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Vaping goes mainstream: implementing regulatory testing in a burgeoning industry.

Manufacturers in the relatively new and, up until now, unregulated electronic cigarette industry have had little need for analytical testing until recently. As vaping has become mainstream, the market for e-cigarettes has come under increased scrutiny. In May 2016, the EU implemented the updated Tobacco Products Directive (TPD), which governs the manufacturing and selling of tobacco products, to include e-cigarettes and e-liquids. In 2016 the U.S. Food and Drug Administration (FDA) also updated the Premarket Tobacco Application (PMTA) to include vaping products. These updated directives and regulations require manufacturers to register and rigorously test their products if they want to continue to market them. As regulations continue to evolve, the industry is looking to advanced instrumentation and analytical testing to comply with new quality standards.

Meeting new emissions requirements

An e-cigarette operates by heating a nicotine-containing solution (e-liquid) to create a vapor which is inhaled by the user. The pyrolysis of the nicotine containing liquids can form harmful by-products, which in certain instances can be present at levels that may pose a risk to the consumer. While it is generally accepted that vaping products offer a less harmful alternative compared to combustible tobacco products, the lack of regulation in this industry has meant that there were limited controls in place to protect the user.

Careful control of input materials during e-liquid manufacturing ensures that only ingredients of the highest purity are used, verifying that consumers get what they paid for as well as safeguarding them from potential health risks. To protect consumers, the new EU guidelines dictate that e-cigarette manufacturers must list all ingredients contained in, and emissions resulting from, the use of their products. along with information on the nicotine doses and uptake when consumed under normal or reasonably foreseeable conditions.

To meet upcoming regulations, including the first new nicotine dose assessment and emissions testing requirements, manufacturers can now choose from a range of techniques for collecting and analyzing nicotine and other potentially undesirable compounds. That's where a company such as Broughton Laboratories comes into the picture.

As a privately-owned good manufacturing practices (GMP) lab, Broughton has been serving the e-cigarette and vaping industry since 2010, using robust testing and sampling methods, along with advanced instrumentation, to collect, extract and analyze nicotine and emissions with a high degree of specification and quality assurance. A history of testing e-cigarettes for current manufacturers has made it possible to anticipate upcoming market testing needs and more reliably respond to potential regulatory changes, with best practice lab and analytical techniques as they occur.

As a whole, to comply with new requirements, e-cigarette testing labs across the industry are producing more emissions data to demonstrate the integrity of products. As new players enter the market, there is a risk that some of this data is being generated with limited technical understanding, potentially generating inaccurate or imprecise data. It is inevitable that over time the industry will recognize the benefits of Quality Standards and apply its own GxP standards for improved quality control In addition, as the consumer market becomes more familiar with the testing data for vaping products, the industry will likely see increased pressure for even more rigorous testily and ongoing quality control

More flavors, more complexity

The regulatory landscape is only one factor changing how e-cigarettes are produced and tested. E-liquids used for vaping are usually made up from solutions containing propylene glycol (PG) and vegetable glycerol (VG), to which nicotine and other flavorings are added. The issue is that PG and VG can break down at high temperatures, generating low molecular weight carbonyl compounds with established toxic properties (e.g., formaldehyde, acetaldehyde and acrolein).

In the last year, we've seen a relatively simple assortment of basic e-cigarette flavors expand into a wide variety of complex flavor concentrates. While the ability to create unlimited offerings for consumers is a marketers dream, it creates new challenges back in the lab. Where an end product was historically made up of seven to eight different chemical ingredients, the number of chemicals in any given product may now have doubled or even tripled. The ability to continuously satisfy and surprise the consumer requires an ever-increasing mix of ingredients in the flavor concentrates.

Due to the increasing range, diversity and complexity of e-liquids in the globalized e-cigarette market, we've had to become more innovative from a chromatography and compound detection standpoint to generate data that meets the rigid requirements of regulatory authorities. To ensure accurate and precise results, a scientifically sound approach must be taken, and the more simplistic testing methodologies utilized in the past may no longer be rigorous enough. With a more complex and vast range of flavored products being offered, the number of unique chemicals that can interfere with quantification has vastly increased.

