The Food and Drug Administration has approved Philip Morris International to sell its iQOS heated tobacco product.
Philip Morris had filed two separate petitions with the regulator, one who merely sold the appliance, the tobacco instead of the burn, and another to make it less harmful than cigarettes. The Agency has not yet taken a decision on the latter request.
"Although the authorization of new tobacco products does not mean they are safe, the review process ensures that the marketing of the products is suitable for the protection of public health, taking into account the risks and benefits for the population as a whole "Director of the FDA for Tobacco Products," Mitch Zeller said in a statement.
PMI is now authorized to sell the iQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks. therefore, Altria, headquartered in Richmond, Virginia, will distribute the products in the US
Even without stating the risk with reduced risk, the FDA's decision is a benefit for Philip Morris and Altria, and iQOS is an important part of their future Enterprises as they try to pass cigarettes and smoking quotas in the US continue to reach record highs and led to a diversification of tobacco giants looking for growth.
PMI shares rose 1
The iQOS tobacco heating system contains three parts: a holder, a tobacco stick and a charger. The pen-like device contains a ceramic and gold plate that heats Philip Morris brand tobacco rods up to 350 degrees Celsius. Tobacco in cigarettes burns at temperatures in excess of 600 degrees Celsius.
In examining the application for PMI, the FDA found that aerosol iQOS products contain less toxic chemicals than cigarette smoke and that many of the toxins found are present in lesser amounts in cigarette smoke. "The agency also found that iQOS delivered nicotine similar to conventional cigarettes," suggesting that IQOS users may be able to switch completely from flammable cigarettes "and only use iQOS.
The data also suggests that Nonsmokers and children do not feel attracted to iQOS, the FDA said, but the agency still sets "strict restrictions" on the marketing of iQOS, especially online and on social media. Inform marketing agendas and restrictions on adolescent access, advertising and promotions.
"We fully support this goal," said PMI chief Andre Calantzopoulos in a statement, "The FDA has set a high standard and we are pleased to work with them to implement the order so that iQOS reaches the right audience – a Contemporary adult smokers. "
Altria will soon start selling iQOS in Atlanta The company did not specify when. Altria plans to open an iQOS store and numerous mobile stores. Heatsticks, Marlboro tobacco sticks used with the iQOS device, will be available in approximately 500 retail outlets, including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway, and other retailers, Altria said.
"PM USA will respond to market intelligence and expect to scale IQOS quickly and efficiently," Altria chief Howard Willard said in a statement.
Last year, reduced-risk products generated $ 4.1 billion in sales or approximately 14 percent of PMI's total revenue of $ 29.63 billion. The company wants to increase these statistics by 2025 to 38 to 42 percent.
Since launching iQOS in Nagoya (Japan) and Milan in 2014, Philip Morris has launched it in over 40 markets worldwide. In some places growth has increased. In the US, iQOS will enter a market where e-cigarette growth is rising strongly thanks to a large proportion of Juul. Altria invested 12.8 billion US dollars in a 35 percent stake in Juul in December.
The Centers for Disease Control and Prevention estimate that 34.3 million adults currently smoke cigarettes in the United States. Philip Morris says iQOS will appeal to adult smokers as this is a more obvious experience than traditional cigarettes and has a less harmful effect.
Anti-tobacco groups do not agree. They claim that Heat-Not-Burn products are just Big Tobacco's latest twist on keeping people loyal to their products.
Former FDA Commissioner Scott Gottlieb accepted the idea that nicotine alternatives can serve as an option for people who want to continue smoking. Under him, the FDA has believed that nicotine products exist on a continuum of risk where traditional cigarettes are fatal and others may not be as harmful.
Read the full FDA statement below:
The US Food and Drug Administration today granted approval for the commercialization of new tobacco products from Philip Morris Products SA for the IQOS "Tobacco Heating System" known – an electronic device that heats paper-filled tobacco rods to produce a nicotine-containing aerosol. The FDA has imposed strict marketing restrictions on the products to prevent access and exposure of adolescents.
Following a rigorous, scientifically-based review by the PMTA route (Pre Market Tobacco Product Application), the agency decided that these products are approved for the EU The US market is suitable for the protection of public health as the products in addition to some important considerations, produce less or less toxins than flammable cigarettes.
Products for sale include the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks.
While today's measures allow the sale of tobacco products in the US, this does not mean that these products are safe or "FDA-approved."
All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should not do so. In addition, today's measure is not a decision on the separate applications for Modified Risk Products for Tobacco Products (MRTP), which the company has also submitted for these products in order to market them with claims for reduced risk or reduced risk.
