February 28, 2019 – The FDA Scott Gottlieb unveiled new details of plans for alternative ways to regulate CBD, and also admitted that the federal ban is conducting research into medical marijuana abroad on Wednesday.
Gottleb’s latest comments were in response to questions from representatives D-CA, Cheli Pingri (D-ME), and Mark Pokan (D-WI) during a hearing before the Sub-Committee on Budgets.
Among the revelations that emerged from the hearing was that Gottlieb would soon announce that the FDA would hold a public meeting “somewhere in April” to hear from stakeholders how to best regulate CBD obtained from hemp that was legalized at the end of last year as part of the Farm Act 2018. He also said he would form a working group of experts from the agencies to inform him of the regulatory options for the CBD.
Askan wanted to know “how active” the FDA was considering different ways to regulate food and dietary supplements containing a cone-derived CBD, and asked for a time frame for which the agency expects to publish guidelines on the issue.
“I will say at first that we have heard Congress strongly and clearly on this legislation,” Gottlieb said, referring to the farm bill. “I understand that Congress wants to have a way to access CBD.”
But he added that this is not just a matter. Not only is the FDA approved drug therapy for epilepsy, Epidiolex, which usually means that the compound can not be added to the food but is also “subject to significant clinical manifestations”. investigation “- another reason why it would not be allowed in food supplies.
That said, “The law allows us to go through a regulatory process and go through a notice and comment the rules to create a framework that will allow it to be fed into the food supply,” Gottlieb said. Their first step in this direction will be a public meeting “somewhere in April”, which the agency will soon announce officially.
The Commissioner proposed a theoretical regulatory model that the FDA could apply to the CBD.
CBD may potentially exist “in high concentration, pure formulations as a pharmaceutical product” and also exist “at a different concentration as a food or nutritional supplement.” The reason why the agency would want this separation is “because we want to keep an incentive to study CBD as a pharmaceutical product, “Gottlieb said.
“We believe it has therapeutic value and is proven,” he said. “But I will tell you that this is not an easy process. There is no good indicator to do this by regulating us. “
If the task of developing an alternative regulatory approach to the CBD proves to be “sufficiently complicated,” Gottlieb said the FDA would “come back and hold a discussion with Congress on how we could work together on this issue,” proposing a further legislative beyond the farm bill may be needed.
Andy Harris (R-MD) briefly examined Pokan’s question and said he was going to the markets and seeing “products containing CBD and is not in the pharmacy behind a prescription counter. “
“I think this is something that steals and appreciates your response to Mr. Pokan,” Harris said.
Pingrey is the lead author of a bipartisan letter that was sent to the commissioner last week asking about the deadlines for FDA guidelines on how businesses can legitimately sell hemp products produced by the CBD through state lines. At the hearing, the congressman said she wanted to “stress the need for a sense of urgency” on the issue.
“I will tell you that we are deeply focused on this. We have already taken other difficult challenges, “Gottlieb said. “I think we have good results and we are trying to come up with a solution to other challenges. You have my commitment that I’m focused on that. “
The Commissioner said he would soon announce “a a high-level task force that will report to me, like some senior officials in the agency that will chair this. “
“I will tell you that if we decide that the road here will be a multi-year regulatory process that may take two, three or four years, I will go back to Congress to discuss whether or not there are other frameworks that could help solve this problem, “he said.
In addition, the FDA may “need a law that either treats this as an overall framework or deals specifically with the CBD. “
Lee, who became the first woman and co-chair of the Canadian Congress Congress in January, said she was excited about talking about two of her favorite themes: Cuba and Cannabis.
For the latter, it focuses on FDA approval by Epidiolex. In particular, she wanted to point out that the UK-based pharmaceutical company was approved for the drug because the UK government allowed them “private cannabis for drug development”.
“Is it possible, according to our US federal system I, list, whether a US company can market cannabis-like plant production through the traditional FDA review and approval? “Lee asked. “Because so many countries have now passed medical initiatives for marijuana and it is a pity we have not been able to move forward with research.”
“With regard to cannabis-derived compounds, it really depends on which active ingredient you are talking about – whether you are talking about THC or CBD, and whether it is derived from marijuana or hemp,” Gottlieb said.
He added that it remains an “active question” whether CBD-certified hemp has been legalized under the Farm Act of 2018, which means 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 has removed products derived from hemp from the Controlled Substances Act.)
The commissioner said he had “his own personal opinion” on the matter, but said his lawyers would not want him to “give legal advice”.
“I think we will adopt a resolution on this very soon if CBR obtained from hemp does not fall into the planning process, “he said.
Finally, Gottlieb admits that existing federal marijuana laws mean that “the ability to conduct marijuana research is more limited, more regulated.” only one licensed marijuana maker in the US, and that lack of sourcing leads some researchers to do research in other countries.
“Over the years you’ve seen, frankly, companies go abroad to do research with a product grown abroad is easier to get for the purposes of clinical trials, “he said. “I think the question you get is valid. The only thing I can say is that the environment here is changing rapidly. “
“We will certainly support more research,” Gottlieb said.
“Very fast,” Lee agreed.
