Tight regulation doesn’t necessarily hamper product development, and stricter requirements could even work to companies’ advantage, according to the technical director of British tobacco harm reduction specialist Kind Consumer.
“Having worked in respiratory drug delivery for approaching 20 years, I’d say it has one of the most stringent regulatory requirements of any product area, but it hasn’t stopped development,” says Andrew Walker.
“With a product that people inhale into their lungs, regulation is important to ensure suitable safety standards are met, and some companies are recognising this is also a competitive advantage.”
By contrast, he suggested to ECigIntelligence, “ENDS have got away with almost no regulation.
“It’s surprising how little control has been applied to the market, but this does allow quicker development.”
As long as products can be sold to consumers without licensing, the pharmaceutical route may be less appealing for companies in the nicotine market, Walker acknowledges – even though Kind Consumer itself did obtain UK pharma licensing for its Voke nicotine inhaler product.
“It’s very expensive, takes significant time and requires specialist pharmaceutical and medical device expertise,” says Walker.
“Once on the market the life cycle requirements are significant and introducing line extensions is difficult compared to non-regulated products. We are also dealing with a drug that is freely available without the burden of following such a pathway in most countries.”
Meanwhile, under the current system there is uncertainty among consumers about concepts like “reduced risk” and the “continuum of risk”, he believes.
“The two terms have been deliberately interchanged with ‘regulated’ and ‘medically approved’ to suggest something that they are not. The consumer is totally confused.
“The difficulty seems to originate in defining the degree to which reduced risk products reduce risks of smoking, and as scientists debate the issue, consumers are increasingly attributing risk equivalence.”
But he hopes this might play into Kind Consumer’s hands as it prepares to launch Voke in the UK next year, and later in international markets: “As a medically licensed product, we can be very clear about its safety credentials.”
And, however the ENDS market is regulated, Walker anticipates further innovation.
“I’d expect to see alternative technologies that delivers far smaller doses of nicotine. There is the opportunity to look at other types of inhaled platforms that have been successfully used in other ‘therapeutic’ areas, and we will continue to see the form factor continuing to evolve.
“I think it would be good to see more excipient development too, as a way to improve product performance and improve safety even further.”
Walker will speak next week at the Next Generation Nicotine Delivery event in London, along with ECigIntelligence’s Tim Phillips.
– ECigIntelligence staff