Electronic cigarettes require a regulatory framework to protect consumers and businesses. Health Canada is requesting regulation as medicines and drug devices. The FDA is proposing regulation as tobacco. Electronic cigarettes are neither.
ECTA, members of the industry, scientific and medical researchers, and consumer interest groups, worldwide, are calling for regulations in line with similar consumer products.
Electronic Cigarettes are not medicines, as they do not treat anything and have no therapeutic value. In Canada, they are clearly exempt from the “Prescription Drug List” of the Food and Drug act, which exempts nicotine delivered by inhalation device in 4mg or less per dosage (usage) unit. Electronic cigarettes deliver between 0 and 0.24 mg of Nicotine per puff and users “self-titrate” nicotine in the same manner as with cigarettes (based on depth and length of puff).
Health Canada’s request to obtain Market Authorization as a “new medicine” is simply not possible, as medical authorization requires that the product have “efficacy” in treatment and a measurable “dose” that can be prescribed. Electronic cigarettes are used at the discretion of a consumer and marketed as a reduced harm substitute for tobacco, not as a therapy or treatment.
As is true with any consumer or recreational-use product – from milk to cell phones – it is certainly possible for both medical and scientific fields to observe how the product is used and its effects on consumers. Numerous such tests and observations have been carried out by recognized medical and scientific researchers world-wide, with the overwhelming majority agreeing that electronic cigarettes are a positive “harm reduction” product that should be embraced as a way to reduce tobacco use – but not a medical product.
Electronic Cigarettes are not a tobacco product. They do not contain, nor utilize tobacco and those who use the product do so in order to avoid tobacco and its harmful effects.
Nicotine used in eliquid (the consumable portion) does not transform the product into a tobacco. It is a chemical derivative of organic matter with multiple uses across several industries. The tobacco plant is the most widely utilized for the extraction process. Other plants with organic nicotine are common food sources (vegetables) – thus precious commodities.
The electronic cigarette industry has no control over the organic matter used in creating nicotine as a chemical extract, nor is it engaged in the process. We use the same ingredient from the same source as all other industries – whose products are not classified “tobacco”.
Tobacco regulations in Canada are based on the World Health Organization’s “Framework Convention on Tobacco Control” (FCTC) with the intention of reducing and removing tobacco products and their use entirely. Electronic cigarettes simply do not belong in this category – and meet no criteria exclusive to the Tobacco Act.
3. Common Consumer Products
Manufacturing of all parts of an electronic cigarette and eliquid are already guided by standards applied to common consumer products. Hardware components are electronic devices. Eliquid is created from already approved additives widely used in food and every-day consumables.
A Regulatory framework for eliquid, by national policy makers, with standards we can all attain, understand and follow is beneficial to manufacturers, retailers and consumers.
ECTA has developed (and continues to develop) standards guiding manufacturing and retail sales based on existing regulations for similar products. Our organization looks forward to the day we can sit with policy makers and discuss this in greater detail.