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What is the difference between FDA approval and authorization?

The FDA, or the Food and Drug Administration, is the government agency in the United States  responsible for protecting the public health. 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.​

Philip Morris International submitted a set of MRTP applications for the IQOS system. After thorough reviews, the FDA issued a modified exposure order recognizing that IQOS “significantly reduces the production of harmful or potentially harmful chemicals” and that “switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals*.

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

*Source: PMI 3-month reduced exposure studies conducted in Japan and the US in near real-world conditions. These studies measured exposure to 15 harmful chemicals, and compared the levels observed in smokers who switched to IQOS with levels measured in smokers who continued to smoke cigarettes.

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