WSLCB Virtual Listen and Learn Forum Session #2: Rules Regarding Marijuana Vapor Products

WASHINGTON:  The Washington State Liquor and Cannabis Board (WSLCB) is hosting two Listen and Learn forums to consider establishing new and amending existing sections of rule concerning marijuana definitions and marijuana vapor products. This is the second of two planned sessions. The full text of the draft conceptual rules are provided here.

For this session, we are discussing only draft conceptual rule sections 314-55-550 to implement House Bill 2826 pertaining to marijuana vapor products, and the Marijuana Vapor Product Disclosure Form. The Disclosure Form is provided here.

Please join us virtually on Tuesday, September 29, 2020, from 2:00 p.m. until 4:00 p.m. via WebEx.

**Attendees wishing to provide feedback are encouraged to participate early in the meeting, as the meeting may end early dependent on level of participation.**

Background
On March 25, 2020, HB 2826 passed the legislature in response to concerns related to marijuana vapor product and vapor related lung illnesses. The bill contained an emergency clause, and in its intent section, found that “recent reports of lung illnesses associated with vapor products” demanded “serious attention by the state in the interest of protecting public health and preventing youth access.

HB 2826 provides that the Board may adopt rules prohibiting any type of marijuana vapor product device, or prohibit the use of any type of additive, solvent, ingredient, or compound in the production and processing of marijuana products, including marijuana vapor products. However, before adopting either of these types of rules, the Board must have determined, following a consultation with the Department of Health (DOH), or any other authority the Board deems appropriate, the device, additive, solvent, ingredient, or compound may pose a risk to public health or youth access.

HB 2826 authorizes the Board to require marijuana processors to submit, under oath, to the Department of Health, a complete list of all constituent substances and the amount and sources of all constituent substances in each marijuana vapor product. HB 2826 also provides that Board may adopt rules prohibiting the use of a characterizing flavor in marijuana vapor products.

Rules are needed to implement the provisions of HB 2826, and to establish definitions for terms including, but not limited to “characterizing flavor,” botanical terpenes,” and others.

The Pre-proposal Statement of Inquiry filed by the Liquor and Cannabis Board may be found here.

Meeting Details
An agenda is attached. Please come prepared to offer feedback and suggestions regarding this rule section.

If you wish to participate virtually, we’d like to offer the following reminders:

  • Virtual participation will be structured to allow one speaker at a time through a hand-raising feature on WebEx.
  • If you experience difficulty with audio or visual elements of virtual participation, please be patient.

Please remember that we are still in the developmental phase of rulemaking, and there are not yet any proposed or final rules amendments. To help you prepare for this listen/learn/contribute forum, please review the guidance document prepared for this and future forums.

Questions? Contact Casey Schaufler at casey.schaufler@lcb.wa.gov

To join the WebEx meeting online:
https://watech.webex.com/watech/j.php?MTID=m208eaad1ec16f31cfccdf6970963e1cb


To join the WebEx meeting via audio conference only:
Dial: (415) 655-0001
Access Code: 372 115 47

FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

Office of Marijuana Policy Unveils New Details On Planned Launch Of Adult Use Marijuana In Maine

Retail sales to the public permitted to begin on or after October 9, 2020.

MAINE: The Office of Marijuana Policy, a part of the Maine Department of Administrative and Financial Services, unveiled plans for the issuance of Maine’s first active licenses for adult use marijuana establishments. The Office intends to issue the first active licenses to recreational cannabis businesses on Tuesday, September 8, 2020. Retail sales of adult use marijuana to consumers 21 years of age or older will be permitted starting on Friday, October 9, 2020.

The issuance of active licenses will continue the Office of Marijuana Policy’s structured rollout of Maine’s nascent adult use industry, which had been indefinitely postponed in April in response to the COVID-19 pandemic.

