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,
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 testing 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
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
