FDA vs. Curaleaf

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The Meals and Drug Administration issued a warning letter on July 22, 2019 to Massachusetts and Florida-based Hashish company and dispensary Curaleaf.

The FDA has demanded that Curaleaf take away the “unsubstantiated well being claims on its CBD merchandise.” In response to the letter: “introducing or delivering these merchandise for introduction into interstate commerce for such makes use of violates the FD&C Act.”

The FDA states that it has “concluded based mostly on out there proof that CBD merchandise are excluded from the dietary complement definition below sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Below these provisions, if an article (akin to CBD) is an lively ingredient in a drug product that has been permitted below part 505 of the FD&C Act, 21 U.S.C. 355, or has been licensed for investigation as a brand new drug for which substantial scientific investigations have been instituted and for which the existence of such investigations has been made public, then merchandise containing that substance are outdoors the definition of a dietary complement.”

Curaleaf responded to the FDA letter with the next press launch:

Curaleaf is dedicated to the best requirements of high quality and compliance, and can work collaboratively with the FDA to resolve all points addressed within the company’s letter. The Firm will reply to the FDA letter inside the required 15 working days. Compliance is a prime precedence for Curaleaf and the Firm is absolutely dedicated to complying with FDA necessities for all the merchandise that it markets. We will affirm that nothing within the letter raises any points in regards to the high quality and consistency of any Curaleaf product or calls into query the excessive security requirements of the Firm’s cultivation and manufacturing processes. Curaleaf CBD merchandise are all derived from hemp and meet the necessities of the Farm Invoice.

For extra data, go to www.FDA.gov and go to www.Floridamarijuana.web for Hashish trade information.

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