© OFFICE OF DRUG POLICY © Artisanal CBD Epidiolex©   Legal       Undergoing scientifically sound research to measure effectiveness  Plant product Claims not to cause impairment Prescribed by a physician Free from potential contaminants Regulated and consistent         1 Using artisanal CBD oils can cause risk in patients because the products are unregulated. Researchers have found that CBD may interact with other anti-epileptic medications1, warranting the need for oversight by a neurologist. This is the first time in recent history that “medication” has gone through a legislative process instead of the FDA process. In 2015, the FDA sent 18 warning letters to “CBD” dispensing companies for health fraud. As of February, the FDA has sent 22 letters in 2016. Families that moved to Colorado to use oral cannabis extracts were 3 times as likely to report a reduction in seizures as families already living in Colorado using oral cannabis extracts.2 “We are however opposed to the use of artisanal preparations of unregulated compounds of cannabis that contain unverified content and are produced by people with no experience in pharmaceutical production (7/13/2015).” Amy Brooks-Kayal, MD American Epilepsy Society, President Children’s Hospital of Colorado, Chief & Ponzio Family Chair “... We must let the science, and not anecdotal success stories and high media interest, lead this national discussion. Taking CBD in a controlled medical setting is vastly different from going to a state where medical marijuana is legal and experimenting with dosing and CBD strains (12/23/2015).” Orrin Devinsky, MD NYU Comprehensive Epilepsy Center, Director “... Not a single pediatric neurologist in Colorado recommends the use of artisanal cannabis preparations (7/13/2015).” Amy Brooks-Kayal, MD American Epilepsy Society, President Children’s Hospital of Colorado, Chief & Ponzio Family Chair No placebo. This is an EAP, not a clinical trial; therefore, all participants enrolled receive Epidiolex©, not a placebo. Legal Access. Because the EAP is FDA approved, Epidiolex© is legally available to all participants. There is no need to travel great distances and break federal law. Quality. Epidiolex© is a pure, plant-derived medication that is consistent and contaminant free.    11 participants are currently enrolled. 8 patients are partially through the screening process. Several other patient charts have been received to begin the screening process to fill the remaining 6 slots. Friedman, D., Cilio, M.R., Tilton, N. Sullivan, J., Hedlund, J., Rosenberg, E., Bluvstein, J., & Devinsky, O. (2014). The effect of epidiolex (cannabidiol) on serum levels of concomitant anti-epileptic drugs in children and young adults with treatment-resistant epilepsy in an expanded access program. Abstract presented at the annual meeting of the American Epilepsy Society, Seattle, WA. 2 Press, C., Knupp, K., & Chapman, K. (2014). Parental reporting of response to oral cannabis extract as adjunctive treatment for medically refractory epilepsy. American Epilepsy Society. (Abstract #1.326).