cbdMD Files Novel Foods Dossier With UK and European Regulators
cbdMD (NYSE American: YCBD) announced the filing of its Novel Food Application with the UK’s Food Standards Agency on March 26. The application includes comprehensive data for validation and scientific assessment, with a similar submission made to the European Food Safety Authority. The review process is expected to conclude by the end of 2021, although no assurance of approval can be guaranteed. This step is crucial for cbdMD's future regulatory submissions globally, potentially impacting their market presence.
- Filed Novel Food Application with the UK’s Food Standards Agency for validation.
- Simultaneously submitted to the European Food Safety Authority for compliance.
- No guarantee of passing the administrative check or achieving validation.
- Uncertain outcome for the suitability review expected by end of 2021.
cbdMD, Inc. (NYSE American: YCBD, YCBDpA) (the “Company”), one of the leading, and most highly trusted and recognized cannabidiol (CBD) brands, announced today that on March 26th, it officially filed its Novel Food Application (“Application”) with the United Kingdom’s Food Standards Agency (“FSA”). The Application included all of the requisite data to allow for a validated submission and thorough scientific assessment. A similar submission was simultaneously made to the European Food Safety Authority (EFSA) to ensure compliance for the European markets. The Company’s products have been offered for sale in the UK since mid 2019.
The Application is currently undergoing an administrative check for appropriateness and will then move to the validation process. Upon the successful validation of the Application, the FSA and the EFSA will each individually undertake a suitability review of the data in the Application. The Company estimates this suitability review to be completed by the end of 2021, although no assurance can be made that the Company will pass the administrative check, receive validation for its Application or a favorable result from the suitability review.
“This Application includes detailed analysis of the ingredient characterization, quality and stability of our product, hemp sourcing and extraction controls, labelling and testing requirements, and the underlying intake and toxicological data related to the safe consumption of the proprietary cannabinoid blend ingredients in our cbdMD product line. cbdMD believes this step is important as a precursor for its preparation of its FDA NDIN submissions, Australian TGA submissions, various Sanitary Registrations in Latin America and other regulatory submissions throughout the world. Completion of the extensive pre-clinical research required to support the Application provides cbdMD with a valuable tool for other regulatory approvals around the world," said Dr. Sibyl Swift, Scientific & Regulatory Affairs advisor to cbdMD and Co-Chair of cbdMD Therapeutics.
About cbdMD, Inc.
cbdMD, Inc. is one of the leading and most highly trusted and most recognized cannabidiol (CBD) brands with a comprehensive line of U.S. produced, THC-free1 CBD products. Our cbdMD brand currently includes over 130 SKU’s of high-grade, premium CBD products including CBD tinctures, CBD gummies, CBD topicals, CBD capsules, CBD bath bombs, CBD bath salts, CBD sleep aids and CBD drink mixes. Our Paw CBD brand of pet products includes over 45 SKUs of veterinarian-formulated products including tinctures, chews, topicals products in varying strengths, and our CBD Botanicals brand of beauty and skincare products features 15 SKUs, including facial oil and serum, toners, moisturizers, clear skin, facial masks, exfoliants and body care. Please visit www.cbdMD.com, follow cbdMD on Instagram and Facebook, or visit one of the 6,000 retail outlets that carry cbdMD products. To learn more about cbdMD and their comprehensive line of U.S. grown, THC-free1 CBD oil products, please visit www.cbdmd.com.
Forward-Looking Statements
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 by the use of 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 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, 2020 as filed with the Securities and Exchange Commission (the "SEC") on December 22, 2020 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.
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FAQ
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