Electronic cigarettes, or e-cigarettes, have become relatively popular in recent times, due to their benefits for smoking cessation. Despite those benefits, e-cigarettes face opposition around the world, due to their unregulated nature and the debate about whether ‘e-cigarettes help with smoking cessation.’
Confirmation from the MHRA
Recently, e-cigarettes manufacturer Totally Wicked received written confirmation from the Medicines and Healthcare Products Regulatory Agency or (MHRA) that ‘none of their current products are considered a medicinal device,’ meaning that their e-cigarettes products don’t need to have medicines marketing authorization. The ‘medicinal’ angle, in accordance to e-cigarettes, originates from the debate about handling e-cigs as a medicinal product.
E-cigarettes have been growing in popularity over the years, though researchers haven’t yet pinpointed any long term health risks with using the product.
The widespread use of e-cigarettes has essentially sparked ‘conversation’ over its potential regulation in many countries, notably several countries in Europe. Its purported benefits for smoking cessation has also threatened both tobacco companies and those that make smoking cessation products, an element that makes the ‘regulation of e-cigs’ a more complex battle than one would consider.
Though, the current situation in Europe is clear: e-cigarettes aren’t considered medicinal, though there are provisions still in place that could threaten the relatively unregulated status of the smoking cessation tool.
The MHRA, shortly after the aforementioned news broke, that e-cigarettes aren’t medicinal products or medical devices. According to the ‘Human Medicine Regulation 2012 as well as the Medicinal Products Directive 2001/83/EC, no electronic cigarette products can be considered medicinal or medical devices under the Medical Devices Directive 1993.’
Thanks to that confirmation, Totally Wicked and any other retailer of e-cigarette products don’t have to seek marketing authorizations or licenses to sell their products within Europe. That confirmation doesn’t exactly prevent the prospect of e-cigarettes from becoming regulated as a medicinal product from happening in the future.
A ‘potential’ future for e-cigs
If the European Union’s draft Tobacco Products Directive (TPD) from early September 2013 was passed, retailers like Totally Wicked would have had to market their e-cig products as medicinal products and obtain the authorization to do so. This also indicates that any e-cigarette product that’s available now will potentially get banned after 2016 if the EU’s TPD passes into law in the future.
The ‘potential ban’ will potentially apply to any retailer that sells e-cigarette products across the United Kingdom. Interestingly enough, those potential provisions might actually have a ‘catch.’
The MHRA went on record to say that they ‘accepted conventional tobacco cigarettes as a capable candidate for medicinal regulation, though they don’t intend on including nicotine-harboring products within the new proposed regime.’ Conventional tobacco cigarettes, as a result, won’t be subject to the same ‘marketing ban’ as their electronic counterparts.
The insinuation that conventional tobacco cigarettes don’t face a ban has naturally drawn the attention of e-cigarettes retailers. The Chief Executive Officer of Totally Wicked, Fraser Cropper, commented that ‘[Totally Wicked] and their customers have made it clear that their products weren’t and couldn’t be legally or ethically categorized as medicinal products.’
Companies like Totally Wicked do fully endorse electronic cigarettes and their benefits for smoking cessation. The fact that the government and their regulators are considering e-cig regulation over regulation for tobacco, however, is a ‘concerning matter’ for many e-cigarette retailers and their customers.
The question stands: will the MHRA regulate e-cigarettes as medicinal products? As of now, we can not be sure.
The MHRA and similar government institutions around the world still have to struggle with legalities stemming from e-cigarette companies, retailers and opposing companies who are concerned about the e-cigarette industry becoming ‘too competitive.’ The ongoing precedents set by the EU, too, leave the MHRA at a standstill, regarding the regulation of electronic cigarettes today.