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FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information

FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information

Last Reviewed : 01/05/2021
FDA Authorizes Marketing of IQOS Tobacco Heating System with ‘Reduced Exposure’ Information

Press Release: 

The U.S. Food and Drug Administration authorized the marketing of Philip Morris Products S.A.’s “IQOS Tobacco Heating System” as modified risk tobacco products (MRTPs). This marks the second set of products ever to be authorized as MRTPs and the first tobacco products to receive “exposure modification” orders, which permits the marketing of a product as containing a reduced level of or presenting a reduced exposure to a substance or as being free of a substance when the issuance of the order is expected to benefit the health of the population.

The IQOS Tobacco Heating System includes the electronic IQOS device that generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper, specifically Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks and Marlboro Fresh Menthol Heatsticks. The FDA previously authorized the marketing of these products without modified risk information in April 2019 via the premarket tobacco application (PMTA) pathway.

This action pertains to the separate MRTP applications for these products and further authorizes the manufacturer to market these specific products with the following information:

  • 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.” The exposure modification orders also do not permit the company to make any other modified risk claims or any express or implied statements that convey or could mislead consumers into believing that the products are endorsed or approved by the FDA, or that the FDA deems the products to be safe for use by consumers.

There are two types of MRTP orders the FDA may issue: a “risk modification” order or an “exposure modification” order. The company had requested both types of orders for the IQOS Tobacco Heating System. After reviewing the available scientific evidence, public comments and recommendations from the Tobacco Products Scientific Advisory Committee, the FDA determined that the evidence did not support issuing risk modification orders at this time but that it did support issuing exposure modification orders for these products. This determination included a finding that issuance of the exposure modifications orders is expected to benefit the health of the population as a whole.

In particular, the agency determined the company demonstrated that because the IQOS Tobacco Heating System heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke. Furthermore, studies showed switching completely from combusted cigarettes to the IQOS Tobacco Heating System significantly reduces the body’s exposure to 15 specific harmful and potentially harmful chemicals. The toxicological assessment also found that, compared with cigarette smoke, IQOS aerosols contain considerably lower levels of potential carcinogens and toxic chemicals that can harm the respiratory or reproductive systems.

The authorization for these products requires the company to conduct postmarket surveillance and studies to determine whether the MRTP orders continues to be appropriate, including assessing the potential for increased use among youth. These requirements are in addition to the postmarket requirements and restrictions previously placed on these products in their April 2019 PMTA authorizations, such as reporting information to the FDA about consumer research studies, sales and advertising information and adverse experiences, among others. 

 

Source: U.S. Food And Drug Administration. 

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