One Hemp Coalition Fights for Dietary Product Regulation for CBD on Capitol Hill

The One Hemp Coalition went to Capitol Hill on Wednesday, December 6^th to make the case for regulating CBD as a dietary supplement, briefing both the House and Senate on the issues. They held an open briefing afterwards, offering an overview of who they are and what the One Hemp Coalition stands for. 

Kelly Fair, a partner at Dentons who serves as strategic advisor to One Hemp, explained to us by email that, “Our goal is to spur Congress to create a clear regulatory framework for CBD products as dietary supplements. The key next step is for the Congressional committees of jurisdiction in Congress (House Energy and Commerce and Senate HELP) to hold markups on CBD legislation. We met with staff from both committees and encouraged them to push ahead.”

As well as discussing it with One Hemp themselves, we watched the briefing and looked through the group’s detailed response to the recent congressional RFI to offer a quick run-down of who they are and what they think Congress needs to do to address the realities of the modern CBD and hemp industries.

RELATED: Hemp and Cannabis Associations Answered Questions for Congress: Here’s What They Said

The One Hemp Briefing: Five Experts Weigh in on CBD Regulation

The briefing took place on December 6^th, and five experts coming at the issue from slightly different perspectives gathered in a meeting room to discuss their work and CBD regulation more broadly.

These experts were:

• Kelly Fair (Dentons US & Strategic Advisor to One Hemp)
• Paige Figi (Coalition for Access Now)
• Nicole Hemmenway (US Pain Foundation)
• Jennifer Baxter (Balanced Veterans Network)
• Dr. Rayetta Henderson (ToxStrategies LLC)

Kelly Fair (Dentons US)

Kelly Fair from Dentons opened up the briefing, focusing on the consequences of the lack of regulation on CBD.

So without federal regulation, traditional retail, big box, large grocery, traditional pharmaceuticals club, they won’t sell the products. …until the FDA blesses these products as dietary supplements or otherwise, that point of distribution is constrained.

Kelly D. Fair, Partner at Dentons

She notes that:

“I think the USDA did a great job of stepping in early after the farm bill legalized the commodity to regulate the crop. The states have piecemeal along the way, tried to regulate the finished goods through manufacturing standards, et cetera. But where the supply chain breaks entirely is by lack of federal regulation. And it bottlenecks at the traditional retail point of distribution for non intoxicating hemp-derived products including CBD. So without federal regulation, traditional retail, big box, large grocery, traditional pharmaceuticals club, they won’t sell the products. They want to sell the products they’re ready to; the consumers are demanding the products. But until the FDA blesses these products as dietary supplements or otherwise, that point of distribution is constrained.”

Paige Figi (Coalition for Access Now)

Kelly then introduced Paige Figi, mother of Charlotte Figi and co-founder of the Coalition for Access Now.

Paige described how her journey with CBD started when she needed something to help Charlotte manage her “catastrophic” epilepsy. She comments that “It was a wild success.” However, back in 2010, CBD was basically treated like marijuana – literally a Schedule I substance – which left other people who didn’t live in a state like Colorado either having to travel with a controlled substance, change their state’s laws or simply be left without adequate treatment.

She said, “We started the Coalition for Access now to just simply help those people who had to choose to move to Colorado. We passed the law or helped pass the law in 50 states and multiple countries. We went to the federal government and those first federal CBD bills were named after Charlotte. And what they did, they asked for two things. They asked for CBD to be descheduled, removed from the cannabis conversation, because this is a non-intoxicating, benign plant extract.”

…these bills would require CBD to have basic dietary supplement labeling. So we would have accuracy of what’s in the product and we would get that through independent testing.

Paige Figi, co-founder of the Coalition for Access Now

Paige then discussed the push to establish dietary supplement regulation for CBD products, particularly through HR 1629 and the companion Senate Bill. She explained that, “these bills would require CBD to have basic dietary supplement labeling. So we would have accuracy of what’s in the product and we would get that through independent testing. And these are things I required for before I gave this to Charlotte, and I just think it’s important to know what you’re taking and what’s in there. So this, right now we’re in this absence of regulation, this five-year vacuum as Kelly said, and problems are occurring and this really is way long overdue. It’s a very small push to get this last bit done. It’s very widely bipartisan. It’s a no-brainer.”

Nicole Hemmenway (US Pain Foundation)

Next up to speak was Nicole Hemmenway, CEO of the US Pain Foundation and a long-term suffer from chronic pain.

