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FDA Approved Epidiolex®, a purified form of CDB, this week.
What’s the difference between
Epidiolex and other CBD products?

Families whose children suffer seizures from epilepsy have asked legislators in several states to “legalize” cannabidiol (CBD), “medicinal” marijuana, and “whole-plant extracts” so they can use them to reduce their children’s seizures. The marijuana industry has been happy to accommodate, helping parents lobby legislators and, when successful, producing CBD products.
 
But none of these products is approved by FDA as safe or effective. All make unsubstantiated medical claims. Few contain what their labels claim. Some contain contaminants. Recently, the Centers for Disease Control and Prevention reported that 52 people in Utah were poisoned by an unregulated CBD product, which contained a synthetic cannabinoid. The agency warned regulations are needed to address “this emerging public health threat.”
 
This week, FDA approved Epidiolex to treat two forms of epilepsy in patients ages 2 and older. Epidiolex is an extract of marijuana called cannabidiol (CBD) that is purified and delivers a reliable, consistent dose. Clinical trials proved it reduces epileptic seizures. Now families have a choice. They no longer need to risk giving their children unregulated products that may harm their already fragile health. 

 
Epidiolex
  • FDA approved
  • Proven to be safe
  • Proven to reduce seizures
  • A purified extract of marijuana that is 99% CBD, less than 1% THC, marijuana’s psychoactive ingredient
  • Doctors prescribe.
  • Patients buy at pharmacies.
  • Likely to be insured.
  • Likely moved to a lower Schedule
CBD Products States Have Legalized
  • Not FDA approved
  • Not proven to be safe
  • Not proven to reduce seizures
  • Unpurified extracts containing up to 20% CBD, THC, other components. Some are contaminated.
  • Doctors recommend.
  • Patients buy at dispensaries.
  • Not insured.
  • Likely to remain in Schedule 1
Many media outlets are reporting that FDA’s approval of Epidiolex means CBD will be placed in a lower schedule of the federal Controlled Substances Act. But FDA Commissioner Scott Gottlieb clarifies, “This is the approval of one specific CBD medication for a specific use . . . based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition.” Just as Marinol, Cesamet, and Syndros, FDA-approved forms of THC, are in lower schedules but THC remains in Schedule I, Epidiolex is likely to be placed in a lower Schedule while CBD likely will remain in Schedule I.
 
Commissioner Gottlieb says FDA continues to support rigorous scientific research into potential medical treatments using marijuana or its components but is concerned about the proliferation and illegal marketing of unapproved CBD-containing products making unproven medical claims. FDA will continue to act to end such behavior, he says. 
 
Action is certainly needed. Searching for CBD Oil on Amazon brings up 929 results. All unregulated.
Examples of unregulated CBD products. None has applied to FDA to conduct clinical trials for FDA approval.
Read the Centers for Disease Control and Prevention’s warning about unregulated CBD products here
Read the FDA announcement of its approval of Epidiolex here.
Read See FDA CBD warning letters here.
Download The Marijuana Report Issue Paper on CBD here.


Disclosure: The author holds stock in GW Pharmaceuticals, the company that makes Epidiolex®.

The Marijuana Report is a weekly e-newsletter published by National Families in Action in partnership with SAM (Smart Approaches to Marijuana).

Visit National Families in Action's website, The Marijuana Report.Org, to learn more about the marijuana story unfolding across the nation.

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Our mission is to protect children from addictive drugs
by shining light on the science that underlies their effects.

 
Addictive drugs harm children, families, and communities.
Legalizing them creates commercial industries that make drugs more available,
increase use, and expand harms.

Science shows that addiction begins in childhood.
It is a pediatric disease that is preventable.
 
We work to prevent the emergence of commercial
addictive drug industries that will target children.

We support FDA approved medicines.

We support the assessment, treatment, and/or social and educational services
for users and low-level dealers as alternatives to incarceration.

 
About SAM (Smart Approaches to Marijuana)
 
SAM is a nonpartisan alliance of lawmakers, scientists and other concerned citizens who want to move beyond simplistic discussions of "incarceration versus legalization" when discussing marijuana use and instead focus on practical changes in marijuana policy that neither demonizes users nor legalizes the drug. SAM supports a treatment, health-first marijuana policy.  SAM has four main goals:
  • To inform public policy with the science of today's marijuana.
  • To reduce the unintended consequences of current marijuana policies, such as lifelong stigma due to arrest.
  • To prevent the establishment of "Big Marijuana" - and a 21st-Century tobacco industry that would market marijuana to children.
  • To promote research of marijuana's medical properties and produce, non-smoked, non-psychoactive pharmacy-attainable medications.

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