Issue link: http://read.dmtmag.com/i/743340
tobaccoasia 33 PMI believes that RRPs need to meet two conditions in or- der to benefit public health: they must significantly reduce risk of disease compared to cigarettes and they must be acceptable enough to smokers to encourage them to switch to such re- duced-risk alternatives. PMI is currently developing four product platforms – two with tobacco and two without tobacco – which produce aerosol that significantly reduces or eliminates the formation of harmful and potentially harmful constituents (HPHCs) when compared with cigarette smoke, while preserving as much as possible the taste, satisfaction, and ritual characteristics of cigarettes. The four product platforms are electrically heated tobacco product (EHTP) or tobacco heating system (THS), carbon-heated to- bacco product (CHTP), nicotine delivery system, and e-vapor products. PMI is said to have invested more than US$2 billion devel- oping its iQOS device, which was launched in Japan in 2015 and has been extremely successful. Japanese smokers consumed 1.2 billion of the new heat sticks used in iQOS devices in Q2 alone, up from 400 million in Q1. It was also found that 70% of the people who tried iQOS fully or predominantly converted to the system. British American Tobacco (BAT) was the first international tobacco company to launch an e-cigarette, Vype, in the UK in 2013, which was followed by three other products – Vype ePen, Vype eStick, and Vype eTank, as well as a wide range of liquids. In 2014 BAT also became the first tobacco company to receive a medicine license for its nicotine inhalator, Voke, and in 2015 introduced its tobacco heating product. "To develop less risky choices for smokers that give them a true alternative choice to cigarettes will require strong consumer insights, tremendous innovation, and comprehensive science to ensure these next generation products do offer reduced-risk po- tential," said Dr. David O'Reilly, BAT's group scientific and r&d director. "We think it is important to offer a range of products, including tobacco heating products, e-cigarettes, and licensed nicotine products because consumer needs vary." PMI has over 300 world-class scientists from 30 fields of expertise, such as toxicology, systems biology, and medicine, developing and assessing RRPs. Their scientific findings are shared through scientific publications, presentations at scien- tific conferences, and the company's r&d website (PMIScience. com). All PMI clinical studies are registered with ClinicalTrials. gov, and since 2011 PMI has published over 160 book chap- ters and articles in peer-reviewed scientific journals. Likewise, BAT's r&d unit has been conducting research and sharing find- ings since 1956 through similar channels, including its website (Bat-science.com). In its second science and technology report released earlier this year, BAT shared details of the significant strides in the sci- ence of tobacco harm reduction made by BAT's r&d depart- ment over the last year. Research was conducted in a number of areas – from plant biotechnology and aerosol science to toxicity testing and population modelling — to ensure BAT's e-ciga- rettes and tobacco heating products (THPs) are fully character- ized and as safe as possible. The company also shared the results of its studies in product testing and risk assessment. Qualifying as an MRTP Despite tobacco companies' transparent, scientific approach to the development of modified risk products and their willingness to work with policymakers and government offices, it appears that it is not all smooth sailing henceforth. There are currently no products in the market that have been approved as modified risk products by the FDA, though not for lack of trying on the tobacco companies part. Swedish Match, the third-largest producer of tobacco prod- ucts in Europe after British American Tobacco and Imperial Tobacco, according to the 2015 Financial Times Global 500 list, produces snuff, chewing tobacco, cigars, matches, lighters, and is most famous for producing snus. In 2014 Swedish Match submitted an MRTP application to FDA, asking to change the health warnings on its snus packaging to one that said that the product had substantially lower health risks than conventional cigarettes. Two years later and the application seems to still be lost in the vortex of FDA review. 22nd Century Group Inc., a plant biotechnology company that provides technology that allows for the level of nicotine and other nicotinic alkaloids in tobacco plants to be decreased or increased through genetic engineering and plant breeding, develops smoking cessation products and modified risk tobacco products for smokers who are unable or unwilling to quit smok- ing and who may be interested in cigarettes which reduce expo- sure to nicotine or to certain tobacco smoke toxins and/or pose a lower health risk than conventional cigarettes. In January 2016, 22nd Century submitted an MRTP applica- tion to FDA for its Brand A very low nicotine (VLN) cigarettes. Company executives met with FDA administrators and scien- tific reviewers who had been assigned to review the application less than two weeks later. 22nd Century's Brand A cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette. In each case, this represents a reduction of at least 95% less nicotine compared to convention- al cigarettes. The company's MRTP application also requested that Brand A packaging and marketing be allowed to disclose to consumers that the product contains 95% less nicotine than conventional brands and drastically reduces smokers' exposure to nicotine. FDA formally acknowledged receipt of the MRTP applica- tion for Brand A in March this year, assigning submission track- ing numbers (STN) to the application. The company said that even though the STNs were not yet publicly linked on FDA's website, these tracking numbers will remain with the company's MRTP application throughout FDA's review and authorization process. As of September, 22nd Century's MRTP application has still not appeared on FDA's website. A major challenge that tobacco companies trying to develop modified risk products face is the fact that recent regulations make letting consumers know about the benefits of their prod- uct extremely difficult. The EU's revised tobacco product direc- tive (TPD2) bans manufacturers from claiming that their prod- ucts have fewer risks than cigarettes. Across the pond in the US, FDA's deeming rule also prohibits products from claiming to be a modified risk product unless approved by FDA, for which an application and extensive review process must be conducted. It would seem that until FDA figures out how to best move forward with MRTP approvals, and hopefully set a precedence for other countries, the industry is stuck in a Catch-22.