The Foundation’s goal is helping the millions of Americans who live with illnesses or injuries which cause pain, through education, advocacy and direct support.

She described the challenges of living with chronic pain, “But what keeps me up at night are the countless emails that I receive from everyday individuals who have lost everything because of chronic pain. Their lives have been robbed, they have lost their jobs, they have lost their financial security, they have lost their relationships. They have lost the ability to participate in hobbies and things that make them happy. What I hear from them is that I’ve been dismissed, I’ve been marginalized. I don’t have doctors who will treat me. I can’t find options to help me. I don’t have access. All I want to do is make a meal for my family or take a shower or have coffee with a friend, go to my grandchild’s soccer game, even just receive a hug from a loved one.”

But what keeps me up at night are the countless emails that I receive from everyday individuals who have lost everything because of chronic pain. …there’s also been a lot of concern that people don’t know where to turn to. They don’t know what products are safe. …we need to do more as a society to make sure that people have access to independently tested, high quality, safe products that could really change the trajectory of their life.

Nicole Hemmenway, CEO of the US Pain Foundation

“What we hear is that people just want options. They want access to multidisciplinary care. And CBD is one of those options, and it has been life-changing for millions of people that I represent. But there’s also been a lot of concern that people don’t know where to turn to. They don’t know what products are safe. They don’t necessarily trust the labels that are out there, and we need to do more. And that is why I am here. I am here as a representative for myself as well as the countless people that I serve through my job at US Pain Foundation to be that voice, to let people know that you are not alone on this journey, that we need to do more as a society to make sure that people have access to independently tested, high quality, safe products that could really change the trajectory of their life.”

Jennifer Baxter (Balanced Veterans Network)

Jennifer Baxter spoke next, Executive Director of the Balanced Veterans Network.

She opened by telling her own story, serving as a US Air Force Security Services member for over 14 years before having to retire for medical reasons in 2012. After an unfortunate complication in an initial surgery, she found herself deemed unfit for service and put on 600 pills per month, which she continued to take for six and a half years. This led her to a low point:

“One day I had thoughts crossed through my head that stopped me in my tracks, and I knew that my existence was solely dependent on finding a new path. It was then I decided to research a more holistic and alternative approach to my healing. CBD has been an influential part of my wellness journey and something I have relied on extensively to help me manage both physical and mental ailments. It has been instrumental in providing actual beneficial relief and allowing for improved quality of life both physically and mentally. But I am not alone. I am here today not only to share my story, but to be the voice of all veterans who rely on alternative therapies as a vital tool for their healing and wellness. My story is not one of a kind.”

However, we face significant concerns of safety and reliability of CBD due to the current lack of regulation, myself nor the veteran community did not transition from toxic pharmaceutical medications to a natural approach where I must worry about harmful and dangerous substances, including heavy metals and toxins and pesticides.

Jennifer Baxter, Executive Director of the Balanced Veterans Network

She continued, “It is no secret that we face a severe epidemic of opioid addiction and veteran suicide with the daily number of veteran suicides, actually closer to 44 veterans a day, as determined through an intensive substantial study deemed Operation Deep Dive. The regulation of CBD is essential for the safety and protection of veterans who have incorporated this into their lives. However, we face significant concerns of safety and reliability of CBD due to the current lack of regulation, myself nor the veteran community did not transition from toxic pharmaceutical medications to a natural approach where I must worry about harmful and dangerous substances, including heavy metals and toxins and pesticides. Veterans have found a viable solution with alternative therapies, and I’m a walking testament to this. Now is the time to act. Now is the time to do what is right for a veteran community to regulate CBD to ensure they’re only obtaining reliable and safe products.”

Dr. Rayetta Hendersen (ToxStrategies LLC)

Dr. Rayetta Hendersen from scientific consulting firm ToxStrategies LLC spoke next, offering an overview of her group’s research into establishing a recommended daily intake value for CBD.

This made her talk a little different from the others, being more of a science-focused talk on the data and the work they did with it to produce their recommendation. In brief, they looked at all of the available evidence on CBD’s safety in a systematic fashion, while also accounting for the quality of the studies themselves.

The result of this process and the resulting meta-analysis were two estimates. For a healthy adult, they recommend an upper intake limit of 70 mg/day, but for adults who aren’t trying to conceive, pregnant or lactating, this was increased to 100 to 160 mg/day.

