The petition to the FDA didn’t come directly from cbdMD. Nonetheless, Natural Products Association recently filed what is known as a Citizen’s Petition on cbdMD’s behalf. It was filed with the US Food and Drug Administration in an effort to get the FDA to remove the drug exclusion for CBD. They are also requesting that the FDA review cbdMD’s extensive data that shows identity, safety, and quality data.
What Is the Importance?
Asking the FDA to remove the drug exclusion for CBD sounds interesting. But what does that really mean and what would it really look like?
The CBD industry has been plagued with uncertainty and instability since the 2018 Farm Bill was passed. In the years since then, the FDA has really not provided any set guidelines or regulations. This has allowed some shady CBD products to enter the market and has also led to lower consumer confidence.
The hope is that excluding CBD from the FDA drug list would help to create a more accurate and level playing field for everyone. Not only for CBD companies but also for consumers. The belief is that it would also help to provide stability and clarity in a market that has lacked this kind of structure.
CbdMD is also hoping that the FDA will acknowledge a new dietary ingredient notification. If they can get this to happen then it would allow them to better inform customers of the benefits of CBD products. Right now they are very limited in the language they can use. Along with that, it would give cbdMD better access to expand retail sales in the United States.
Bringing clarity and stability to the CBD industry is long overdue. This is something that the FDA has dragged its feet on for far too long. Not only has it hurt the CBD industry as a whole but it has also hurt consumers. A set of standards that are enforced at a federal level across the board would give guidance to the CBD industry that it has not seen before.
“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.”
CbdMD is not only taking the matter up with US Food and Drug Administration. They have also submitted documentation to the European Union Food Safety Authority and the UK Food Standards Agency. These organizations both play similar roles to the FDA. CbdMD would like to roll this out on a global scale and get all of these organizations on the same page.
It will be interesting to see where this goes and how it plays out. CBD has clearly been on the fringe for far too long. It is simply just too popular and accessible for the FDA to continue to ignore. Decisions must be made and it is time to bring standard rules and regulations to the CBD industry as a whole.