The US Food and Drug Administration (FDA) has confirmed its commitment to eventually creating an alternative route to market for non-pharmaceutical CBD products, such as foods and dietary supplements.
However, the commitment has been vaguely defined in terms of timeframe and details.
The FDA has only committed to exploring various pathways to market for CBD products. It is currently collecting information on various issues surrounding CBD and said it will continue to inform the public on its progress and what it believes its path forward will be.
Currently it has some concerns about the use of CBD which would prevent it from giving a green light to uninhibited routes to market for consumer products.
“While we recognize the potential benefits of CBD, questions remain regarding its safety,” the FDA said. “During our review of the marketing application for Epidiolex, we identified certain safety risks, including the potential for liver injury. Furthermore, unsubstantiated therapeutic claims—such as claims that CBD products can treat serious diseases—can lead consumers to put off getting important medical care.”
It added that this last point was also the main reason for enforcement action by the agency against some products advertised as treatments for cancer or Alzheimer’s.
And it noted that in the course of doing this it had tested the chemical content of some products and found levels of CBD to be significantly below what was claimed.
The FDA also said it would like to see further evidence on a number of questions it had about the use of CBD. These included:
- How much CBD is safe to consume in a day?
- How does it vary depending on what form it’s taken in?
- Are there drug interactions that need to be monitored?
- What are the impacts on special populations, like children, the elderly, and pregnant or lactating women?
- What are the risks of long-term exposure?
“These and other questions need to be considered if there is interest in exploring a framework under which CBD might be available more widely,” the FDA said.
The agency added that it had received a significant amount of feedback from its recent public hearing.
One issue brought up multiple times during that meeting which it hoped to address soon was the difficulty of conducting the sort of research with cannabis and CBD that would answer the questions the FDA was asking.
“We take to heart concerns from stakeholders about the challenges in conducting research with cannabis and CBD. The FDA is committed to doing what we can to facilitate and preserve incentives for clinical research,” the agency said.
“To conduct clinical research that could potentially lead to an approved new drug, researchers need to submit an Investigational New Drug application to the FDA’s Center for Drug Evaluation and Research. For use as an animal drug product, researchers would establish an Investigational New Animal Drug (INAD) file with the FDA’s Center for Veterinary Medicine.”
However, the agency also said it thought the continued availability of consumer CBD food and dietary supplement products could “reduce commercial incentives to study CBD for potential drug uses, which would be a loss for patients.”
In short, the FDA has not committed to much in its first response on CBD since its public meeting. But it does appear sympathetic to the need for an alternative non-pharmaceutical drug approval route to market for some CBD products.
It also asks some legitimate questions that probably should be answered before such a decision is made. And it understands that more needs to be done to facilitate the research required to answer those questions.
Let’s see what the agency’s next move is in terms of encouraging that research—though its comment on consumer CBD reducing commercial incentives for such research will certainly strike many as disconcerting.
CBD-Intel (www.CBD-Intel.com) provides impartial, independent and premium market and regulatory analysis, legal tracking, and quantitative data for the cannabidiol (CBD) sector.
We provide our clients with the tools to navigate this fast-moving sector, tailor their business strategy, optimize resources and make informed decisions. In addition, we offer customized research and consultancy support.
Image Credit: The Washington Post