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FDA Authorization for IQOS

What is the FDA?

The FDA or Food and Drug Administration is a federal agency within the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for regulating the manufacturing, marketing, and distribution of tobacco products in the US.

After reviewing the scientific evidence on IQOS, the US FDA authorized the marketing order of IQOS, concluding that:

  • The IQOS system heats tobacco but does not burn it.
  • The absence of combustion significantly reduces the production of harmful or potentially harmful chemicals.
  • Switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals*, and communicating this is appropriate for the promotion of public health.

  • Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: FDA’s marketing order for the IQOS system dated July 7, 2020.

    What is an MRTP?

    MRTP stands for Modified Risk Tobacco Product.

    On July 7, 2020, the US Food and Drug Administration (FDA) authorized IQOS, along with three different HeatSticks variants, to be marketed in the US with a claim of reduced exposure to harmful chemicals. This makes IQOS the first and only heated tobacco system authorized as a Modified Risk Tobacco Product with reduced exposure information in the US.

    The US FDA decisions came after several years of reviews of all of the scientific evidence available on IQOS. Between the opening and the closure of the scientific review, the FDA asked 86 questions related to the applications, seeking clarifications or additional data.

    After reviewing the scientific evidence on IQOS, the US FDA authorized the marketing order of IQOS, concluding that:

  • The IQOS system heats tobacco but does not burn it.
  • The absence of combustion significantly reduces the production of harmful or potentially harmful chemicals.
  • Switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals*, and communicating this is appropriate for the promotion of public health.

  • Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: FDA’s marketing order for the IQOS system dated July 7, 2020.

    What is the difference between FDA approval and authorization?

    The FDA, or the Food and Drug Administration, is the government agency in the United States responsible for protecting the public health.  The FDA regulates a variety of consumer products, including tobacco. However, US law expressly prohibits making any claims, expressed or implied, that a tobacco product is “FDA approved,” as the statutory standards applicable to tobacco products are not intended to show, among other things, that a tobacco product is “safe” or “effective” (i.e., the standards applicable to drugs and medical devices) given that all tobacco products are not risk-free. Instead, the FDA authorizes (or not), the marketing of tobacco products as “modified risk tobacco products” in the US when they are intended to be sold with exposure modification or risk modification claims.​ Philip Morris International submitted a set of MRTP applications for the IQOS system.

    After thorough reviews, the FDA issued a modified exposure order recognizing that IQOS “significantly reduces the production of harmful or potentially harmful chemicals” and that “switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals*.

    Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: PMI 3-month reduced exposure studies conducted in Japan and the US in near real world conditions. These studies measured exposure to 15 harmful chemicals, and compared the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.

    What is the difference between IQOS as an MRTP and cigarettes?

    The US FDA decisions, authorizing IQOS to be marketed with a reduced exposure information show that IQOS is a fundamentally different product compared to cigarettes. IQOS is a better choice for adults who would otherwise continue smoking. Unlike cigarettes, the IQOS system heats tobacco instead of burning it. This significantly reduces the production of harmful or potentially harmful chemicals compared to cigarette smoke.

    Furthermore, scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces the body’s exposure to harmful or potentially harmful chemicals.*

    Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: PMI 3-month reduced exposure studies conducted in Japan and the US in near real world conditions. These studies measured exposure to 15 harmful chemicals, and compared the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.

    What is the difference between IQOS as a Modified Risk Tobacco Product and vaping products?

    Similar to our IQOS heat-not-burn system, vaping products are smoke-free alternatives to continued smoking. However, there are also important differences between the two. E-cigarettes don’t contain tobacco. Instead, they heat an e-liquid containing nicotine and flavors to produce an aerosol.

    So far, no vaping product has been authorized for marketing by the US FDA. The IQOS system is the first and only tobacco heating system authorized in the US as a Modified Risk Tobacco Product. The FDA concluded that switching completely to IQOS reduces the body’s exposure to harmful or potentially harmful chemicals.*

    Important information: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: PMI 3-month reduced exposure studies conducted in Japan and the US in near real world conditions. These studies measured exposure to 15 harmful chemicals, and compared to the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.

    How does the US FDA announcement change the marketing of PMI’s smoke-free products?

    The US FDA’s decisions, authorizing IQOS to be marketed in US with reduced exposure information encourages us to continue our mission of replacing cigarettes with science-based, smoke-free products applying our responsible marketing practices.

    PMI’s marketing practices must always adhere to the following four core principles:

    1. We only market and sell our products to adult smokers.
    2. We warn consumers about the health effects of our products.
    3. Our marketing is honest, transparent and accurate.
    4. We respect the law.

    Unsure? Contact us.

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