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cbdMD Requests the Food and Drug Administration (FDA) Remove the Drug Exclusion for CBD and Review cbdMD’s Extensive Safety Submission
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Rhea-AI Summary
cbdMD, Inc. (NYSE American: YCBD) announced a Citizen's Petition filed by the Natural Products Association with the FDA, requesting the removal of the drug exclusion for CBD. This move aims to create market clarity and enable cbdMD to submit a New Dietary Ingredient Notification, which could help expand its sales across mass retail channels in the U.S. The company stresses its commitment to safety and quality, supporting its petition with an extensive dossier that meets FDA requirements. The UK and EU agencies are also reviewing the company’s safety data for its products.
Positive
Potential to remove the drug exclusion for CBD, enhancing market clarity.
Ability to submit a New Dietary Ingredient Notification could lead to increased sales.
Strong scientific data backing the safety of cbdMD's products for consumer confidence.
Negative
The FDA has previously fallen back on the drug exclusion, creating uncertainty.
CHARLOTTE, N.C.--(BUSINESS WIRE)--
cbdMD, Inc. (NYSE American: YCBD, YCBDpA) (the “Company”), one of the world’s leading and most highly trusted and recognized health & wellness CBD companies, today announced that the Natural Products Association (NPA) filed a Citizen’s Petition on cbdMD’s behalf with the Food and Drug Administration (FDA) requesting the FDA to remove the drug exclusion for CBD and to review the Company’s extensive dossier of identity, safety and quality data.
Removing the drug exclusion for CBD will achieve clarity in the market and create a level playing field for all participants. The final outcome of this process is expected to result in the ability of the Company to submit and receive acknowledgement for a New Dietary Ingredient Notification (NDIN). This will finally allow the Company to inform consumers of the benefits of its cannabinoid products and expand its sales in the United States by opening up mass retail channels. Since passage of the Farm Bill 2018, the FDA has not provided any clear regulation on the CBD market. The lack of a clear, regulated framework has allowed an expanding pool of producers, manufacturers and marketers to flood the market with substandard products and an abundance of questionable advertising tactics. Creating and enforcing industry-wide standards would help create a necessary roadmap for all CBD products and bring organization to an industry that has otherwise been operating without order.
“FDA has asked for good science and solid safety data. We offered it to them in our pre NDI submission meeting and the FDA was excited to review our data, but fell back on the drug exclusion. We want them to review our science, which we believe contains the requisite studies to clearly demonstrate the safety of our products for consumers. We want a scientific path to market consistent with the Dietary Supplement Health and Education Act (DSHEA), one that does not bureaucratically reward companies that aren’t putting consumers first with safety and science. Our science is so strong that we are confident when we are given the opportunity to submit an NDIN we will achieve another first, the first acknowledgment letter for a NDIN for CBD,” said Sibyl Swift, Ph.D., Vice President of Scientific & Regulatory Affairs for cbdMD.
The Company submitted its dossier of identity, quality and safety data as a novel food ingredient for the European Union (EU) Food Safety Authority (EFSA) and the United Kingdom (UK) Food Standards Agency (FSA). The UK FSA has already begun to review this data and EFSA is on track to begin shortly. “cbdMD is an industry leader with exceptional quality and scientific standards. We believe that our studies will withstand the rigorous review in the EU and UK. We are asking for the FDA to give us the same opportunity as other government agencies have done. cbdMD sets the bar within the industry for safety and quality. This citizen’s petition is yet another example of why cbdMD is the market leader. We stand behind our science and our quality and look forward to the day when we are no longer precluded from sharing our data with our customers,” says Martin A. Sumachrist, Chairman & co-CEO of cbdMD.
About cbdMD, Inc.
cbdMD, Inc. is one of the leading and most highly trusted and recognized cannabidiol (CBD) brands with a comprehensive line of U.S.-produced, THC-free1 CBD products. The cbdMD brand currently includes over 130 SKUs of high-grade, premium CBD products including CBD tinctures, CBD gummies, CBD topicals, CBD capsules, CBD bath bombs, CBD bath salts, CBD sleep aids, CBD drink mixes and full spectrum CBD options. Our Paw CBD brand of pet products includes over 45 SKUs of veterinarian-formulated products including tinctures, chews and topical products in varying strengths, and our cbdMD Botanicals brand of beauty and skincare products features 15 SKUs, including facial oil and serum, toner, moisturizers, facial masks, exfoliants and body care. To learn more about cbdMD and their comprehensive line of U.S.-grown, THC-free1 CBD oil and full spectrum products, please visit www.cbdmd.com, follow cbdMD on Instagram and Facebook or visit one of the 6,000 retail outlets that carry cbdMD products.
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 and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements, including, without limitation, statements made with respect to results of reviews by the FDA, EFSA, and FSA; our ability to increase our market share; our ability to expand our business and significantly increase our revenues; our ability to effectively leverage our brand partnerships and sponsorships, our ability to effectively compete in our market; and our ability to report profitable operations in the future. 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, 2021 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 methods.
