On July 8, according to the official website of FDA and Fimo international, iqos, a heating and noncombustible product of Fimo, has officially passed the FDA’s review of marketing as an improved risk tobacco product (MRTP), and will be officially listed in the United States as a harm reduction product.
This is a huge symbol for the global new tobacco industry.
Iqos passed the PMTA tobacco pre marketing application in April 2019, and then MRTP conducted a new review.
Li Youqiang, a well-known new type of tobacco expert, told the new consumption of blue hole that the previous new type of tobacco was a little fuss, and from this moment on, it will meet the arrival of a new era.
Li Youqiang said that it used to be used as tobacco product control, but now it is used as harm reduction product management, which will have a profound impact on publicity, brand influence and audience feeling.
The Swedish match company passed the FDA MRTP review last October.
The following is the full text of FDA’s official circular:
Today, the U.S. Food and Drug Administration authorized Philip Morris Products’ iqos tobacco heating system to market as an improved risk tobacco product (MRTP). This marks the approval of the second set of products in the history of MRTP, and the first batch of tobacco products have obtained the “exposure modification” directive, which enables the marketing of the products to reduce the exposure of certain substances, or to expect the release of the order to be beneficial to people’s health. It is important that the licensing of these products requires companies to conduct post market surveillance and research to determine whether MRTP continues to be appropriate, including assessing the potential for increased use among young people.
Jitch Mitch Zeller, head of the FDA’s tobacco products center, said the FDA’s goal is to ensure that consumer information about risk reduction or exposure reduction from the use of tobacco products is supported by scientific evidence and is easy to understand.
Data submitted by the company show that the use of licensing information to market these specific products can help addicted adult smokers get rid of burning cigarettes and reduce their exposure to harmful chemicals, but only if they are completely converted.
The FDA will closely monitor how consumers use iqos to determine whether these products meet this potential without causing more use by young people.
Please note that these products are not safe, especially for young people.
Iqos tobacco heating system includes an electronic iqos device that generates nicotine containing aerosols by heating tobacco filler rods wrapped in paper (especially Marlboro, Marlboro menthol and Marlboro fresh menthol).
FDA has previously authorized the marketing of these products without modifying risk information through the pre marketing tobacco application (PMTA) pathway in April 2019.
Today’s action relates to the separate MRTP applications of these products and further empowers manufacturers to use the following information to market these specific products:
Available evidence to date:
Iqos system heats tobacco but does not burn.
This greatly reduces the production of harmful and potentially harmful chemicals.
Scientific research shows that the complete conversion from traditional cigarette to iqos system can greatly reduce the human exposure to harmful or potentially harmful chemicals.
Even with this measure, these products are not safe and have not been approved by the FDA. The exposure modification directive also does not allow companies to make any other modified risk statement or any express or implied statement to convey or possibly mislead consumers into believing that the product has been approved or approved by FDA, or that FDA considers that the product is safe for use by consumers.
The FDA may issue two types of MRTP directives: “risk modification” directive or “exposure modification” directive.
The company has requested orders for two types of iqos tobacco heating systems.
After reviewing the available scientific evidence, the public comments and recommendations of the Scientific Advisory Committee on tobacco products, FDA determined that the evidence currently does not support the issuance of risk modification orders, but does support the issuance of exposure modification orders for these products. The determination included the finding that the release of exposure amendments was expected to benefit the health of the entire population.
In particular, the agency determined that the company had demonstrated that, since iqos tobacco heating system heated tobacco without burning tobacco, it significantly reduced the production of harmful and potentially harmful chemicals compared to cigarette smoke.
In addition, studies have shown that the complete conversion from burning cigarettes to iqos tobacco heating systems can significantly reduce human exposure to 15 specific and potentially harmful chemicals.
Toxicological assessment also found that iqos aerosol contained much lower levels of potential carcinogens and toxic chemicals than cigarette smoke, which could damage the respiratory or reproductive system.
In addition, the FDA found that these applications support the consumer understanding results required.
Today’s authorization requires Philip Morris Products SA to conduct post market surveillance and research to determine the impact of these orders on consumer cognition, behavior, and health, and to enable the FDA to review the accuracy of the determinations on which these orders are based. These after-sales requirements include rigorous toxicity studies using computer models to help predict potential adverse reactions from users. The orders also require companies to monitor young people’s awareness and use of products to help ensure that the marketing of MRTP does not have unintended consequences for young people’s use.
Companies must also inform the FDA of efforts to prevent exposure and exposure by adolescents.
These requirements are in addition to the post marketing requirements and the restrictions previously imposed on these products in its April 2019 PMTA authorization, such as reporting to FDA information on consumer research research, sales and advertising information, and adverse experiences.
In particular, in order to restrict young people’s access to products and their access to iqos advertising and promotion activities, PMTA authorized strict restrictions on the marketing methods of products (especially through websites and social media platforms), including requiring adults of legal age with advertising as the target to purchase tobacco products.
Companies must request and obtain FDA authorization to continue marketing products with the same modified exposure information after the initial order expires four years later.
If the FDA determines, among other things, that the directive is no longer expected to benefit the health of the entire population as a result of increased food intake, the FDA may also withdraw the initial and any possible subsequent exposure modification directive. There was a decrease in the use of the product by adolescents or former smokers, or the number of current smokers who completely converted to the product.
The MRTP approach outlined in the family smoking prevention and tobacco control act of 2009 enables companies to submit applications to the FDA to assess whether tobacco products can be sold or distributed to reduce the risk of harm or tobacco related diseases.
Under the law, the FDA must also ensure that modified risk products are advertised and labeled so that the public can understand the modified risk or modified exposure information and understand its significance for overall health and all tobacco related diseases and health conditions.