In a letter delivered last week, Oregon Sens. Ron Wyden and Jeff Merkley—both Democrats—urged FDA Commissioner Dr Scott Gottlieb, MD, to begin the process of updating its federal regulations around fractions of industrial hemp (which the Senators were designating as Cannabis sativa L.).
They noted that the 2018 Farm Bill has removed the plant from the Drug Enforcement Administration’s schedule 1 list of banned substances. Thus, some aspects of the regulation of this plant at the federal level are at odds with others.
“Under this definition, Congress legalized the production and sale of industrial hemp and hemp derivatives, including hemp-derived cannabidiol,” they wrote.
After the passage of the Farm Bill, there was widespread speculation in the industry that this would open the flood gates for CBD in interstate commerce. The remaining regulatory impediments were a matter of interpretation and nuance, or so the thinking seemed to go.
Gottlieb: Farm Bill does not change language in DSHEA
Not so, Gottlieb said. In a statement timed to coincide with the signing of the bill, Gottlieb reiterated the agency’s position that CBD is not a legal dietary ingredient because of the so-called ‘exclusionary clause’ in DSHEA.
That clause states that a substance that is first investigated as a drug via publicly available research cannot subsequently be made into a supplement ingredient. The reverse case is allowed, as is the case with fish oil supplements, which have been on the market for decades and for which higher purity drug forms were subsequently developed.
In 2018 FDA approved Epidiolex, a drug developed over the course of more than a decade by the English company GW Pharmaceuticals. The drug is approved for the treatment of forms of childhood epilepsy for which there are no other satisfactory drug treatments.
“[B]oth 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 in the statement.
Room for negotiation
In the same statement, however, he signaled that there is room for negotiation on the topic.
“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.
The senators gave FDA a 30-day deadline to respond to specific questions or requests. These included a request to clarify FDA’s authority on the matter of interstate CBD trade, a question on whether there is any scenario in which hemp or CBD containing products would be allowed in interstate commerce, and whether FDA is planning to initiate a rule making process to address the situation.
FDA employees who would normally be available to respond to a request for comment on the matter were on furlough because of the government shutdown, which is now the longest in history.
While the agency is required to respond to such a request from members of Congress, it is unclear if it will be able to meet the senators’ deadline because of the likely backlog in agency work caused by the shutdown.