Colorado Senator Gardner Calls On USDA To Protect Hemp Industry

DISTRICT OF COLUMBIA: U.S. Senator Cory Gardner (R-CO) is calling on the U.S. Department of Agriculture (USDA) to delay implementation of the U.S. Domestic Hemp Production Program Interim Final Rule (IFR), which, as currently drafted, threatens the industrial hemp industry’s potential for Colorado’s farmers and seriously undermines this growing industry.

“The United States is now poised to transition from being a world-leading hemp importer to a world-leading hemp producer, and many look to Colorado farmers for guidance and clarity for the industry because Colorado is home to one of the longest-running state hemp programs,” wrote Senator Gardner. “I have worked with my colleagues and state officials to share with the USDA Colorado’s hemp experience, encourage greater flexibility for farmers, and encourage innovation of the industry. This includes echoing comments submitted by the State of Colorado during the IFR comment period.”

“I appreciate your leadership to the nation’s farmers throughout this extraordinary challenging time. Given these challenges, it is hard to overlook the great promise that the industrial hemp industry could provide to farmers if regulation is done in the proper manner. I encourage you to delay the final implementation of the IFR and work directly with state regulators and the industry to ensure workable rules that allow the industry to thrive,” Gardner concluded.

The full text of the letter can be found here and below:

Dear Secretary Perdue:

I write regarding the United States Department of Agriculture’s (USDA) U.S. Domestic Hemp Production Program Interim Final Rule (IFR), which, as currently drafted, threatens the industrial hemp industry’s potential for Colorado’s farmers and seriously undermines this burgeoning industry. I join the growing chorus of my colleagues, the National Association of State Departments of Agriculture, and the National Industrial Hemp Council in requesting that you use your secretarial discretion to delay implementation of the final rule in order to address several outstanding issues.

The nation’s hemp industry was given an enormous boost when hemp was de-scheduled in the Agriculture Improvement Act of 2018. The United States is now poised to transition from being a world-leading hemp importer to a world-leading hemp producer, and many look to Colorado farmers for guidance and clarity for the industry because Colorado is home to one of the longest-running state hemp programs. Since 2014, Colorado’s program has grown to include about 2,600 active registrations. In 2019, there were nearly 90,000 acres of registered hemp production in the state. Colorado farmers have been at the forefront of the hemp industry, driving change and innovation across the country. The state carefully balances regulatory oversight and economic support, allowing it to have a thriving industry and be a leader to other states.

I have worked with my colleagues and state officials to share with the USDA Colorado’s hemp experience, encourage greater flexibility for farmers, and encourage innovation of the industry. This includes echoing comments submitted by the State of Colorado during the IFR comment period. Despite my communications, there remain serious concerns about how the IFR will impact the Colorado industry.

I appreciate your leadership to the nation’s farmers throughout this extraordinary challenging time. Given these challenges, it is hard to overlook the great promise that the industrial hemp industry could provide to farmers if regulation is done in the proper manner. I encourage you to delay the final implementation of the IFR and work directly with state regulators and the industry to ensure workable rules that allow the industry to thrive.

Ohio Board Of Pharmacy Publishes Updated Patient & Caregiver Numbers For July 2020

OHIO:  The State of Ohio Board of Pharmacy today published updated patient & caregiver numbers for July 2020.

These numbers include:

  • 159,513 Recommendations
  • 125,087 Registered patients
    • 8,862 Patients with Veteran Status
    • 9,286 Patients with Indigent Status
    • 690 Patients with a Terminal Diagnosis
  • 100,224 Unique patients who purchased medical marijuana (as reported to OARRS by licensed dispensaries)
  • 13,944 Registered Caregivers

For the full list of program numbers, please visit the Program Update page.

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.

Colorado Legal Cannabis By The Numbers

COLORADO: How big is Colorado’s legal cannabis business?  According to statistics reported on the official Colorado State website, there are more than 460 medical marijuana grows, and more than 700 adult use cultivations in the Centennial State; with more than 1100 retail stores: 430 medical dispensaries and 700 recreational shops.

