It has been a decade now since the first commercial e-cigarette units went on sale, and there is still no consensus as to whether or not e-cigarettes are safe. Last year the World Health Organisation issued a clear statement: “Until such time as a given ENDS [Electronic Nicotine Delivery System] is deemed safe and effective and of acceptable quality by a competent national regulatory body, consumers should be strongly advised not to use any of these products, including electronic cigarettes.” The WHO’s position – echoed by many other national and global health bodies – is that the “safety of [these devices] has not been scientifically demonstrated”, and that the “potential risks they pose for the health of users remain undetermined.”
Early generations of e-cigarettes were marketed as aids to help people quit smoking, but those claims were subsequently removed from the marketing materials following challenges from health agencies like the WHO, which argued that there was no controlled scientific evidence indicating that electronic cigarettes were “a legitimate therapy for smokers trying to quit”. This left e-cigarettes in a classification limbo somewhere between tobacco products (which are covered by their own legislation) and regulated medicinal products like nicotine replacement therapies (including gum, patches, lozenges and inhalers).
For manufacturers, the distinction was an important one. Tobacco Products Control Acts provide a regulatory framework – like prohibiting the sale of tobacco products to people under 18 – but don’t stipulate performance requirements outside of what is determined to be responsible marketing, distribution and public awareness around tobacco products. Regulated medicines or drugs, on the other hand, come with a completely different set of conditions – ones that are much stricter, requiring clinical trials to prove that they are safe and effective; and involving potential classification as a scheduled substance (meaning it may only be available on prescription, or from authorized outlets like pharmacies).