In late October, a Mexican health regulatory agency announced that its scientists have developed a new method for analyzing the aerosol in electronic cigarettes (Electronic Nicotine Delivery Systems, ENDS). Alejandro Svarch, head of Cofepris, stated that the final results of using this new method to analyze ENDS products will be published in scientific journals in the coming months. Svarch added that Mexico's "cutting-edge method" will pique the interest of other health departments in other countries.
This situation is perplexing because researchers have been able to evaluate the aerosols in ENDS products for some time. Additionally, Mexico banned the sale of ENDS products in June. This has left many in the vaping industry wondering how the country can defend its ban on ENDS when it now claims it lacks the ability to test product safety.
Every country that regulates electronic cigarette products requires testing for various elements, such as harmful and potentially harmful constituents (HPHC) and heavy metals. According to Kim Hesse, Vice President of Sales and Marketing for the regulatory science consulting firm McKinney, researchers have been using aerosol testing methods for years to evaluate air quality, combustible cigarette smoke, and aerosols in inhalable medical products. ENDS aerosol testing has been around for nearly 15 years.
According to Hesse, it is important to test ENDS products to ensure that the public is not inhaling potential harmful compounds, such as heavy metals or diacetyl. By testing these products, the industry can ensure consistency and provide regulatory agencies, such as the US Food and Drug Administration and other government entities, with the data needed to evaluate ENDS products.
Hesse responded to questions regarding ENDS testing in the tobacco publication Vapor Voice. Below is a transcript of the interview.
Vapor Voice: What type of experience do you have in testing tobacco and ENDS products?
Hesse stated that they have published several scientific articles demonstrating their knowledge, skills, and experience in testing tobacco and ENDS products. For example, they recently published an article highlighting the importance of traditional toxicology indicators in generating and characterizing ENDS aerosols.
Vapor Voice: What are the differences between testing the vapor from electronic cigarettes and testing combustible tobacco cigarettes?
Hesse says that it depends on the situation. Testing combustible cigarette smoke that contains both particles and gas is more challenging than simply testing ENDS aerosols.
However, when considering product variability, ENDS products present many challenges that cigarettes do not. ENDS products come in a variety of shapes and sizes, some with round mouthpieces and others with square ones. This alone presents a challenge in connecting the device to smoking equipment, as the adapter is typically round. Some devices also have buttons, with all of these buttons located in different places. Some e-cigarettes have a push-button mechanism that does not match with various button shapes and locations. In contrast, cigarettes are uniform in size, and 20 cigarettes can easily be ignited with a standardized lighter built into smoking machines.
After conducting tests, it was found that combustible cigarettes were tested alongside a fixed amount of cream puffs, while electronic cigarettes were only tested with a set number of cream puffs. Once all aerosol or smoke was collected, the remaining testing was carried out in essentially the same manner for both aerosol and smoke. While electronic cigarettes and combustible cigarettes were both tested using the same equipment, there were slight differences in methodology (such as the number of cream puffs used and the spacing between the cream puffs and volume).
Vapor Voice: How do companies determine which standards to use and ensure there are no discrepancies in testing? Translation: Vapor Voice inquires about the process companies employ to determine which standards of testing to utilize and how they ensure there are no inconsistencies.
Hesse stated that both combustible cigarettes and ENDS products have standardized Coresta environmental (ISO) testing procedures. The electronic cigarette method used by Health Canada was determined by the manufacturer's scientists and established based on the limitations of the equipment (some devices have puff duration limits).
Due to the marked reduction in ingredients in electronic cigarettes, the analytical methods between combustible cigarettes and electronic cigarette products may also differ slightly. In the analysis of electronic cigarettes, the calibration curve is usually much lower. Other variations relate to the angle of testing for electronic cigarette devices. The testing angle of the device is based on models such as tanks and wicks.
Vapor Voice: Are there many challenges in testing electronic cigarettes? How can these difficulties be overcome?
Hesse emphasized the need to share data with the FDA, even if it is not favorable. Some companies only test their products and send reports to the FDA without ensuring if the data supports their products, in order to protect public health.
There is always room for improvement. We found that most laboratories are working hard to improve their methods. As previously stated, the variety of sizes and shapes of ENDS devices pose a challenge. The lack of standardized testing methods for all HPHC and variability among labs present opportunities for improvement.
Vapor Voice: What is the accuracy of the testing methods and results?
Hesse stated that current analysis methods are capable of detecting chemicals at extremely low levels. However, the levels at which chemicals are typically detected do not pose a risk to human health. Some public health officials may report on chemical levels detected, rather than reporting on levels of harmful chemicals, which can result in public panic and have a negative impact on efforts to reduce harm.
Coresta has a highly effective working group focused on testing and analyzing ENDS. We should prioritize encouraging more companies and laboratories to actively participate in research aimed at simplifying and reducing variability in current methods.
A standardized field should involve creating a reference ENDS device that can be used with any remaining e-liquids - similar to the reference cigarette (1R6F) used to compare combustible cigarette data generated in different laboratories.
Vapor Voice: Based on your test results, would you say that e-cigarettes pose a lower risk compared to combustible smoking?
Hesse stated that this is not about him personally. He reported that Brian King, director of the Center for Tobacco Products at the US Food and Drug Administration (FDA), recently stated in the media that he understands the risks of e-cigarettes to be “significantly reduced” compared to combustible tobacco products. King acknowledged that the risks associated with tobacco products are a continuum and that e-cigarettes fit within that continuum. During the recent GTNF 2022 conference Hesse attended, King also mentioned that certain e-cigarette products have lower risks than combustible tobacco and that this is an important part of FDA dialogue. The FDA recognizes that e-cigarettes have lesser harm than combustible tobacco, which is significant.
Vapor Voice: Do you have any advice for companies looking to test their products?
Hesse advised that sending samples to a laboratory without understanding the testing requirements or how to interpret the data is a waste of money. It is important to work with a group of trustworthy scientists who can guide the process of generating scientific data.
Here are some suggestions: Ensure that the laboratory you choose is ISO 17025 accredited. It is recommended to use an FDA-recognized laboratory. This will improve the data review process and may prevent data submission rejection due to insufficient laboratory integrity. When selecting a laboratory, make sure they have submitted a Tobacco Product Master File (TPMF) to the FDA and have validated their methods, with the validation report included in their TPMF.
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