FDA Authorization for IQOS
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:
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.
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:
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.
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, express 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.
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 use 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 the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.
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.
Heat not Burn Technology
No, we can’t say that at this point. While switching completely to IQOS presents less risk to your health, IQOS is not risk-free and delivers nicotine, which is addictive. If you are concerned about the health effects of smoking, your best option is to quit tobacco and nicotine use altogether. However, switching completely to IQOS is a better choice than continuing to smoke
Nicotine is addictive. However, it is not the main cause of smoking-related diseases. IQOS delivers nicotine in a comparable way to cigarettes. Our clinical studies show that the amount and rate of nicotine absorbed when using one tobacco stick with IQOS is comparable to that of smoking one cigarette.
The totality of evidence includes PMI’s clinical data (we conducted 10 clinical studies with thousands of participants in the US, UK, Japan and Poland), aerosol chemistry, and data from 18 nonclinical studies. The totality of evidence demonstrates that switching completely to IQOS, while not risk-free, presents less risk of harm compared with continuing to smoke cigarettes.
We use PMI Financials or estimates, IQOS user panels and PMI Market Research. The number of total users we report refers to IQOS users for whom PMI HeatSticks represent at least 5% of their daily tobacco consumption over the past 7 days, while the number of people we estimate have completely quit cigarette smoking refers to IQOS users who have completely quit cigarettes and for whom PMI HeatSticks represent at least 70% of their past 7-day heated tobacco consumption.
It is a cigarette independently designed by the University of Kentucky in the US for scientific research purposes. It is a comparator commonly used in tobacco research, which allows the data of a given study to be compared to that of another study. 3R4F research cigarettes are not commercially available to consumers.
Orders and Commercial Information
We are always here for you and at your disposal through different platforms.
You can always contact us at:
You can immediately call us on our free customer support line: 08001515. Our IQOS experts will contact you promptly and find the safest way to assist you.
Cleaning IQOS is very easy and includes only a few steps:
1. Use a sanitizing wipe (62-71% isopropyl or ethanol).
2. Wipe the outside of the Charger, the Holder and the
associated accessories you own.
3. Thoroughly clean the blade, the inside area of the
holder surrounding the blade and the whole extractor
with the dedicated IQOS cleaning sticks and cleaning tool.
4. Dispose of the
used sticks and wipes in the bin.
Register here or call 08001515 and an expert will contact you, to bring the IQOS device at your preferred location.
We have extended the IQOS lending period to 30 days. You do not need to worry about returning the device. We can decide together on the most suitable time to return it
Visit our Offers category, dedicated to special offers for online purchases, which is frequently being updated.
Also, you can get free cleaning sticks for each online purchase.
IQOS vs. e-cigarettes
IQOS is not an e-cigarette. IQOS heats real tobacco. It does not vaporize a liquid solution containing nicotine. IQOS is used with HeatSticks which contain naturally present nicotine, whereas in e-cigarettes, nicotine derived from tobacco is added to the liquid.
The U.S FDA has authorized the sale of IQOS in the U.S as "appropriate for public health". FDA press release here.
IQOS™ Information
You can buy IQOS™ and heatsticks in all IQOS zones. In order to find the closest IQOS zone to your location, please click here.
Please contact Customer Care:
Other channels: “IQOS Albania” on Facebook or ask for enrollment in the nearest IQOS™ Zone.
Registration & Profile
By registering, you will receive news and information about IQOS™ products and services, invitations to take part in special events and activities, such as the presentation of new products or discount and other promotions, personalized product information and special offers and/or services, access to exclusive content or events, news and updates of relevance for participants.
You can register your IQOS™ device by filling all the required fields on the registration form and accepting the Terms and Conditions, or by going to an IQOS zone and registering the device with the help of our IQOS Sales Experts.
Services & Repairs
If your IQOS™ device is not working, simply perform a reset (under Support section). Still no luck? Please contact Customer Care:
Other channels: “IQOS Albania” on Facebook or ask for enrollment in the nearest IQOS™ Zone.
Yes. In case of nonconformity of the purchased IQOS™ device, you are entitled to a legal warranty starting from the purchase date.
