FDA Tobacco Products Scientific Advisory Committee Weighs in on IQOS | Citizens Against Government Waste

FDA Tobacco Products Scientific Advisory Committee Weighs in on IQOS

The WasteWatcher

On January 24 and 25, 2018, the Food and Drug Administration’s (FDA) nine-member Tobacco Products Scientific Advisory Committee (TPSAC) reviewed the Modified Risk Tobacco Product Applications (MRTPA) on an innovative tobacco product, named the IQOS, which is designed to reduce the harm associated with tobacco use.  CAGW discussed the MRTPA and the advisory committee meeting in a January 21 WasteWatcher.

The IQOS is currently sold in key cities in 31 countries, is very popular in Japan and South Korea, and growing in popularity in other countries.  For it to be sold in the United States, it must receive marketing approval by the FDA due to the Tobacco Control Act.

The IQOS is a heat-not-burn system composed of a charger and an inhaling device that heats a processed tobacco plug called a Heatstick.  Unlike a cigarette that burns tobacco at temperatures of 1,100°F or greater, which creates toxic and harmful chemicals such as tar, benzene, and carbon monoxide that cause cancer or other tobacco-use related diseases, the IQOS warms the Heatstick to approximately 570°F. The device imitates smoking a cigarette, but users inhale an aerosol instead of smoke, thus reducing harmful chemicals by as much as 90 to 95 percent.  Philip Morris admits their product is not a smoking-cessation device, but is instead a harm-reduction device that delivers the nicotine smokers crave.  The goal is to get smokers, that cannot, or do not want to, quit smoking and move to a less harmful product.

Almost from the beginning of the meeting, it became clear that the majority of advisory committee members were not interested in seeing the IQOS being advertised and sold as a MRTP, even though the data presented showed that the device did reduce harm and that in other countries, smokers are switching to the heat-not-burn technology in growing numbers.

For most of the committee members, there could never be enough information to show the product was less harmful than smoking cigarettes.  Some behaved as if they had not read any of the materials provided beforehand or even listened to the presentation by Philip Morris.  Others seemed to look for any excuse not to approve the product and continually brought up non-related concerns to the issue at hand, such as it was very techy and sleek and because it looked like a cell phone, it might attract young people or perhaps it was too sophisticated for people “who are left behind.”

Others seemed to suggest the system might be too dangerous to sell because five percent of the people that tested the product used it inappropriately, such as chewing a tobacco plug or trying to insert a regular cigarette into the holder.  No doubt a lot of innovative products are used incorrectly until people become more familiar with them.  Even after a product has been in commercial use for years and even when given clear directions on its use, there are many items that are used inappropriately by the public.  It is impossible to regulate stupidity.

At the end, and as expected, by an 8-0 vote, with one abstention, the committee recommended to the FDA that Philip Morris should not be allowed to sell the IQOS as a product that would reduce the risks of tobacco-related diseases.  However, 8 to 1 members of the committee agreed that switching to IQOS completely would reduce exposure to harmful chemicals.

The FDA does not have to follow their advisory committee’s recommendations and it is likely the agency may ask for additional studies.  Also, Philip Morris has a Premarket Tobacco Application (PMTA) filed with the FDA that if approved, would allow the company to market the heat-not-burn system.  However, receiving the MRTPA order would allow the company to market IQOS as less-harmful than smoking, which would be valuable to get people to switch away from cigarettes that are known to be harmful.

The IQOS seems to fit into FDA’s new Strategic Policy Roadmap to pursue key public health initiatives that includes taking “a fresh look at products that can deliver satisfying levels of nicotine to adults who want access to it without burning tobacco.” The question is: will the FDA allow IQOS to fit in?  A decision on the PMTA is expected in February.