FDA Authorizes IQOS for Sale in the USA

Did you hear the news? IQOS will soon be available in the US!

The US Food and Drug Administration announced on April 30th, that they have authorized IQOS for sale across America. This decision comes after a nearly two-year wait during which IQOS technology underwent a scientific review process in what is known as the premarket tobacco product application (PMTA). “The […] evaluation includes reviewing a tobacco product’s components, ingredients, additives and health risks, as well as how the product is manufactured, packaged and labeled.” The PMTA found that IQOS released fewer/lower levels of toxins than traditional cigarettes which burn tobacco. These levels are low enough that they are not considered a risk to public safety and therefore can be made available to the public. The FDA did announce that IQOS products, though approved for sale, would still face restrictions, such as age requirements for purchase and warning labels.

So far, the FDA has approved only the IQOS device (although they did not specify which version(s)), and three Marlboro for IQOS HeatStick flavors: Balanced-Regular, Smooth Menthol, and Fresh Menthol. This is an interesting choice of HeatStick flavors since Marlboro for IQOS is predominantly sold in Asia, whereas most Western countries, including Canada, sell HEETS.

An important distinction to make is that although IQOS has been authorized for sale, it does not have FDA approval. This means that the FDA has not endorsed the product. As they said in an official statement Tuesday, “the authorization of new tobacco products doesn’t mean they are safe.” However, the agency has declared on numerous occasions that they wish to lower the risk of tobacco-related diseases, this may be a step towards doing so.

The device will be first launched in Atlanta, Georgia in approximately 3 months time. Philip Morris and their American counterpart, Altria, plan on opening official IQOS retail locations to help familiarize consumers with the brand, products, and concept of Heat-Not-Burn.

Why is the FDA’s Decision Important?

IQOS is the first ever Heat-Not-Burn product to be legally sold in the United States. FDA approval of IQOS has brought international recognition to Heat-not-Burn products, meaning that more people may be introduced to them and begin turning to HnB as a smoking alternative. Moreover, the sale of IQOS in the American market could pave the way for other Heat-not-Burn devices to be approved and sold. This could provide HnB with the opportunity to achieve the same success that vaping and other forms of harm reduction have seen.

Access to HnB products is the most important outcome of this decision as it offers smokers an alternative to traditional cigarettes. 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.” The introduction of harm reduction devices that still feel and taste like traditional cigarettes may be what is needed to help individuals switch or quit altogether therefore possibly improving their health and general well-being.

Even though IQOS does not currently have FDA approval, that does not mean the product is not beneficial to individuals’ health. Philip Morris and Altria are still waiting on their Modified Risk Tobacco Product application to the FDA, which, if approved, would allow the companies to market IQOS as a safer alternative to cigarettes. April 30th’s decision could be a game changer for the harm reduction industry in the United States. Stay tuned!

SOURCE: https://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos-tobacco-heating-system-through-premarket-tobacco-product-application-pathway

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