The US FDA has rejected two New Dietary Ingredient (NDI) notifications for CBD as a dietary supplement. The ingredients submitted by both applicants – Charlotte’s Web and Irwin Naturals – were described as “full-spectrum hemp extracts”. FDA rejected the filings on the basis that CBD is the active ingredient in an approved drug (GW Pharmaceutical’s Epidiolex) and because the companies failed to provide sufficient scientific evidence to substantiate their submissions. In objection letters to Charlotte’s Web and Irwin Naturals, the agency said full-spectrum hemp extracts containing CBD “may not be marketed as or in a dietary supplement”.
According to CRN President & CEO Steve Mister, CBD regulation and mandatory product listing are the most important supplement-related issues pending for the VMS industry on Capitol Hill, as revealed in a recent panel interview organised by Nutrition Industry Executive as part of “Turning Point: Washington and the State of the Natural Products Industry“.
Mister also stated in a recent CRN press release that: “Despite very clear direction from Congress when it removed hemp from the Controlled Substances Act in 2018, FDA seems to have made up its mind not to support CBD in supplements and is now trying to justify it. That’s the only logical conclusion to draw from FDA’s actions – and its continued inaction … CRN has publicly endorsed HR 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021 and is actively lobbying Congress to do what FDA has refused to do – create a legal pathway to market CBD as a dietary supplement.”
Nicholas Hall commented: It was Lenin who spoke of taking “one step forward, two steps back”. Those of us with a less revolutionary nature aim for a more positive journey, with only the occasional backward glance! But regardless of the number of steps in either direction, the news that the FDA has rejected two important dietary supplement notifications for CBD seems highly retrograde. I fully endorse the view of the Council for Responsible Nutrition, which has denounced the FDA decision and urged Congress to act.
In CRN’s view, the FDA has mischaracterised these products as being the same as prescription CBD drugs and has “ignored, dismissed and downplayed ample evidence” that hemp products can be marketed safely. This seems like a re-run of the FDA’s inability to deal with the whole dietary supplements sector many years ago, which ultimately led to Congress’s stepping in with the all-important DSHEA legislation under which supplements are now regulated with a very light touch.
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