UNITED NATURAL PRODUCT ALLIANCE

  • About
    • UNPA Members >
      • Executive Members
      • Science & Technology Services Members
      • Associate Members
      • Featured Member Profiles
    • MOU Partners
    • UNPA Staff >
      • National Staff
      • Political Advisors
    • Policies & Endorsements
    • Education and Training
    • Photo Galleries >
      • Members' Retreat 2019
      • China Delegation 2018
      • UNPA 2019 Staff Retreat
    • UNPA Headquarters
    • Testimonials
  • News
    • UNPA News
    • UNPA In the News
    • Media Releases
    • Member/MOU Partner News
    • Employment Opportunities
  • Member Resources
    • Regulatory Resources >
      • GMPs >
        • Regulatory Dietary Supplements
      • FSMA >
        • PCQI
        • FSVP
      • Organics
      • Labeling/Claims >
        • Nutrition Facts label
      • Guidelines/Best Practices >
        • Monographs
      • Links and Resources
      • Global >
        • Canada
    • Member Memos
    • UNPA Digest
    • UNPA Forums
    • UNPA Presentations
    • Expert Insights Webinars
    • Education Archive
    • Exclusive Member Offers
    • Member Logos
  • Events
    • UNPA Events & Training >
      • 2021 Training Schedule
    • 2020 DSRS Speakers
    • Industry Calendar of Events
  • Join
  • Media
  • For Consumers
    • About Dietary Supplements
    • Dietary Supplement Caucus
    • Dietary Supplement Caucus Members
    • Additional Resources >
      • Botanical Adulteration Prevention Program
      • Integrative Medicine
      • Industry Associations
      • Terms & Acronyms
  • Contact
  • About
    • UNPA Members >
      • Executive Members
      • Science & Technology Services Members
      • Associate Members
      • Featured Member Profiles
    • MOU Partners
    • UNPA Staff >
      • National Staff
      • Political Advisors
    • Policies & Endorsements
    • Education and Training
    • Photo Galleries >
      • Members' Retreat 2019
      • China Delegation 2018
      • UNPA 2019 Staff Retreat
    • UNPA Headquarters
    • Testimonials
  • News
    • UNPA News
    • UNPA In the News
    • Media Releases
    • Member/MOU Partner News
    • Employment Opportunities
  • Member Resources
    • Regulatory Resources >
      • GMPs >
        • Regulatory Dietary Supplements
      • FSMA >
        • PCQI
        • FSVP
      • Organics
      • Labeling/Claims >
        • Nutrition Facts label
      • Guidelines/Best Practices >
        • Monographs
      • Links and Resources
      • Global >
        • Canada
    • Member Memos
    • UNPA Digest
    • UNPA Forums
    • UNPA Presentations
    • Expert Insights Webinars
    • Education Archive
    • Exclusive Member Offers
    • Member Logos
  • Events
    • UNPA Events & Training >
      • 2021 Training Schedule
    • 2020 DSRS Speakers
    • Industry Calendar of Events
  • Join
  • Media
  • For Consumers
    • About Dietary Supplements
    • Dietary Supplement Caucus
    • Dietary Supplement Caucus Members
    • Additional Resources >
      • Botanical Adulteration Prevention Program
      • Integrative Medicine
      • Industry Associations
      • Terms & Acronyms
  • Contact

member memos

UNPA / FDA approves GW's CBD drug for two rare forms of epilepsy

6/26/2018

 
​Dear Colleagues,

As you may have already heard, yesterday, FDA gave its highly anticipated approval to Greenwich Biosciences, a subsidiary of England's GW Pharmaceuticals, for Epidiolex, a purified cannibidiol (CBD) extract derived from the cannabis plant (cannabis sativa). It is the first FDA-approved drug that contains a purified drug substance derived from cannabis.
The approval covers two rare forms of epilepsy that previously had no viable remedies. The approval does not change DEA's listing of cannabis as a Schedule 1 drug, nor does it clarify the role of CBD as a possible dietary supplement, which FDA currently says is illegal. We hope that this action sets in motion a sensible, science-based process that leads to a federal standard allowing for the sale of CBD products that fall under the umbrella of the Dietary Supplement Health and Education Act.

UNPA is in the formative stages of creating a hemp oil/CBD committee to address the regulatory and many other issues surrounding the non-psychoactive components of cannabis and will begin its work this summer, including a proposed conference call/webinar with a representative of GW Pharma to discuss the company's plans for Epidiolex and how it fits into the broader potential market for CBD products.
 
Below is FDA's press release announcing the Epidiolex appproval.
Attached is GW's press release announcing the approval.
Also see FDA Commissioner Scott Gottlieb's comments on the importance of research to prove safe and effective medical uses for the active constituents in cannabis.


FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated withtwo rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the firstFDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatmentof patients with Dravet syndrome.

Continue reading...U.S. Food and Drug Administration
10903 New Hampshire Avenue, Silver Spring, MD 20993
1-888-INFO-FDA (1-888-463-6332)
1_gw_pharm_fda_approval_press_release_-_final__003_.pdf
File Size: 193 kb
File Type: pdf
Download File


Comments are closed.
 © 2021 United Natural Products Alliance. All Rights Reserved.
Headquarters: 716 Fourth Avenue Salt Lake City, UT 84103
Mailing Address: 
6503 S Datura Street Littleton, CO 80120
801.474.2572 | info@unpa.com | homepage