Today the US was shocked to see a notification from FDA commissioner Scott Gottlieb that he has resigned from his position and will be leaving the FDA sometime next month.
Is this good or bad for the CBD/Hemp industry?
Scott posted on his twitter:
I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of @SecAzar and @realDonaldTrump – This has been a wonderful journey and parting is very hard. https://t.co/1Zu9y7NTwR
— Scott Gottlieb, M.D. (@SGottliebFDA) March 5, 2019
This came as a real surprise to the CBD industry after months of meetings, press releases and statements about plans, possibilities and future options for CBD regulations. Only last week, a press release hinted that Scott had made great advancements in the progress of new regulations over the last few months, some of which looked promising for the CBD industry.
With many outlets reporting last week, that the FDA seems to want to regulate CDB isolates as drugs and full spectrum products as food.. But, there is still a possibility isolated cannabinoids could be regulated to be both drugs and foods.
Courtney N. Moran, LL.M., spent two days last week in Washington, D.C. working on high-priority hemp issues that surround the implementation of the 2018 Farm Bill.
Courtney testified Tuesday before the USDA on the need for proper and timely implementation of regulations by the Department to enable U.S. farmers to benefit from the changes in federal law this planting season. She highlighted the need for crop insurance, the ongoing issues with transportation and shipment of the commodity, as well as the need for directive to financial institutions to allow farmers and agribusiness owners access to traditional banking just like any other agricultural crop and ancillary business. Moran, who was intimately involved in the drafting of the Hemp Farming Act of 2018, working closely with the offices of Senate Majority Leader Mitch McConnell and Senator Ron Wyden, emphasized the Congressional intent of the law around the felony clause. She further requested an immediate update to the NOP guidance on organic certification for farmers and processors. Please click here to see her full testimony.
Her questions resulted in Dr. Gottlieb making the most important statement concerning hemp CBD products to date, finally giving the industry insight into how the FDA intends to regulate these products in the future:
“I can speculate at a high level about some theoretical frameworks that you can contemplate for example, the product existing in a high concentration, pure formulation as a pharmaceutical product. While consisting in a different concentration as a food product or dietary supplement because we want to preserve the incentive to study CBD as a pharmaceutical product. We believe it does have therapeutic value and has been demonstrated. I will tell you this is not a straight forward process. There is not a good proxy for us doing this through regulations and if we get comments back and find that this is sufficiently complicated for the agency we will come back and have a discussion with Congress about how we might be able to work together on this.” ~Dr. Scott Gottlieb, FDA Commissioner. This statement further added to the idea of purified compound regulated as medical drugs and full plant extracts to be regulated as foods.
More on the full press release here.
Chellie Pingree also addressed this and asked:
Today I asked Commissioner Gottieb about FDA’s timeline and resources to develop legal pathways for food products with #CBD. He said the agency is developing a working group focused on this issue, but if it takes too long Congress may need to act. #mepolitics pic.twitter.com/l8TX0DrrVD
— Chellie Pingree (@chelliepingree) February 27, 2019
Scott said: “is not a straightforward issue.” Not only has the already FDA approved a CBD medication for epilepsy, Epidiolex, which generally means the compound can’t be added to food, but it’s also the “subject of substantial clinical investigation”—another reason it wouldn’t be be allowed in the food supply.
That said, “the law does allow us to go through a regulatory process and go through a notice and comment rule-making to establish a framework to allow it to be put into the food supply,” Gottlieb said. Their first step to that end will be a public meeting “sometime in April” that the agency will soon formally announce.
The commissioner offered a theoretical regulatory model that the FDA could implement for CBD.
CBD could potentially exist “in a high concentration, pure formulation as a pharmaceutical product” and also exist “at a different concentration as a food product or dietary supplement.” The reason the agency would want that separation is “because we want to preserve the incentive to study CBD as a pharmaceutical product,” Gottlieb said.
“We believe it does have therapeutic value and has been demonstrated,” he said. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”
With all these advancements, and what only a day or so ago, seemed we were really getting close to a public answer and solid guidelines.. He’s quit!?
So, what happens now? Are we back to square one? Will a new appointed Commissioner want to reset? Will they be opposed completely or will they be for full food legalization and standard FDA food classification?