Asterra Labs was one of 12 CBD brands that took part in ValidCare’s industry sponsored, decentralized human safety study of hemp derived CBD products. This study was commissioned and designed in response to the Food and Drug Administration’s requests to help the agency confidently determine the appropriate regulatory path(s) for hemp derived CBD products. Preliminary findings are validating and reassuring, according to the study’s investigators, with no evidence of liver disease in the 839 participants in the clinical trials.
“Asterra Labs was founded by veteran scientists from the pharmaceutical industry. So, when we were made aware of the opportunity to participate, we did not hesitate to join this important study to support the safe use of our products by the millions of Americans who consume and find them beneficial.” said Kevin Sills, CEO Asterra Labs. “We are very pleased with this study’s positive outcome and ValidCare’s work to support the industry.” said Mr. Sills.
According to this 7-month study, which ran from August 2020 to February 2021, the research demonstrated a ~9% elevation in liver enzymes, labeled as “clinically insignificant”. “We are encouraged by these findings and are hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Keith Aqua, MD, co-principal investigator of this IRB-approved study.
ABOUT ASTERRA LABS
Asterra Labs is a team of pharmaceutical scientists and CBD industry leaders that innovates, develops, and manufactures a pharmaceutical-grade line of cannabinoid products. After the release of a 2019 FDA study indicating that 90% of CBD products available at the time were tested and found to contain misleading information on their labels, Asterra Labs responded with a commitment to apply the same rigorous safety, quality, and purity standards of the pharmaceutical industry to our line of cannabinoid products. Participation in the ValidCare liver safety study is an example of that commitment.
For more information visit http://www.asterralabs.com or contact us at 1-800-430-9074 or firstname.lastname@example.org.