At a public meeting hosted by FDA in Washington, DC, last Friday, agency representatives repeatedly asked the more than 140 stakeholders who presented to submit more safety and efficacy data for CBD and other cannabis-derived compounds to help it establish a regulatory framework.
However, as many industry leaders pointed out, industry is unwilling to invest in research without a clear path to market or safe way to conduct the research without running afoul of conflicting state and federal regulations.
“The thing that concerns me about what I am hearing today is so much emphasis on asking the presenters. ‘What is your safety data? Do you have safety data? Can you give us safety data?’” said Steve Mister, president and CEO of the Council for Responsible Nutrition.
He explained this is worrisome because some companies are reluctant to invest in safety research until they know there is a path to market that FDA will accept.
Despite this, Mister and other stakeholders who presented at the meeting, said several paths to market already exist for CBD and other cannabis-derived compounds, but there also are major roadblocks for using the ingredients in conventional food and dietary supplements.
The path forward for CBD in conventional food is less clear
Of the two, the path forward for conventional food may be more difficult than for dietary supplements due to the different labeling and safety standards for each.
Douglas MacKay, senior vice president of scientific and regulatory affairs for CV Sciences, explained that unlike for dietary supplements, conventional food labeling does direct consumers how to use – and not use a product.