The new paper, by Dr. Mark Tallon and Dr. Rob Child of the UK’s Legal Products Group details three separate OECD (Organisation for Economic Co-operation and Development) rodent experiments carried out by a Eurofins laboratory that investigated: 1) prenatal development; 2) a 14-day dose range research study; and 3) a 90-day subchronic safety study with a recovery period.
The study specifically refers to cbdMD’s proprietary Broad Spectrum CBD blend, with Drs Tallon and Child stating: “It should be noted that other extracts will have their own toxicological profile that may not match this extract and, for therefore, ingredient-specific toxicological testing should be conducted to determine safe doses.”
“The NOAEL [no observable adverse effect level] for oral administration of this CBD isolate was 460.5 mg/kg bw/d for male Sprague-Dawley rats and 230.25 mg/kg bw/d for female Sprague-Dawley rats when they delivered in an MCT oil vehicle,” they wrote.
“Using an uncertainty factor of 100 (10 (between species) x 10 (within species)), this indicates that subchronic intake of the CBD isolate in this trial is safe for reference adult humans (70 kg ) at a dose of 161 mg per day.”
cbdMD: “We will continue to advocate tirelessly for regulatory clarity for hemp-derived products”
Commenting on the findings, Dr. Sibyl Swift, cbdMD Chief Scientific Officer and Vice President of Regulatory Affairs, said, “In light of the recent regulatory discussions and congressional interest in our industry, we felt it was important to publish our data because it serves as a resource for the industry, our consumers and regulators around the world.The publication has already been referenced in a security review and formed the basis of the review paper’s arguments for a safe upper dose limit, and will be shared with congressional staff as a follow-up to the company’s recent response to the bicameral information request.
“We know our products are safe and effective because we’ve invested in the science to support them; we will continue to tirelessly advocate for regulatory clarity for hemp-derived products to ensure our customers have access to botanically-derived solutions for their products . everyday health and well-being needs.”
The company noted that the data presented in the new document was referenced in its citizen petition, which was submitted in April 2022 to the FDA after a meeting with the Agency, and will be resubmitted as part of the public filing to “support the company’s lobbying efforts in Washington DC for reasonable CBD regulations.”
In addition, data from this study was used to support successful regulatory submissions to both the UK Food Standards Agency and the EU Food Safety Authority. The company stated that it was one of only two international publications demonstrating the safe level of cannabidiol consumption for humans.
Other scientific data
The release of the paper follows a recent review, also published in Regulatory Toxicology and Pharmacology, commissioned by Canopy Growth Corporation and Charlotte’s Web.
As reported by NutraIngredients-USA, this review concluded that higher levels of CBD intake ranging from 70 mg to 160 mg per day for dietary supplements are acceptable and do not harm the liver. The 100-160 mg range was determined for healthy adults and does not apply to those who are trying to conceive, or are pregnant or lactating, according to the study, at which point the upper intake limit (UL) drops at 70 mg per day.
The review applied publicly available safety data to develop recommendations for oral consumption of hemp-derived CBD.
In response to the review, an FDA spokesperson told NutraIngredients-USA that the Agency appreciates reviews of this type to bring needed attention to CBD.
“In general, however, the FDA does not comment on specific studies, but instead evaluates them as part of the body of evidence to improve our understanding of a particular topic and help our mission of protecting the public health.” said the spokesman.
Source: Regulatory Toxicology and Pharmacology
Published online ahead of print, doi: 10.1016/j.yrtph.2023.105496
“Evaluation of the subchronic oral toxicity of a cannabis extract”
Authors: MJ Tallon, R. Child
