age.”
As we wait for FDA and Congress to enact a new regulatory framework for CBD products, FDA already promised to continue to “take action against CBD and other cannabis-derived products” to protect the public as necessary. This requires CBD industry members to carefully navigate this unchartered territory. The National Cannabis Industry Association (NCIA) published a statement regarding FDA’s announcement, reporting “[c]annabis industry advocates are disappointed with this result . . . but are hopeful the decision will put more pressure on Congress to move to sensibly regulate CBD and other cannabis products.” That, of course, has now become an ever more critical piece of the 2023 Farm Bill, which is currently being developed and debated in the halls of Congress. Where FDA and Congress will land remains to be seen, so as the CBD industry awaits a new regulatory framework, we’ll be here to help you navigate the “pit” falls of the current framework. In the interim, continue to watch this space as we provide regulatory updates.