On Tuesday the US Food and Drug Administration published a list of guidance documents it expects to publish within the next year. The list included a number of FSMA rules and food safety questions and two entries that bear directly on the dietary supplement industry: a commitment to publish at least a portion of a revised New Dietary Ingredient guidance and a guidance on the convening of self affirmation GRAS panels.
Notably absent was a commitment to publish anything about the hemp/CBD question. FDA had given itself a deadline of July 2022 to publish the documents. Given the time that has passed since the hemp/CBD market began to explode in late 2018 the omission was met with disappointment by industry stakeholders.
“FDA has not devoted very much attention to this issue since the last Farm Bill in 2018,” said Jonathan Miller, chief counsel for the US Hemp Roundtable and an attorney in the firm Frost Brown Todd.
“It makes it that much more clear that we need to pass legislation,” Miller told NutraIngredients-USA. “If we wait on the FDA we will be waiting a long time.”
High profile meeting in 2019
FDA convened a public meeting on the issue in May 2019. The early comment returns from that meeting laid bare the regulatory complexity of the issue. FDA had focused on the safety questions surrounding the ingredient. While the Agency promised a communication on the subject ‘soon’ at that time, teh issue hung fire until the advent of the global pandemic pushed many items to teh back burner.
At the moment FDA considers CBD not to be a legal dietary ingredient. This is because of the work down by GW Pharmaceuticals in researching the effects of its drug Epidiolex, which has been approved for the treatment of seizures for some forms of childhood epilepsy. According to federal law, ingredients first researched as drugs remain in the pharmaceutical realm and can’t subsequently be used in supplements. To date no company has brought forth proof that CBD was on the market as a dietary ingredient before GW began its clinical work.
Miller said his organization is throwing its weight behind several legislative options for resolution of the issue.
“I think there is a real debate going on within the Agency and there are a number of folks there who would prefer to be told what to do by Congress,” Miller said.
Steve Hoffman, principal of Compass Natural Marketing, a firm that has worked on a number of cannabis initiatives, said interested parties can participate in an initiative called Regulate Hemp Now, sponsored by teh roundtable. It seeks to throw support behind two bills before Congress, one in the US House (HR8412) and another in the Senate (SB1698) that would mandate that FDA create regulations for the ingredients.
“Constituents in the hemp industry have come to teh conclusion that it is going to take a literal act of Congress to get FDA to move off the dot,” Hoffman said.
Miller said his group is confident that a bill of some sort will pass this calendar year.
A statement from an FDA spokesman laid open the possibility that the Agency may still move on teh CBD issue even though it’s not on the formal list of priorities.
“The FDA may decide on which guidance topics to publish based on, among other things, current and emerging public health issues and presidential priorities. However, Agency resources and focus may shift at any time to support emerging and the most pressing public health needs during the calendar year. The FDA cannot give specific details about any of the listed guidance topics,” the statement said.