Date: Tuesday, September 19, 2023
CBD Industry Leaders Form Historic Alliance to Advance Regulation of CBD Products as Dietary Supplements
WASHINGTON – Today, the nation’s leading cannabidiol (CBD) companies, including BayMedica, Charlotte's Web, ECS Brands, FSOil, Hemp Beverage Alliance, Kazmira, MAD TASTY, Open Book Extracts, and Wyld, joined together in a historic alliance to advocate for U.S. Food and Drug Administration (FDA) regulation of hemp-derived CBD products as dietary supplements. These companies are uniting as a coalition called ONE HEMP in direct response to the collaborative process outlined by the FDA in January and the bipartisan, bicameral Request for Information (RFI) that Congress issued in July. ONE HEMP is encouraged by the FDA’s proactive engagement and believes the opportunity has arrived for substantive federal CBD policy reform in Congress. We look forward to working with policymakers, regulators and stakeholders to advance the future of CBD regulation.
ONE HEMP will continue to offer policymakers a science-backed and safety-minded industry resource for the development of a regulatory approach that aligns with the need to ensure access for the more than 45 million Americans who rely on the benefits of CBD every day, including veterans, seniors, families, athletes, and more.
“This coalition has and will continue to offer Congress science-backed policy solutions, including an FDA mandate to regulate hemp-derived products through the existing regulatory framework for dietary supplements,” said Kelly D. Fair, Strategic Advisor to ONE HEMP, Dentons U.S. Cannabis and Hemp Group Partner, and organizer of ONE HEMP’s RFI submission. “ONE HEMP advocates for industry requirements to disclose hemp-derived product warning statements addressing the FDA's public risk concerns and product safety and non-impairment recognition at certain dose levels based on credible scientific data.”
Scientific support of ONE HEMP comes from:
Dr. Marcel Bonn-Miller Ph.D., Chief Scientific Officer at Charlotte’s Web and a leading cannabinoid scientist who was pivotal in bringing cohesion to the scientific data presented to Congress. He has spent many years highlighting the implications of existing regulatory gaps, like his study on inaccurate labeling of many CBD products.
“It was critical to systematically and comprehensively review all of the existing literature speaking to the safety of CBD so we could provide a data-driven framework for its safe use to legislators. Equally vital was the presentation of data to inform standardization of product labeling to ensure transparency and consumer safety.”
ONE HEMP’S perspective on CBD serving recommendations and its non-intoxicating nature received added reinforcement through the unveiling of two new studies.
Dr. Rayetta G. Henderson Ph.D., Senior Managing Scientist at ToxStrategies LLC, successfully led a team of researchers to conduct a comprehensive study to derive potential upper oral intake limits for safe CBD usage by consumers. This study was specifically designed to address concerns regarding potential liver and reproductive toxicity, such as those raised by FDA, and appropriate dietary supplement thresholds for CBD safety. She presented these findings during an informal meeting. Dr. Henderson remarked, “The study’s suggested Upper Intake Limits for dietary supplement use by healthy adults not only closely correspond with the recommendations put forth by leading regulatory bodies (Health Canada, TGA, FSA), they also provide a sufficient margin of safety for potential adverse effects and help to establish a safe framework for CBD consumption.”
Dr. Ryan Vandrey Ph.D., a cannabis researcher at Johns Hopkins University, is conducting a second pivotal study evaluating whether THC doses found in full spectrum hemp products are associated with impairment after acute or twice-daily use. Dr. Vandrey stated, "Through this research, we are seeking to understand impairment in relation to different ratios and doses of THC and CBD commonly found in full-spectrum hemp products. This can serve as a tool for legislators seeking data to inform regulatory guidelines.”
In a joint remark, the founding members of ONE HEMP said, “We firmly believe that the time has come for Congress to stand with us in advocating for responsible legislation that prioritizes the safety of the countless individuals who rely on CBD products every day. We extend an invitation to all responsible players in our industry to join us in spearheading this crucial dialogue. Together, we can shape a brighter, safer future for the CBD industry and for the millions of CBD consumers who seek its wellness solutions. ONE HEMP will strive to strike the right balance between FDA concerns and industry stability."
ONE HEMP's core mission is to advance CBD as a dietary supplement through bipartisan legislation. 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 all aimed at equipping Congress and the FDA with the knowledge and support required to pass sensible guidelines for a standardized CBD industry. The group has enlisted some of the world's foremost cannabinoid researchers and toxicologists, ensuring that their approach is firmly rooted in robust scientific research and a deep understanding of CBD's safety profile. ONE HEMP aims to set industry benchmarks, nurturing trust and innovation in the CBD sector.