Tuesday, December 12, 2023
On December 6th, ONE HEMP held a briefing regarding the regulation of hemp and CBD products as dietary supplements. The panel included representatives from the Coalition for Access Now, U.S. Pain Foundation, Balanced Veterans Network, ToxStrategies LLC, and Dentons. Fresh from Capitol Hill meetings with Congress members and their staff, the panelists highlighted the absence of federal regulation impacting the hemp supply chain, emphasized the need for regulation to ensure consumer safety, and delved into the critical role of CBD options for populations with limited pharmaceutical alternatives. The briefing also touched on ONE HEMP’s RFI proposed policy solution submission.
Kelly Fair, Strategic Advisor and Legal Counsel to ONE HEMP, Dentons U.S. Cannabis and Hemp Group Partner, began the discussion by outlining the challenges faced by the hemp-derived product supply chain due to a lack of federal regulation. While the USDA regulates the crop, the absence of comprehensive federal oversight, especially from the FDA, hinders the distribution of non-intoxicating hemp-derived products, such as CBD, in traditional retail outlets. This regulatory gap affects farmers, manufacturers, and consumers, leading to market constraints, safety concerns, and a lack of standardized labeling. She emphasized how crucial the call for FDA approval as dietary supplements is for addressing these issues and ensuring a functional and safe supply chain.
Paige Figi, Executive Director of the Coalition for Access Now, shared her personal journey with CBD and its success in treating her daughter Charlotte’s epilepsy, emphasizing the necessity of dietary supplement regulation for CBD. The Coalition for Access Now represents the consumer voice advocating for CBD regulation to ensure safety and accessibility. Paige highlighted CBD as a crucial option for various populations, including but not limited to seniors, athletes, veterans, and those with chronic pain.
Nicole Hemmenway, CEO of the U.S. Pain Foundation, emphasized the personal and profound impact of chronic pain and the need for CBD as an option for those lacking pharmaceutical alternatives. She stressed the importance of independently tested, high-quality, and safe CBD products.
Jennifer Baxter, Executive Director of Balanced Veterans Network, and a retired Air Force veteran, shared her personal journey of opioid dependence after surgeries and how CBD has positively impacted her physical and mental well-being. She advocates for CBD regulation to ensure safety and reliability, especially for fellow veterans relying on it as an alternative therapy.
Dr. Rayetta Henderson, Ph.D., Senior Managing Scientist at ToxStrategies, presented a study on the safe use of CBD. The study assessed human clinical trials and animal studies, focusing on liver and reproductive effects as critical endpoints. Following systematic and industry-standard approaches, the study derived acceptable daily intake values for various populations, recommending an upper limit of 70-100 mg/day for healthy adults using CBD products. The findings aim to provide recommendations for the safe use of CBD, emphasizing evidence-based conclusions for regulatory guidelines and consumer safety.
The briefing concluded by emphasizing the urgent need for CBD regulation and proposing potential legislative solutions. ONE HEMP’s proposed policy solution defines non-intoxicating hemp-derived products, including CBD, as dietary supplements. The proposal safeguards State’s rights, differentiates between dietary supplement dosing levels and pharmaceuticals, recommends labeling with warning disclosures for known and unknown risks, sets a threshold for THC levels, and prohibits the concentration or synthesis of cannabinoids.
In Kelly’s words, “Our proposed solution elegantly threads the needle to address all the stakeholder concerns, including the FDA’s stated concerns… There are a myriad of approaches that could be taken. I think this is the best one, but I think the bigger message is not to take that lock stock and barrel. It’s really to get something done and that there is urgency to get these products that are regulated and safe into the hands of consumers who need them, based on the science.”
Mr. Pulak Sharma, ONE HEMP member, co-founder and co-CEO of Kazmira, attended the live briefings on Capitol Hill and commented, “Consumer need-states are really what matters. People want these products, so they need to be safe, and they need to know what’s in them. At Kazmira, we care and we want consumers to have safe therapeutic products, end of story.”
The briefing not only underscored the importance of addressing all stakeholder concerns, protecting State’s rights, and implementing science-based regulations but, most significantly, acknowledged the need to meet the market where it is, considering the absence of federal regulation more than 5 years after descheduling hemp.
LISTEN IN: To watch a recording of the briefing, follow this link: 12-6-2023 ONE HEMP Hill Briefing
The opportunity has arrived for substantive federal CBD policy reform in Congress. The ONE HEMP briefing is part of a broader effort to urge the committees of jurisdiction in Congress – House Energy and Commerce and Senate HELP – to move ahead with marking up legislation. The nation’s hemp and CBD producers, and the millions of Americans who rely on their products, will all benefit from a clear regulatory framework for CBD products.
With an unwavering commitment to science and consumer safety, ONE HEMP is an industry coalition comprised of respected voices and CBD market leaders whose concerted efforts are aimed at equipping Congress and the FDA with the knowledge and support required to pass sensible guidelines for a standardized CBD industry. Learn more at www.onehemp.org.