The FDA regulates a variety of consumer products, including tobacco. However, US law expressly prohibits making any claims, express or implied, that a tobacco product is “FDA approved,” as the statutory standards applicable to tobacco products are not intended to show, among other things, that a tobacco product is “safe” or “effective” (i.e., the standards applicable to drugs and medical devices) given that all tobacco products are not risk-free. Instead, the FDA authorizes (or not), the marketing of tobacco products as “modified risk tobacco products” in the US when they are intended to be sold with exposure modification or risk modification claims.
After reviewing the scientific evidence on IQOS, the US FDA authorized the marketing order of IQOS, concluding that:
- The IQOS system heats tobacco but does not burn it.
- The absence of combustion significantly reduces the production of harmful or potentially harmful chemicals.
- Switching completely to IQOS reduces your body’s exposure to harmful or potentially harmful chemicals*, and communicating this is appropriate for the promotion of public health.
Important information: Not FDA approved. IQOS is not risk-free. It delivers nicotine, which is addictive.