On September 24, 2019, Governor Charles D. Baker declared a public health emergency and the Commissioner of Public Health issued a temporary ban on the sale of all vaping products, including devices that rely on vaporization or aerosolization. Cartridges, vaping accessories and devices, and refills for cartridges were removed from shelves and prohibited from sale. On November 12, 2019, the Cannabis Control Commission (Commission), acting through the Executive Director, issued its Quarantine Order Applying to Vaporizer Products (the “Initial Order”). The Initial Order required all licensees to quarantine all vaporizer products.
On December 12, 2019, the Commission issued its First Amended Quarantine Order authorizing licensees to sell newly manufactured vaporizer products, but requiring that vaporizer products manufactured before December 12, 2019 remain subject to quarantine. At this time, vaporizer products that were prohibited for sale or subjected to quarantine between September 25, 2019 and December 12, 2019, continue to be restricted from sale.
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.
As part of its ongoing investigation into vaping safety, Commission staff have engaged stakeholders in discussions regarding the capability of Independent Testing Laboratories to test vaporizer products. Commission staff have also engaged licensees affected by the First Amended Order to gain a better understanding and industry perspective about best practices for vaporizer product manufacturing, concerns regarding device quality, product stability and methods for testing of vaporizer products. Commission staff continues to research and evaluate information relative to vaporizer device product manufacturing processes and safety standards in furtherance of our obligation to ensure a safely regulated industry.
Independent Testing Laboratories have not detected vitamin E acetate in any of the quarantined products that have been tested. Of the tested vape products, preliminary results indicate that the heavy metal deposits within those cartridges consistently increased with time. Testing limitations identified during the ongoing investigation include limited sampling scope, product batch homogeneity, inconsistent extraction procedures for testing finished cartridge samples, and lack of known sources of metal contamination. Whether the heavy metal content within collected vape cartridges are more prominent without use over time or post-use also requires further investigation.
During the Commission’s investigation, some samples collected and tested from the same production batch produced disparate results or findings. While an initial test may have identified impermissible levels of lead, well above those levels that are deemed safe for inhalation or ingestion (500 – 1,000 parts per billion), subsequent tests would return a result of non-detect or as having registered lower than could be detected with the lab’s methodology or instrumentation. The Commission has not tested every production batch currently under quarantine, but instead has chosen a representative sample. Additionally, the quarantined products have not been tested for all possible containments. There are no state or national studies that provide proof that these products do not pose a risk to public health, safety, and welfare.
As of April 24, 2020, approximately 619,362 individual units of vaporizer product were held in virtual quarantine. Continuing to restrict the sale of the quarantined vaping cartridges is a financial burden on licensees and creates a potential risk of diversion. Before making a dispositive decision regarding cannabis vaporizer products subject to quarantine, the Commission invites public comment regarding the question of what, if any, conditions would allow for the retesting and safe sale of vaporizer products that were prohibited for sale or subjected to quarantine between September 25, 2019 and December 12, 2019.
The Commission welcomes responses to the question by or before July 15, 2020. While the Commission will not respond directly to these responses, the comments and/or supporting evidence provided will be considered in determining whether an amendment or rescission of the Quarantine Order would further the public interest. To promote public awareness and transparency, any responses received by the Commission will be made available to the public.
Under what conditions should the Commission allow the sale of vaporizer products that were prohibited for sale or subjected to quarantine between September 25, 2019 and December 12, 2019? Where applicable, please provide a rationale for or evidence of your position. *