- The first FDA public hearing on CBD and other cannabis products starts on Friday in Maryland.
- U.S. Hemp Roundtable lawyer says it could take a year or more for the FDA to finalize regulations.
- Companies, led by retailers, are pushing ahead despite legal grey zone.
Don’t expect the U.S. Food and Drug Administration to say much on Friday about how it intends to regulate CBD-infused foods and nutritional supplements, says Jonathan Miller, general counsel to the U.S. Hemp Roundtable, the largest hemp lobby group in the country.
The FDA is hosting a full-day public hearing into CBD regulation on Friday in Maryland – the first such meeting since hemp-derived CBD was removed the Controlled Substances Act in December as part of the 2018 Farm Bill.
The meeting, which is being pitched as an opportunity for the FDA to collect “scientific data and information about the safety, manufacturing, product quality, marketing, labelling, and sale of products containing cannabis or cannabis-derived compounds,” is being watched closely by hemp growers, CBD product manufacturers, retailers and pharmaceutical companies. Dozens of individuals and organizations will be presenting throughout the day.
"I've been cautioning our membership not to have high expectations that we're going to get any clarity or any policy announcements tomorrow. I'm under the strong impression that the FDA is here to listen," Mr. Miller told Cannabis Professional.
He expects the FDA to give some guidance on CBD in food and nutrition products in the coming months, but any legally binding regulations – published in The Federal Register – are likely at least a year away, if not more.
“Typically these kinds of things take two to three years, but my FDA experts tell me that it can be done within a year period if they’re focused and they keep to their deadlines. And the fact is there’s already been a whole lot of research done on CBD, including by the FDA, including by the World Health Organization, so it’s not like they’re having to start from scratch,” Mr. Miller said.
Although hemp-derived CBD is no longer a federally illegal drug, it remains a regulated substance under the jurisdiction of the FDA. Since the passage of the Farm Bill, the FDA and its former commissioner Scott Gottlieb have issued several statements on CBD, all of which have affirmed that it’s illegal to sell CBD in food or as a nutritional supplement. This has created a chill across the industry, Mr. Miller said: "It's tough to figure out how [to sell CBD] if it's not a food, or if it's not a nutritional supplement, and it’s not a drug.”
The FDA hasn’t issued any enforcement actions against CBD manufacturers and retailers, only sending warning letters to firms making false health claims. But its public position is creating a legal grey area, Mr. miller said.
"What we see is that state agencies and local law enforcement officials have used the FDA’s commands as a pretense to seize products, or embargo products and in the rare cases to arrest people. So we need to get the FDA to develop this clear path and provide clarity and certainty, so that kind of behaviour will stop," he said.
The FDA has suggested that it’s open to the idea of CBD-infused foods. In a statement in April, shortly before he departed the agency, Mr. Gottlieb said the FDA would “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
There are challenges to doing this, which derive from the fact that FDA has already approved a CBD-based product, Epidiolex by GW Pharmaceuticals, as a prescription drug. But Mr. Miller thinks the way around this is to use a dosage threshold to distinguish between a CBD drug and a CBD food additive or nutritional product.
“The analogy for that is fish oil. Fish oil is available in certain concentrations as a drug, and doctors can prescribe it for medical effect; but below is that concentration you get at the grocery store," he said.
Despite all the legal uncertainty, companies are pushing ahead to get CBD products on the shelves, relying on state-level legislation to provide some semblance of legality. Charlotte's Web Holdings Inc., for instance, is now shipping product to “four national retailer locations covering 18 states combined,” the CBD manufacturer said in a news release on Wednesday that accompanied its quarterly earnings report.
“A major grocery retailer is carrying all categories of the Company’s product portfolio including oils, capsules and topicals, while the remaining national retailers have begun their Charlotte’s Web product introduction with topical products only,” the company said.
“We believe we’ll continue to see expansion in this area with additional retailers coming onboard and we expect continued roll-out to new states from existing retail customers throughout the year. Some retailers may wait for further clarity from the Food and Drug Administration (FDA) before including ingestible products, while others have been moving forward and expanding the number of stores that carry Charlotte’s Web products,” said Deanie Elsner, President and CEO of Charlotte’s Web, in the news release.
It’s been retailers, in fact, that have been leading the charge for CBD, according to Brendan Kennedy, CEO of Tilray Inc., which bought hemp food maker Manitoba Harvest earlier in the year as part of its U.S. CBD strategy.
“A lot of the demand right now is driven by consumers and retailers and not the large CPG companies,” Mr. Kennedy said on Tilray’s most recent earnings call earlier in May.
“There are retailers in the U.S. that are going to do this, no matter what, which I think is going to lead to really interesting second half of the year. And so there are retailers in the U.S. that aren’t waiting for the FDA. And then there are, as you can imagine… more conservative retailers that are going to wait and see what happens with some of the FDA hearings at the end of this month and over the course of the summer.