In a statement timed to coincide with the signing of the bill into law, Dr Gottlieb refuted the widespread misconceptions about what the bill actually does. Many companies in the hemp industry have hailed the 2018 Farm Bill as essentially legalizing the CBD trade in all 50 states.
CBD story far from over, FDA says
Not so, says Gottlieb. The bill does remove industrial hemp from the definition of marijuana in the federal Controlled Substances Act. So that’s one hurdle to knocked down for free access to the market for CBD supplements. But others are still standing.
According to Gottlieb’s statement, “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.”
“Additionally, it’s unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” Gottlieb went on to say.
Drug development means CBD is an illegal dietary ingredient
FDA’s position on CBD for while now has been that the compound is one that has been previously investigated as a drug before it was ever on the market as a dietary ingredient. This takes it permanently off the list of legal dietary ingredients, the agency has ruled.
“This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug,” Dr Gottlieb said.
If some stakeholder were to come forward with evidence that CBD had in fact been legally on the market as a dietary ingredient prior to beginning of GW Pharmaceuticals drug development, that would alter the case. It seems telling that with all the hundreds of millions of dollars of investment on the line that apparently no one has yet done so.
NDI, GRAS questions
Further, FDA has mentioned that even if the prior drug development were not an issue, CBD would fall under the New Dietary Ingredient provisions. No company has yet filed a NDI Notification on the ingredient, though one company, CV Sciences, claims it has completed a self affirmed GRAS dossier, which could provide a work around for a dietary supplement to go to market.
Dr Gottlieb mentioned that three GRAS dossiers on hemp products have been submitted to FDA and have been returned without comment (that’s as close as the agency gets to ‘approving’ something. Those were on hemp seed oil, hemp seed protein and hulled hemp seeds. CV Sciences’ dossier has not been submitted to FDA, and the agency has in the past said that without having seen the dossier it can’t comment on that development.
Disease claims
Dr Gottlieb said that the agency’s prime concern continues to be the illegal drug claims associated with the marketing of CBD-containing products. These have included claims relted to cancer, Alzheimer’s disease, psychiatric disorders and diabetes.
“We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” Dr Gottlieb stated.
Possible compromise?
But he also signalled a willingness to work on a compromise solution for the sector going forward. Such a compromise would have to include an opportuinity for the agency to evaluate the safety of CBD, such as via a NDI Notification.
“FDA has authority to issue a regulation allowing the use of a pharmaceutical ingredient in a food or dietary supplement. We are taking new steps to evaluate whether we should pursue such a process. However, the FDA would only consider doing so if the agency were able to determine that all other requirements in the FD&C Act are met, including those required for food additives or new dietary ingredients,” he said.