To remove potential interference from flavor compounds, Broughton has adopted a workflow that features liquid chromatography with triple quad mass spectrometry (LC-MS/MS) as a highly sensitive and selective method to help eliminate interfering peaks in the carbonyls analysis. Using a combination of chromatography and advanced detection systems, the lab now integrates, quantifies, verifies and reports on a total of 16 compound peaks. At first, the team was spending a significant amount of time manually integrating and processing the LC-MS data. That's why the lab decided to implement the analytical workflows offered by an enterprise chromatography data system (CDS).

A new workflow gets results

The goal was to achieve higher specificity in the analysis of the e-cigarette products it was testing, and for this a CDS became a critical necessity in its labs. Broughton selected Thermo Fisher Scientific s Chromeleon 7.2 CDS to support its existing ultraviolet (UV) and MS instrumentation, enabling it to run tests in both modes simultaneously. Having multiple systems controlled by a single software solution simplified workflows and allowed for even higher quality standards for its analysis.

Using a CDS also proved invaluable for helping keep up with the growing demands placed on labs. Under TPD, e-cigarette manufacturers had until November of 2016 to have their products tested to comply with new quality measures. As Broughton's manufacturing partners prepared to meet the deadline in the second half of 2016, its e-cigarette testing workload increased significantly. As a result, the company was handling a huge surge in data.

The lab grew its team to keep up with the physical aspect of the data prep, but from an analysis perspective it had no need to add headcount. Instead, it could rely on efficiencies in the CDS software to handle the increased demand. Over a few short weeks, using the new workflows developed with the help of the lab's chromatography partners at Thermo Fisher, Broughton doubled its data-processing throughput.

Preparing for future regulations

Current legislation regulates e-cigarettes as a consumer product, meaning buyers can purchase without a prescription. However, at least one device in the UK has been approved as a nicotine replacement therapy product (NRT), and other devices are now applying for the classification. To promote the use of e-cigarettes as a NRT, manufacturers will need to provide more detailed documentation to enable doctors to prescribe them for this purpose.

While we don't expect the revenue from e-cigarettes being sold as NRTs will surpass their sales as a consumer good, we do expect the industry to continue to move in this direction. Manufactured with high standards, it may not take much additional effort for a product to cross the line from consumer device to medicinal device. However, for manufacturers looking to market e-cigarettes as medical products, a CDS will be essential for achieving and documenting data integrity to the extent required to meet GMP compliance standards, especially for regulated products used as a medical device.

As a pharmaceutical testing lab, Broughton has been working with the UK MHRA and U.S. FDA in a highly-regulated industry for the past ten years, and is already implementing testing methods that are far more rigorous than current guidelines require. Where other tests provide a "not present" result on anything less than 100 parts per million, Broughtons tests can report anything down to one part per million. Embracing rigorous testing and GMP ensures an extremely high level of quality in the tested e-cigarettes, and consumers can be more confident in what they are buying. As the industry matures, establishing best practices to meet the increasingly stringent standards is expected.

--Leslie Henderson, Operations Director, Broughton Laboratories and Darren Barrington-Light, Software Marketing Specialist, Informatics & Chromatography Software at Thermo Fisher Scientific

Caption: By choosing a CDS that supports full integration of the MS detector, it is easy to combine all data and eliminate manual, multi-step processes for data entry and analysis. Source: Broughton Laboratories

Caption: As vaping has become more mainstream, the market for e-cigarettes has come under increased scrutiny. Source: Stock photo

Caption: Broughton Laboratories selected Thermo Fisher Scientific's Chromeleon 72 CDS to support its existing UVand MS instrumentation and simplify workflows, doubling the lab's data processing throughput over the course of a few weeks. Source: Broughton Laboratories

Caption: As a privately-owned GMP lab serving the e-cigarette and vaping industry, Broughton Laboratories has adopted a workflow that features liquid chromatography with triple quad mass spectrometry (LC-MS/MS) as a highly sensitive and selective method to help eliminate interfering peaks in its analysis. Source: Broughton Laboratories
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Author:Henderson, Leslie
Publication:R & D
Geographic Code:4EUUK
Date:Feb 1, 2017
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