FDA’s Rejection of CBD New Dietary Ingredient Notifications: Four Practical Takeaways

HempGrower

An article by Kelley Drye partner Kristi Wolff breaks down the most important aspects of the government agency’s decision on the hemp-derived cannabinoid.
The U.S. Food and Drug Administration (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. Charlotte’s Web took the unusual step of issuing a public response to the refusals, which responds directly to the agency’s criticisms of the data provided and alleging factual inaccuracies in its response,” stated Wolff.
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