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FDA official reveals new details on the Agency's CBD regulatory plans

Commissioner Scott Gottlieb of the Food and Drug Administration (FDA) has revealed new details regarding plans to seek alternative routes for CBD regulation and also acknowledged that the federal ban is pushing marijuana research for medical purposes overseas Wednesday.

Gottlieb's latest comments were given to representatives Barbara Lee (D-CA), Chellie Pingree (D-ME) and Mark Pocan (D-WI) at a House credit sub-committee hearing .

In particular, the hearing revealed that Gottlieb would announce shortly that the FDA would hold a public meeting "in April" to hear from stakeholders on the best hemp CBD regulation, legalized at the end of the year. last year. He also stated that he would form a working group of agency experts to brief him on regulatory options for the CBD.

Pocan wanted to know "how much" the FDA was actively considering different ways to regulate dietary supplements containing CBD derived from hemp, and he asked for a timetable for the release of guidelines on the subject.

"I will say from the beginning that we have heard Congress speak loudly about this legislation," said Gottlieb, referring to the Farm Bill. "I understand that Congress wants the CBD to be available."

But he added that "it's not a simple problem". Not only has the FDA already approved a drug for epilepsy with CBD, Epidiolex, which usually means that the compound can not be added to food, but it is also investigating "- another reason why it would not be allowed in the food supply.

That said, "the law allows us to go through a regulatory process and a notification and comment process to establish a framework for placing it in the food supply," Gottlieb said. Their first step in this direction will be a public meeting "somewhere in April" that the agency will announce officially soon.

The Commissioner proposed a theoretical regulatory model that the FDA could implement for the CBD.

CBD could potentially exist "in a pure formulation at high concentration as a pharmaceutical product" and also "at a different concentration as a food product or food 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 that it has therapeutic value and that it has been shown," he said. "But I will tell you that it's not a simple process. For us, this is not a good proxy through regulation. "

If the task of developing an alternative regulatory approach for CBD turns out to be "sufficiently complicated," Gottlieb said, the FDA "will come back and discuss with Congress how we could work together on this," suggesting that new legislative measures the agricultural bill may be necessary.

Representative Andy Harris (R-MD) briefly mentioned Pocan's interrogation and said he was going to the markets and seeing "displays of products containing CBD, and it is not at the pharmacy behind the counter obtained with a prescription. "

"I think it's something that has invaded us and I appreciate your response to Mr. Pocan on this," Harris said.

Pingree was the lead author of a bipartisan letter sent to the commissioner last week, asking for clarification on the timing of the FDA's recommendations on how companies can legally sell hemp-derived CBD products across states. At the hearing, the congressman said that she wanted to "insist on the need for a sense of urgency" around the problem.

"I will tell you that we are deeply focused on this. We have already faced other difficult challenges, "said Gottlieb. "I think we have a good track record of trying to solve other problems. You are committed to staying focused on this one. "

The Commissioner announced that he would soon announce "a high-level working group that will report to me on this, with some senior agency officials who will chair. "

"I'll tell you that if we decide that the way forward will be a multi-year regulatory process that can take two, three or four years, I'll come back to Congress to discuss whether other executives could help resolve this. problem, "he said.

In addition, the FDA may "need to a law that deals with either this issue as a whole or the CBD in particular. "

Lee, who became the first woman and the first person of color to co-chair the congressional caucus on cannabis in January, said she was pleased to have the opportunity to talk about two of his favorite subjects: "Cuba and Cannabis".

For the latter, she focused on the approval of Epidiolex by the FDA. Specifically, she wished to point out that a UK-based pharmaceutical company had obtained approval of the drug because the UK government allowed it "to privately cultivate strains of cannabis at medical facilities". purposes of drug development ".

"Is it possible, under Schedule I of our US federal system, for a US-based company to similarly place on the market a herbal-derived cannabis drug by through the process of review and approval of the traditional FDA? "Because so many states have now adopted marijuana initiatives for medical purposes and it's unfortunate that we have not been able to advance the research."

"When it comes to cannabis-based compounds, it really depends on the active ingredient you're talking about – whether you're talking about THC or CBD and whether or not it's derived from marijuana or hemp," Gottlieb said. .

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

The commissioner said that he had his "personal opinion" on the issue, but that his lawyers would not want him to give a "legal opinion".

"I think we will have a resolution soon on whether the hemp CBD is not part of the planning process, "he said.

Finally, Gottlieb conceded that existing federal marijuana laws meant that "the ability to conduct marijuana research is more restricted, more regulated." S & # 39; he said not to know "all the nuances," a problem lies in the fact In the United States, only one licensed marijuana manufacturer by the federal government, and this lack of supply has led some researchers to lead studies in other countries.

"Over the years, you've seen frankly that companies are going abroad to do research on products made abroad. which is more easily accessible for clinical trials, "he said. "I think the question you want to come up with is valid. The only thing I can say is that the environment is changing rapidly. "

"Very quickly," Lee agreed.

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

FDA Explores "Alternative Approaches" to CBD Regulations, says Commissioner

Photo courtesy of YouTube / House Credits Committee.

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