It seems as though the Food and Drug Administration is starting to listen. Over the past six months, the FDA has been bombarded with messages urging it to promptly develop a regulatory pathway for the lawful use of hemp-derived CBD (hemp-CBD) in foods and dietary supplements. A few of these messages came from Oregon’s hemp hero, Senator. Ron Wyden, who on more than one occasion has publicly pressured the FDA to take action with hemp.
In January of 2019, Wyden issued a joint letter with Senator Jeff Merkley, within the letter the Oregon senators demanded that the agency update federal regulations governing the use of certain hemp-derived ingredients in food, beverages and dietary supplements.
Towards the end of June 2019, Wyden issued a second letter to the agency in which he found fault in former commissioner Scott Gottlieb’s suggestion that it may take the FDA 3 – 5 years to issue a final regulation authorizing the lawful use of hemp-CBD in foods and dietary supplements. Basically, Wyden stated that the regulatory confusion and uncertainties surrounding hemp derived cannabidiol could not keep going much longer. To that end, Senator Wyden recommended that the agency follow specific steps to streamline the regulatory process and told the agency to issue “enforcement discretion guidance” by Aug. 1 of this year he also asked them to follow up by issuing final rules as quickly as possible while they develop concrete final regulations.
In response to the senator and other stakeholders’ demands, the FDA’s acting chief information officer Amy Abernethy announced on Twitter that:
“[FDA] is expediting its work to address the many questions about cannabidiol (CBD). This is an important national issue with public health impact, & an important topic for American hemp farmers and many other shareholders.”
Abernethy continued to explain that while the FDA is enthusiastic about research into the therapeutic values of CBD-infused products, it is also concerned with the need for safety which is completely understandable.
“To understand the breadth of issues and gather data on safety we have conducted a public hearing, reviewed the medical literature, and have an open public docket.”
If you were paying attention at this time you may recall that the public hearing to which Abernethy is referring to was held on May 31 this year and offered stakeholders a platform to share their thoughts and experiences with the FDA as well as stress the importance of coming up with a regulatory framework that would legalize the marketing and sale of CBD-infused foods and dietary supplements.
They gave the public an opportunity to put their two cents in with the FDA through July 16. Just four days before the deadline,over 3,000 comments have been published on the public docket. Now that the public comment period is over, the FDA will review the submitted data and anticipates reporting on its progress towards the end of summer/early fall this year.
Boosting the rulemaking process of CBD products will not only help clarify the legality of these products as well as render the cultivation and processing of hemp economically viable. This push will also settle the position of many federal agencies on this issue.
Now whether or not the FDA meets its proposed timeline we do not know. However we will continue to monitor and report on its progress.