Copy
View this email in your browser
Breaking news: FDA says CBD products cannot be marketed as dietary supplements. Hints at possible enforcement actions against producers of CBD products not proven to be safe or effective.
 
In a Q&A posted Friday, the US food and Drug Administration says that cannabidiol (CBD) products cannot be marketed as dietary supplements. That’s because CBD products are excluded from the definition of dietary supplements under a provision of the Food, Drug, and Cosmetic Act (Act). Cannabidiol is under development as a new drug, substantial clinical investigations have been instituted, and the existence of those investigations has been made public. This places other products containing CBD outside the definition of dietary supplements.
 
FDA warns that under the Act, it may decide to take enforcement actions against CBD products being sold without having shown they are safe and effective for the medical claims they are making. At the same time, FDA says it will continue to work with companies “interested in appropriately bringing safe, effective, and quality products to market, including scientifically-based research concerning the medical uses of marijuana.”
 
FDA is aware that states are making marijuana and marijuana-derived products available for various medical uses, but that to date, “FDA has not approved a marketing application for a drug product containing or derived from botanical marijuana and has not found any such product to be safe or effective for any indication.”

Q&A explains FDA's expanded access, compassionate use programs for those who do not qualify for clinical trails.
 
“We know that a number of states are interested in allowing access to cannabinoid oil, or cannabidiol, in an attempt to treat childhood epilepsy. It is important to conduct medical research into the safety and effectiveness of marijuana products through adequate and well-controlled clinical trials. We welcome the opportunity to talk with states who are considering support for medical research of marijuana and its derivatives to provide information on Federal and scientific standards.”
 
Read full FDA statement
here.

To Our Subscribers
 
With this issue, we welcome many new subscribers. We hope you find our e-newsletter will keep you up to date on the marijuana story. More than 23,500 readers have clicked through to read the health report from Colorado featured in the February 4th issue of The Marijuana Report. Many of you shared that issue with others and apparently so did they. More than 10,500 readers have clicked through to the Colorado public safety report featured in our February 11th issue. Thank you for being such effective, committed networkers. For those who missed the Colorado health report, click here (note new link); the public safety report, click here.
National Families in Action and partners, Project SAM and the Treatment Research Institute, welcome our new readers. We hope you enjoy this weekly e-newsletter to keep up-to-date with all aspects of the marijuana story. Visit our website, The Marijuana Report.Org, and subscribe to the weekly e-newsletter The Marijuana Report to learn more.

National Families in Action is a group of families, scientists, business leaders, physicians, addiction specialists, policymakers, and others committed to protecting children from addictive drugs. We advocate for:
  • Healthy, drug-free kids
  • Nurturing, addiction-free families
  • Scientifically accurate information and education
  • A nation free of Big Marijuana
  • Smart, safe, FDA-approved medicines developed from the cannabis plant (and other plants) 
  • Expanded access to medicines in FDA clinical trials for children with epilepsy
What is our call to action?
  • Ask your leaders to establish FDA expanded access to Epidiolex® for children with epilepsy.
  • Ask your leaders to find a middle road between incarceration and legalization of addictive drugs.
National Families
National Families
National Families
National Families
National Families
National Families
The MJ Report
The MJ Report
The MJ Report
The MJ Report
The MJ Report
The MJ Report
Copyright © 2015 National Families in Action, All rights reserved.


unsubscribe from this list    update subscription preferences