What happened
Original notice title
Green Roads of Florida LLC 10/31/17
From the archived source record
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, “CBD Oil” (100mg, 250mg, 350mg, 550mg), “CBD Tincture” (1000mg and 1500mg), “CBD Oil 100mg + Terpenes Flavor”, “CBD capsules 100mg”, “CBD Crumble 250mg”, “Chamoile Calming Tea” (with CBD), “CBD Edibles Gummie Blocks 60mg”, “CBD Edibles Jollies 30mg”, “CBD Edibles Gummie Men 60mg”, “CBD Edibles Lollypops 30mg”, “CBD Pain Be Gone” Cream 150mg, “CBD Shatter 450mg”, “CBD Dab Wax 250mg”, “CBD Dab Crystal 250mg” and “CBDreem” (Cannabidiol syrup) fail to bear adequate directions for their intended use 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)]. The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction. Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur in the future. If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. If you have any questions concerning this letter, please contact Ms.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- d6988500277c
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →