Jonathan Miller, General Counsel, US Hemp Roundtable Discusses FDA Regulation of the Hemp Market

Pharm Exec: Recently, you were a part of a coalition of nonprofit organizations that sent a letter to the leaders of the House Energy and Commerce Committee, urging the committee to expedite a hearing on the FDA's regulation of the rapidly growing hemp market, including products such as CBD. Has there been a response? If not, what are you expecting the response to look like?

Miller: We don't expect a formal response. Generally, members of Congress don't respond that way, but we have already met with the staffs of both the chair and the ranking member of the the Energy and Commerce Committee and had some good discussions. Hopefully, we'll see a hearing at some time in the near future, the challenge is not any opposition to our subject matter, or our legislative agenda, it's just a matter of priorities and how crowded everything is in Congress right now. It's our goal to try to make this a priority so that they will hold a hearing and start moving on legislation.

Pharm Exec: In the six years since the Farm Bill effectively legalized hemp, the FDA hasn’t done much to regulate potential products. Why do you think this is the case and what have been the repercussions?

Miller: It's been a, a real devastating blow to the industry. In 2018, the FDA announced that it would taking steps to investigate regulatory pathway. They didn't do anything substantive. In the beginning of last year, they said "we need more legal authority to be able to move forward." It's been quite frustrating for the industry. Where we agree is we want to provide them with that legal authority through legislation that would require them to regulate CBD as a dietary supplement or a food and beverage additive and we're hopeful that we'll start seeing some movement on that legislation in the near future.

Pharm Exec: How do you think properly regulated hemp products can benefit patients?

Miller: It's more of a nutritional supplement, a dietary supplement. that people have been taking CBD for many years now. It's a very popular product, people use it for a wide variety of ways to improve their health and wellness. There have been just simply no examples of of any injuries or any health risks posed by CBD products. So, we are quite confident that this is something that is good for the body and the FDA hasn't come out with anything that would otherwise demonstrate that CBD is not safe. There have been a number of studies that have come out as well that have demonstrated CBD safety. It really isn't about substance, it's more about trying to make this a priority in Washington to get it done.

Pharm Exec: Regarding the letter, who led the charge and how were you able to get a total of 28 organizations to be a part of it?

Miller: Last year, We last year, the US hemp roundtable got together with two of the other major national organizations, the Hemp Industries Association, and the National Industrial Hemp Council and said "Let's let's try to work together to provide an industry wide consensus plan that that would educate legislators for the Farm Bill." We were helped by the NoCo Hemp Expo, which is the leading hemp event in the country. With their help, we brought together dozens of other organizations to start talking through the legislative agenda. After a lot of work, we came up with the plan that you see. 33 different organizations support our farm bill agenda. 27 of those have jumped on to this particular letter to the House Energy and Commerce Committee.It demonstrates that there are there are plenty of hemp voices out there, not everybody agrees on everything, but there is a consensus view of what's important and this is part of what we all are struggling for and hoping for.

Pharm Exec: Going forward, what will your strategy be to address the issues with the FDA?

Miller: Our strategy is to keep the accelerator on and to continue to push Congress to develop legislation to provide for regulation as a dietary supplement or food beverage additives and to try to get a hearing to try to get legislation passed that will make these requirements. So, we don't think that talking to the FDA will serve any purpose right now. It's about getting Congress to provide them with a legal mandate to take action.

Pharm Exec: Do you have any other plans in the works that aim to get Congress to act on this issue?

Miller: We're continuing to do creative things. We've had an effort in Washington to get local farmers and small businesses to petition their Congresswoman, Cathy McMorris Rodgers, who happens to be the chair of the powerful House Energy and Commerce Committee. of the powerful House Energy and Commerce Committee. We're trying to do this in other locations to let members of Congress know that their constituents really care about this and that's ultimately what what the members of Congress care about.

Pharm Exec: What do you think the future holds for this industry?

Miller: We've had a tough few years because of the lack of regulation. But again, there is a consensus that needs to be done and once it is done, I think it's going to unleash a really exciting industry and provide a lot of good benefits to consumers and importantly, help provide a new economic opportunity for a lot of farmers across the country.