Breaking Barriers: cbdMD's Research Validates Safe CBD Upper Dose
Charlotte, North Carolina--(Newsfile Corp. - September 22, 2023) - cbdMD, Inc. (NYSE American: YCBD) (NYSE American: YCBD-PA) (the "Company"), one of the nation's leading providers of premium cannabidiol (CBD) products, today announced the publication of the Company's safety data supporting a safe upper dose of its proprietary Broad Spectrum CBD blend. The data was published in Regulatory Toxicology and Pharmacology.
The publication includes three separate OECD experiments on rodents performed by a Eurofins lab on the Company's proprietary broad spectrum blend to investigate 1) prenatal development, 2) a 14-day dose-range finding study, and 3) a 90-day subchronic safety study with a recovery period. The prenatal screening study did not identify any substance-related changes in key areas related to maternal health. The 14-day study demonstrated that animals were safely able to consume up to 460 mg/kg daily of the blend of cannabinoids. The 90-day repeated dose safety study was designed following the 14-day study data on the cannabinoid blend with a recovery period at the end. In the 90-day study, the animals did not exhibit any significant adverse effects. Based on these findings, the study determined that cbdMD's proprietary broad spectrum blend is safe when consumed in an average person at 2.29 mg/kg of bodyweight daily (i.e., 160 mg per day in a 70 kg or 154lb human), as used in dietary supplement products.
As a leader in the industry, cbdMD believes the publication of this safety data reinforces to its customers, stakeholders, and regulators, the Company's unwavering commitment to science and safety. The data discussed in the publication was referenced in cbdMD's Citizen Petition, which was submitted in April of 2022 to the FDA following a meeting with the Agency, and will be resubmitted as part of the public docket to support the Company's lobbying efforts in Washington D.C. to obtain sensible CBD regulations. Furthermore, the data from this study was used in support of successful regulatory submissions to both the UK Food Standards Agency and the EU Food Safety Authority; It was one of only two international publications demonstrating the safe level of cannabidiol consumption for humans, underscoring the Company's role as a leader in the space.
The significance of this paper is demonstrated by the fact it has already been cited in other meta-study papers on the subject of CBD safety. It is also a key example of cbdMD's approach to science, which has laid the foundation for cbdMD to deliver superior everyday wellness products that are formulated to specifically address the needs of its customers.
"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 Dr. Sibyl Swift, cbdMD's Chief Science Officer and VP of Regulatory Affairs. "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."
To view the complete published paper titled, Subchronic Oral Toxicity Assessment Of A Cannabis Extract, please visit https://www.sciencedirect.com/science/article/abs/pii/S0273230023001642.
cbdMD, Inc. is one of the leading and most highly trusted and recognized hemp-derived cannabidiol (CBD) brands with a comprehensive line of U.S. produced, THC-free1 CBD products as well as Full Spectrum and Delta 9 THC products. The cbdMD brand currently includes high-quality, premium CBD products including tinctures, gummies, topicals, capsules, sleep aids and more. The Company's Paw CBD brand includes formulated pet products including tinctures, chews and topicals in varying strengths. To learn more about cbdMD and the complete line of products, please visit www.cbdmd.com, follow cbdMD on Instagram and Facebook or visit one of the thousands of retail outlets that carry cbdMD products.
This press release contains certain forward-looking statements that are based upon current expectations and involve certain risks and uncertainties within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified using words such as ''should,'' ''may,'' ''intends,'' ''anticipates,'' ''believes,'' ''estimates,'' ''projects,'' ''forecasts,'' ''expects,'' ''plans,'' and ''proposes.'' These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond our control and difficult to predict. You are urged to carefully review and consider any cautionary statements, including but not limited to federal and state CBD regulation, and other disclosures, including the statements made under the heading "Risk Factors" in cbdMD, Inc.'s Annual Report on Form 10-K for the fiscal year ended September 30, 2022 as filed with the Securities and Exchange Commission (the "SEC") and our other filings with the SEC. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, many of which are generally outside the control of cbdMD, Inc. and are difficult to predict. cbdMD, Inc. does not undertake any duty to update any forward-looking statements except as may be required by law. The information which appears on our websites and our social media platforms, including, but not limited to, Instagram and Facebook, is not part of this press release.
1 THC-free is defined as below the level of detection using validated scientific analytical tools.
Ronan Kennedy, Interim CEO & CFO
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