Here’s how the numbers break out:

Medical Marijuana Business License Numbers:

  • 466 Cultivations
  • 4 Delivery (Permits)
  • 7 Operators
  • 217 Product Manufacturers
  • 1 Research and Development and Research Cultivation
  • 439 Stores
  • 10 Testing Facilities
  • 7 Transporters

 Retail Marijuana Businesses License Numbers:

  • 703 Cultivations
  • 3 Hospitality
  • 9 Operators
  • 284 Product Manufacturers
  • 597 Stores
  • 11 Testing Facilities
  • 10 Transporters

Individual Licensees:

  • 1,732 Business Owners Licensees
  • 39,642 Employee Licensees

Acreage Announces Sale Of Maryland Dispensary

NEW YORK: Acreage Holdings, Inc., a vertically integrated, multi-state operator of cannabis licenses and assets in the U.S., today announced it has entered into a definitive agreement with an undisclosed buyer, pursuant to which the Buyer, when permitted by state law, will purchase all of the issued and outstanding membership interests of Maryland Medicinal Research & Caring, LLC. MMRC is licensed to operate a medical cannabis dispensary in Baltimore, Maryland.

The terms of the deal were not disclosed.  Due to regulatory restrictions regarding license transfers, the Buyer, upon approval by the Maryland Medical Cannabis Commission, will enter into a managed services agreement with MMRC until the requisite time has elapsed before Acreage and the Buyer can close the transaction under the definitive agreement.  Closing of the transaction is contingent upon regulatory approvals.

“The sale of our Maryland dispensary is another step forward in our refocused strategy to accelerate our pathway to profitability,” said Bill Van Faasen, Interim Chief Executive Officer of Acreage. “It follows our divestiture in North Dakota, plus other cost-cutting measures completed earlier this year.  We are moving forward with our refocused plan as quickly as possible and we will continue to update shareholders on our progress as new events transpire.”

WSLCB Invitation For Public Comment: Draft Conceptual Rules For Marijuana Business Premise Certificate of Compliance

WASHINGTON: The Washington State Liquor and Cannabis Board (WSLCB) is seeking public comment regarding draft conceptual rules. These draft conceptual rules are narrowly scoped to include a new rule subsection that provides a marijuana business premise certificate of compliance.  A draft, conceptual version of WAC 314-55-020 is linked here. The new subsection (6) is highlighted in blue.

Background
On July 8, 2020, the WSLCB filed a pre-proposal statement of inquiry (CR 101) to consider amending WAC 314-55-020 to establish a certificate of compliance for marijuana business premises consistent with the mandates of Substitute Senate Bill (SSB) 6206 (Chapter 154, Laws of 2020). The CR-101 filing and supporting documents are located here.

Specifically, SSB 6206 amended RCW 69.50.331 to create a certificate of compliance for marijuana business premises, and became effective June 11, 2020. The amendment requires the Board to issue a certificate of compliance for a marijuana business applicant’s premises, if the premises met the distance requirements from restricted entities (such as parks, schools, and playgrounds) at the time the application was filed. The certificate allows the licensee to operate the business at the proposed location notwithstanding a later occurring, otherwise disqualifying factor regarding restricted entities.

The WSLCB invites and encourages your comment on the draft conceptual rule language offered as WAC 314-55-020 (6). Your feedback will be reviewed and considered before a CR 102, or rule proposal, is presented to the Board for approval.

Public Comment
Please forward your comments to Casey Schaufler at casey.schaufler@lcb.wa.gov by September 4, 2020. The CR102 proposal is anticipated to be presented to the Board on or after September 30, 2020.

Planet 13 Awarded Nevada Dispensary License

Planet 13 awarded Nevada retail cannabis license through settlement of the lawsuit against the Nevada Department of Taxation

NEVADA:  Planet 13 Holdings Inc., a leading vertically-integrated Nevada cannabis company, today announced it has agreed to a settlement of its ongoing lawsuit against the Nevada Department of Taxation and other parties which subsequently joined the litigation. As part of the Settlement, Planet 13 is receiving one provisional adult-use dispensary license in unincorporated Clark County, Nevada. The License will be used to re-open Planet 13’s former dispensary located at 4850 Sunset Road in Las Vegas, Nevada that closed on October 30, 2018 (the “Medizin Dispensary”).

