U.S. Food and Drug Administration (FDA) Commissioner Dr. Scott Gottlieb is resigning from his role next month, leaving the fate of the agency‚Äôs forthcoming CBD policy uncertain.
Gottlieb announced his departure from the agency March 5 in a letter to staff, according to a CNN report. An FDA official familiar with the situation said the move has been underway for several months, CNN reported.
In December, upon passage of the Farm Bill and the legalization of U.S. hemp production and sales, the FDA issued a statement saying that hemp-derived CBD would not be permitted as a food or beverage ingredient, and would instead be treated as any other pharmaceutical compound.
‚ÄúIt‚Äôs unlawful under the [Federal Food, Drug, and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,‚ÄĚ Gottlieb wrote in the statement. ‚ÄúThis is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.‚ÄĚ
This, of course, refers to Epidiolex, which contains CBD as an active ingredient, and which has set a precedent that any products containing CBD need to undergo FDA approval, which includes clinical trials.
Jonathan Havens, co-chair of Saul Ewing Arnstein & Lehr‚Äôs Cannabis Law Practice, said he expected the FDA‚Äôs position.
‚ÄúIn the reaction statement, the FDA said, ‚ÄėWe know the Farm Bill got passed. It doesn‚Äôt do anything for our authority. We still regulate food and drug ingredients as we always have. The Farm Bill had language that said as much. We‚Äôre on good footing there,‚Äô‚ÄĚ Havens said.
In testimony presented before the House Appropriations Committee on Feb. 27, Gottlieb indicated that the FDA would revisit CBD policy, and that the agency had plans for a public meeting in April to develop a set of rules for CBD regulation.
‚Äú[The FDA] acknowledged that there‚Äôs a lot of attention in the space, and that the agency would possibly consider pursuing regulation to allow CBD as a dietary ingredient,‚ÄĚ Havens said. ‚ÄúThat‚Äôs really all they said. They didn‚Äôt give any sort of timeline. They didn‚Äôt say how seriously the agency was thinking about it.‚ÄĚ
Gottlieb indicated in his remarks before the appropriations committee that if the FDA goes through its process of notice, public comment and rulemaking, outlining CBD regulations will take longer than if Congress were to take legislative action.
‚ÄúI know that Gottlieb is surrounded by very competent advisors and folks at the relevant centers across the FDA, but his comments to me suggested that he was very well-versed in the issue, that he had talked to people about it [and] that he had really been working with senior staff,‚ÄĚ Havens said. ‚ÄúIt, for me, was encouraging that he was thinking about it ‚Ä¶ seriously, so much so that he proposed, low-level, that CBD could be regulated as a food [and], high-level, ‚Ä¶ as a pharmaceutical, so the agency was starting to put pen to paper and say, ‚ÄėThis is what regulating this might look like.‚Äô‚ÄĚ
Danny Davis, founder and chairman of Convectium, an automation equipment provider, was also encouraged by Gottlieb‚Äôs comments.
‚ÄúAlthough a bit murky, it was certainly encouraging to see progress on the Farm Bill in regards to CBD,‚ÄĚ he said. ‚ÄúIt is still unclear if all that effort will continue to gain momentum by another changing of the guard or if some of these conversations and ideas will be left in the dust. There is clearly public support for this to continue, but we are keeping our fingers crossed, as we never know how the tides may turn with the current chaotic environment we are in.‚ÄĚ
Certainly, in the wake of Gottlieb‚Äôs departure, many industry stakeholders fear that any sort of CBD policy reform will be delayed during the transition ahead.
“My concern would be in further delay of that process, which I think we are hoping the FDA was going to embark upon,‚ÄĚ said Rachel Gillette, partner and chief of Greenspoon Marder‚Äôs Cannabis Law Practice. ‚ÄúAny time there‚Äôs a change in a head of a federal agency that is responsible for regulatory changes, we‚Äôre likely to see delays in the implementation of the evolution of law. ‚Ä¶ When it comes to industrial hemp, we have a lot of work to do. I think the industry is really wanting to see some additional clarity in the law, especially with the FDA and USDA, and the hope is that this wouldn‚Äôt further delay that from happening.‚ÄĚ
‚ÄúMy fear is that the momentum that seemingly was occurring in the FDA around CBD and potentially clarifying what is and is not permissible around CBD ‚Ä¶ could slow down [or] could be stopped altogether,‚ÄĚ Havens added. ‚ÄúMy fear is that [Gottlieb‚Äôs] departure might stall that progress. That‚Äôs one side of the coin.‚ÄĚ
The other side of the coin, Havens said, is that Gottlieb‚Äôs resignation could have no real impact on the FDA‚Äôs regulation of CBD at all.
‚ÄúAs most people know, the FDA commissioner is not making the day-to-day policy of the agency,‚ÄĚ Havens said. ‚ÄúThe commissioner is the person who leads with vision and makes sure that the agency is well-represented publicly when he or she speaks on Capitol Hill, to the press [and] at conferences. So, it‚Äôs very possible that Gottlieb‚Äôs departure has no impact on CBD whatsoever, but I think realistically, this is not going to help the timeline.‚ÄĚ
‚ÄúI am hopeful that in his final month in office, he will continue to push CBD reform in the right direction and that change will still come,‚ÄĚ added Jeffrey Zucker, co-founder and president of cannabis business strategy firm Green Lion Partners. ‚ÄúThis could be dependent on his replacement, and while it’s unclear at this time who the administration will put in his place, that individual will hopefully see the need for expediency in regulating CBD in consumer products.‚ÄĚ
Although it remains uncertain who will take over Gottlieb‚Äôs role, Andrew Farrior, co-founder of Greenbox, is optimistic that the next commissioner will continue to orchestrate regulations to guide the growing CBD market.
‚ÄúThe CBD market is growing significantly year-over-year, and I‚Äôm hopeful that the next commissioner will be more progressive in his or her actions to introduce meaningful and positive legislation,‚ÄĚ Farrior said.
In the meantime, companies selling CBD products should mitigate risk while regulations remain hazy, Havens said. This includes not making aggressive disease claims about their products and instead ensuring that all claims are substantiated.
‚ÄúIf you ‚Ä¶ still make aggressive disease claims like some companies have done and that the FDA has taken action against, I think you‚Äôre asking for trouble,‚ÄĚ Havens said.
Many states and municipalities have been prohibiting CBD in food products, aligning with the FDA‚Äôs previous stance, until the agency rolls out a new policy, Havens added.
‚ÄúCompanies need to pay attention to where they are selling this product, where they‚Äôre manufacturing it [and] how they‚Äôre sourcing it, making sure it‚Äôs coming from hemp and not from marijuana,‚ÄĚ he said. ‚ÄúThe sourcing discussion becomes very critical.”