The US Food and Drug Administration (FDA) rejected the application of Philip Morris International Inc (PMI) to market its heat-not-burn (HNB) tobacco product, namely IQOS, as modified risk tobacco product for its insufficient evidence support.

The decision was made in the meeting of FDA’s Tobacco Products Scientific Advisory Committee in January 2018. The committee concluded that PMI failed to provide adequate scientific support to their claims of their HNB tobacco products in helping to reduce the risk and harm of tobacco-related illness, aiding adult smokers to switch to the use of HNB products completely and realize the risks after reading their labels and advertisements.

With overwhelming majority, the committee did not agree to PMI’s claim that switching from conventional cigarettes to their HNB tobacco products reduces the risks of tobacco-related diseases. Another claim by PMI stating that switching to their products can significantly reduce one’s exposure to harmful or potentially harmful chemicals. However, the committee found that smokers are unlikely to switch completely, but may contrary become long-term dual users. Both novel and conventional tobacco products release harmful chemicals, thus the committee remains in doubt whether HNB tobacco products could reduce one’s exposure to the chemicals.

The committee also unanimously doubted that consumers would not precisely realize the risks of their HNB tobacco products after reading the modified risk labels and advertisements. Consumers may still be misled about the risks of the products.

Novel tobacco products, including heat-not-burn tobacco products and e-cigarettes, have not been proven able to reduce the health risk and could impose unknown impacts in long-term. COSH advises the public not to try any forms of smoking. Smokers should quit completely using legitimate methods to reduce the risk of tobacco-related diseases. In addition, COSH urges the Government to formulate policy and impose strict regulations on all kinds of tobacco products.

Chinese Association on Tobacco Control Copyright © 1992-2011
  906-907 Anhuidongli, Chaoyang District Beijing 100101

Tel: (8610)64983905  Fax: (8610)64983805     Email: