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ASTM D37 Passes Standards for Cannabis Vape Ingredient Safety Based on Framework by True Terpenes Head of Research
News provided by
True Terpenes
Nov 13, 2024, 08:00 ET
Guide and Procedure Published to Promote Science-Based Standards and Help Protect Consumer Health
HILLSBORO, Ore., Nov. 13, 2024 /PRNewswire-PRWeb/ — True Terpenes, the cannabis industry leader in terpene flavor, safety, and innovation, announced today the passage of two ASTM International Global Standards for ingredient safety for inhalable cannabis products. The Standards are adopted from research published by True Terpenes Head of Research & Toxicology Shawna Vreeke, Ph.D., in collaboration with Echoleah Ruffer, Ph.D., DABT, and were reviewed and voted on by a diverse group of industry stakeholders including terpene blend manufacturers, producers of cannabinoid vape products, toxicologists and regulators.
The new ASTM Global Standards are:
(1) ASTM D8587-24 Standard Guide for Determining a Point of Departure (POD) or Assigning a Threshold of Toxicological Concern (TTC), if needed, for Use in a Toxicological Risk Assessment of a Non-Cannabinoid Ingredient Intended for Vaporization
(2) ASTM D8588-24 Standard Practice for an Approach to Calculating the Daily Inhalation Exposure Limit for a Non-cannabinoid Ingredient Intended for Use in Cannabinoid Products for Vaporization
The first Standard is a guide to finding scientific data on a particular ingredient, choosing the most relevant data, and assessing the data in order to draw a scientific conclusion that will be the basis of the risk assessment calculation. It also includes guidance in situations where data is lacking.
The second Standard is a procedure for calculating an acceptable inhalation limit of an ingredient for a new product or for comparing it to current formulations.
Combined, these Standards provide the first standardized methodology for performing a toxicological risk assessment for non-cannabinoid ingredients intended for use in cannabinoid vape formulations based on scientific research.
These standards protect consumer health and provide a science-backed resource for regulators to easily reference when creating regulations. For manufacturers, the standards answer fundamental questions such as: Which ingredients can I use and at what concentration levels?
Vaporization is an increasingly popular method of cannabis consumption, making vape pens one of the fastest-growing segments in the industry. However, there is little science-based or regulatory guidance for consumers, manufacturers, or regulators to evaluate the safety of additives in cannabis extracts, notably in cannabinoid formulations intended for vaporization.
This knowledge gap is further complicated by the federal status of the scheduling of cannabis and divergence across state regulations, which could, in some cases, lead to regulations based on arbitrary guidelines, which may not necessarily reduce consumer health risk.
With 38 states and the District of Columbia currently allowing some form of consumption, whether for adult use or medical purposes, these Standards close the gap by providing a solution to a fundamental challenge to consumer safety and to the long-term health of the industry.
“Our mission at True Terpenes has always been to create not just high-quality but exceptionally safe products, and that means sharing the tools to make consumer safety universal across the industry,” said Chris Campagna, Founder and Chief Innovation Officer at True Terpenes. “Cannabis brands shouldn’t have to choose between innovation and consumer trust. With these ASTM standards, we’re setting a foundation to protect both, allowing brands to grow responsibly while consumers can feel safe with each product they choose.”
“My goal is always to protect the end consumer and to take the burden of determining product safety off the consumer’s shoulders,” said Dr. Shawna Vreeke, whose contribution to cannabis industry safety is the result of four years of research and counting. “Regardless of their purpose for use, cannabis consumers have the right to trust the products they use.”
Dr. Vreeke’s work, first published in the peer-reviewed paper A First-Tier Framework for Assessing Toxicological Risk from Vaporized Cannabis Concentrates, is ongoing today as part of the True Terpenes Continuous Materials Review, which informs the formulation of every True Terpenes product, based on the latest safety data as it becomes available.
“Prohibition doesn’t work. Commonsense regulation does,” said Darwin Millard, Technical Director of Cannabis Safety and Quality and current Subcommittee Chair of ASTM Intl. D37.08 on Personal-/Household-use Cannabis Devices and Appliances, who worked to help shepherd the standards through the process. Millard noted that these standards are among the most impactful to have come out of the D37 in its six years of existence. “Without safety data for inhalation, regulators have been left with very few options other than ingredient restrictions and bans. This is where the amazing work done by the volunteer members of ASTM International D37 comes in. Rather than banning non-cannabinoid ingredients, these standards provide a means of determining limits when used in cannabinoid products intended for vaporization and will help to generate needed safety data.”
True Terpenes is the cannabis industry’s foremost partner for terpenes and active ingredient solutions. Through groundbreaking safety research, innovative applications solutions, and a fundamental commitment to quality, True Terpenes empowers global brands to thrive amidst the ever-changing challenges of the emerging cannabis industry.
Media Contact
Cate Crabtree, True Terpenes, 1 917-723-4703, cate@trueterpenes.com, https://trueterpenes.com/
SOURCE True Terpenes; True Terpenes
