CBD suppliers form an alliance to push dietary supplement regulation
25 Sep 2023 --- In what has been described as a historic move, several US cannabidiol companies have formed the One Hemp alliance to push for the US Food and Drug Administration (FDA) to further regulate hemp-derived CBD products as dietary supplements.
Alliance members include BayMedica, Charlotte’s Web, ECS Brands, FSOil, Hemp Beverage Alliance, Kazmira, Mad Tasty, Open Book Extracts and Wyld. The move comes as a direct response to the collaborative process outlined by the FDA in January and the bipartisan, bicameral request for information (RFI) issued by Congress in July.
“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,” says Kelly Fair, strategic legal advisor to One Hemp.
The founding members jointly state: “We firmly believe that the time has come for Congress to advocate for responsible legislation that prioritizes the safety of the countless individuals who rely on CBD products every day. We invite all responsible players in our industry to join us in spearheading this crucial dialogue.”
On a CBD mission
The alliance, including researchers and toxicologists, seeks to advance CBD as a dietary supplement through bipartisan legislation to provide Congress and the FDA with information and support to pass the guidelines for a standardized CBD industry.
“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,” Fair explains.
The alliance will serve as a resource for developing a regulatory approach for the more than 45 million US citizens who rely on the benefits of CBD daily, including veterans, seniors and athletes.
Several US companies have allied to advocate for regulation ensuring CBD is considered a dietary supplement.
“It was critical to systematically and comprehensively review all of the existing literature on 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,” explains Dr. Marcel Bonn-Miller, chief scientific officer at Charlotte’s Web.
He spent years highlighting the implications of existing regulatory gaps and conducted a study on the inaccurate labeling of many CBD products. He was instrumental in bringing cohesion to the scientific data presented to Congress.
Research guidelines for CBD intake
One Hemp reinforced CBD dosage recommendations and its non-intoxicating properties with two new studies. In one of these studies, researchers set out to determine the potential oral intake limit values for the safe usage of CBD and dietary supplements by consumers.
“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,” says Dr. Rayetta Henderson Ph.D., lead study author and senior managing scientist at Tox Strategies.
The study addressed liver and reproductive toxicity, endpoints of potential concern previously noted by the FDA. Henderson presented the findings during an informal meeting.
The second study is being conducted by Dr. Ryan Vandrey, Ph.D. at Johns Hopkins University, which evaluates whether THC doses found in full-spectrum hemp products are associated with impairment after acute or twice-daily use.
“Through this research, we seek 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,” Vandrey explains.
Edited by Inga de Jong
