• Jeffrey Friedland

The Impact of Scott Gottlieb’s Resignation as FDA Commissioner on CBD Policy

We were as surprised as anyone with yesterday’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. We’re 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 Congress, and pressure from hemp growers, CBD product manufacturers, and consumers, as all the media attention to CBD, Gottlieb’s resignation could be the result of not wanting to devote the time consuming, very political and challenging task of determining CBD policy quickly, a no-win situation.

We have concluded that Gottlieb, in his likely desire to avoid overseeing the determination of CBD policy is either the reason he resigned as Commissioner, or a significant 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?

We’ve concluded that Gottlieb’s resignation will speed-up the FDA’s determination of the Agency’s CBD policy.

The main reason for this has to do with the need for the Trump Administration having to nominate 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. The hearings on CBD would likely become very contentious on CBD. Our conclusion is that any nominee for FDA Commissioner who doesn’t strongly endorse a positive framework for CBD regulations will not be confirmed by the Senate.

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 strategy to establish a positive regulatory framework for CBD that is beneficial for hemp growers, CBD product manufacturers and American consumers.

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