The U.S. Food and Drug Administration (FDA)on May 31 held a nearly 10-hour public hear-ing to collect scientific information and data

on cannabis and cannabis-derivedproducts, including cannabidiol(CBD). Americans for Safe Access'sDirector of Patient Focused

Certification (PFC), Heather Despres, wasamong those selected to present. Her testimo-ny can be seen on ASA’s YouTube channel.

As part of the ASA and PFC mission to ensureaccess to safe products, Despres told FDA offi-cials about safe production and how standard-ization of the industry across all states willimprove patient access and provide consistentproducts to patients across the country.

The questions posed by the FDA include ques-tions around manufacturing and product safe-ty, industry standards, and labeling. The PFCprogram was created around these very issues,so Despres was able to advise the FDA on cur-rent industry standards that can be adapted ona national level to encourage consistency inproducts between states.

The FDA received almost 400 requests to pres-ent and/or provide oral remarks at the hearing.Americans for Safe Access was one of 113organizations selected to give a formal presen-tation, and one of only 72 organizations select-ed to give a full presentation with slides.

Several organizations argued that the FDAshould allow the sale of hemp-derived CBD-infused under the 2018 Farm Bill. Some alsosuggested that these products be regulatedunder the existing dietary supplement frame-work.

Patient advocates urged additional scientificresearch on the therapeutic value of CBD in

treating conditions such as epilepsy,Alzheimer’s and dementia. Many Americanshave already turned to CBD products to assistwith general wellness.

A critical review by the World HealthOrganization determined last year that CBD’ssafety profile and lack of abuse potentialmeans it does not need to be a controlled sub-stance. The FDA classifies CBD as a controlledsubstance but does not currently allow the saleand marketing of CBD-infused productsbecause a CBD medicine, Epidiolex, has beenapproved by the agency as a Schedule V drug.

The FDA commissioner said in April that regu-lations may be released as early as this sum-mer. The FDA is taking written public com-ments until July 2. See this month’s ActionAlert for how to submit comments.

Americans for Safe AccessA C T I V I S T N E W S L E T T E R

Defending Pat ients ’ Access to Medical Mari juanaJUNE 2019 Volume 15, Issue 6

Americans for Safe Access • 1624 U Street NW, Suite 200 • Washington, D.C. 20009 202-857-4272 • info@AmericansForSafeAccess.org • www.AmericansForSafeAccess.org

ASA Testifies at FDA Hearing on Regulating CBD

Colorado Now AllowsDoctors to SubstituteCannabis for Opioids

Colorado Governor Jared Polis has signed intolaw SB-013, a bill that allows Colorado physi-cians to authorize individuals to use medicalcannabis instead of opioids, including foracute pain. The bill also removes specific spe-cialist physician requirements for patients whoare minors and allows them to consume non-smokable forms of cannabis on schoolgrounds. The law goes into effect August 2.

A majority of states allow medical cannabis tobe used for chronic pain, but only a handfulallow its use for acute pain or other conditionsfor which an opioid may be prescribed.

“ASA applauds Governor Polis for signing SB-013 and state lawmakers for doing their partto reduce opioid overdose deaths by allowingthe substitution of cannabis for opioids in painmanagement,” said David Mangone, ASA’sDirector of Government Affairs. “ASAlaunched a national campaign End Pain, NotLives in 2017 to promote cannabis as a tool tocombat the opioid crisis, and we’re gratified tosee another state adopt this approach."

Americans for Safe Access provided testimonyin support of this bill in January.

Colorado joins Illinois and New York in allow-ing cannabis to be substituted for opioids.

ASA has released an educational booklet, thePatient’s Guide to CBD. The publication comesin conjunction with ASA’s presentation to theFederal Drug Administration (FDA) regardingproducts containing cannabis and cannabis-derived compounds.

At the May 31 hearing, ASA was one of organ-izations chosen to formally present scientificinformation with slides and data aboutcannabis, cannabidiol (CBD), and othercannabis compounds.

The Patient’s Guide to CBD is a comprehensiveresource that covers a wide range of topics,including available forms for use, what to lookfor on package labels, how to read a certificateof analysis, how CBD interacts with the endo-cannabinoid system, the current state ofresearch, the compound’s legal status, andhow to talk to one’s doctor about CBD.

Interest in CBD has been increasing with accu-mulating medical research on its benefits andthe FDA approval of a CBD medicine for thetreatment of seizures in children. Congressmade hemp, a potential source of CBD, legalnationally with the Agriculture Improvement

Act of 2018 (also known as the 2018 Farm Bill),which has further heightened interest, as wellas confusion, regarding CBD products.

“ASA created the guide tobe an educational referenceso that patients, healthcareproviders, consumers, policymakers, and regulatorscould have an accurate andscientific source to turn to inorder to make informed

decisions regarding CBD,” said DebbieChurgai, ASA Interim Director.

ASA submitted written comments to the FDAto supplement the information provided inthe oral presentation by Heather Despres, theDirector of ASA’s Patient Focused Certification(PFC) program.

