WASHINGTON – Setting a safe level of daily consumption for CBD products remains the best pathway for regulating the CBD marketplace following the Food and Drug Administration’s (FDA) objection to Charlotte Web’s safety notice. The FDA in a recent letter concluded that Charlotte’s Web’s NDI for full-spectrum hemp extract “is subject to the exclusion from the definition of dietary supplement.”
A provision that would set a safe level of daily consumption for CBD products was included in a draft bill released by Senator Chuck Schumer (D-NY) as part of a larger cannabis reform effort. The OMB is currently considering guidance that would provide more clarity on the NDI process. It is imperative that future guidance on NDIs add clarity on safety evaluations on Cannabinoids for the millions of Americans that use them daily.
“Future NDI guidance without real clarity on cannabinoids including CBD, doesn’t help the millions of Americans who already believe FDA regulates the space. The response to this NDI indicates that there is confusion and misunderstanding on all sides of the issue and it must be addressed by the forthcoming guidance. There have to be clear safety rules and thinking on these matters,” said Daniel Fabricant, Ph.D. President and CEO of NPA.
NPA has led efforts to urge the FDA to regulate CBD since 2017, including regular official testimony, top level meetings with FDA officials and supporting legislative action on the issue. , NPA was the first to craft legislation passed by the U.S. House of Representatives that provides resources so the FDA can perform a Health Hazard Evaluation (HHE) and set a safe level of CBD for consumers to use each day. The process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe. With the exception of Epidiolex, all CBD products in the U.S. are considered illegal by the federal government.