“The public’s health and safety are at the forefront of every decision we make at the Office of Marijuana Policy,” said OMP Director Erik Gundersen. “While we were poised to launch this new industry earlier this year, we were unwilling to sacrifice the high standards we have set for this program by launching during an emerging public health pandemic and in the absence of a testing facility. With the support of the public health community, municipalities across the state, and the industry we regulate, we have used the last few months to ensure this new industry is introduced to Maine consumers in a manner that is as responsible as possible.”

Active licensure is the culmination of a three-step application process which also includes conditional licensure and local authorization, respectively. An active license is required for adult use establishments to come into possession, process and sell adult use marijuana, including initiating plant transfers from Maine’s existing medical marijuana program.

It is expected adult use licensees will utilize the time between active licensure and Maine’s retail sales launch date to harvest and process marijuana, ensure those products satisfy the mandatory testing requirements, and move product through the supply chain to stock retail store shelves. Additionally, businesses which will conduct retail sales will prepare to implement and support social distancing and other public health guidance at a time when public interest may attract a significant consumer presence to their retail locations.

“Today’s announcement is a major milestone in honoring the will of Maine voters and a significant step toward launching a new industry in the state,” added Gundersen. “Many of the business owners we have spoken with during the application process are ready and eager to commence operations.”

The application process required by the adult use law requires state regulators to review application materials for form and substance, with an eye toward details such as ensuring that all applicants have completed their required state and federal criminal history record checks; that the establishment’s operation, facility, and security plans satisfy the requirements of both the Marijuana Legalization Act and the adult use program rule; and that the designated host municipality has provided the applicant with authorization to conduct business in their community.

OMP expects to issue licenses in each of the four categories of adult use establishments: cultivation, products manufacturing, retail sale, and testing. Information on the specific number of licenses issued and the identities of active licensees will be made available on Tuesday, September 8, 2020.

The Mills Administration created OMP within DAFS in February 2019. The Office is responsible for the oversight of all aspects of legalized marijuana, including Maine’s existing Medical Use of Marijuana Program.

Nevada CCB Launches Investigations Into Three Nevada Dispensaries, Selling Potentially Unsafe Product

NEVADA: The Nevada Cannabis Compliance Board (CCB) has opened investigations into three dispensaries for selling product that twice failed microbial testing.

On March 5, 2020, the Department of Taxation and CCB issued a directive to all dispensary/retail stores to immediately stop selling the product, Cherry OG F3, which failed laboratory testing for yeast and mold, coliforms, Enterobacteriaceae and Aspergillus.

At that time, the CCB instructed dispensary/retail stores to destroy or return the affected product to the cultivator and communicate that they took such action with the State. Despite the CCB’s directive, it appears three dispensaries retained their inventory of Cherry OG and began selling the product again in May.

Approximately 375 grams of the Cherry OG product were sold between May 19, 2020 and June 29, 2020 at the following Retail Stores/Medical Dispensaries:

1. Waveseer of Las Vegas, LLC (Jenny’s Dispensary), 5530 N Decatur Blvd, Las Vegas, NV 89130 (License # 83760475147127946601);

2. Paradise Wellness Center, LLC (Las Vegas ReLeaf), 2244 Paradise Road, Las Vegas, NV 89104 (License # 54283805068313943868); and

3. Desert Aire Wellness, LLC (Sahara Wellness), 420 E Sahara Ave, Las Vegas, NV 89104 (License # 25729455103203031356)

On May 16, 2020, a hold on the product was temporarily lifted due to a CCB error that occurred during an unrelated investigation. However, the CCB’s health and safety advisory remained in effect; and under the directive, dispensaries should not have had the product in their inventory.

The CCB advises those who have purchased the product to avoid consuming it. Consumers should check any Cherry OG products for the source package # 1A404030000076F000006649. The CCB notified the aforementioned dispensaries and initiated investigations which are ongoing. There are no known reports of illness.

