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    Online Exclusives

    FDA Rejects Two New Dietary Ingredient Notifications for CBD

    The decision likely means the agency will not approve future NDIs for CBD barring a directive from Congress.

    FDA Rejects Two New Dietary Ingredient Notifications for CBD
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    By Mike Montemarano, Associate Editor08.13.21
    The U.S. Food and Drug Administration rejected two New Dietary Ingredient Notifications (NDINs) for full-spectrum hemp extracts containing cannabidiol (CBD) submitted by manufacturers Charlotte’s Web and Irwin Naturals. According to industry stakeholders, the decision signifies that FDA does not intend to approve of the use of CBD as a dietary ingredient, and by default, doesn’t intend to regulate it as such.
     
    Notably, these were the first NDI notifications to receive a response from the FDA, making this a new development over the course of deliberations on where the ingredient stands.
     
    “Based on how FDA engaged these companies over the course of months—having meeting after meeting, request after request for more safety data—and then an invitation to submit NDI notifications, we’re certainly disappointed and surprised that FDA rejected the two NDI notifications,” Steve Mister, president and CEO of the Council for Responsible Nutrition, told 

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