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FDA approves IQOS to enter the US market for sale, heated tobacco products in a new competitive situation

FDA approves IQOS to enter the US market for sale, heated tobacco products in a new competitive situation


Keywords: FDA, IQOS, heat not burn, Philip Morris Products S.A., Heatsticks, Marlboro


The U.S. food and drug administration(FDA) announced on April 30, 2019, that it has licensed a new tobacco product from Philip Morris Products S.A., the world's largest tobacco manufacturer, for usage in the IQOS "tobacco heating system." This is an electronic device used to heat a paper-wrapped tobacco filler to produce a nicotine-containing tobacco aerosol. FDA has imposed strict marketing restrictions on products to prevent teen exposure. 


The licensed products include IQOS devices, Marlboro heating stick, Marlboro silky mint heating stick and Marlboro fresh mint heating stick.



After a rigorous scientific review of the company through the pre-marketing tobacco application (PMTA) pathway, FDA said those products could protect public health because they have fewer toxins which contain lower levels than combustible cigarettes. In addition, FDA is still reviewing the company's low-risk tobacco products application (MRTP). 


It is foreseeable that the arrival of IQOS in the United States will have a significant impact on the American e-cigarette market. The move comes after FDA approved the arrival in the US of a heat-not-burn product from British American Tobacco, the world's second-largest Tobacco group and which is rival of Philip Morris.


Allowing the tobacco products to be sold in the United States does not mean they are safe. Ensuring that new tobacco products pass pre-marketing assessments protects the public, especially adolescents, and reduces illness and even death from tobacco use, said Mitch Zeller, director of FDA's center for tobacco products. Just because new tobacco products are licensed does not mean they are safe. However, our review process ensures that products are marketed in a way that protects public health. We also seek to take into account the risks and benefits for all, including the effect of the product on the use of nicotine and tobacco by adolescents and the possibility that smoking adults who use the product may stop smoking combustible cigarettes." 


Mickey zeller added:  FDA is developing after-market requirements that include monitoring market dynamics, such as the impact on young people. we will closely monitor the market, including tobacco companies, to meet relevant marketing restrictions to prevent youth exposure." "


According to the pre-market tobacco application pathway, tobacco manufacturers must demonstrate to FDA that new tobacco products are marketed in a way that protects public health. FDA also considers the risks and benefits for all people, including both users and non-users of tobacco products, especially young people. FDA reviews the ingredients, additives and health risks of tobacco products, as well as the manufacturing, packaging and labelling of products, and so on.




FDA's review of IQOS products took into account whether current smokers were more or less likely to quit and nonsmokers to start smoking. In particular, FDA found that the IQOS tobacco heating system produced aerosols that contained fewer toxic chemicals than cigarette smoke and contained lower levels of many toxins than cigarette smoke, based on a scientific review of the company's application, relevant publications and other sources.


IQOS can provide nicotine levels close to those of combustible cigarettes, indicating that IQOS users can stop smoking and switch to IQOS. In addition, although the data is small, it also shows that very few nonsmokers, including teenagers, start using IQOS.


Although these unburned cigarettes may be described as "unburned" or "heated" tobacco products, they meet the definition of cigarettes in <the Federal Food, Drug and Cosmetic Act>. As a result, these products must comply with existing FDA restrictions on cigarettes and other federal laws that prohibit television and radio advertising.


Philip Morris already sells IQOS in more than 40 countries, usually in fashion stores. The product was once popular in Japan, but a recent drop in demand has forced the company and rivals to cut prices and ramp up marketing. Altria plans to launch the product in Atlanta this summer, including opening its first IQOS store and several mobile retail stores. The company will also distribute the special cigarettes used with the cigarettes at about 500 retail stores in Atlanta, including Circle K, QuikTrip and Speedway. A spokesman said the product will soon be available in other markets.

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