Massachusetts Cannabis Control Commission Approves Final Adult Use, Medical Use of Marijuana Regulations and Rescinds Colocated Regulations

MASSACHUSETTS: The Cannabis Control Commission (Commission) today approved new medical- and adult-use regulations and phased out 935 CMR 502, Colocated Adult-Use and Medical-Use Marijuana Operations, after bringing sufficient parity to the medical- and adult-use regulations.

“I’m excited that the revised medical- and adult-use regulatory revisions poise the Commission to make significant progress in our mission and statutory mandates on equity, patient access, and public health and safety,” Chairman Steven J. Hoffman said. “While we’ve made tremendous headway over the past three years, we now turn to critical work to implement new provisions, including; the increased caregiver/patient ratio, development of guidance documents, rollout of the Delivery Operator application, and a host of provisions establishing a more equitable and safe industry.”

In the coming weeks, the final regulations will be filed with the Secretary of State’s Regulation Division for promulgation and published on the Commission’s website.

Approved policies include:

Medical Use of Marijuana Program

  • Optimizing Patient access and preserving public safety by:
    • Allowing Caregivers to care for up to five Patients with a Canopy not in excess of 500 square feet;
    • Clarifying that Caregivers may seek a waiver to care for more than five Patients but cannot exceed the 500-square-foot limitation;
    • Preventing perceived risk of diversion by requiring Caregivers to create a log-of-growing and make that log available to the Commission upon request;
    • Broadening the types of physicians who can serve as the second physician making the recommendation for pediatric patients;
    • Requiring Certifying Health Care Providers (Providers) to have a plan to provide discounts to low-income Patients;
    • Allowing Patients with certain hardships to renew every two years instead of one year;
    • Permitting Patients to cultivate up to 12 flowering plants without hardship cultivation, and if more are needed, requiring hardship cultivation;
    • Allowing certain out-of-state Patients to be certified and registered as a Patient in Massachusetts; and
    • Restricting Caregivers from participating in paid advertising.

Equity Programming

  • Promoting a more inclusive and diverse industry by:
    • Waiving all Delivery application and license fees for Certified Economic Empowerment Priority Applicants (EEA) and Social Equity Program (SEP) participants in their first year of licensure under the exclusivity period;
    • Reducing annual license fees by 50%, or to $2,500, for EEAs and SEP participants upon renewal and all subsequent years for applicants;
    • Expanding SEP eligibility to certain categories of individuals and EEAs;
    • Requiring majority ownership by SEP participants in order to access license-related benefits, and potentially expanding these program benefits to microbusinesses and minority-owned, veteran-owned, and women-owned businesses; and
    • Clarifying that individuals who are EEAs, whether on their own or as part of a business entity, can apply as part of a new entity with EEA status so long as it continues to meet three or more of the six criteria, at least one of which shall be a majority-equity-ownership criterion.

Delivery

  • Increasing adult-use access and evolving the Delivery license type by:
    • Approving the Delivery Operator license type, which allows licensees to purchase wholesale Finished Marijuana Products with stringent requirements to warehouse;
    • Clarifying the statutory allowance of up to three Retail licenses and the regulatory allowance of up to a combined total of two Marijuana Courier and/or Delivery Operator licenses;
    • Extending the initial exclusivity period to three-years;
    • Allowing Third-Party Technology Platform Providers to contract with an unlimited number of Delivery Licensees;
    • Authorizing Delivery Operator Licensees to white label, or affix a product label that includes the branding (name and logo) of a specific Marijuana Establishment (ME) to a finished marijuana product that was previously produced and packaged by a licensed Product Manufacturer, Cultivator, Microbusiness, or Craft Marijuana Cooperative for sale to consumers;
    • Allowing Delivery Licensees to sell marijuana accessories and ME-branded goods and non-edible items directly to consumers; and
    • Automatically converting existing Pre-Certified “Delivery-Only” applicants to Delivery Courier Applicants.

Ownership & Control

  • Tightening stringent ownership and control measures further by:
    • Requiring EEAs to report to the Commission all changes of ownership and control and upon renewal and certifying to the Commission that the requisite ownership and control has been maintained by the requisite class of people identified on the EEA’s certification;
    • Preventing monopolies with the addition of safeguards between Third-Party Technology Platforms and Delivery Licensees by explicitly prohibiting:
      • monopolization or attempts at monopolization;
      • inducements;
      • direct or indirect investments from Third-Party Technology Platforms; and
      • restricting determinations of product and licensee placement on an app to objective, customer-oriented criteria.
    • Updating the definition of Persons or Entities with Direct Control by encompassing the equivalent of a Director in a business entity such as a Limited Liability Company, which has Managers in lieu of a Board of Directors, and setting a specific dollar amount with respect to what the Commission considers “significant contracts;” and
    • Confirming that EEAs hold majority ownership (51% or more) over the license to maintain priority status.

Product Database

  • Ensuring that the public is knowledgeable of the hallmarks of legally sourced products, preventing underage access, and lowering the risk of purchasing illicit products by adopting a requirement that Marijuana Establishments, including Delivery Operators, and MTCs comply with the Product Database requirement, just as adult-use licensees must.

Advertising and Branding

  • Modifying advertising and branding regulations by:
    • Allowing of branding sponsorships at certain events, with continued prohibitions on activities that target underage participants or entrants; and
    • Approving targeted advertising through mechanisms such as geofencing, provided they retain documentation of audience composition data related to these marketing activities.

Testing

  • Increasing testing accountability for licencees by:
    • Allowing marijuana products that fail initial contaminant screens to be:
      • Reanalyzed;
      • Remediated and retested by at least the original Independent Testing Laboratory, and a different Independent Testing Laboratory; or
      • Licensees may attempt remediation of a batch that has failed a second test prior to disposal or destruction.
    • Adding new pesticides to the list of pesticides currently required of Independent Testing Laboratory protocols; and
    • Requiring continued testing for vitamin E acetate and a secondary screen for heavy metals from finished vapes.

Video recordings of the Commission’s previous policy discussions and public hearings regarding the new regulations are available on Facebook and YouTube.

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.