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.