Oklahoma Medical Marijuana Authority Says No To Pot Slushy Machines

OKLAHOMA: The OMMA has received multiple inquiries regarding the processing and dispensing of marijuana-infused slushies on-site at medical marijuana dispensaries.  It is the OMMA’s position that marijuana-infused slushies are unlikely to meet requirements set forth in Oklahoma statutes and rules, including, but not limited to:  

  • All products must be in child-resistant packages. Generally, this means the package must be difficult for a 5-year-old to open; opaque; and, if intended for multiple uses (for example, containing multiple servings), capable of being resealed while remaining child-resistant. [See 63 O.S. 427.2 and OAC 310:681-1-4]
  • The medical marijuana production batch that must be tested is the finished product. In this instance, the finished product is the slushy mixture to be dispensed to patients/caregivers, not the syrup. If water, ice, or any other substance is added to the product, additional testing is required to ensure the product is safe for consumption and final-product labeling is accurate.  [See OAC 310:681-1-4 and OAC 310:681, Subchapters 7 and 8]
  •  Dispensaries are not allowed to alter, package, or label products. In addition, dispensaries must refuse to accept or return any medical marijuana products that have not been properly tested, packaged, and labeled by a licensed processor. [See OAC 310:681-1-4 and OAC 310:681-7-1(b)]

Additionally, slushies are considered food products and must be compliant with the Oklahoma State Department of Health food regulations. For more information, please visit the  OSDH Consumer Health Service Food website.

Rep. Tulsi Gabbard’s Defense Bill Amendment Removes DOD CBD/Hemp Prohibition

DISTRICT OF COLUMBIA: Rep. Tulsi Gabbard (HI-02), a senior member of the House Armed Services Committee, secured an amendment to the annual national defense bill that would ensure that the U.S. Department of Defense may not prohibit the possession, use, or consumption of hemp products — in compliance with applicable Federal, State, and local law — by servicemembers. This would apply to hemp that meets the Agricultural Marketing Act of 1946 definition (amended by the Agricultural Improvement Act of 2018). The Gabbard amendment was included in the final version of the bill which passed on Tuesday, 295-125, and now goes to the Senate for consideration.

“There is great research being done around hemp, resulting in new products coming to market that are proven to help with ailments like insomnia, inflammation, chronic pain, epilepsy, Traumatic Brain Injury, Post-Traumatic Stress and more. Hemp products provide a form of treatment that serves as an alternative option for those who would rather pursue natural remedies rather than prescription drugs. This amendment passed with strong bipartisan support, ensuring our servicemembers have access to the same over-the-counter products that Americans all across the country benefit from today,” said Rep. Tulsi Gabbard.

The 2018 Farm Bill, known as the Agricultural Improvement Act, legalized hemp, defined as cannabis (Cannabis sativa L.) and derivatives of cannabis with extremely low concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC) (no more than 0.3 percent THC on a dry weight basis). Currently, many over-the-counter products are sold that meet these parameters.

Oregon Marijuana Retail Licensees Allowed To Provide Curbside Delivery

Temporary Rule Aligns With Governor’s Executive Order to Promote Social Distancing

OREGON: The Oregon Liquor Control Commission approved a temporary rule that supports social distancing to promote prevention of the spread of the COVID-19 virus, by allowing licensed marijuana retailers to conduct limited transactions outside their licensed premises.  The action will permit retail licensees to take orders and deliver product from the retail store to a person who is outside of the store and within 150 feet of the retailer’s licensed premises.

At an emergency meeting to consider temporary rules impacting the business activity of OLCC licensees in the alcohol and marijuana industry, the Commission took its action to promote social distancing in the wake of the COVID-19 virus.  The Commission’s action aligns with the Governor’s Executive Order that prohibits public gatherings of 25 people or more, and encourages people to distance themselves by at least 3 feet while in public.

The temporary rule also increases the amount of flower that OMMP cardholders and caregivers can purchase to 24 ounces per day and no more than 32 ounces per month. This change temporarily increases the daily purchase limit for OMMP cardholders to match their personal possession limit. This rule does not change the total monthly amount a cardholder or caregiver is currently permitted to purchase from an OLCC-licensed retailer.

