Source: https://www.newcannabisventures.com/breaking-fda-cbd-warning-letters/
Timestamp: 2019-04-21 16:58:25+00:00

Document:
FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) 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. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.
Note that this is a very broad attack on the CBD-from-hemp industry and includes products from CannaVest (OTC: CANV) as well as other companies like Endoca and Bluebird Botanicals.
This is to advise you that the Food and Drug Administration (FDA) reviewed your website at the Internet address www.calistores.com in January 2016 and has determined that you take orders there for the products “CBDy CBD Drops Unflavored Hemp Oil Supplement Cannabidiol Tincture” and “Hermosa Farm CannaHoney CBD, Cannabidiol Honey CBD 6oz” both of which claim to contain cannabidiol (CBD). We have also reviewed your website at the Internet address www.cbdy.com, which provides a link to your website www.calistores.com where these products can be purchased directly. The claims on your websites establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Based on the product label it appears you may intend to market your “CBDy CBD Drops Unflavored Hemp Oil Supplement Cannabidiol Tincture” product as a dietary supplement. You should be aware that, based on available evidence, FDA has concluded that CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) 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. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.
Your products “CBDy CBD Drops Unflavored Hemp Oil Supplement Cannabidiol Tincture” and “Hermosa Farm CannaHoney CBD Cannabidiol Honey 6oz” are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your products “CBDy CBD Drops Unflavored Hemp Oil Supplement Cannabidiol Tincture” and “Hermosa Farm CannaHoney CBD Cannabidiol Honey 6oz” are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, “CBDy CBD Drops Unflavored Hemp Oil Supplement Cannabidiol Tincture” and “Hermosa Farm CannaHoney Cannabidiol Honey 6oz” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to Mabel Lee at Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions concerning this letter, please contact Ms. Lee at FDAADVISORY@fda.hhs.gov.
 See “Sativex Commences US Phase II/III Clinical Trial in Cancer Pain,” available at http://www.gwpharm.co.uk/Commences%20US%20Phase%20IIIII%20Clinical%20Trial.aspx and “GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome,” available here.

References: § 321
 § 321
 § 321
 § 321
 § 352
 § 331