ARTICLE
25 September 2021

FDA's Rejection Of CBD New Dietary Ingredient Notifications: Four Practical Takeaways

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Kelley Drye & Warren LLP

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Kelley Drye & Warren LLP is an AmLaw 200, Chambers ranked, full-service law firm of more than 350 attorneys and other professionals. For more than 180 years, Kelley Drye has provided legal counsel carefully connected to our client’s business strategies and has measured success by the real value we create.
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.
United States Food, Drugs, Healthcare, Life Sciences

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.

Read the full HempGrower article here. (May require a subscription)

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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