"Ensuring that new tobacco products undergo a solid market preview from the FDA is a vital part of our mission to protect the public, particularly youth, and reduce tobacco-related illnesses and deaths www.socialistgroup.eu/gpes/sessiond…05&place=STR The review will ensure that the marketing of the products takes into account the risks and benefits of the population. Englisch: www.socialistgroup.eu/gpes/newsdeta…ome&site=msc Overall, it is suitable for the protection of public health, including the effects of nicotine on youth tobacco and the potential of products to completely eliminate adult smokers from using flammable cigarettes, "said Mitch Zeller, JD, director of the FDA Center for Tobacco Products ,
"It is important that the FDA establishes postmarket requirements that, among other things, aim to monitor market dynamics, such as the adolescent intake.
We will closely monitor the market, including the marketing of these products appropriate to ensure that the sale of these products continues to be guaranteed in the United States and to ensure that the company complies with the Agency's marketing restrictions in order to prevent adolescents from accessing and threatening them as other manufacturers wish to market new tobacco products Continue to uphold the vital public health standards and use all available tools to ensure efficient and adequate monitoring of tobacco products. "
Under the PMTA route, manufacturers must, among others, contact the Authoritydemonstrating The marketing of the new tobacco product would be appropriate for health protection. Under this standard, the FDA must consider the risks and benefits to the whole population, including users and non-users of tobacco products. Also important is the youth. The evaluation of the Agency involves the review of the ingredients, ingredients, additives and health risks of a tobacco product as well as the manner in which the product is manufactured, packaged and labeled. The review of IQOS products has taken into account the increased or decreased likelihood that tobacco users will refrain from using tobacco products and the likelihood that those who do not use tobacco products will begin to use them.
Through the FDA's scientific appraisal of the company's applications, peer-reviewed published literature and other sources, the agency found that the aerosol generated by IQOS Tobacco Heating System contains less toxic chemicals than cigarette smoke and many of the identified toxins levels are lower than in cigarette smoke. For example, carbon monoxide exposure of IQOS aerosol is comparable to environmental exposure, and the levels of acrolein and formaldehyde are 89-95% and 66-91% lower, respectively, than for combustible cigarettes.
In addition, IQOS delivers nicotine near flammable cigarettes, suggesting that IQOS users may be able to switch completely from flammable cigarettes and use only IQOS. The limited data available also indicate that only a few non-tobacco users would likely start with IQOS, including young people.
While these unburned cigarettes can be described as "heat-not-burning" or "heat". Heated tobacco products fulfill the definition of a cigarette in the Federal Foodstuffs, Pharmaceuticals and Cosmetics Act. Therefore, these products must comply with existing restrictions on cigarettes under FDA regulations and other federal laws prohibiting, inter alia, television and radio advertising. In addition, to further restrict adolescent access to the products and their advertising and advertising efforts, the FDA is placing stringent restrictions on the marketing of its products, including through websites and social media platforms, by including requirements that include: Target advertising to adults. The company must also notify the FDA, among other things, of labeling, advertising, marketing plans, including information on specific adult audiences, as well as information on how to restrict access for adolescents and how adolescents are affected by product labeling and advertising; Marketing and advertisement. The Agency has issued a document that substantiates these postmarket requirements and highlights important considerations for examining the Company's proposals and possible future PMTAs for other products.
The FDA also requires all package labels and advertisements for these products to include a warning about the addictive nature of nicotine, in addition to other cigarettes warnings, to help consumers avoid misunderstandings about the relative dependency risk of using IQOS compared to burned cigarettes ,
With the approval of these products, the FDA evaluates new products available product data by post-marketing records and post-marketing reports. The Company must periodically provide the FDA with information about the products on the market, including, but not limited to, ongoing and completed consumer studies, advertising, marketing plans, sales data, current and new user information, manufacturing changes, and adverse experiences. The FDA may withdraw a marketing decision if it determines, among other things, that the further marketing of a product is no longer suitable for the protection of public health, eg. For example, if the product is taken up by adolescents.
The FDA continues its in-depth scientific review of the company's MRTP applications. The company would need to obtain an MRTP order from the FDA before it could market a tobacco product, with implicit or explicit assertions that a product, inter alia, reduces exposure to certain chemicals or that the use of the product is less harmful than another tobacco product or product would reduce the risk of illness. If a company markets a non-prescription tobacco product as MRTP, the company violates the law and may face FDA advisory or enforcement action.