IQOS has passed the FDA MRTP review in the U.S. and is recognized as a reduced-risk cigarette altern

On July 8, news came that, according to the FDA website and Philip Morris International's website, Philip Morris's heated tobacco product IQOS has officially passed the FDA's review as a Modified Risk Tobacco Product (MRTP) for sale, and will officially be marketed as a reduced-risk product in the United States.
This is a significant milestone for the global new tobacco industry.
IQOS passed the PMTA tobacco pre-market application in April 2019, and subsequently underwent a new MRTP review.
Renowned new tobacco expert Li Youqiang told Blue Hole New Consumption that previous new tobacco products were small-scale operations, and from this moment on, a new era is about to begin.

Li Youqiang stated that previously, products were regulated as tobacco products, but now they are managed as reduced-risk products, which will have far-reaching impacts on marketing, brand influence, and consumer perception.

The Swedish Match company’s oral tobacco passed the FDA MRTP review last October.

Below is the full FDA official announcement:

Today, the U.S. Food and Drug Administration authorized Philip Morris Products Company's "IQOS Tobacco Heating System" as a Modified Risk Tobacco Product (MRTP) for marketing. This marks the second product ever approved for MRTP and the first tobacco product to receive an "exposure modification" order, allowing the marketing of this product to reduce exposure to a certain substance or to anticipate that the issuance of this order will benefit public health. Importantly, the authorization for these products requires the company to conduct post-market surveillance and research to determine whether the MRTP remains appropriate, including assessing the potential for increased use among youth.

FDA Tobacco Products Center Director Jitch Mitch Zeller stated that through the application for modified risk tobacco products, the FDA aims to ensure that information regarding the reduced risks or reduced exposure of tobacco products is supported by scientific evidence and is easy to understand for consumers.
The data submitted by the company indicates that using authorized information to market these specific products can help addicted adult smokers switch from combustible cigarettes and reduce their exposure to harmful chemicals, provided they fully transition.

The FDA will closely monitor how consumers use IQOS to determine whether these products meet this potential and do not lead to increased use among youth.

It is important to note that these products are not safe, especially for young people.

The IQOS tobacco heating system includes an electronic IQOS device that generates a nicotine-containing aerosol by heating tobacco sticks (specifically Marlboro HeatSticks, Marlboro Menthol HeatSticks, and Marlboro Fresh Menthol HeatSticks) wrapped in paper.
The FDA previously authorized the marketing of these products without modified risk information through the PMTA route in April 2019.

Today's action relates to the individual MRTP applications for these products and further authorizes the manufacturer to use the following information to market these specific products:

Available Evidence to Date:

The IQOS system heats tobacco but does not burn it.

This significantly reduces the production of harmful and potentially harmful chemicals.

Scientific research shows that completely switching from traditional cigarettes to the IQOS system can significantly reduce the likelihood of 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 order also does not allow the company to make any other modified risk statements or any explicit or implied statements that may mislead consumers into believing that the product has been approved or endorsed by the FDA or that the FDA considers the product to be safe for consumer use.
The FDA may issue two types of MRTP orders: "risk modification" orders or "exposure modification" orders.

The company has requested both types of orders for the IQOS tobacco heating system.

After reviewing the available scientific evidence, public comments and recommendations from the Tobacco Products Scientific Advisory Committee, the FDA determined that the evidence currently does not support the issuance of a risk modification order but does support the issuance of an exposure modification order for these products. This determination includes findings that the issuance of the exposure modification order is expected to benefit public health overall.

Specifically, the agency determined that the company demonstrated that the IQOS tobacco heating system, by heating tobacco without burning it, significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke.

Furthermore, research indicates that completely switching from combustible cigarettes to the IQOS tobacco heating system can significantly reduce human exposure to 15 specific harmful and potentially harmful chemicals.

Toxicological assessments also found that the levels of potential carcinogens and toxic chemicals in IQOS aerosol are much lower than those in cigarette smoke, which may harm the respiratory or reproductive systems.

Additionally, the FDA found that the applications supported the necessary consumer understanding outcomes.

Today's authorization requires Philip Morris Products SA to conduct post-market surveillance and research to determine the impact of these orders on consumer perception, behavior, and health, allowing the FDA to review the accuracy of the determinations on which these orders are based. These post-market requirements include rigorous toxicological studies using computer models to help predict potential adverse reactions in users. These orders also require the company to monitor youth awareness and use of the products to help ensure that MRTP marketing does not lead to unintended consequences for youth use.

The company must also report to the FDA on efforts to prevent youth access and exposure.

These requirements are in addition to the post-market requirements and restrictions previously imposed on these products under its April 2019 PMTA authorization, such as reporting to the FDA information about consumer research studies, sales and advertising information, and adverse experiences.

In particular, to limit youth access to the products and restrict youth exposure to IQOS advertising and promotional activities, the PMTA authorization imposed strict limitations on the marketing of the products (especially through websites and social media platforms), including requiring that advertising target legal-age adults purchasing tobacco products.

The company must request FDA authorization to continue marketing products with the same modified exposure information after the initial orders expire in four years.

If the FDA determines, among other things, that the issuance of the order is no longer expected to benefit public health due to increased food intake, the FDA may also withdraw the initial and any subsequent exposure modification orders. This could occur if there is an increase in youth or former smoker use of the products or a decrease in the number of current smokers fully switching to the products.

The MRTP pathway outlined in the 2009 Family Smoking Prevention and Tobacco Control Act allows companies to submit applications to the FDA to assess whether tobacco products can be sold or distributed to reduce harm or the risk of tobacco-related diseases.

Under the law, the FDA must also ensure that advertising and labeling for modified risk products enable the public to understand the modified risk or modified exposure information and its implications for overall health and tobacco-related diseases and health conditions.
Due to time constraints, some translations may contain errors; those proficient in English can refer to the original text on the FDA website.

Supplementary Information:

On December 5, 2016, PMI submitted an application to the FDA for the IQOS Modified Risk Tobacco Product (MRTP) to allow marketing of products with modified risk statements. After the substantial scientific review of the IQOS MRTP application was completed, the FDA authorized it. The FDA approved the use of these reduced exposure statements for IQOS.
On March 31, 2017, PMI submitted a pre-market tobacco product application (PMTA) for IQOS to authorize commercialization as a new tobacco product in the United States. The FDA authorized the IQOS PMTA on April 30, 2019. Under the PMTA authorization, Philip Morris USA is responsible for the marketing and sales of IQOS in the United States (version 2.4).

In 2019, PM USA began leading the market for IQOS in Atlanta, Georgia in September and Richmond, Virginia in November. PM USA previously announced that the next leading market for IQOS would be Charlotte, North Carolina.

On March 30, 2020, PMI submitted a supplemental PMTA for the IQOS 3 tobacco heating device. This IQOS 3 supplemental PMTA is unrelated to the FDA's MRTP authorization for the current IQOS device (version 2.4) commercialized in the United States on April 30, 2019.