She explained the purpose of the research simply, “our goal was to derive evidence-based conclusions and recommendations that could be carried forward and used by those who are interested in setting regulatory guidelines or recommendations and guidance for consumers to continue to use these products safely in their lives.”

The One Hemp Coalition’s RFI Response and the Proposed Policy Solution

The Request for Information (RFI) regarding FDA regulation of CBD and hemp issued this summer gave many in the industry the chance to make some important points to Congress about the way forward when it comes to hemp and CBD. As many other organizations did, the One Hemp Coalition issued a detailed response to these questions to help lawmakers move in the right direction on CBD.

The full response to the RFI of course has all of the information if you want the full detail on the questions and their responses. However, it must be said that a substantial percentage of the questions could be answered by anybody with a more-than-passing knowledge of the CBD and hemp market in the US. In other words, you probably won’t learn much from many of the responses unless you’re pretty new to this area.

The proposed policy solution (summarized on page 23 and given in full detail in Appendix A/page 66) gives an overview of what the One Hemp Coalition thinks needs to be done. Kelly Fair described the main idea: 

The key change we are seeking from Congress is a mandate for the FDA to regulate nonintoxicating hemp-derived CBD products through the existing regulatory framework for dietary supplements, including appropriate product warning statements to address FDA concerns. Hemp-derived products not marketed as dietary supplements or with impairing levels of hemp-derived THC would be regulated by other existing federal and state regulations.

Kelly D. Fair, Partner at Dentons

Their solution essentially splits hemp products into two groups: low-dose hemp derived products and ordinary hemp-derived products.

For low-dose products, containing less than 1.5 mg of any THC and no more than 100 mg of total hemp cannabinoids per serving, there would be no requirement for premarket approval from the FDA. However, they must contain warning labels and generally abide by the rules for dietary supplements, as well as submitting basic information and test results to the FDA within 60 days of the product going onto the market.

Higher-dose products would also have to be registered with the FDA prior to sale, including the same submission of results of safety and potency testing. Kelly Fair explained that most of the regulation of intoxicating products would be left to states, “Our recommendation is that products with impairing levels of hemp-derived THC be regulated at the state level, and not under the federal regulatory pathway for dietary supplements or otherwise. Currently more than 40 states have regulations addressing these types of hemp products.”

The proposal would also exempt hemp products from some problematic parts of the federal Food, Drug and Cosmetic Act, making it legal to make and sell hemp edibles at the federal level.

Importantly, the bill would establish a minimum age of 18 for the sale of any hemp product with more than 0.5 mg of THC, and would make sure that all of these THC limits apply to every isomer. This is something lawmakers should have done a long time ago, and something missing in more states than you might like to think. 

Kelly Fair explained that they went with 18 as the minimum age rather than 21, “The ONE HEMP framework proposes to regulate nonintoxicating hemp products only, so a 21+ age gate, historically applicable to intoxicating alcohol and cannabis products, is neither appropriate nor necessary for these non-impairing products.“

Overall, the bill is a great example of a sensible regulatory system whereby low-dose products are basically allowed to continue operating as now, except with some basic requirements that any self-respecting company would already be meeting. For higher-dose products, it leaves most of the choice up to states rather than imposing a blanket “ban-or-allow” rule. It does a good job of striking a balance between allowing the industry to flourish and not letting shady operators make a quick buck at the expense of the consumer.

RELATED: How Should the FDA Regulate CBD and Hemp? Here’s What the Experts Think

Conclusion: A Proposal and a Presentation Lawmakers Should Listen To

With the Farm Bill set to expire in September 2024, and historical precedent putting the time needed to produce a passing draft at about a year, lawmakers would do well to listen to One Hemp’s passionate talk and their sensible set of policy recommendations. Kelly Fair said that from her perspective, things are looking positive:

“We came away from our meetings with Members of Congress and staff feeling encouraged. There is an understanding on Capitol Hill that the status quo is untenable, and Congress must step in to provide a clear framework for the FDA. Members and staff were particularly interested in the perspectives of patient and veterans advocates.”

She concluded that, “we believe the opportunity has arrived for substantive federal CBD policy reform in Congress. Key Members of Congress understand the problem and the path forward. To be sure, it’s difficult to get new legislation through this Congress. But we have bipartisan support and a strong legislative fix, so we are absolutely in the game.”