FDA Rejects Filing of Charlotte’s Web Hemp as a Dietary Extract

High Times

FDA released a letter that questioned how safe Charlotte’s Web is, and if it should be labeled as a dietary supplement.  The FDA letter was sent out on August 11 with an explanation regarding why it felt it was necessary to address the uncertainty of CBD products. “FDA has concluded that CBD products are excluded from the dietary supplement definition.” The letter was in response to Charlotte’s Web’s initial filing of a New Dietary Ingredient notification (NDI) that was originally submitted on March 31, 2021. After concluding that CBD products are excluded from being listed under the definition of a dietary supplement, Cara Welch, Acting Director of the Office of Dietary Supplement Programs elaborated on the issue. “FDA has also determined that CBD was not marketed as a dietary supplement or conventional food before it was authorized for investigation as a new drug. FDA has concluded based on the record that your NDI 1202 is carefully designed to ensure consistent levels of CBD, and that it is produced from your proprietary that provide robust levels of CBD. In addition, your NDI 1202 contains a significant amount of CBD per mL and you also appear to market ‘full-spectrum hemp extract’-containing products as CBD products.” Charlotte’s Web responded to the FDA’s letter with a public press release on August 11 that was signed by Tim Orr, Senior Vice President of Charlotte’s Web, Inc. “Today the U.S. Food & Drug Administration (FDA) published an ‘objection’ to Charlotte’s Web’s New Dietary Ingredient notification (NDI) submitted for our full spectrum hemp extract (FSHE), due largely to its drug preclusion provision. This response from the FDA indicates to Charlotte’s Web that without legislation by Congress, this market will remain unregulated.” Orr further wrote that the company has been working with the FDA for 18 months and…

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Source : FDA Rejects Filing of Charlotte’s Web Hemp as a Dietary Extract

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