FDA Allows IQOS to be Marketed as Reduced-Risk


Another huge victory for Heat-not-Burn and harm reduction, as today the United States Food and Drug Administration (FDA) authorized the marketing of IQOS as a modified-risk tobacco product (MRTP). MRTP are tobacco products that are deemed to  pose “significantly lower risks to individual users and benefits the population as a whole.” So what today’s ruling means is that, within the United States, IQOS can now be marketed as less harmful than traditional tobacco products, not just for the user, but for all people who come into contact with that product.

IQOS is now the second ever product to be classified as a MRTP by the FDA and is the first ever product “to receive ‘exposure modification‘ orders,” which let potential consumers know that their level of exposure to a certain aspect of harm — in this case smoke — is reduced.

An important note to make is that although IQOS has been authorized to market as modified-risk, it does not have FDA approval. This means that the FDA has not endorsed IQOS nor has it deemed IQOS to be safe.


Before this ruling, Philip Morris, the marker of IQOS, was legally unable to market IQOS as being less harmful. This was disadvantageous for IQOS, as the device’s main purpose is to provide a less harmful alternative to traditional cigarette smokers. Barring Philip Morris from accurately marketing IQOS could be the reason why IQOS has not yet achieved major success in the American market. If consumers are not aware of the benefits of a product, why would they purchase it? With today’s ruling Philip Morris can now state that by heating tobacco rather than burning it, IQOS reduces the production of harmful chemicals and user exposure to such.

This will hopefully allow more people to become aware of IQOS and Heat-not-Burn in general. There are approximately 40 million smokers in the US. In 2017, the Centers for Disease Control and Prevention (CDC) reported that tobacco-related diseases are “the single largest preventable cause of death and disease in the United States.” Introducing Heat-not-Burn as a viable option for Americans hoping to reduce their exposure to harmful substances could help save lives.We look forward to watching IQOS as it enters this new phase of growth in the US.

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-iqos-tobacco-heating-system-reduced-exposure-information

SOURCE: https://www.pmi.com/media-center/press-releases/press-details/?newsId=22631

SOURCE: https://www.fda.gov/tobacco-products/advertising-and-promotion/fda-authorizes-modified-risk-tobacco-products

SOURCE: https://www.pmi.com/media-center/news/fda-authorizes-sale-of-iqos-in-the-us

SOURCE: https://www.cdc.gov/tobacco/campaign/tips/resources/data/cigarette-smoking-in-united-states.html