The US Food and Drug Administration wants cannabinoid companies to know that they can play a crucial role in federal regulators obtaining important cannabis data and research. And for those squeamish about revealing how, say, their CBD products are made, there’s a way for companies to wind through the process without lifting the hood on whatever gives them a competitive edge.
Last week, the FDA held a webinar called Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations. The discussion, led by Cassandra Taylor, a chemist with the FDA’s Botanical Review Team Office of Pharmaceutical Quality, was focused on ensuring attendees could “gain understanding of FDA’s role in regulating cannabis products,” and expanding on best practices as they relate to clinical trial research on cannabis and cannabinoids.
The presentation also covered Drug Master Files (DMF), which, according to the FDA, are “used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products,” and included examples of how the DMF process could be a pathway for cannabis research.
The FDA is in a unique regulatory role when it comes to cannabis, as it is tasked with ensuring the safety of foods, human and veterinary drugs, and cosmetic and dietary supplements. And there is, as Cannabis Wire has reported, robust interest in developing cannabinoid-containing products in each of these categories—namely CBD—but the FDA has yet to release regulations for those hoping to go the non-pharmaceutical route.
At the same time, the FDA has already approved a pharmaceutical product containing CBD extracted from cannabis: GW Pharmaceuticals’ Epidiolex, in 2018. And, as Taylor noted during the presentation, “cannabis products intended for use under clinical trials with a claim of therapeutic benefit or with any other disease claim are drugs.” This poses a wrinkle for, say, aspiring CBD beverage makers because such pharmaceutical compounds generally cannot be added to foods.
When discussing the impact of the 2018 Farm Bill, which federally legalized cannabis with .3% THC or less, also known as hemp, Taylor pointed out that products including cannabis-derived compounds like CBD, “are subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
While CBD products can already be found on shelves from gas stations to high-end makeup counters, that does not mean they are regulated or legal. Some CBD products, like lotions or soaps, “might be lawful,” according to Taylor, and “oils or other products labeled ‘pure CBD’ without any other claims may be difficult to assert FDA jurisdiction over.”
Still, Taylor emphasized, “I wanted to remind everyone that many products containing CBD are illegal under the Food, Drug and Cosmetics Act. It is illegal to make a therapeutic claim unless an approved drug, and it’s illegal to put it in food or dietary supplements.”
Taylor also covered the many other compounds that can be derived from cannabis, including cannabigerol (CBG), cannabichromene (CBC), and cannabinol (CBN), among about 100 other cannabinoids, as well as terpenes like limonene, pinene, and myrcene. (Terpenes are responsible for cannabis’ distinct smell.)
“There is very little known about these compounds,” Taylor said. “You can help us close the gap on this huge scientific challenge that we’re having because people don’t know enough about these compounds.”
Taylor highlighted that the FDA is collecting public comments on CBD “indefinitely” through the Federal Register, and suggested that comments could be made about potential challenges faced by people in the cannabis industry, topics for the FDA to consider related to guidance, and data.
“We had a lot of information provided to us. And it was important that our team continue to work together to help solve some of the challenges that our stakeholders are facing,” Taylor said. “We encourage you, and we appreciate any comments, data, information related to CBD submitted to that public docket,” she added, asking that people share draft guidance on CBD with employees, colleagues, coworkers and “networks who operate in the cannabis space.”
Taylor also said that during the FDA’s hearing on cannabis and cannabis-derived compounds in May 2019 officials fielded many concerns from people “about their ability to protect proprietary information while participating in drug development,” and suggested that these people might want to consider the “well-established” Drug Master File (DMF) route.
When an applicant pursues a DMF, information is only shared between the FDA and the applicant. Anyone, including those conducting research, can submit a DMF. The FDA, after conducting a technical review, will deem the plan “adequate” or “inadequate,” but submissions are not approved or denied. A letter of authorization and the stamp of “adequate” could be used by a researcher seeking support for a clinical trial, for example.
Taylor gave a hypothetical example of how a DMF could be used. Say that Bob owns Bob’s CBD Emporium, which extracts CBD from industrial hemp using a proprietary process, and that Bob has fielded outreach from two researchers, Dr. Smith and Dr. Rhodes, who want to use Bob’s CBD extract in two separate clinical trials. Bob decides that a DMF would allow confidential processing and manufacturing info to stay that way, because he doesn’t have to share that with the researchers who want to use his CBD extract for their clinical trials.
“We really want to encourage you to continue to study as many of these compounds as possible,” Taylor said.
