Dr Fabricant appeared in a segment this week that featured a debate of sorts between him and Tracy Ryan, CEO of a California-based company called CannaKids that says it,“specializes in the creation of lab tested, and PhD scientist extracted cannabis oils.” On the show Ryan told the story of giving a CBD product to her daughter Sophie during her four-year successful battle with cancer.
Proving the benefits
Some advocates of CBD products, like Ryan, advocate for their purported health benefits without regard to a particular regulatory category. Indeed, on her company’s website, Ryan talks of the benefits of the, “medicinal powers of medical marijuana in treating her own daughter’s disease, as well as all other pediatric and adult cancers, epilepsy, autism and beyond.” The company claims to be working with an institute in Israel to help broaden research into these indications.
"I couldn't be happier for Tracy and Sophie, but selling any substance, be it natural or chemical, to the public as a cure for cancer without clinical research is dangerous from a public health perspective, because it would lead to widespread abuse, delay proven treatments, and create a real public health crisis,” Dr. Fabricant said on the show.
Advocates of CBD products who are marketing their products as functional foods or a dietary supplement-like positioning are more circumspect in their messaging about health benefits. They have sought various ways to bring the products to market, with most strategies seeming to hinge on hemp’s status as a food. This tack emphasizes that the ingredients are extracted from industrial hemp, which by law has ultra low THC content (THC, or tetrahydrocannabinol, is the narcotic fraction of cannabis).
Proper path is NDI Notification
Dr Fabricant, who came to NPA after a stint overseeing dietary supplements at FDA, said his concern with CBDs is similar to the one he has made public in the past about kratom. While CBDs might not have the same safety concerns as does kratom, there is a path for these products to come to market. Companies should play by those rules, and shouldn’t try to circumvent them just because they are perceived to be difficult or expensive. In either case, companies ought to put together dossiers for a New Dietary Ingredient Notification, Dr Fabricant believes.
“There is a legal system in place. When I was at FDA, we enforced that system. The highway to hell is paved with good intentions, as they say. We didn’t get the safest food and drug system in the world with testimonials,” Dr Fabricant told NutraIngredients-USA.
One big hurdle to following the path that Dr Fabricant advocates is FDA’s current position that CBDs are not legal dietary ingredients for use in supplements because of prior Investigation New Drug filings taken out by English drug company GW Pharmaceuticals. That company is bringing two drugs to market to treat certain forms of intractable childhood epilepsy. CBD advocates have weighed in with the argument that if they are not aiming to address those conditions, the IND exclusion should not apply to them. Many CBD products have been marketed for general wellness or with generic claims such as “supports a healthy endocannabinoid system.”
Dr Fabricant said he has a hard time taking such arguments seriously, if companies only want to put words and not dollars behind the effort.
“Where do yo want to be? Do you want to be taken seriously? They might have a legitimate argument there, but how would we ever know if they don’t submit it to a regulatory authority or take it to court?” Dr Fabricant said.
“I know I’ll get a lot of heat over this. We certainly don’t agree over here with everything that FDA does. But if you are fighting from the shadows, that’s not how you get a product on the market that you truly believe in,” he said.