I was as surprised as anyone with last week's announcement that Scott Gottlieb, the Commissioner of the Food and Drug Administration (FDA) was resigning.
Since becoming Commissioner two years ago, Gottlieb commuted from his home in Connecticut to Washington DC. The general conclusion was that his resignation was to enable him to spend more time with his family. I’m not so sure. There are two other possibilities not mentioned in the general media:
Over the past months Gottlieb focused on combating what he concluded was a major “epidemic” of teen vaping. He recently submitted to the White House a regulatory proposal that many Republicans viewed as overreaching regulation. Gottlieb’s resignation could be the result of his conclusion that his recommendations were doomed to failure in the Trump White House, and that all the time and work that he and the FDA devoted to regulatory changes regarding the sale of e-cigarettes were going nowhere.
The FDA was pulled in to having to deal with CBD policy as a result of the 2019 Farm Bill, which required the Agency to regulate the use of the cannabinoid as a food additive, a cosmetic additive and for health, wellness and nutritional purposes. Over the past years the FDA had for the most part avoided getting involved with cannabis regulation, including that of CBD. Gottlieb has been under increasing pressure from some members of Congress to determine the FDA’s policy and regulations for CBD immediately. With the pressure from vocal members of Congress, hemp growers, CBD product manufacturers, and consumers, as well as all the media attention about CBD, Gottlieb’s resignation could be the result of his not wanting to devote the time consuming, very political, and challenging task of determining CBD policy quickly. This would be a no-win situation for any FDA Commissioner.
I’ve reached the the conclusion that Gottlieb’s resignation as Commissioner was the result of his desire to avoid overseeing the Agency’s CBD policy, or that CBD policy was a major factor in his resignation.
With Gottlieb’s resignation, what happens with the FDA’s CBD policy? Does his resignation result in the determination of CBD regulations being slowed down?
My conclusion is that it’s likely that Gottlieb’s resignation and the appointment of a new Commissioner will likely speed-up the FDA’s determination of the Agency’s CBD policy.
The main reason for the accelerating the FDA’s determination of CBD policy has to do with the Trump Administration’s nomination of a new FDA Commissioner. With a very vocal group of members of Congress pushing the FDA on CBD policy, it’s clear that the a new nominee for FDA Commissioner will be grilled by the Senate as to how he or she feels about the regulatory pathway for CBD, and must be a proponent of CBD. The Senate confirmation hearings will likely become very contentious, and a nominee for FDA Commissioner who doesn’t agree to accelerate the determination of the Agency’s CBD policy will unlikely be confirmed.
Assuming a “pro-CBD” Commissioner is confirmed by the Senate, it’s a real unknown as to how the entrenched FDA bureaucracy will react to a push by a new Commissioner to a fast and positive regulatory framework for CBD that is beneficial for hemp growers, CBD product manufacturers and American consumers.
Author: Jeffrey Friedland