FDA vs. Curaleaf

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The Food and Drug Administration issued a warning letter on July 22, 2019 to Massachusetts and Florida-based Cannabis corporation and dispensary Curaleaf.

The FDA has demanded that Curaleaf remove the “unsubstantiated health claims on its CBD products.” According to the letter: “introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act.”

The FDA states that it has “concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”

Curaleaf responded to the FDA letter with the following press release:

Curaleaf is committed to the highest standards of quality and compliance, and will work collaboratively with the FDA to resolve all issues addressed in the agency’s letter. The Company will respond to the FDA letter within the required 15 working days. Compliance is a top priority for Curaleaf and the Company is fully committed to complying with FDA requirements for all of the products that it markets. We can affirm that nothing in the letter raises any issues concerning the quality and consistency of any Curaleaf product or calls into question the high safety standards of the Company’s cultivation and manufacturing processes. Curaleaf CBD products are all derived from hemp and meet the requirements of the Farm Bill.

For more information, visit www.FDA.gov and visit www.Floridamarijuana.net for Cannabis industry news.

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