cbdMD announces results of safety data supporting a safe upper dose of its broad spectrum CBD

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CbdMD (Charlotte, NC) has announced the publication of safety data that support a safe upper dose of its proprietary broad spectrum CBD blend. The publication includes the results of three separate OECD experiments on rodents performed by a Eurofins lab. The experiments investigating the CBD blend included a study on prenatal development, a 14-day dose-range finding study, and a 90-day subchronic safety study with a recovery period.

The prenatal development and 90-day study exposed test subjects to either 0 (control), 30 mg/kg/body weight (bw) per day, 115 mg/kg/bw per day, 230 mg/kg/bw per day, or 460 mg/kg/bw per day. The 14-day study did not include a 30 mg/kg/bw/day group, but the other dosage groups were the same as the other two studies. In the prenatal development study, results showed that consumption of the CBD blend reduced body weights and food consumption in the highest dose group but no substance-related changes were found in pregnancy rate, maternal or placental gross abnormalities, or premature deliveries.

The 14-day study saw no test-related mortalities or clinical signs that could be attributed to the administration of the CBD product. According to the researchers, the small changes in clinical chemistry parameters that did occur were within historical data values and were of no toxicological significance up to 460 mg/kg bw/d. During the 90-day study, researchers observed non-adverse organ and tissue changes, which were reverse during the recovery period in all groups except the high-dose group. Based on these results, the CBD blend used in this study is safe for consumption in humans at a dose of 161 mg per day, with the reference adult human weighing 70 kg, or 154 pounds.

"In light of the recent regulatory discussions and Congressional interest in our industry, we felt that it was important to publish our data so that it serves as a resource for the industry, our consumers, and regulators worldwide. The publication has already been referenced in a safety review and formed the basis for 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 Request for Information," said Sibyl Swift, PhD, cbdMD's chief science officer and vice president of Regulatory Affairs, in a press release. "We know that our products are safe and effective because we invested in the science to support them being so. We will continue to tirelessly advocate for regulatory clarity for hemp-derived products to ensure that our customers have access to botanically-derived solutions for their everyday health and wellness needs."

Reference

1. Tallon, M.J.; Child, R. Subchronic Oral Toxicity Assessment of a Cannabis Extract. Regulatory Toxicology and Pharmacology. Article ASAP. DOI: 10.1016/j.yrtph.2023.105496 (accessed 2023-09-22)