What is the FDA?

You can find answers to questions about the FDA's decision in the Frequently Asked Questions section.


The FDA or Food and Drug Administration is a federal agency within the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for regulating the manufacturing, marketing, and distribution of tobacco products in the US.

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: IQOS is not risk-free. It delivers nicotine, which is addictive.

    *Source: FDA’s marketing order for the IQOS system dated July 7, 2020.

    Important information: This product is not risk free and provides nicotine, which is addictive. Only for use by adult smokers.