"We look forward to providing the FDA withadditional data to inform their decision-mak-ing,” said Steph Sherer, ASA’s President andFounder. “We are eager to clear up any misun-derstandings and contribute to the body ofknowledge regarding cannabidiol through therelease of our Patient's Guide to CBD."

ASA Releases Patient’s Guide to CBD

In 2011, ten years afterenlisting in the U.S. Armyand serving tours of dutyin Egypt and Afghanistan,Todd Larkin was dis-charged an E5 Sergeantand returned to his wife

and kids in his hometown of Ardmore,Oklahoma. He had joined the military straightout of high school, and returned to work andcoach at that school, but within a year, theVeterans Administration diagnosed him withpost-traumatic stress disorder and depression.His mental health deteriorated over the nextfew years until his mood problems got him sus-pended from coaching football for a couple ofgames and he became suicidal.

“I was going down a road that wasn’t me,” hesays. That’s when a friend from high schoolintervened, telling him repeatedly that heneeded to try cannabis. “I didn’t think it woulddo anything,” Todd says. “My wife was prettyadamant about me not trying it.”

But Todd began to do research and reachedout to people in the cannabis industry withquestions. He became convinced it was wortha try, and broached the idea with his wifeagain. They decided to do a short trial usingcannabis obtained on the illicit market, asthere was not legal access in Oklahoma yet.

“After about a month, we were completelysold,” Todd says. “We both saw a completechange in my mentality and mood. It wasnight and day from the VA meds.”

Todd was being prescribed nine separate med-

ications, including Xanax, Prozac, a sleepingmedicine and two more drugs to control thestomach problems from the other medica-tions. To identify and obtain the types ofcannabis medicine that work for him, Toddand his wife made trips to neighboringColorado.

In 2017, sitting at dinner one night, Todd toldhis wife she should prepare herself, because hewas ready to share more of his story. She was

ready for itbecause she’dseen how muchit helped notjust his life buthers and thefamily’s.

Todd resignedfrom the highschool to workfull time on pro-

viding safe access to veterans and otherpatients in need in Oklahoma. He and his wifewent to Las Vegas to meet with friends in theindustry, tour facilities and meet manufactur-ers. When they came home, Todd was puttinggas in his car when he discovered CBD beingsold in his local gas station.

“I was disheartened by how it was being soldand what people were being told,” he says. Hedecided he needed to get involved to helpensure quality products and educate con-sumers and other veterans.

In January 2018, Todd opened Pure WellnessMedical providing CBD products. He was also

involved in the campaign that got StateQuestion 788 on the June primary ballot. Junewas also the month he formed TexomaVeterans Alliance, a cannabis-specific groupthat now has over 100 members, with 70 or soparticipating at meetings that include educa-tion on topics such as safety and cultivation.

After the state’s voters approved one of themost robust medical cannabis programs in thenation, they became a full-fledged medicalcannabis dispensary in October 2018, now see-ing as many as 200 or more patients a day. Insupport of his patients who are veterans, Toddreaches out to local businesses such as aplumbing company for donations to cover thecost of medicine. As a result, he was able tooutfit 58 veterans with WarFighter CBD lastmonth. Like him, many were being treated bythe VA but not seeing good results.

Todd’s outreach includes lobbying at the statecapitol and in Washington, D.C. The took agroup of veterans to the state house inFebruary to testify before lawmakers aboutprogram changes, pushing for, among otherthings, a reduced-price registration for veter-ans. Originally set at $500 per patient, the gov-ernor just signed a bill to reduce it to $22 forveterans, starting November 1. Oklahomanson fixed incomes will be eligible for the samereduced-cost registration.

This Memorial Day, Todd went to D.C. for arally with the veterans’ group Plants Over Pillsacross from the White House.

“It was the second time I’d ever told my story.It was very refreshing,” Todd says of speakingat the rally of about 80 veterans. “Listening toother vets reminded me I’m not alone.”

Borrowing from what he learned attendingASA’s Lobby Day in March, he organized lob-bying visits for the veterans, getting 40 veter-ans into 12 different meetings with nationallawmakers or their staff.

Todd’s end goal is federal medicinal legaliza-tion, but he’s also focused on ensuring thatOklahoma has a good program. The state willnot allow medicinal cannabis to be givenaway, but Todd’s working on establishing aprogram similar to one in Oregon that allowsfor “waste” or “expired” medical cannabis tobe donated to veterans.

Activist Profile: Todd Larkin, Ardmore, Oklahoma

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ACTION ALERT: Last Chance for CBD Comments! This month is your final opportunity to help the Food and Drug Administration (FDA)regulate cannabis and derivatives such as CBD. The FDA is accepting public commentson their website until July 2. The FDA is asking for feedback on specific areas, includ-ing: 1) Health and Safety Risks, 2) Manufacturing and Product Quality, and 3)Marketing/Labeling/Sales. ASA has prepared guidelines to make it easy to submitcomments that make a difference. Read the blog and submit your comment today atwww.safeaccessnow.org/fda_comments_blog.