The Food and Drug Administration (FDA) is again asking the public to submit information about CBD as the agency prepares to issue regulations for legal marketing of the compound.
In a draft notice set to be published in the Federal Register on Wednesday, the agency said that a public comment period, which was originally open from April to July of last year, will be reopened on an indefinite basis.
“To provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available, we are reopening the comment period and extending it indefinitely to allow interested parties to continue to comment,” FDA said. “We are particularly interested in data that may help to address uncertainties and data gaps related to the safety of cannabidiol (CBD).”
FDA first announced it would be reopening the comment period in a report it submitted to Congress last week, detailing the status of its rulemaking efforts for CBD to date. That report explained that the agency is considering ways to allow the cannabis compound to be marketed as a dietary supplement and that it is actively developing enforcement discretion guidance for CBD businesses.
Lawmakers and stakeholders have put extensive pressure on FDA to craft regulations that would provide for the lawful marketing of CBD. Since hemp and its derivatives, including cannabidiol, were legalized under the 2018 Farm Bill, many farmers have started cultivating the crop to extract and sell the non-intoxicating ingredient.
But as of now, while CBD is available in shops across the country, it remains unregulated by FDA and is technically not allowed to be sold as food items or dietary supplements. FDA has used enforcement discretion to target only companies making outlandish claims about the therapeutic benefits of their products.
The decision to reopen the comment period could provide the agency with information in needs to identify a pathway for lawful CBD sales, at least in dietary supplements.
“In light of the continued interest and increased research activity in this space, as well as the need for additional scientific data on this topic, we have decided to reopen the comment period and extend it indefinitely to allow interested parties to continue to comment and to provide relevant data to the Agency on this subject,” FDA said in the draft notice. “This extension will allow stakeholders to continue to provide new and emerging information, in as close to real time as possible, as research in this area evolves.”
FDA listed several areas of particular interest that they hope stakeholders will address in their comments.
The agency said it wants to learn about the potential impact of CBD on the liver, toxicity of its active metabolites, potential damage to the male reproductive system associated with use, drug and alcohol interactions, impact on neurological development and its sedative effects, among other issues.
While it’s not clear what decisions FDA will ultimately make with regard to CBD, its newly appointed commissioner recently conceded that banning the compound would be a “fool’s game.”
Over at the U.S. Department of Agriculture (USDA), meanwhile, an interim final rule for hemp was released last year. Officials have received significant pushback over certain restrictive provisions and recently announced that they would be temporarily lifting lab testing and disposal requirements as requested by stakeholders.
That said, USDA argued it couldn’t change other provisions for statutory reasons. The head of the department said in a congressional hearing last week that the Drug Enforcement Administration is partly to blame for the strictness of the proposed rules.
Photo by Kimzy Nanney.