The International Conference on the Science of Botanicals wrapped up last week on April 11 at the University of Mississippi at Oxford. The conference has been put on for 19 years now by the National Center for Natural Products Research.
The conference this year had an overarching theme of looking at what has changed in the dietary supplements industry in the 25 years since the passage of the Dietary Supplement Health and Education Act. But it also had a significant focus on hemp products.
A panel on the hemp industry on Wednesday laid bare the challenge that faces this industry as it enters into a phase of figuring out its proper regulatory positioning. The recent federal Farm Bill clarified the picture in terms of the legality of hemp farming. It did not, however, clean up all of the regulatory ambiguities surrounding the use of isolated and purified CBD as a dietary ingredient in supplements or as an ingredient in foods. That subject will the focus of a meeting set for May to be put on by the Food and Drug Administration.
FDA’s willingness to discuss a new regulatory paradigm for CBD came partly from direct inquiries from federal lawmakers. But it also seems to be a recognition of what’s happening in the real world with hundreds, perhaps thousands, of products with 'CBD' on the label now for sale in a variety of channels.
Drug entities, not copies of a botanical
Holly Johnson, PhD, chief science officer of the American Herbal Products Association, said the term ‘synthetic cannabinoids’ is something of a misnomer and causes confusion in the marketplace. It’s a fundamentally different issue than FDA’s pronouncements in the draft NDI guidances about the legality of so-called ‘synthetic botanicals.' It is also a distinct issue from the development of different ways of producing CBD that don't involve extraction from a hemp plant, such as new fermentation-based products that are now coming to market.
The synthetic cannabinoids in question function along similar pathways as naturally occurring cannabinoids, but are not copies of the molecules themselves, she said.
“These are wholly synthetic molecules that also affect the body’s endocannabinoid system as CBD or full spectrum hemp does,” Johnson told NutraIngredients-USA. “These synthetic cannabinoids are not ‘from plants.’ Many of them are known to be dangerous. People need to understand that difference.”
“There is a regulatory concern and there is a transparency issue,” she added.
Market reminiscent of early days of supplement industry
James Neal Kababick, director of Flora Research Laboratories, who was one of the speakers on the panel, said the present state of the CBD/hemp market reminded him of the early days of the supplement industry itself, both in its freewheeling nature and in how consumers banded together were able to change government policies. Sadly, what is also reminiscent is the immaturity of the market from a quality perspective.
“This industry reminds me of 30 years ago in the dietary supplement industry. It is a great example of how the people acting together can affect change,” Neal Kababick said. “But from a quality control standpoint it is a disaster.”
Neal Kababick said many of the synthetic cannabinoids arose from drug discovery efforts. This work was done by scientists associated with Pfizer and with Hebrew University of Jerusalem and Clemson University in South Carolina that took place shortly after the discovery of the body’s endogenous endocannabinoid system in the early 1980s.
“They were looking for something for pain relief that would not be as addictive as opiods,” Neal Kababick said.
Hundreds of molecules with unknown safety profiles
Eventually hundreds of these types of molecules were discovered. It’s a library that has been mined by chemists in China, where these molecules are now being manufactured in quantity, he said.
Neal Kababick said there can be a real safety concern with some of these molecules. He said one of them has been the focus of an Interpol investigation after it was associated with 11 deaths in Europe. Some of these molecules have been linked to a risk of sudden cardiac death and another with the onset of chronic tinnitus, he said.
Flora recently announced that it has now developed the capability of testing for as many as 370 of these molecules. Neal Kababick said his lab has done a lot of recent work testing these kinds of products, and the results have not been encouraging.
“We tested some vape products, and nine out of 10 contained an undisclosed synthetic cannabinoid,” Neal Kababick said.
On the other hand, he said he has also tested products for some of the more mainstream supplement companies seeking to enter the CBD market, and those products have come out clean for the most part.
Testing the unknowns
Neal Kababick said that many of the labs testing these products are at the moment only looking for 10 or 20 of the best known of the synthetic cannabinoids. That might not be enough, he said.
“There are numerous families of these synthetic cannabinoids and in some cases we are now into the second or third generations of these molecules,” he said. “I think that’s why it’s important not only to test for what you know could be there, but also to do non targeted testing.”
