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The U.S. FDA authorizes Heat Not Burn devices as a modified risk tobacco product

Our smoke-free innovation becomes the first and only electronic nicotine product to receive such

authorization from the Food and Drug Administration.



The U.S. Food and Drug Administration (FDA) has authorized the marketing of our flagship

electronically heated tobacco system, as a modified risk tobacco product (MRTP), which represents a historic opportunity for public health. In doing so, the agency found that issuing an exposure modification order for the Tobacco Heating System (THS) is appropriate to promote the public health, and is expected to benefit the health of the population as a whole.


This decision demonstrates that Heat Not Burn device is fundamentally different from combustible cigarettes, and a better choice for adults who would otherwise continue smoking.

It follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications.


The FDA’s action authorizes the marketing of Heat Not Burn in the USA with the following information:

The Heat Not Burn system heats tobacco but does not burn it.

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

Scientific studies have shown that switching completely from conventional cigarettes to the Heat

Not Burn system significantly reduces your body’s exposure to harmful or potentially harmful

chemicals.


In April 2019, the agency authorized Heat Not Burn device for sale in the U.S. through issuance of premarket tobacco product application marketing orders, that deemed marketing the product to be appropriate for the protection of the public health.


Now, the FDA has concluded issuing an Heat Not Burn exposure modification order is appropriate to promote the public health, and is expected to benefit the health of the population as a whole, taking into account both users and nonusers of tobacco products. Notably, the FDA’s issuance of an exposure modification MRTP order does not mean Heat Not Burn device is FDA-approved. FDA does not ‘approve’ tobacco products. Further, the FDA’s decision does not mean device is risk-free. The FDA’s decision is consistent with earlier conclusions of other leading regulatory and scientific bodies, including in the U.K., Germany, and the Netherlands, which have found that the product emits lower levels of harmful toxicants.


Furthermore, the FDA’s MRTP authorization shows that Heat Not Burn system is a fundamentally

different product than combustible cigarettes, and must be regulated differently, as the FDA has

recognized.


A cooperative approach to a smoke-free future PMI’s CEO André Calantzopoulos said: “The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit – but many won’t.

“The FDA determined that scientific studies have shown that switching completely from conventional cigarettes to Heat Not Burn system device reduces exposure to harmful or potentially harmful chemicals.


“Heat Not Burn system device is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now, more than ever, there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future.

“The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.


“We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product. “As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to Heat Not Burn device. We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth.


“Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible.

“We look forward to working with the FDA to provide any additional information they may require in order to market Heat Not Burn device with reduced risk claims.


“Harnessing innovations like Heat Not Burn device to dramatically speed-up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.”


Under the Family Smoking Prevention and Tobacco Control Act, as summarized by the FDA, “there are two types of MRTP orders the FDA may issue: a ‘risk modification’ order or an ‘exposure modification’ order. The company had requested both types of orders for the 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 did not support issuing risk modification orders at this time, but that the scientific evidence package did support issuing exposure modification orders for these products.


“This determination included a finding that issuance of the exposure modifications orders is appropriate to promote the public health, and is expected to benefit the health of the population as a whole, taking into account both users and nonusers of tobacco products.”

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