FDA Chief Reveals New Details on Agency's CBD Regulatory Plans


Food and Drug Administration (FDA) commissioner Scott Gottlieb unveiled new details on plans to seek alternative avenues for CBD regulation and also acknowledged that the federal ban conducts medical marijuana research abroad on Wednesday.

Gottlieb's latest comments came in response to questions from Barbara Lee (D-CA), Chellie Pingree (D-ME) and Mark Pocan (D-WI) during a hearing before a House Appropriations subcommittee.

Among the revelations that came out of the hearing was Gottlieb will shortly announce that the FDA will hold a public meeting "sometime in April" to hear stakeholders on how best to regulate the CBD derived from hemp, which was legalized last year as part of the agricultural bill of 2018. He also said he would be forming a working group composed of agency experts to inform him about regulatory options for the CBD.

Pocan wanted to know "how actively" the FDA was considering different ways to regulate dietary and dietary supplements containing CBD derived from hemp, and requested a timeline for when the agency hopes to release guidelines on the subject.

"I will say at the outset that we hear Congress loud and clear about this legislation," Gottlieb said, referring to Farm Bill. "I understand that Congress wants there to be a way for CBD to be available."

But he added that this "is not a direct issue." The FDA has not only approved a drug for CBD for epilepsy, Epidiolex, which generally means that the compound can not be added to food, but it is also the "subject of substantial clinical". research "- another reason, would not be allowed in the food supply.

That said, "the law allows us to go through a regulatory process and go through a regulatory and commentary process to establish a framework that allows it to be placed in the food supply," Gottlieb said. The first step towards this end will be a public meeting "sometime in April" that the agency will announce formally soon.

The commissioner offered a theoretical regulatory model that the FDA could implement for CBD.

CBD could exist "in high concentration, pure formulation as a pharmaceutical" and also exist "in a different concentration as a food product or dietary supplement". The reason the agency would like the separation to be "because we want to preserve the incentive to study CBD as a pharmaceutical," Gottlieb said.

"We believe it has therapeutic value and has been demonstrated," he said. "But I will tell you that this is not a simple process. There is no good proxy to do this through regulation. "

If the task of developing an alternative regulatory approach to the CBD is "complicated enough," Gottlieb said the FDA "will come back and have a discussion with Congress about how we can work together on it," suggesting that more legislative action on Farm Bill may necessary.

Deputy Andy Harris (R-MD) briefly followed Pocan's questioning and said he enters markets and sees "displays of CBD-containing products, and is not present at the pharmacy behind the counter, obtained with a prescription. "

"I think this is something that got us and thank you for your response to Mr. Pocan about it," Harris said.

Pingree was the lead author of a bipartisan letter that was sent to the commissioner last week asking about the timeline for FDA guidance on how companies can legally sell CBD products derived from hemp through state currencies. At the hearing, the congresswoman said she wanted to "emphasize the need for some sense of urgency" around the issue.

"I think we have a good track record of trying to come up with a solution to other challenges," said Gottlieb. "I have a commitment to focus on this.

The commissioner said he would shortly announce "a high-level working group that will inform me about this, with some senior agency officials who will preside over this. "

"I will tell you that if we determine that the path here will be a multi-year regulatory process that may take two, three, four years, I will return to Congress to discuss whether or not there are other structures that could help resolve this," he said.

In addition, the FDA may "need status that addresses this as an entire structure or specifically addresses the CBD. "

Lee, who became the first woman and first person to co-chair the Congressional Cannabis Caucus in January, said she was excited to have the opportunity to talk about two of her favorite topics: "Cuba and Cannabis."

For the latter, she focused on FDA approval of Epidiolex. Specifically, she wanted to point out that a UK-based pharmaceutical company has received approval for the drug because the UK government authorizes them to "cultivate, in particular, cannabis varieties for drug development purposes."

"Is it possible, according to our US federal system, Annex I, a US-based company to bring a plant-derived cannabis drug to market through the FDA's traditional review and approval process? "Lee asked. "Because many states have already gone through medical marijuana initiatives and it's a pity that we have not been able to move forward with the research."

"With regard to compounds derived from cannabis, it really depends on which active ingredient you are talking about – whether you are talking about THC or CBD and whether or not it is derived from marijuana or hemp," Gottlieb said.

He added that it remains an "active issue" whether the CBD derived from hemp was legalized under the Farm Bill 2018, which would mean that the compound "can be studied in a more fluid way." (Some experts do not see this as an open question, however, as agricultural legislation removed hemp products from the Controlled Substances Act.)

The commissioner said he has his "personal opinion" on the matter, but said his lawyers did not want him to give a "legal opinion."

"I think we will have a resolution on this very soon about whether the CBD derived from hemp is not included in the programming process, "he said.

Finally, Gottlieb acknowledged that existing federal marijuana laws mean that "the ability to conduct marijuana research is more restricted, more heavily regulated." Although he said he did not know "every nuance," one problem is that there is only one federally licensed marijuana maker in the United States, and that the lack of supply has led some researchers to conduct studies in other countries.

"Over the years, you have seen, frankly, companies go abroad to conduct research with products created abroad. which is more easily originated for clinical trial purposes, "he said. "I think the problem you're facing is valid. The only thing I can say is that the environment here is changing rapidly."

"Very quickly," Lee agreed.

"We would certainly support more research," Gottlieb said.

The FDA is exploring "alternative approaches" to CBD regulation, says the Commissioner

Photo courtesy of the YouTube / House Appropriations Committee.

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