Skyrocketing sales of dietary supplements containing cannabidiols isn't information the Food and Drug Administration is using to determine the products' fate in the US. Neither are most of the roughly 4,500 comments the agency received about its consideration of making lawful the use of hemp and CBD as dietary ingredients.
FDA ISO Data On CBD Safety In Supplements, Sees Potential As Well As Risks
There's a reason the FDA continues accepting comments on questions about using hemp- and cannabis-derived ingredients in products other than drugs months after the comment period closed. "It's safe to say say that in 4,500 comments, we did not receive a lot of hard data around the issues that we specifically requested comments on," says Sharon Mayl, senior advisor for policy in the commissioner's office.
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CRN petition argues against general preclusion while NPA petition addressed specifically FDA’s wielding of the provision to prohibit the use of NMN supplements available in US. “FDA has acknowledged that they really can't answer one without answering. The two are inextricably linked,” says CRN CEO Steve Mister.
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Eliminating self-affirmation process would require companies to publicly notify FDA of their intended use of ingredients and provide safety data before they’re introduced. Kennedy says the process is “a loophole” for introducing ingredients and chemicals “with unknown safety data.”