On March 4, 2022, the Department of Cannabis Control (DCC) released a comprehensive regulatory proposal entitled “Consolidated Medicinal and Adult-Use Cannabis Regulations” to streamline and simplify cannabis regulations, enhance consumer protections and make permanent changes currently in effect as emergency regulations. Comments on the proposed rulemaking were solicited and closed on April 19, 2022. The DCC held a webinar with information about the rulemaking process and proposed regulatory changes on March 3, 2022 and can be viewed here. The new regulations come eight months after California signed California Assembly Bill 141, which consolidated the former  three  cannabis licensing authorities (Bureau of Cannabis Control, Manufactured Cannabis Safety Branch, and CalCannabis Cultivation Licensing) to form the DCC in an effort to simplify and centralize regulations.

We applaud the DCC for its decision to provide guidance to cannabis business operators and other stakeholders to establish the best practices for the industry and the public that it serves. This will aid in the standardization of procedures to bring legitimacy to an industry plagued by non-meaningful quality and safety claims.

Enthalpy submitted the following public comments and suggestions to the DCC that highlight the need to reevaluate current cannabis testing regulations, valuable compliance lessons from other legal states, and a push to move cannabis science forward by broadening its research grant requirements.

Comment #1

Applicable regulation number: §17303.1. Additional Requirements for Inhaled Products. (a) Cannabis products intended for inhalation shall only contain cannabis; cannabis concentrate; botanically-derived terpenes; rolling paper or leaf; or ingredients permitted by the United States Food and Drug Administration as an “inactive ingredient” for inhalation, as specified in the United States Food and Drug Administration Inactive Ingredients Database, available at https://www.fda.gov/drugs/drugapprovalsanddatabases/inactiveingredients-database-download.

Enthalpy commends the DCC for including more guidance and regulations for the additives in cannabis inhalables. However, the recall of vape products in Pennsylvania last Nov. 2021 exemplifies the implications a vape ingredient ban can have on the industry and its consumers. The recall has caused a financial hardship totaling nearly $18 million for cannabis cultivators, manufacturers, and retailers. The state withheld cannabis from the patients who prefer vaping concentrates because the higher concentration is able to provide greater medicinal benefits without conducting any safety studies on the banned ingredients. Looking at the FDA list on inactive ingredients, the first compound listed is alpha-tocopherol which is a type of Vitamin E. Given the EVALI outbreak of 2019 linked to Vitamin E acetate, it is not prudent to include this as an acceptable additive. There is insufficient research on the composition of the emissions of the vape/inhalable products to justify a blanket ban. Not all terpenes are generally recognized as safe (GRAS), any regulation related to added terpenoids or other compounds in the formulary ought to be compound specific and backed by scientific data. If added terpenes are allowed without data-based evidence that they’re safe, the public health and safety are put at risk. Furthermore, this type of ban may cause product diversion to the black market, increasing the risk of public harm.

We propose that the department follow the example of the state of Pennsylvania in requesting that manufacturers and cultivators release a list of additives used in the cultivation and processing of cannabis. This would allow the industry to begin a proper assessment and identification of what is to be considered harmful or potentially harmful compounds in the emissions produced by those devices. We recommend the Department partner with the FDA to perform risk-assessment studies to identify the composition of the cannabis emissions. For the safety of all consumers, any cannabis or cannabis product intended for inhalation should be required to undergo emissions testing before preparing it to be marketed. Colorado was the first state to require emissions testing for heavy metals but their labs were unable to meet the Jan. 2022 deadline to have the methods ready for production. We understand method development for cannabis emissions is a large undertaking for cannabis labs that are in full production. We propose California allow for other third-party labs with a strong history of emissions testing to conduct this type of testing without the need to complete all other methodologies outlined in chapter 6 of the proposed text of regulations. The aerosols produced by electronic cannabis delivery systems (vape pens, dab rigs, etc) and the smoke produced by pre-rolls have undergone a physical and chemical change from the concentrate and flower in the starting material. Testing the inhaled emissions is the most accurate way to measure exposure risks for the consumer.

