Last week, the U.S. Food and Drug Administration (“FDA”) maintained its strict and narrow Location By rejecting two new dietary ingredients (“NDI”) Notification submitted Charlotte’s Net with Owen NaturalBoth companies are seeking institutional permits to market their full-spectrum cannabis extracts as “dietary supplements.”
In the letter to these two major brands, the FDA pointed out two main reasons for rejection:
- Drug exclusion rule: Because CBD is the active ingredient in approved drugs (e., Epidiolex), CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug, and Cosmetic Act (“FDCA”); Therefore, it cannot be sold as a dietary supplement.
- Insufficient data: The FDA raised safety concerns about the adequacy of the evidence provided by the two companies. The agency specifically pointed out: (a) The “vagueness” of the preclinical and clinical studies provided, it believed that it failed to fully compare the use history with the company’s proposed use conditions of cannabis extract; (b) failed to adequately resolve a certain Some toxicity endpoints, including reproductive toxicity.
The FDA’s conclusion is disappointing because the two companies:
- The difference between full-spectrum products is resolved, such as their extract from CBD isolate, which is the substance contained in Epidiolex.
- Provide sufficient evidence, including published peer-reviewed toxicological studies and years of real-world safety evidence, proving that their products can be sold in a safe manner that is reasonably expected.
The FDA’s objections seem to indicate that the agency is placing hemp-derived CBD companies on higher NDI standards. This dynamic has strengthened the need for Congress to participate in clearing legal channels for the sales and marketing of hemp-derived CBD products.Legislation such as Human resources841Exempting hemp-derived CBD from the drug exclusion rules will also play a key role in advancing the data subjects needed to support the successful NDI of these products.
As suggested by several people Stakeholders, The FDA’s objection to Charlotte’s Web and Irwin Naturals’ NDI notifications once again demonstrates that the agency has no intention of creating a regulated market for CBD products. In addition, in rejecting NDI notifications from these two well-known companies, the FDA is inhibiting the industry from seeking compliance and submitting its own NDI notifications.
Ironically, by delaying its rulemaking process and failing to implement meaningful reforms to CBD products, the FDA caused the problems it pointed out when it justified its position: Inappropriate labelling and proliferation of unsafe products.
The FDA’s continued reluctance to open up legal legal channels for CBD products is untenable. Due to the failure to perform its administrative functions quickly, the FDA further denied the ability of the CBD industry to succeed and jeopardized the agency’s responsibility: protecting public health and safety.