Panel: Regulation: International Perspectives

Regulation of nicotine products is at a tipping point, said David Bertram, director at EUK Consulting, who moderated the panel. Generational bans and mandatory nicotine reduction for combustible cigarettes have been introduced, whereas taxation of flavors and the move against disposable vapes have the potential to threaten the whole next-generation products (NGPs) category. Panelists provided overviews of the regulatory situation in their respective countries.

Dave Dobbins, former chief operating officer of the American Legacy Foundation/Truth Initiative, criticized the U.S. Food and Drug Administration’s authorization process for novel products as lacking order. He called for the agency to “clear the field.” “The FDA has two choices: either a market serviced by unregulated actors that don’t have to report to the agency and don’t follow its rules, mandates and instructions or a robust market of approved products that fulfill the demand for adult consumers, and then the FDA can focus its enforcement on actors targeting youth.” The agency, he added, could use its power of post-market surveillance and regulation. Dobbins was concerned that the FDA was paralyzed by fear, making it unable to analyze the benefits of reduced-risk products (RRPs) for adult smokers.

Adam Afriyie, member of Parliament for Windsor, U.K., said his country was in the pole position in tobacco harm reduction (THR) because of five factors: operating according to the principles of THR and encouraging the good instead of the perfect; treating RRPs as consumer products not medicine; encouraging public bodies to spread the word; trying to de-politicize the issue; and applying pragmatism as a response to changes. Pointing out that the U.K. government was currently consulting on disposable vapes and underage vaping on the base of evidence, he argued that it would only ban the products if this made sense from a point of view of harm reduction to the environment, children and healthcare. Regarding the upcoming tenth Conference of the Parties (COP10) to the Framework Convention on Tobacco Control, Afriyie said he was encouraging his contacts to help the U.K. delegation feel sufficiently emboldened to stress that THR needs to be the principle behind regulation and that a greater degree of transparency is required in how decisions at the COP are made.

In its traditionally heavy regulation of nicotine products, Australia has always been driven by health considerations, according to Kezia Purick, member of the Northern Territory Legislative Assembly for Goyder, Australia. Tobacco-related diseases are the single biggest cause of death from behavioral risks in the country, with the disadvantaged indigenous population being affected most. Australia banned all tobacco advertising in 1976 and was the first country to introduce plain packaging in 2012. Nicotine vape products are available only from pharmacies with a doctor’s prescription. Health Minister Butler’s approach to ban all disposable vapes is primarily driven by concerns about the rising popularity of vaping among young school children. Purick expects regulation of RRPs to become ever stricter in the future.

Marina Foltea, managing director at Trade Pacts Consultancy, outlined the complex policy-making process in the European Union. Directives, such as the Tobacco Products Directive (TPD), are binding for all 27 member states and have to be transposed into national law to take effect. The revision of the present TPD2, which already has strict requirements for combustible cigarettes and sets clear product standards for vape products, is currently being discussed. The regulation of tobacco products in the EU is regarded as a model by many countries. However, Foltea said, she didn’t see any explicit recognition of THR in the EU system. “But if you already have this category in the TPD, this means some indirect recognition,” she noted.

Douglas Ming Deng, head of the NGPs Industry Study at Yunnan University, reminded his listeners of Asian diversity and the resulting differences in regulation of NGPs across countries. South Korea and Japan, he emphasized, have set up good tobacco control systems together with the provision of suitable RRPs, thus becoming blueprints for other countries to follow. He noted that the industry had changed more rapidly in the past 20 years than it had in the century before, meaning the sector was no longer static but dynamic. “As a consequence, regulators, consumers and the industry don’t know each other as they did in the combustible era,” Deng said. “Regulators should study the industry and vice versa.”