The U.S. Food and Drug Administration’s announcement Thursday that it won’t regulate products containing CBD and will instead pass that buck to Congress means the preservation of the current, uneasy status quo for now.
It will also mean more work for an increasingly fractious Congress – and further uncertainty for companies deciding whether to enter the $4 billion-plus CBD business.
In addition to grappling with broader marijuana policy reform – including access to banking, tax relief and the question of federal legalization – Congress must decide what to do with intoxicating hemp-derived cannabinoids such as delta-8 and delta-10 THC.
“I don’t think this changes anything for now, whether you’re in the CBD space, the delta-9 space or the delta-8 space – at least not for today,” said Jonathan Havens, a former counsel at the FDA and now a Baltimore-based attorney who co-chairs the cannabis law practice at Saul Ewing.
“The FDA has been saying all along, ‘We don’t want to deal with this, Congress needs to get involved.’
“Now it depends what Congress does with it.”
For now, the FDA has taken a mostly hands-off approach regarding CBD products, sending enforcement letters only to companies marketing products using unfounded medical claims.
Such claims violate the federal Food, Drug, and Cosmetic Act.
That won’t change.
Farm Bill could come into play
But what cannabinoids might be allowed in gummies, drinks or other products is one of the questions that could be answered at the same time Congress negotiates a new version of the 2018 Farm Bill, which expires this year.
A massive piece of legislation that covers farm subsidies, food-stamp benefits and many other topics, the 2018 Farm Bill – promoted by then-Senate Majority Leader Mitch McConnell and signed into law by former President Donald Trump – legalized hemp production nationwide.
In so doing, it also predicated the CBD boom and, along with it, the rise of novel intoxicating cannabinoids derived from hemp.
Since that time, the FDA has been on notice to figure out how to regulate an onslaught of products containing CBD and other cannabinoids derived from hemp.
Rather than do that, the FDA declined Thursday to regulate CBD products including other food supplements, saying its existing regulatory frameworks were inadequate – and that Congress should tell the FDA what to do.
In a statement Thursday, Dr. Janet Woodcock, the FDA’s principal deputy commissioner, said the agency “has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
“The use of CBD raises various safety concerns, especially with long-term use,” Woodcock added.
“The agency is prepared to work with Congress on this matter.”
Though Woodcock did not mention other cannabinoids that have gained popularity over the past four years – including delta-8 and delta-10 THC, which can be derived from CBD via a chemical process, as well as delta-9 THC – the FDA has noted the “serious health risks” posed by so-called alternative cannabinoids and has been tracking reports of adverse health effects.
That means either the next Farm Bill or a separate stand-alone measure would likely have to address those compounds, said Shawn Hauser, a partner at Vicente Sederberg who chairs the Denver firm’s Hemp and Cannabinoids Department.
For that, Congress does already have a model to follow.
Several states, including Colorado and Utah, have regulated hemp products in a manner similar to how they oversee marijuana.
Trade groups ‘disappointed’
Trade associations representing hemp growers and product manufacturers said Thursday they were “disappointed” by the FDA’s announcement, hoping instead the agency would have provided clear rules rather than punting the question.
At the same time, the situation will insert a sense of urgency into ongoing lobbying efforts, said Michael Bronstein, the president of the Washington DC-based American Trade Association for Cannabis and Hemp.
“We will diligently work with Congress to develop and advance a pathway that protects consumers, creates certainty in the marketplace for CBD goods, and provides for sound regulation,” he said.
In the meantime, the uncertainty for existing product makers will continue.
Congress could decide that the FDA is the appropriate agency to also regulate cannabis products.
Or lawmakers could also decide an entirely new agency should be responsible for regulating hemp-derived cannabinoids – an unexpected but irreversible side effect of the Farm Bill revision that’s now been added to Congress’s burgeoning to-do list.
“I think the reality is, people want access to all different types of cannabis, both medicinally as well as recreationally, and people are also feeling that it has benefits as a supplement to their diet,” Hauser said.
“And in states like Texas and Tennessee and Kentucky, this is the only way for people to get access to them.
“This could be something that helps some of the states understand that legalizing cannabis and regulating it and imposing product safety standards is a better approach than prohibition.” (Full Story)