FDA Completes Scientific Review, Authorizes Reduced Exposure Marketing for IQOS Heated Tobacco System
On July 7, FDA authorized the marketing of “IQOS Tobacco Heating System,” which includes the IQOS device, Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks as modified risk tobacco products (MRTPs).
FDA previously authorized the marketing of these products in April 2019 via the premarket tobacco application (PMTA) pathway. To limit youth access to the products and to limit youth exposure to IQOS advertising and promotion, the PMTA authorization placed stringent restrictions on how the products are marketed – particularly via websites and through social media platforms – by including requirements that advertising be targeted to adults of legal age to purchase tobacco products.
With today’s action, FDA issued exposure modification orders authorizing Philip Morris Products S.A. to use the following information in their advertising and marketing of the products:
“AVAILABLE EVIDENCE TO DATE:
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.”
Even with this action, these products are not safe nor "FDA approved"—there are no safe tobacco products. The exposure modification orders do not permit the company to make express or implied statements that convey or could mislead consumers into believing that the product is endorsed or approved by FDA, or that FDA deems the product to be safe for use by consumers.
The company must request and receive authorization from FDA to continue marketing the products with the same modified exposure information after the initial order expires in 4 years. FDA also may withdraw the initial and any potential subsequent exposure modification orders if the agency determines that, among other things, the orders are no longer expected to benefit the health of the population as a whole, for example as a result of an uptake in use of the products by youth or former smokers, or a decrease in the number of current smokers who completely switch to the products.
More information about modified risk tobacco products (MRTPs), including the application process and a summary of past MRTP application actions, is available on the FDA website.
