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

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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 has provided more than enough information about their “cultivation, extraction, manufacturing, use and safety” of their proprietary FSHE.

“The FDA letter asserts that a FSHE cannot be used in dietary supplements because it is precluded and expresses safety concerns. Regarding safety, the conclusions drawn by the FDA do not appear to be based on the data provided in our NDI application.” The company also published a document that it sent to the FDA, dated August 3, stating that they “are disappointed in, and strongly disagree with, not just the FDA’s conclusion and reasoning but in the fact that FDA’s letter contains significant factual inaccuracies.”

Charlotte’s Web released a 48-page document addressing each and every concern that includes trade secrets and commercial, confidential information that has been redacted for the sake of the public response, with the hope to address FDA’s inaccurate concerns. This includes correcting the FDA’s claim that Charlotte’s Web did not provide data on a study that the company submitted (Dziwenka et al. 2020), which was published in the journal Toxicology Reports, among other corrections.

The situation is evidence toward the desperate need for the cannabis industry to have a reliable and solid regulatory foundation. “We have been working with FDA to develop a clear and strong regulatory framework for full spectrum hemp products that protects consumers while offering them access to these important products,” Charlotte’s Web’s statement concluded. “We will continue to do so. We are, however, puzzled about how the agency intends to move forward to develop this framework.”

Legislation has been introduced in both the House of Representatives as well as the Senate to address the need for hemp CBD as a dietary supplement, which would help address the current uncertainties that companies such as Charlotte’s Web continue to experience. “The need for a clear regulatory framework—soon—is clear and we will continue to work for that outcome.”

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