CbdMD Requests FDA Remove Drug Exclusion For CBD And Examine Its Safety Submission

Natural Products Association filed a Citizen's Petition on cbdMD's YCBD behalf with the Food and Drug Administration (FDA) requesting it remove the drug exclusion for CBD and 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 cbdMD to submit and receive acknowledgment for a new dietary ingredient notification. This will allow the company to inform consumers of the benefits of its CBD products and expand sales in the United States by opening up mass retail channels.

Since the passage of the farm bill 2018, the FDA has not provided any clear regulation on the CBD market. Creating and enforcing industry-wide standards would help create a roadmap for all CBD products and bring organizations 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, one that does not bureaucratically reward companies that aren't putting consumers first with safety and science," stated Sibyl Swift, Ph.D., VP of scientific & regulatory affairs for cbdMD. "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 an NDIN for CBD."

The company submitted its dossier of identity, quality and safety data as a novel food ingredient for the European Union Food Safety Authority and the UK Food Standards Agency. The UK FSA has already begun to review this data and EFSA is on track to begin shortly.