Tobacco Asia

Volume 19, Number 4

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54 tobaccoasia / Issue 4, 2015 (September/October) The Swedish Experience In 2014, Stockholm-based Swedish Match AB submitted 10 applications to the FDA seek- ing MRTP designation. All of the applications concerned snus products that at the time were marketed in the US by Swedish Match North America. They also were the first applications that have ever been considered complete by the FDA and were thus accepted for further review. "Snus is a traditional product that has been used in Scandinavia for 200 years, so there is sub- stantial scientific documentation about the health effects among long-term snus users," explained Dr. Lars E. Rutqvist, senior vice president for sci- entific affairs at Swedish Match AB. "This research shows unequivocally that use of snus is associ- ated with dramatically less health risks compared to smoking" According to him, the widespread use of snus instead of smoking in Sweden has led to substantial, positive effects on public health with record low rates of tobacco-related disease com- pared to global prevalence. This phenomenon is often referred to as the "Swedish Experience" and has been been acknowledged worldwide by tobacco scientists, research institutions and NGOs as proof-of-principle for the validity of the concept of tobacco harm reduction. If the FDA should eventually decide to issue a modified risk order for a Swedish snus product, it would indeed constitute a historic event as it would lend further support to the concept of tobacco harm reduction and help pave the way for future MRTP applica- tions for other, more novel tobacco products. "Undoubtedly, it would also have an impact on decision-makers and regulatory agencies in other parts of the world," said Dr. Rutqvist, be- cause many of them tend to follow FDA prece- dence. "However, if the FDA rejects all or some of the applications submitted by Swedish Match, the company would consider the grounds for the rejection and possibly submit further documenta- tion that the agency may require," Rutqvist said. The ramifications of a negative FDA decision could of course be profound, if not to say devas- tating. It has been murmured in tobacco indus- try circles that if Swedish snus cannot meet the standards set by the US Tobacco Control Act for an MRTP, no other product is ever likely to do so. To assess the validity of such claims, Imperial is currently conducting a series of clinical trials. "[These trials] will add to the scientific knowledge base of how the products work as reduced risk products," said Thompson. He added that "as part of our approach to harm reduction we are seeking to gain a medicinal license for [one of our] e-vapor products," although the company has so far not submitted any MRTP application. BAT, too, is "currently doing extensive research into the characterization of potential risks associated with tobacco heating products and e-cigarettes," accord- ing to Proctor. The former, of course, work by gently heating tobacco only to the point where nicotine evaporates, but without actually combusting the tobacco itself, thus preventing more harmful substances from actually being inhaled with the smoke. The company also has already carried out and published research relating to snus, another possible contender for MRTP certification. Not to be confused with chewing tobacco, snus is basically finely ground tobacco enclosed in a small paper or cloth pouch that is inserted behind the cheek by the consumer and left there to develop its stimulating effects. Since nicotine is water soluble, it is then released as the pouch is being soaked in saliva and absorbed by the oral mucosa, supposedly leaving practically all other harmful compounds behind inside the tobacco. While snus consumption is traditionally a domain of the Nordic countries, this smokeless tobacco alternative is reportedly gradually gaining modest popularity elsewhere, too, perhaps as a defiant response by a certain consumer demographic in the face of ever more stringent restrictions on smoking in public places. Interest- ingly, Swedish Match North America Inc. has already submitted applications for dozens of its snus tobacco products to the FDA and must thus be considered a forerunner in the less than hurried scramble for MRTP certification. The Current State of Affairs Disregarding the admirable efforts by Swedish Match, other tobacco firms are hardly rushing the FDA with their MRTP applications. A race to be the first com- pany to claim a foothold in the MRTP arena is evidently not taking place – at least not yet. "Since 2009, the FDA has received a mere 17 MRTP applications, including the 10 applications [from Swedish Match]…," said the FDA's Michael Felberbaum. He added that of these 17 applications, the agency issued "Refusal to Accept" deci- sions on 2 and "Refusal to File" decisions on 4. One unnamed company withdrew their application by themselves. "The other 10 all submitted by Swedish Match North America, are currently pending review," said Felberbaum. Whether Swedish Match will be successful – and it doesn't look all too promising at this moment – of course solely depends on… The FDA Procedure In conformity with its internal regulations, the FDA's goal is to review and act upon each MRTP application within 360 days of receipt. If the application is ac- cepted, the agency will conduct a filing review to determine whether the applica- tion is complete or not, i.e. whether it contains all the items required under Section 911(d) of the FD&C Act. If the application is incomplete, FDA may refuse to file it. If the application is complete, FDA will file the application and begin substan- tive review. An order authorizing the marketing of a modified risk tobacco product may be issued if the evidence submitted in the application meets certain requirements as detailed in section 911. FDA may not issue an MRTP order unless it finds that the MRTP will or is expected to benefit the population as a whole. In making this determination, FDA will, for instance, take into account, among other aspects, the increased or decreased likelihood that non-users of tobacco, including young people, will start using the product that is the subject of the MRTP application. Easy? By no means. Confusing? You bet. Ambiguous? Undoubtedly. "We may apply to the FDA for MRTP status for some of our new products, if and when it makes commercial and regulatory sense to do so," concluded Proctor. And we can't blame him. Gas chromatography for analyzing vapor contents

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