The Family Smoking and Prevention and Tobacco Control Act (TCA) became law in June 2009 and gave the Food and Drug Administration (FDA) authority to regulate the manufacture, distribution, and marketing of all tobacco products.  Included in the law is Section 918, which called for a report to Congress on how best to regulate, promote, and encourage the development of innovative products and treatments to better protect the public health and achieve total abstinence from tobacco use, reduce consumption of tobacco, and decrease the harm associated with continued tobacco use.

Since passage of TCA, the FDA had not been very proactive in promoting and approving new and innovative products that reduce harm associated with continued tobacco use.  For example, in May 2016, the agency published a rule with requirements so stringent it would ultimately prevent the sale of most electronic nicotine delivery systems, or e-cigarettes, which have been marketed since 2007.  If this rule was to be fully implemented, it would be unfortunate because e-cigarettes are being routinely used by smokers to quit or reduce smoking cigarettes.

One only needs to look to England, which has taken the lead in recognizing the benefits of e-cigarettes.  The country’s Department of Health’s June 2017 report “Towards a Smokefree Generation: A Tobacco Control Plan for England,” recommended and promoted the use of these products because the “evidence is increasingly clear that e-cigarettes are significantly less harmful to health than smoking tobacco.”

In December 2016, after taking more than 2 1/2 years, even though the FDA said it intended to act within 360 days, the agency turned down and deferred final action on the first Modified Risk Tobacco Product Applications (MRTPA) submitted by Swedish Match.  The company had requested to remove and change certain warning labels on snus, their smokeless tobacco product, even though the company provided an abundance of data which showed their product is less harmful than smoking.  In Sweden, where snus is popular, smoking rates have dropped precipitously, as well as smoking-related diseases, such as lung cancer.

But, there is an attitude change at the FDA, thanks to its new commissioner, Scott Gottlieb, M.D.  One of Dr. Gottlieb’s first initiatives was to delay enforcement of the burdensome regulations for e-cigarettes until August 2022 as part of a greater plan announced in July 2017 to strike an appropriate balance between regulation and encouraging development of innovative tobacco products that are less dangerous than cigarettes, help people quick smoking, and significantly reduce tobacco-related disease and death.  On January 11, the agency provided more details and a road map on how this would be accomplished.

This week, on January 24 and 25, the FDA and its Tobacco Products Scientific Advisory Committee (TPSAC), will discuss and soon make significant decisions about another innovative tobacco product.  Philip Morris is seeking FDA authorization to sell its heat not burn product, known as the iQOS in overseas markets, as a modified risk tobacco product.

Burning tobacco at temperatures between 1,100° to 1650°F is what creates the harmful chemicals, such as tar, carbon monoxide, and benzene, which lead to serious diseases such as lung cancer.  Philip Morris’s tobacco heating system reaches a temperature of approximately 570° F and produces an aerosol instead of smoke.  As a result, there is no combustion and toxic chemicals are reduced dramatically. The company has posted reams of data on its website to demonstrate that it’s product is noticeably less harmful than smoking cigarettes.  For example, the levels of 18 harmful and potentially harmful constituents that must be reported to the FDA were found to be more than 90 percent lower.

The FDA began its substantive scientific review of Philip Morris’s MRTPA in May 2017 and the TPSAC will meet this week to review the application, answer any questions FDA scientific reviewers may have, and make recommendations, such as whether to approve the MRTP application.

If Philip Morris’s data is as good as it appears to be and demonstrates the iQOS is a harm-reducing tobacco product, it would make sense for the TPSAC to recommend and for the FDA to allow the company to tell consumers their product is safer than smoking.  Having access to another less harmful alternative would be a much better solution for those individuals that cannot or do not want to quit smoking tobacco products.