FDA’s Opinion: CBD You in April…Maybe.
On Wednesday, February 27, 2019, FDA Commissioner Scott Gottlieb, MD, testified before Congress. He testified that the agency planned a public meeting in April to begin a rule making procedure on CBD. The goal is to create “an appropriately efficient and predictable regulatory framework for regulating CBD products,” he said. This is good news for those in the hemp and cannabis market. Unfortunately, the statement also means that CBD infused products are still illegal in the U.S.
Dr. Gottlieb’s testimony is further evidence of the FDA’s policy shift when it comes to the overall viewpoint towards cannabis and cannabinoids. But as full legalization has not yet occurred, problems remain for those in or seeking to enter the marketplace.
CBD infused products are located in almost every market where cannabis (medical or adult use) has been legalized. Many thought the floodgates opened wider with the passage of the 2018 Farm Bill. It did after all remove hemp from the DEA’s schedule one list of controlled substances (THC, the narcotic fraction of the plant, is still on the list). That was a misreading of the legislation by many. On Dec. 20, 2018, Dr. Gottlieb issued a statement reiterating the FDA’s authority to regulate CBD as an ingredient (CBD, or cannabidiol, is a non-narcotic fraction of cannabis that has been researched for a number of health effects). He also noted that according to the FDA, CBD is not a legal dietary ingredient.
Dr. Gottlieb re-affirmed this position on Wednesday, February 28, 2019. He state it remains unlawful to introduce food or supplement products into interstate commerce that contained added CBD. “As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing,” he said.
Dr. Gottlieb noted that this “was not a straightforward issue” due to the FDA having already approved Epidiolex (a CBD based medication for certain types of seizures). Because of this approval, the general holding is that the compound can not be added to food. The other reason for not allowing CBD into the food supply is that it is the “subject of substantial clinical investigation.” Dr. Gottlieb noted that the current laws allows the FDA to “go through a regulatory process and go through a notice and comment rule-making process to establish a framework to allow it to be put into the food supply.”
Dr. Gottlieb noted that CBD could potentially exist “in a high concentration, pure formulation as a pharmaceutical product” and also exist “at a different concentration as a food product or dietary supplement.” He stated the reason for the separation is to “preserve the incentive to study CBD as a pharmaceutical product.”
He also noted that if developing an alternative regulatory approach for CBD proves “sufficiently complicated,” the FDA will “come back and have a discussion with Congress about how we might be able to work together on this,” suggesting that further legislative action beyond the Farm Bill could be required.
Right now, CBD as a drug remains illegal. What about hemp-derived CBD? Dr. Gottlieb testified that it remains an “active question” as to whether hemp-derived CBD was legalized under the 2018 Farm Bill. As many know, the 2018 Farm Bill removed hemp-derived products from the Controlled Substances Act. But states are seizing CBD-infused products, even products with hemp-derived CBD. So where do we stand? Dr. Gottlieb believes we will have a resolution soon on whether or not CBD derived from hemp does or does not fall under the scheduling process.
For right now – CBD as a dietary supplement or as an infused ingredient (water/food) is illegal if transported across state lines. It has also been the subject of sporadic enforcement actions within states where the products are created. So the question remains – will the FDA enforce these findings against companies? What about at the state level? Are there any parameters where the FDA or state agencies could exercise discretion in enforcing the holding? What are they? There is too much interest and too many companies involved in producing CBD and CBD-infused products for the FDA to wait and rule on this issue months or years down the road.