After considering the submission of Philip Morris Products S.A.’s marketing plan for its IQOS Tobacco Heating System as a modified risk tobacco product (MRTP) since December 2016, the Food and Drug Administration (FDA) announced on Monday, July 7, 2020, that the product could be marketed as one that reduces exposure to harmful chemicals that are found in combustible cigarettes.  This is the first electronic nicotine delivery system (ENDS), or e-cigarette, to receive the MRTP designation.  The IQOS also received an exposure modification order, which means the product can be marketed as one that has reduced level or exposure to a harmful substance or is free of such a substance.  This is good news for smokers who want to quit smoking and are looking for something that will assist them in that goal.

Under the Family Smoking Prevention and Tobacco Control Act (TCA), the FDA was given the authority to regulate the manufacture, distribution, and marketing of tobacco products.  In addition to restricting the marketing and banning the sale of tobacco products to minors, the law requires warning labels on tobacco products, disclosure of ingredients, and prevents companies from marketing harm reduction claims like “light” or “low” without filing a MRTP.  The law also requires manufacturers of new tobacco products, those marketed after February 15, 2007, to demonstrate that their products meet certain applicable health standards with a premarket tobacco application (PMTA).

The FDA agreed that IQOS could be marketed with the following specific information:

• The IQOS 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 IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

Smoking a cigarette burns tobacco at temperatures between 1,100° to 1,650°F.  It is the combustion of tobacco that creates the harmful chemicals, such as tar, carbon monoxide, and benzene, which lead to serious diseases such as lung cancer.  The IQOS heat-not-burn system warms tobacco to a temperature of approximately 570° F and produces an aerosol instead of smoke.  As a result, there is no combustion and toxic chemicals are reduced dramatically. The company provided reams of data to the FDA to demonstrate that IQOS is dramatically less harmful than smoking cigarettes.  For example, studies showed that switching from combustible cigarettes to the IQOS reduced exposure to 15 specific harmful and potentially harmful chemicals and that the IQOS aerosol contains significantly lower levels of potential cancer-causing and toxic chemicals.

The FDA has been slow in allowing this innovative product to be sold and marketed appropriately in the U.S.  While citizens in more than 40 countries were using this tobacco harm-reduction product, it took the FDA 3.5 years to review the PMTA and allow the IQOS to be sold, even though it should have only taken no more than 180 days to review the application according to the agency’s own guidance.

PMI will be required to undertake post-market surveillance and studies to see how the public responds to this new product information and report on resulting behaviors and health outcomes, including youth access and exposure.  The marketing order only lasts for four years before it expires and must be renewed.

There are many individuals and organizations opposed to the FDA allowing this product to be marketed.  The simple truth is tobacco is a legal product in the United States and even if Congress foolishly outlawed its use, as it tried to do with alcoholic beverages during the 1920s to 1930s, there would be a black market that would fill the demand for tobacco products.  Since China grows more tobacco than any other country, it would be a willing provider.

According to PMI, as of March 2020, approximately 10.6 million people have quit smoking using the IQOS.  Just as many people use vaping products to help wean themselves off harmful combustible cigarettes, the IQOS will be a valuable harm reduction tool in this effort, saving lives and billions of healthcare dollars.