The temporary action that the Commission has taken is designed to balance the protection of public health while at the same time helping struggling businesses.  Marijuana industry guidance can be found here.

“Every single decision that this agency is making, both for the liquor and the marijuana industries, are there for the consideration of helping people make a living and continue to make a living,” said Paul Rosenbaum, OLCC Commission Chair.

During the period of March 1-18, 2020, OLCC marijuana retailers have seen a 25-30% increase in sales compared to the same period last year.  Retail marijuana stores remain open, but these changes will let them operate in a way that is consistent with the guidance from the Executive Order by decreasing in-store activity.

However the OLCC made it clear that if individual licensees take advantage of the temporary rule by disrupting public safety or public health that the rule could be suspended for the whole industry.

“We’re asking our retailers to make sure to work with the community and local officials so that this can happen in a safe and non-obstructive way to city services, otherwise we’ll need to make changes,” said Steve Marks, OLCC Executive Director.

Ohio Medical Marijuana Control Program Mandatory Product Recall – 3/13/2020

OHIO: The Ohio Medical Marijuana Control Program (MMCP) is issuing a mandatory product recall on plant material cultivated by Pure Ohio Wellness. This recall is being initiated by the MMCP because product that did not receive the full battery of required testing was sold at dispensaries. The product was not tested for heavy metals, water activity, microbials, mycotoxins, or foreign matter. The MMCP has initiated an investigation into the noncompliance and identified product samples to be tested. These results will be communicated publicly.

AFFECTED PRODUCT:

Product Name: Papaya Punch, Hiker’s Blend, and Tahoe Jack

Purchase Dates: May 10, 2019 – Present

Cultivator Name: Pure Ohio Wellness

Product ID:
• M00000022503: Tier 1 Vap-Hybrid-16.4-.04-Papaya Punch
• M00000022504: Tier 1 Vap-Hybrid-16.9-.07-Hikers Blend
• M00000022506: Tier 1 Vap-Hybrid-18.6-.03-Tahoe Jack
• M00000028027: Tier 1 Vap-Hybrid-14.21-0.05
• M00000032648: Tier 1 Vap-Hybrid-14.48-0.03
• M00000036302: Tier 1 Vap-Sativa-15.50-0
• M00000036303: Tier 1 Vap-Sativa-18.50-0
• M00000036307: Tier 1 Vap-Sativa-14.75-0
• M00000039234: Tier 1 Vap-Sativa-18.50-0 (103) 28.3g
• M00000039235: Tier 1 Vap-Sativa-14.75-0 (104) 8.49g
• M00000039236: Tier 1 Vap-Sativa-14.75-0 (104) 28.3g
• M00000039239: Tier 1 Vap-Sativa-14.75-0 (107) 8.49g
• M00000039240: Tier 1 Vap-Sativa-14.75-0 (107) 28.3g
• M00000039241: Tier 1 Vap-Sativa-15.50-0 (108) 8.49g
• M00000039242: Tier 1 Vap-Sativa-15.50-0 (108) 28.3g

No reports of adverse reactions for this product have been reported to the MMCP at this time.

Patients who have purchased the recalled product should stop using it. All unused product should be returned to the dispensary where purchased. Returned products will not count toward a patient’s 90-day possession limit. For more information on returns, please contact the dispensary where the product was purchased.

Anyone who thinks that they may be experiencing serious or life-threatening issues should seek immediate medical attention. Patients are reminded that any adverse reactions should be reported to the MMCP toll-free helpline (1-833-464-6627).

USDA, DEA Provide Options For Labs, Disposal Of Non-Compliant Hemp Plants

usda-logoDISTRICT OF COLUMBIA: The U.S. Department of Agriculture (USDA) today announced the delay of enforcement of certain requirements under the interim final rule (IFR) establishing the U.S. Domestic Hemp Production Program.

