Industry Companies Form Group to Study Effects of CBD on Liver
Seven companies and more than 700 consumers will participate to answer the FDA's call for more studies on CBD's impact on the liver.
CENTENNIAL, Colo. (PRWEB) JUNE 9, 2020
ValidCare announced June 9 that BoulderBotanical & Bioscience Labs, CBDistillery, CBD AmericanShaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway will participate in an industry-wide study measuring the effects on the liver of daily use of full spectrum hemp-derived CBD and CBD isolate by healthy adults. The companies are answering the U.S. Food and Drug Administration’s repeated request, including the agency’s March 5, 2020 report to Congress, for science-based data so it can confidently determine the appropriate regulatory path for hemp-derived CBD products.
“After inviting and screening over 100 brands to participate in this water-shed research, seven companies have chosen to demonstrate real leadership, collaboration and commitment to consumer safety,” said Patrick McCarthy, CEO of ValidCare. “With over 3,500 brands vying for market share, these brands put a premium on science, data and consumer safety over just marketing and revenues. ValidCare is proud to sponsor this research and help answer important questions for the industry, while preserving intellectual property and rights to re-use this data with FDA for individual product submissions at a later date.”
Federal regulation of hemp-derived CBD products by the FDA has been stalled since the passage of the 2018 Farm Act, despite thousands of brands being available for purchase. “The lack of regulatory clarity creates risk for the industry and the American consumer,” said Jason Mitchell, president of HempFusion.
The first step of the process is to collect and provide information from healthy American adults who have consumed oral CBD products for at least 60 days. Measures include reported product experiences and a blood sample to understand how the consumer’s liver reacts. “Charlotte’s Web invests in precision science through our CW Labs and also through important research studies such as this ValidCare study because this research will provide much needed data,” said Tim Orr, vice president of innovation at Charlotte’s Web. “By being both science and data-driven we can secure long term consumer trust, while also addressing the FDA’s safety concerns with CBD products.”
The observational study was designed with significant input from the FDA, the brands and third-party principal investigators Keith Aqua, MD and Jeffrey Lombardo PharmD, BCOP. The study is planned to start in early Q3, 2020 and is expected to be completed by the end of the year. The design calls for participation by a minimum of 700 consumers. This data will be combined with personal history, blood tests and product data to provide investigators with the opportunity to understand multiple variables across populations, products and lifestyles.
“At this time, the FDA continues to assert that, without additional data from qualified experts, they're unable to develop an appropriate regulatory scheme specific to CBD,” said Chase Terwilliger, CEO of The CBDistillery. “That’s why continued data collection is vital for all parties involved, and why, as a group, we've engaged the FDA on study protocol and partnered with academic experts. We are confident in our products and processes and are committed to consumer safety. This data will help pave the path forward for our industry."
Source: HempGrower
Seven companies and more than 700 consumers will participate to answer the FDA's call for more studies on CBD's impact on the liver.
CENTENNIAL, Colo. (PRWEB) JUNE 9, 2020
ValidCare announced June 9 that BoulderBotanical & Bioscience Labs, CBDistillery, CBD AmericanShaman, Charlotte’s Web, Columbia Care, HempFusion, and Kannaway will participate in an industry-wide study measuring the effects on the liver of daily use of full spectrum hemp-derived CBD and CBD isolate by healthy adults. The companies are answering the U.S. Food and Drug Administration’s repeated request, including the agency’s March 5, 2020 report to Congress, for science-based data so it can confidently determine the appropriate regulatory path for hemp-derived CBD products.
“After inviting and screening over 100 brands to participate in this water-shed research, seven companies have chosen to demonstrate real leadership, collaboration and commitment to consumer safety,” said Patrick McCarthy, CEO of ValidCare. “With over 3,500 brands vying for market share, these brands put a premium on science, data and consumer safety over just marketing and revenues. ValidCare is proud to sponsor this research and help answer important questions for the industry, while preserving intellectual property and rights to re-use this data with FDA for individual product submissions at a later date.”
Federal regulation of hemp-derived CBD products by the FDA has been stalled since the passage of the 2018 Farm Act, despite thousands of brands being available for purchase. “The lack of regulatory clarity creates risk for the industry and the American consumer,” said Jason Mitchell, president of HempFusion.
The first step of the process is to collect and provide information from healthy American adults who have consumed oral CBD products for at least 60 days. Measures include reported product experiences and a blood sample to understand how the consumer’s liver reacts. “Charlotte’s Web invests in precision science through our CW Labs and also through important research studies such as this ValidCare study because this research will provide much needed data,” said Tim Orr, vice president of innovation at Charlotte’s Web. “By being both science and data-driven we can secure long term consumer trust, while also addressing the FDA’s safety concerns with CBD products.”
The observational study was designed with significant input from the FDA, the brands and third-party principal investigators Keith Aqua, MD and Jeffrey Lombardo PharmD, BCOP. The study is planned to start in early Q3, 2020 and is expected to be completed by the end of the year. The design calls for participation by a minimum of 700 consumers. This data will be combined with personal history, blood tests and product data to provide investigators with the opportunity to understand multiple variables across populations, products and lifestyles.
“At this time, the FDA continues to assert that, without additional data from qualified experts, they're unable to develop an appropriate regulatory scheme specific to CBD,” said Chase Terwilliger, CEO of The CBDistillery. “That’s why continued data collection is vital for all parties involved, and why, as a group, we've engaged the FDA on study protocol and partnered with academic experts. We are confident in our products and processes and are committed to consumer safety. This data will help pave the path forward for our industry."
Source: HempGrower
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