News Search | All News Topics > Tobacco Industry News Topics : By Country | By State ; Press Releases by Industry Channel > All Tobacco Industry Press Releases Philip Morris International (PMI) Announces Filing of Application for Its Electronically Heated Tobacco Product with the US Food and Drug Administration (FDA) LAUSANNE, Switzerland--(BUSINESS WIRE)--Dec. 6, 2016-- Philip Morris International Inc. (“PMI”) (NYSE / Euronext Paris: PM) on Dec. 5 submitted a Modified Risk Tobacco Product (MRTP) application for its electronically heated tobacco product with the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products. This is consistent with the company’s stated goal of submitting its MRTP application in 2016. PMI anticipates the FDA taking a minimum of 60 days to complete an administrative review to determine whether to accept the application for substantive review. Philip Morris International Inc. (PMI) is the world’s leading international tobacco company, with six of the world's top 15 international brands and products sold in more than 180 markets. In addition to the manufacture and sale of cigarettes, including Marlboro, the number one global cigarette brand, and other tobacco products, PMI is engaged in the development and commercialization of Reduced-Risk Products (“RRPs”). RRPs is the term PMI uses to refer to products with the potential to reduce individual risk and population harm in comparison to smoking cigarettes.
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The BBW was not associated with decline in the use of bupropion. Passage of BBW may have a substantial impact on the utilization of certain medications. In 2009, the FDA required a black box warning (BBW) on bupropion and varenicline, the two commonly prescribed smoking cessation agents due to reports of adverse neuropsychiatric events. We investigated if there was a decline in use of bupropion and varenicline after the BBW by comparing the percent using these medications before and after BBW. We conducted a retrospective observational study using data from the Medical Expenditure Panel Survey from 2007 to 2014. The study sample consisted of adult smokers, who were advised by their physicians to quit smoking. We divided the time period into “pre-warning”, “post-warning: immediate”, and “post-warning: late.” Unadjusted analysis using chi-square tests and adjusted analyses using logistic regressions were conducted to evaluate the change in bupropion and varenicline use before and after the BBW. Secondary analyses using piecewise regression were also conducted. On an average, 49.04% of smokers were advised by their physicians to quit smoking. We observed a statistically significant decline in varenicline use from 22.1% in year 2007 to 9.23% in 2014 (p value < 0.001). In the logistic (Adjusted Odds Ratio = 0.36, 95% CI = 0.22–0.58) and piecewise regressions (Odds Ratio = 0.64, 95% CI = 0.41–0.99) smokers who were advised to quit smoking by their physicians were less likely to use varenicline in the immediate post-BBW period as compared to pre-BBW period.
Since there has been evidence of a local source of tendu leaves as well as seizures of smuggled tendu leaves, these are “additional components” that need to be included in the calculation, she said. Some smokers of Capstan cigarettes, the company’s lowest-priced brand, have cut back on the number of sticks they buy after the price increases and also purchase beedis, said K.K. Badra, 58. She runs a kiosk that sells soft drinks, packaged snacks and other food items apart from tobacco products in Maligawatta, a Colombo suburb. Ceylon Tobacco is looking to contain the impact from higher levies. It has shut some of its leaf depots and reduced factory shifts to curb costs. To sustain profitability it’s working on “smart cost management, streamlining processes, identifying consumer segments and addressing their needs,” said Ridley. The company is also widening its portfolio. It started selling its popular Gold Leaf brand in a smaller packet of 12 sticks apart from the 20-stick packet, introduced a new product Gold Leaf Red and is unveiling John Player Navy Cut, which will be sold for 40 rupees a stick. Still, those efforts may not completely offset the impact from the higher levies. Both revenue and net income will grow at a slower pace this year, according to Chayanika Ranasinghe, an analyst at CT CLSA Securities Ltd., in Colombo.