CBD is all the rage among certain product developers in the dietary supplement industry. But the molecule is still a source of angst for many industry stakeholders, some of whom participated in a ‘town hall’ style meeting at the recent Oxford International Conference on the Science of Botanicals held at the University of Mississippi. The meeting was put on by the National Center for Natural Products Research.
Drug development background
CBD, or cannabidiol, is a non narcotic fraction of cannabis. The molecule has been researched as a drug. English company GW Pharmaceuticals has filed INDs on it for a couple of applications. It is developing two drugs with trade names Sativex (an oral spray meant to deal with certain complications of multiple sclerosis including neuropathic pain) and Epidiolex (an anti-seizure medication aimed at certain forms of intractable childhood epilepsy).
FDA’s hardening stance
It is this drug development that is the major, immediate hurdle for CBD in dietary supplement development, according to the FDA. The agency ruled in 2015 that the prior INDs filed by GW Pharmaceuticals means the molecule cannot be used in dietary supplements. If it had been on the market ‘as an article in food’ prior to the IND filing date, that would not be the case. But FDA says it has received no information from industry to convince it that that is true.
FDA sent four warning letters to CBD companies in 2015 that hinged on illegal disease claims and sidestepped the issue of the ingredient’s legality. In 2016 the agency sent an additional eight warning letters to CBD companies that mentioned claims language as well as the IND issue. Last year, the agency sent four more warnings that also specifically cited the IND issue.
What’s the enforcement picture?
Then there is the presence of the source plant on the federal Drug Enforcement Administration’s schedule 1 list of controlled substances. A Department of Justice source has told NutraIngredients-USA that far from putting the matter up on a back shelf, DEA agents are prepared to commence investigations and bring enforcement actions. They are restrained by only the current admittedly fuzzy policy on the issue.
In January US Attorney General Jeff Sessions signaled an end to the Obama Administration’s policy of letting states where voters have approved marijuana in one form or another go their own way. It is unclear how much cooperation Sessions will get across the DOJ bureaucracy. For example, shortly after Sessions’ announcement, Colorado lawmakers, including GOP Sen. Cory Gardner, said Sessions had overstepped his authority. And Bob Troyer, the US Attorney in the state of Colorado, said there would be no change of enforcement policy in that state, where voters have approved full legalization of the plant.
Legitimate pathway to market
Given all that, where does the industry stand? Is there a path forward for a legitimate dietary supplement application? There was a range of opinion expressed at the meeting in Mississippi, reflecting perhaps the unsettled nature of the question on the national level.
Dan Fabricant, PhD, CEO and executive director of the Natural Products Association and one of the chairs of the session in Oxford, said he believes there may be a path forward for dietary supplement companies. That would include GRAS applications, NDI filings and so forth, something which he said he hasn’t seen yet.
“Could there be a legitimate pathway to the market? I think there probably is. Have people gone that way? That’s the question,” Fabricant said.
What kind of claims can be made?
Rick Kingston, PharmD, was the other host of the session. Kingston, who is a professor at the University of Minnesota, said claims substantiation for dietary supplements is a big issue. If a CBD product is on the market making no claims, the company is pretty much leaving it up to the consumer to decide what they think it’s supposed to do for them. This is not an issue for products like multivitamins, whose health effects are well known. But if the consumer doesn’t really know what effects CBD is supposed to have, does an ‘under the radar’ product really benefit them?
If the company does communicate with the consumer more directly by making a claim, where’s the evidence?
“I don’t know of any CBD product outside of the GW Pharma products that have evidence that could substantiate claims,” said Kingston, who is also the president of scientific and regulatory affairs at the firm SafetyCall International. “What are the expectations of consumers now that DSHEA is almost 25 years old? What does it do to us as an industry to embrace ingredients that have no data behind them?”
Interstate commerce complications
Fabricant said even for those companies that are in business without present interference from authorities, the complications still are many. Because the raw material is still a controlled substance on the federal level, any amount of interstate commerce is problematical. Perhaps companies might refrain from shipping finished goods across state lines, but the issue doesn’t stop there, he said.
“If you are in the state of Colorado and you are making edible products, where are you getting your sugar from? Any amount of interstate commerce could be a problem,” Fabricant said.
Khan: Industry needs to come together on issue
NCNPR director Ikhlas Khan, PhD, at the meeting called for industry groups to come together to make a joint statement on CBD policy. The present situation of merely observing events only leads to confusion, he said. Fabricant countered that the solution will have to be a top-down one.
“Ultimately there is going to have to be a federal solution,” Fabricant said. He said one sign that there might be some movement at that level was a recent request by FDA to other countries to see how they are handling the cannabis issue. Just don’t look to Congress for any near term help, he said.
“Election years are notorious for a lot of talk and nothing getting done, but I guess you could say that about every year lately,” he said.