Comment #2

Applicable regulation number: 15714. Required Testing. (7) if applicable, terpenoids.

Terpenoids, like beta-caryophyllene and beta-myrcene, have been proven to provide medicinal benefits similar to cannabinoids. The natural abundance of terpenoids in cannabis is variable per plant. Smoking flower, the consumer receives terpenoids as nature intended though there are still insufficient studies on the toxicity of those terpenoids. In high concentrations (>7%) when exposed to heat, terpenoids may degrade into toxic compounds like isoprene. Making this type of testing optional withholds valuable information that prevents consumers from having all information about the product they choose to inhale. It is not uncommon to see concentrates labeled between 70-90% total cannabinoids but there is no information provided about the remaining 10-30% of the products. It is unclear if the remaining “non-cannabinoid” components are terpenoids or something else not being accounted for.

We suggest terpenoids be a mandatory regulatory compliance method for laboratory testing. This will allow the consumer to have a full understanding of the contents in their products. Additionally, any inhalable product should have their emissions tested to account for the ratio of terpenes that are aerosolized intact versus the terpenes that are thermally degraded into potentially harmful products.

Comment #3

Applicable regulation number: 15700. Definitions. (eee) “Representative sample” means a sample that is comprised of several sample increments of cannabis or cannabis products goods that are collected from a batch for testing

We commend the Department for understanding the complexity of cannabis as a matrix and the need to analyze more than one section of the plant or concentrate to get an accurate representation of what the consumers will receive. We believe there is a need to expand and clarify this definition for the testing of pre-rolls and vape cartridges.

We request that the Department take into consideration that the “representative sample” of a pre-roll and vape cartridge is the emissions of those products and not solely the cannabis or cannabis concentrate that is within the pre-roll and cartridge, respectfully. These two inhalable products introduce new variables (temperature, voltage, chemical reactions, etc) that are not accounted for in the current testing regulations. Consumers rely on the COA produced by a cannabis safety lab to represent the products they will inhale. However, the chemical and physical transformations that occur when vaping or smoking alters the composition of the product originally tested, making the COA insufficient and non-representative. The situation is analogous to describing the tobacco filler in a cigarette without addressing smoke composition. The FDA has required cigarette manufacturers to test the emissions of all products they produce. We recommend the DCC take a more deliberate and considered approach, collaborating with the FDA, to look at cannabis as a natural drug product with a lot of unknowns and develop FDA-style regulatory approach to test flower, concentrates, and inhalable emissions

Comment #4

Applicable regulation number: Chapter 13. Article 1. Research Funding. 17900. Eligibility. (a) Only public universities in California shall be eligible to be selected to receive funds disbursed pursuant to Revenue and Taxation Code section 34019(b).

We commend the Department’s dedication to funding cannabis research and value the unbiased nature that universities are able to provide. However, the cannabis industry is growing exponentially and limiting research to universities stunts the growth and understanding of cannabis science and disallows science to keep up with new and emerging products and technologies dedicated to cannabis consumption. Legalizing consumption without the proper research about the product, its ingredients, and delivery methods available creates a massive social experiment foisted on the public without much thought from the DCC. We strongly believe the cannabis industry, both recreational and medicinal markets, needs guidance from the Department to create safe cannabis, cannabis products, and cannabis delivery systems.

We suggest the eligibility for research funding be extended to neutral unbiased third-party testing labs to perform a blind study on the common and uncommon inhalable products that are in the California market to begin identifying the safety of these electronic devices. Enthalpy labs have standard aerosol collection machines and validated test methods in place to produce high quality results suitable for consumer safety communication and regulatory decision making. The timing of this research is critical to prevent another EVALI-like crisis as the vape markets continues to grow exponentially each year.

 

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