Under the new guidance, USDA will delay enforcement of the requirement for labs to be registered by the Drug Enforcement Administration (DEA) and the requirement that producers use a DEA-registered reverse distributor or law enforcement to dispose of non-compliant plants under certain circumstances. Enforcement will be delayed starting this crop year and until Oct. 31, 2021, or the final rule is published, whichever comes first.

“Because currently there isn’t sufficient capacity in the United States for the testing and disposal of non-compliant hemp plants, USDA has worked hard to enable flexibility in the requirements in the Interim Final Rule for those issues,” said USDA Under Secretary for Marketing and Regulatory Programs Greg Ibach.

Laboratory Testing

Laboratory testing for the purposes of determining compliance under the U.S. Domestic Hemp Production Program can be conducted by labs that are not yet registered with DEA. The laboratories must still meet all the other requirements in the IFR.

All laboratories engaged in the testing of hemp through this interim period will be subject to the same compliance requirements of the IFR. Specifically, labs must adhere to the standards of performance as outlined within the IFR, including the requirement to test for total THC employing post-decarboxylation or other similarly reliable methods. All labs will have to make arrangements to be compliant with registration requirements before this period of delayed enforcement expires. DEA will evaluate all applications using the criteria required by the Controlled Substances Act (21 U.S.C. 823(f)).

Disposal

Based on feedback from states and tribes, and in consultation with DEA, USDA has identified additional options for the disposal of “hot” hemp plants. Some of these new options include, but are not limited to, plowing under non-compliant plants or composting into “green manure” for use on the same land. The new methods are intended to allow producers to apply common on-farm practices for the destruction of non-compliant plants.

Hemp that tests greater than 0.3% THC on a dry weight basis must be disposed of onsite according to the disposal methods approved by USDA. The state, tribe or the state’s department of agriculture will be responsible for establishing protocols and procedures to ensure non-compliant hemp is appropriately destroyed or remediated in compliance with applicable state, tribal and federal law.

A list of allowed disposal techniques and descriptions is available on the U.S. Domestic Hemp Production Program web page.

“One of the top considerations in making these changes was the desire to provide additional options that minimize, to the extent possible, the resource impact to state and local law enforcement in handling hemp that is out of compliance,” said Under Secretary Ibach.

“We look forward to partnering with producers, states, tribes and other stakeholders to deliver regulations that work for everyone,” said Under Secretary Ibach.

OLCC Approves Marijuana License Stipulated Settlement

Starts Additional Rule-making Affecting Bottle Bill & Milk Beverages

OREGON: At a special meeting on January 30, 2020, the Commissioners of the Oregon Liquor Control Commission approved one marijuana violation stipulated settlement agreement.

Cura CS, a licensed recreational marijuana wholesaler, will pay a fine of $110,000 for two violations.

Licensees are: Cura CS, LLC; Cura Partners, Inc., Member; Cameron Forni, President/Director/Stockholder; Nitin Khanna, Director/Stockholder; David Thompson, Secretary; Nicholas Slinde, Director; Kali Mata, LLC, Stockholder; Nitin Khanna, Member; Karan Khanna, Member; Serpico, LLC, Stockholder; Nicholas Slinde, Member; Phil Nelson, Member.

The Commission also undertook the initial step to rescind previous rulemaking that established a definition of “milk” for determining whether or not specific categories of beverage containers are exempt from collection and redemption under the Oregon Bottle Bill.  The Commission initially adopted the rule in December 2019 (OAR 845-020-0005(11)).

To better align with the barriers to accepting empty containers of milk and plant-based milk beverages that do not fall under the statutory exemption, the OLCC has initiated rulemaking to again look at the definition of “milk.”

This rulemaking could result in rescinding the language that was added during the 2019 rulemaking process.  OLCC will work with the Oregon Beverage Recycling Cooperative, grocers both large and small, and manufacturers of milk and milk-beverage products that are or might be exempt from bottle bill redemption, to provide for and ensure orderly compliance within the marketplace.