cbdMD Requests the Food and Drug Administration (FDA) Remove the Drug Exclusion for CBD and Review cbdMD's Extensive Safety Submission
10:45 am ET February 22, 2022 (BusinessWire) Print
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.
