F.D.A. WARNING LETTER Challenging ‘Health Claims of CBD’
MARCS-CMS 579289 — JUL 22, 2019
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://curaleafhemp.com External Link Disclaimer in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).1 We have also reviewed your social media websites at www.facebook.com/CuraleafHemp External Link Disclaimer and https://twitter.com/curaleafhemp External Link Disclaimer; these websites direct consumers to your website, https://curaleafhemp.comExternal Link Disclaimer, to purchase your products. 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. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Unapproved New and Misbranded Human Drug Products
Based on our review of your website, your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following:
On your product webpage for CBD Disposable Vape Pen (Relieve):
• “[F]or chronic pain.”
On your product webpage for CBD Tincture (Relieve):
• “[S]oothing tincture for chronic pain.” …..