1. Scope

This Guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of the method of obtention (source) of the cannabinoids used in the product.

This Guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of whether the cannabinoids can be classified as intoxicating.

This Guide shall cover all formulated (manufactured) cannabinoid-containing products intended for vaporization regardless of the regulatory classification of the consumer product.

This Guide shall cover all non-cannabinoid ingredients, regardless of the method of obtention (source), used in formulated (manufactured) cannabinoid-containing products intended for vaporization.
Discussion - Because naturally-derived and synthetic compounds produce comparable biological effects, so long as their chemical structure and spatial orientation are identical, the method of obtention (source) of the compound is irrelevant to the need to conduct a toxicological risk assessment of the non-cannabinoid ingredients.
This Guide includes considerations for thermal breakdown products of the non-cannabinoid ingredient through the process of aerosolization via vaporization device usage.

This Guide excludes formulated (manufactured) cannabinoid-containing products intended for combustion as well as dry herbal materials and inhalers (e.g., dry powder and metered-dose).

This Guide excludes the cannabinoids themselves.

Discussion - Exclusion does not mean risk assessment of cannabinoids is unnecessary or that they are risk-free, only that they are beyond the scope of this standard. Investigation into these areas is encouraged to expand knowledge and safety of cannabinoid-containing products.

This Guide excludes impurities and contaminants within the non-cannabinoid ingredient that are otherwise regulated. It is the responsibility of the user of this standard to know the impurities and contaminants and action limits set by the AHJ.

This Guide excludes interactions between the compounds in the cannabinoid-containing product intended for vaporization. Interaction may include chemical interactions between two or more substances that might form new substances. Interactions may also include biological interactions such as a terpene altering cannabinoid binding to a receptor or other types of pharmacokinetic or pharmacodynamic or toxicokinetic or toxicodynamic interactions.

Discussion - Exclusion does not mean risk assessment of interactions between compounds in the cannabinoid-containing product intended for vaporization are unnecessary or that they are risk-free, only that they are beyond the scope of this standard. Investigation into these areas is encouraged to expand knowledge and safety of cannabinoid-containing products.

Keywords

cannabis; marijuana; hemp; THC; CBD; inhalation; consumer product

Rationale

The following guide for conducting a risk based assessment of potential non-cannabinoid ingredients for use in cannabinoid products intended for vaporization was developed in collaboration with a diverse group of stakeholders representing device manufacturers, terpene blend producers, cannabinoid product manufacturers, consumers, scientists, toxicologists, and others.

The intent of this standard is to, among other things:
Improve consumer health risks based on information available today.
Enable cannabinoid product and terpene blend manufacturers to assess the risk of what they’re producing.
Provide guidance on how to choose a point of departure (POD) that can be used to calculate the acceptable daily inhalation limit, or select a threshold of toxicological concern (TTC) value to use as the acceptable daily inhalation limit, of non-cannabinoid ingredients of interest.
Outline a means for weighing the data collected during a risk-based toxicological assessment to determine its usefulness in choosing between a POD or a TTC.
Provide guidance on how to walk through the logic progression while conducting a risk-based toxicological assessment.
Provide example scenarios to help the user with understanding how to conduct a risk-based assessment.

While most of the input for this standard did come from North America, an effort was made to solicit as much feedback from impacted global marketplaces as possible. This standard is only the beginning and attempts to address a major gap regarding the safety of non-cannabinoid ingredients used in cannabinoid products intended for vaporization.

Please remember that ASTM International standards are living documents and are intended to be updated and revised over time. This initial version will not be perfect, but it will serve to provide marketplaces with the information they need to make informed decisions regarding requirements and regulations for non-cannabinoid ingredients used in cannabinoid products intended for vaporization.


Considerations for the Reviewer:

This standard does not differentiate between naturally extracted (from cannabis or other botanicals) and synthetically made versions of the same compound, because natural and synthetic compounds produce identical biological effects so long as their chemical structure and spatial orientation are identical, and the quality, including impurity profile, is controlled.

No specifications for the non-cannabinoid ingredients used in cannabinoid-containing formulated vaporizer products exist. Without clear specifications for non-cannabinoid ingredient concentrations in cannabinoid products intended for vaporization, the market is opening itself up to potential liability. This specification seeks to provide methods to derive initial limits that are intended (the limits not the procedure) to be modified as more data becomes available.

Recognize limitations of the standard:
This approach may not be appropriate for substances that have a lot of conflicting toxicological data to be assessed by a non-expert toxicologist (e.g., cannabinoids, impurities).
Most of the data available will be oral not inhalation studies. Utilizing oral data for inhalation assessment is not widely accepted, but is the extent of data available today.
There is not a clear method for deriving a point of departure from in vitro data.
Read-across may be applicable for some substances, but that is not in the scope of this standard/guide and is better to be conducted by an expert toxicologist.
Not accounting for exposure from other sources (e.g., dietary, e-cigarettes, and others.).

The title and scope are in draft form and are under development within this ASTM Committee.