“We’ve always known that as one of the top operators in Nevada, responsible for 9% of the state’s sales, we deserved to win a license from the Nevada Department of Taxation. Although we are not happy with how long the process took for us to obtain the license to re-open our original location, we are thrilled to be able to service our loyal customers who supported Planet 13 from day one,” said Larry Scheffler, Co-CEO of Planet 13. “The Medizin Dispensary at 4850 Sunset Road in Las Vegas is a fully built-out 4,750 sq. ft. store that offers the same dedication to customer service, high-quality products, and innovation that Planet 13 is known for, all in a compact footprint designed to compliment its local neighborhood.”

The Medizin Dispensary was closed on October 30, 2018, to transfer the license to the Planet 13 SuperStore located next to the Las Vegas Strip. During the last full quarter of operations, Q3 2018, the Medizin Dispensary generated $4.9 million in revenue with a gross margin of 53%. The Medizin Dispensary requires no additional CAPEX to open.

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.

Massachusetts Cannabis Control Commission Issues Second Amended Quarantine Order for Vaporizer Products

Cannabis Control Commission Issues Second Amended Quarantine Order for Vaporizer Products

Following the agency’s three-phased testing and public comment period, licensees may retest and release, or destroy quarantined products subject to order requirements

MASSACHUSETTS:The Cannabis Control Commission (Commission) has issued a Second Amended Quarantine Order Applying to Vaporizer Products following three phases of testing and a public comment period which examined conditions that could allow for the retest and sale of vaporizer products that were previously quarantined since December. Under the second amended order, licensees may retest and release—or destroy—certain products with enhanced warning labels, depending on testing and remediation outcomes, and compliance with Commission regulations and policies. The order emphasizes that measured, transparent testing mitigates, but does not eliminate, all public health risks posed by quarantined vaporizer products.

This latest action modifies previous Commission quarantine orders issued in November and December 2019 and related investigative findings from the US Centers for Disease Control and Prevention (CDC) that identified vitamin E acetate (VEA) as a chemical of concern among people with e-cigarette, or vaping, product-use associated lung injury (EVALI). On December 12, 2019, the Commission issued the First Amended Quarantine Order authorizing licensees to sell newly manufactured vaporizer products, but requiring that more than 600,000 vaporizer products manufactured before December 12, 2019 remain subject to quarantine.

“Since the Commonwealth declared a vaping public health emergency last fall, the Commission has dedicated significant energy and resources to investigating the additives, hardware, and storage practices that licensees use to produce and sell cannabis vaporizer products,” Commission Executive Director Shawn Collins said. “Fortunately, repeat tests of licensed product samples did not return any detectable levels of VEA; unfortunately, they did establish that heavy metal contamination may increase in vaping products over time.

“This new order seeks to strike a balance between those products that can be retested or remediated safely for sale or repurposing with proper warning to patients and consumers, and those that cannot. As the nation continues to learn more about the broader health implications of vaping in all forms, I urge patients and consumers to understand the risks when they choose to consume any cannabis vaporizer product.”

The Commission’s regulations require all marijuana products to undergo contaminant testing, including testing for heavy metals, by an Independent Testing Laboratory accredited to the International Organization for Standardization 17025 (ISO/IEC 17025: 2017) and in accordance with the Commission’s Protocol for Sampling and Analysis of Finished Medical Marijuana Products and Marijuana-infused Products.

Under the second amended order, previously quarantined products may be:

  • Disposed. Licensees may voluntarily dispose of previously quarantined vaping products at any time, subject to Commission disposal regulations.
    • Production batches that previously failed both Commission-initiated tests for heavy metals shall be deemed unable to be remediated and face mandatory disposal, if, after two attempts at remediation, the product does not pass testing for heavy metals. Respondents may dispose of such products voluntarily or upon receiving an order of destruction from the Commission.
  • Retested and Released. Previously quarantined products may be made available for sale if they are first retested and deemed compliant with the Commission’s regulations and policies, subject to conditions specified in the order.
  • Reclaimed. Previously quarantined products may also be repurposed into other products using the reclaimed marijuana oil, although any new product manufactured with that oil must undergo testing and include a statement indicating to the patient or consumer that the product was manufactured with previously quarantined material.

If, after two attempts at remediation, retested or reclaimed products do not pass testing for heavy metals, they will be considered unable to be remediated and must be disposed. Vaporizer products with original testing dates in excess of one year are considered expired and may not be dispensed, sold, transferred or otherwise conveyed until another screen for all contaminants, excluding pesticides, is conducted. In accordance with Commission regulations, licensees must notify the agency of any vaporizer product test result exceeding acceptable levels for heavy metals and describe the method for remediation or disposal.

