FDA Denies Submission of Charlotte’s Web Hemp as Nutritional Extract |

The FDA released a letter questioning how safe Charlotte’s Web is and whether it should be labeled as a dietary supplement.

The letter from the FDA was mailed on Aug. 11 with an explanation of why it felt it was necessary to address the uncertainty surrounding CBD products. “The FDA has concluded that CBD products are exempt from the definition of dietary supplements.” The letter was in response to Charlotte’s Web’s initial filing of a New Ingredient Notification (NDI), originally on March 31, 2021 was submitted.

After concluding that CBD products are excluded from inclusion under the definition of a dietary supplement, Cara Welch, acting director of the Dietary Supplement Programs Bureau, addressed the issue. “The FDA also determined that CBD was not marketed as a dietary supplement or conventional food before it was approved for investigation as a new drug. Based on the records, the FDA has concluded that your NDI 1202 has been carefully designed to ensure consistent levels of CBD, and that it is made from your own product that delivers robust levels of CBD. In addition, your NDI 1202 contains a significant amount of CBD per ml and you also appear to be marketing products containing ‘full spectrum hemp extract’ as CBD products. “

Charlotte’s Web responded to the FDA’s letter with an August 11th public press release signed by Tim Orr, Senior Vice President of Charlotte’s Web, Inc. mainly due to its provision to exclude medicinal products. This response from the FDA shows Charlotte’s Web that without legislation by Congress this market will remain unregulated. “

Orr went on to say that the company has been working with the FDA for 18 months and has provided more than enough information about their “cultivation, extraction, manufacture, use and safety” of their proprietary FSHE.

“The FDA letter claims that an FSHE cannot be used in nutritional supplements because it is ruled out and raises safety concerns. In terms of safety, the FDA’s conclusions don’t seem to be based on the data in our NDI filing. ”The company also released a document it sent to the FDA on Aug. 3 stating that it did “Is disappointed and not only with the FDA’s conclusions and arguments, but also with the fact that the FDA’s letter contains significant factual inaccuracies”.

Charlotte’s Web released a 48-page document addressing any concerns involving trade secrets and commercial confidential information that had been blacked out for public response in hopes of addressing the FDA’s inaccurate concerns. This includes correcting the FDA’s claim that Charlotte’s Web did not provide data on a study submitted by the company (Dziwenka et al. 2020), which was published in the journal Toxicology Reports, among others.

The situation is evidence that the cannabis industry desperately needs a reliable and solid regulatory base. “We worked with the FDA to develop a clear and strong regulatory framework for full-spectrum hemp products that would protect consumers while giving them access to these important products,” concluded the Charlotte’s Web statement. “We will continue to do that. However, we are at a loss as to how the agency intends to move forward in developing this framework. “

Laws have been passed in both the House of Representatives and the Senate addressing the need for hemp CBD as a dietary supplement, which would help remove the current uncertainties that companies like Charlotte’s Web continue to face. “The need for a clear regulatory framework – soon – is clear and we will continue to work towards that result.”