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FDA sends warning letter to Curaleaf over unapproved, 'misbranded' drugs.

The FDA posted on its website a warning letter sent to Curaleaf Holdings on July 22. The letter reads in part, "FDA has determined that your 'CBD Lotion,' 'CBD Pain-Relief Patch,' 'CBD Tincture,' and 'CBD Disposable Vape Pen' products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your 'Bido CBD for Pets' products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act." [Reference Link]:[]

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Publication:The Fly
Date:Jul 23, 2019
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