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The U.S. Food and Drug Administration announced today that it has authorized Philip Morris Products SA to market a new tobacco product produced by the IQOS "Tobacco Heating System", an electronic device that can heat paper-wrapped tobacco filler rods to produce Nicotine cartridges. aerosol. The FDA imposes strict marketing restrictions on these products to prevent contact and exposure by young people.

After a rigorous scientific review through the Pre-Market Tobacco Product Application (PMTA) route, the agency determined that the authorization of these products for the U.S. market is to protect public health, because among several key considerations, these products are produced less or some The content of these toxins is lower than that of combustible cigarettes. Products authorized for sale include IQOS devices, Marlboro hot rods, Marlboro smooth mint hot rods and Marlboro fresh mint hot rods. Although today's action allows tobacco products to be sold in the United States, it does not mean that these products are safe or "approved by the FDA." All tobacco products are potentially harmful and addictive, and those who do not use tobacco products should continue not to use them. In addition, today’s action is not to make a decision on the separate modified risk tobacco product (MRTP) applications that the company also submits for these products, which are marketed in terms of exposure reduction or risk reduction claims.

“Ensuring that new tobacco products undergo a strong pre-market evaluation by the FDA is a key part of our mission to protect the public, especially youth, and reduce tobacco-related diseases and deaths. Although the authorization of new tobacco products does not mean that they are safe Yes, but the review process ensures that the marketing of the product is suitable for protecting public health, while taking into account the risks and benefits to the entire population. This includes how these products affect the use of nicotine and tobacco by young people, and the potential for these products to keep adult smokers away completely The use of combustible cigarettes," said Mitch Zeller, director of the FDA's Tobacco Products Center and JD. "It is important that the FDA is formulating post-marketing requirements, among other things, to monitor market dynamics, such as the potential absorption rate of young people. We will pay close attention to the market, including how companies market these products, and will take action as needed. To ensure that the continued sales of these products in the United States are still appropriate, and to ensure that the company complies with the agency’s regulations. Marketing restrictions to prevent youth contact and contact. When other manufacturers seek to sell new tobacco products, the FDA remains committed to upholding legal requirements Important public health standards, and use all the tools available to us to ensure effective and appropriate supervision of tobacco products."

Under the PMTA route, manufacturers must prove to the agency that, among other things, the marketing of new tobacco products will be suitable for protecting public health. The standard requires FDA to consider the risks and benefits to the entire population, including users and non-users of tobacco products. Importantly, this includes youth. The agency’s assessments include reviewing the ingredients, ingredients, additives, and health risks of tobacco products, as well as how the products are manufactured, packaged, and labelled. The review of IQOS products takes into account the increase or decrease in the likelihood of existing tobacco product users to stop using tobacco products, and the increase or decrease in the likelihood that people who do not use tobacco products will start using tobacco products.

In particular, through the FDA’s scientific evaluation of company applications, peer-reviewed published literature and other sources, the agency found that the aerosol produced by the IQOS tobacco heating system contains less toxic chemicals than cigarette smoke, and many toxins have been identified. The content is lower than the content in cigarette smoke. For example, the carbon monoxide exposure of IQOS aerosol is equivalent to the environmental exposure, and the content of acrolein and formaldehyde are respectively 89% to 95% and 66% to 91% lower than that of combustible cigarettes.

In addition, the nicotine content provided by IQOS is close to combustible cigarettes, which indicates that IQOS users may be able to completely get rid of combustible cigarettes and use IQOS exclusively. Although the available data is limited, it also shows that very few non-tobacco users may choose to start using IQOS, including young people.

Although these non-burning cigarettes may be called "heat not burn" or "heated" tobacco products, they meet the definition of cigarettes in the Federal Food, Drug, and Cosmetic Act. Therefore, these products must comply with existing cigarette restrictions set by the FDA, as well as other federal laws, including the prohibition of television and radio advertising. In addition, in order to further restrict young people’s access to products and their advertising and promotional activities, the FDA is strictly restricting the marketing methods of products-especially through websites and social media platforms-including requiring advertising to target adults. The company must also report to the FDA Communicate its labeling, advertising, and marketing plans, including information about specific adult target audiences, and how it plans to restrict youth access and labeling, advertising, marketing, and promotion of products that restrict youth access to products. The agency has issued a document that provides reasons for these post-marketing requirements, which highlights important considerations for reviewing company applications and any potential future PMTAs for other products.

The FDA also requires all packaging labels and advertisements for these products to include warnings about nicotine addiction in addition to other warnings required for cigarettes, in order to prevent consumers from misunderstanding the relative addiction risk of using IQOS compared with burning cigarettes.

After obtaining authorization for these products, the FDA will evaluate new available data about the products through post-marketing records and reports required by the marketing order. Companies need to regularly report to the FDA information about products on the market, including but not limited to ongoing and completed consumer research, advertising, marketing plans, sales data, current and new user information, manufacturing changes, and adverse experiences. If, among other reasons, the FDA determines that the continued marketing of the product is no longer suitable for protecting public health, for example, if the product is absorbed by young people, the marketing order can be withdrawn.

The FDA is continuing to conduct substantive scientific review of the company's MRTP application. The company needs to obtain the FDA's MRTP order before it can sell tobacco products with any implicit or explicit statements, including products that reduce exposure to certain chemical substances, or that the use of the product is less harmful than another tobacco product or Will reduce the risk of disease. If a company sells tobacco products as MRTP without authorization, the company will violate the law and may face consultation or enforcement actions from the FDA.