FDA maintained its position that CBD in any ingestible form is subject to the drug preclusion language in the federal Food Drug and Cosmetic Act via refusal letters posted regarding New Dietary Ingredient Notifications (NDIN) filed by Charlotte’s Web and Irwin Naturals respectively. In addition to the drug preclusion position, FDA also expressed concern that the NDIN submissions did not adequately establish that the extracts can be safely consumed by the intended users, or respond to concerns that FDA has previously identified relative to CBD safety, including liver toxicity. Charlotte’s Web took the unusual step of issuing a public response, available here, with a link to the company’s also public letter to FDA here, which responds directly to FDA’s criticisms of the data provided. It’s worth a read.
For anyone wondering what the practical implications of these refusals are, we offer this:
- FDA has relied on the drug preclusion rationale consistently since the very early CBD warning letters but has also expressed an interest in working with industry to explore a non-drug pathway. Now two and a half years since the passage of the 2018 Farm Bill, it’s disappointing to see companies make such significant investments in pursuing the existing regulatory pathway to receive a refusal that, based on the Charlotte’s Web letter, contains several inaccuracies regarding the data provided.
- Many in industry are now looking to Congress to pass one of the bills pending that would regulate CBD as a dietary supplement. These refusals will be a factor in any future legislative language. As proposed, the Sen. Schumer bill would not exempt all CBD supplements from the NDIN process, based on a discussion summary (see p. 27). Now that we’ve seen FDA’s refusals on two such notifications, we should expect both calls to exempt CBD from the NDIN process and concerns about the implications of that. Given the varying degrees of sophistication regarding manufacturing, product safety, testing, etc., some controls will be necessary in any legislation to protect the industry and consumers.
- FDA’s refusals do not signal a change in the agency’s enforcement approach. While FDA maintained its previously-stated reliance on the drug preclusion language as the legal rationale for why the ingredients could not be dietary supplements, the letters do not suggest that the agency is changing its claims-based approach to enforcement.
- FDA’s refusals here may serve as a disincentive for other companies to utilize the NDIN process, whether for CBD or other ingredients. The CBD industry has proliferated in the face of regulatory uncertainty. While we do not know the details of the companies’ submissions, FDA’s rejections in this instance raise fair questions as to why any other company would now pursue the same pathway if the risk of enforcement is limited.
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