FDA ‘Cannabidiol Enforcement Policy’ Draft To W.H.
Posted by Nancy Moraa on 07/31/2020 in News
Updated on August 5, 2020.
Medical content reviewed by Dr. Joseph Rosado, MD, M.B.A, Chief Medical Officer
The Food and Drug Administration(FDA) has been the focus of close attention this past July, by the U.S. cannabis industry. The FDA recently submitted a document to the White House Office of Management and Budget (OMB). The document was a Cannabidiol Enforcement Policy. The contents could be part of marijuana regulation. The CBD industry has needed favorable options for a long time.
The OMB needs to review and approve the new regulations from all federal agencies. The contents of the document remained secret at the time of submission. But, the title and description were “draft guidance for the industry,” which is a revealing clue.
“We’ve been hearing rumors that we’re going to get some good news. That it’s going to provide for formal enforcement discretion. It will offer a safe harbor for companies to sell CBD under strict regulatory guidelines.” —Jonathan Miller, general counsel for U.S Hemp
What Did The FDA Report Say? It’s Confidential (For Now)
But that is yet to be proven because no one knows what exactly the FDA proposed in their document. Others have speculated on social media that the enforcement policy could be claims-focused. Others say the policy is not about laying out specific limits of CBD content in products.
Most of the speculators find it difficult to believe that the agency will relax their stance. Interested parties look forward to the day when the FDA will be ready to regulate CBD in products. Once that happens, the industry will breathe a huge sigh of relief. There will be clear and favorable FDA cannabis laws for the industry to thrive.
Numerous calls for CBD product regulatory frameworks have been going on. This has happened since hemp’s legalization in 2018. The calls come from individual CBD companies declaring the lack of clarity hurting revenues. Industry groups making a push at local and federal levels.
Why You Can’t Talk About CBD “Cures”
The FDA has repeatedly stated that it needs more data on CBD safety. The data is important before deciding on the official FDA cannabis laws. This is even though there are CBD products already flooding the market. To collect more data on the subject, the FDA has re-opened an online docket for the public to give feedback. The comments on this online docket range in the thousands.
The current FDA’s current stance is that CBD is illegal. Its opposing actions have so far been warning letters against CBD companies. They have been making health claims on product labels or websites. In fact, the legal consequences for making health claims on cannabis can (and have) resulted in large fines for manufacturers and retailers.
Evidence-Based Data Without Federal Funding Hard to Get
Because cannabis is a Schedule 1 prohibited and controlled substance, it does not receive Federal funding for research often. The evidence-based research request is difficult, but organizations like Johns Hopkins are tackling that issue now.
The CBD industry is waiting for the contents of the FDA’s latest document to be public knowledge. Many interested parties expect that it could take weeks, but a true regulatory framework for CBD is likely far off.
Many hope that the FDA will give some guidance that will take immediate effect and then further lay bare any plans for the regulatory process. The cannabis industry is waiting for the FDA to change the legal stance. Which would allow more research and evidence-based clinical data on the health benefits of cannabinoids including marijuana and CBD.