The second amended order also specifies labeling requirements for all vaporizer products sold by licensees in the Commonwealth, including, but not limited to those products that are retested or reclaimed in accordance with the second amended order:

  • Labels on previously vaporized products that pass retesting and are made available for sale must disclose, “This product was previously quarantined. Passed retesting for heavy metals and Vitamin E Acetate. Store at room temperature.”
  • Labels on previously vaporized products that have their marijuana concentrate reclaimed for other marijuana products must disclose, “This product was produced using previously quarantined concentrate. Passed retesting for heavy metals and Vitamin E Acetate. Store at room temperature.”

Retailers and Medical Marijuana Treatment Centers (MTCs) must include in the sale of vaporizer products a disclosure that the patient or consumer may request to inspect a copy of the product’s associated testing results. Disposable and reusable vaporizer pens also must include a product insert that identifies the materials used in the device’s atomizer coil. Any quarantined vaping product that is resold also must include the item’s original packaging date.

The Commission has mandated that Marijuana Product Manufacturers retain certain records pertaining to marijuana vaporizer ingredients, additives, devices, component parts, or other materials purchased from any manufacturer or supplier; the name and business address of the manufacturer of any cartridge, battery, atomizer coil (and its materials used), hardware, or other component of marijuana vaporizer products; and the Certificate of Analysis for each thickening agent, thinning agent, and terpene infused or incorporated into a marijuana vaporizer device during production.

Starting last December, the Commission conducted three phases of testing into vaporizer products manufactured and sold by licensees. Results are available on the Commission’s website under MassCannabisControl.Com/Documents.

The Commission’s first two testing phases investigated VEA and heavy metal (lead) levels in samples of vaporizer products collected from geographically diverse locations. Phase III involved confirmatory tests of certain products that failed for heavy metal concentrations above the acceptable limits for inhalation (500 ppb), and found varying results, to suggest that heavy metal contamination may increase over time. Testing limitations identified during the investigation included limited sampling scope, product batch homogeneity, inconsistent extraction procedures for testing finished cartridge samples, and lack of known sources of metal contamination. VEA has not been detected in any Commission-initiated testing.

After testing methods precluded reliable results, the Commission determined further investigation and collaboration was necessary before issuing a second amended order pertaining to the quarantined vaping products. A survey was issued on July 2, 2020 to obtain public comment from government, industry, scientific, and public health stakeholders, among other constituents, including patients and consumers, to help identify the root cause of the heavy metal contamination, the health effects of elevated lead levels, and whether heavy metal content within vaporizer products could become more prominent without use over time or post-use. The survey closed on July 14, 2020 and public comments are currently available on the Commission’s website under MassCannabisControl.Com/Documents.

The Commission continues to research and evaluate information relative to vaporizer device product manufacturing processes and safety standards in furtherance of its obligation to ensure a safely regulated industry.

Surna Announces Largest Contract In Its History

Announces $2.8 million Sales Contract in July

COLORADO: Surna announced today that it recently signed a sales contract valued at $2.8 million.

The project in Illinois is for a multi-state operator with whom Surna has worked on previous facilities in other states. The facility is approximately 88,000 square feet, of which approximately 66,000 square feet is dedicated to cultivation, drying and processing areas. Surna is under contract to provide a full suite of climate control products and technologies for the cultivation and processing spaces (the mechanical engineering design was done by Surna through a previous contract), supply of major mechanical equipment, SentryIQ environmental controls, and system start-up. While Surna can and does provide MEP design and equipment for a wide range of climate control approaches, in this case the priorities of reducing electrical infrastructure requirements and reducing roof loading, along with the desire for precise control of the facility’s environment, resulted in the selection of a 4-pipe hydronic system. The design has integrated dehumidification, in which Surna is providing its proprietary line of multi-function fan coils, destratification fans, dehumidifiers and heat recovery chillers.

Tony McDonald, CEO commented: “The team at Surna has worked diligently to secure the largest single contract in the Company’s history. Now our operations and controls departments will be hard at work ensuring the delivery of a precisely controlled environment and on-time delivery of equipment to meet our customer’s requirements.”