05.15.19

A tale of two sentiments two weeks after FDA permits the sale of IQOS

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It’s been just over two weeks since the U.S. Food and Drug Administration (FDA) authorized the sale of Philip Morris’ IQOS heated tobacco product (HTP) system in regular tobacco and menthol flavors. It’s also been exactly two years since the premarket tobacco product application (PMTA) for this product that creates an aerosol (not smoke) from heating tobacco (not a liquid containing nicotine) was submitted to the agency. The marketing orders are also the second-ever issued under the PMTA pathway since premarket review of tobacco products became required in 2009. The FDA’s decision to categorize this new HTP as non-combusted cigarettes and allow their marketing has also elicited two conflicting sentiments for me: (1) disappointment about the FDA’s balancing of the product’s risks and benefits under the “appropriate for the protection of public health” standard and (2) hope that the availability of new tobacco products along the “continuum of risk” will now bolster efforts to reduce, and eventually eliminate, the most harmful tobacco products along the continuum: conventional combusted cigarettes.

Before explaining more fully, let me unpack the public health significance of this new HTP development. First, you need to know that new tobacco products require premarket review by FDA to be on the market legally. This requirement that new products undergo review by FDA before they’re introduced to the market is a powerful public health tool, but many argue this gatekeeping authority hasn’t been exercised to maximize the protection of public health. One example is that FDA has chosen to not enforce the premarket review requirement for the popular tobacco product, e-cigarettes, until 2022 (or possibly 2021 for certain flavored e-cigarettes if a new enforcement policy proposal announced by FDA is finalized). This essentially means no gatekeeper stands between e-cigarette companies and consumers until then, which may be one contributing factor to the explosive popularity of (technically illegal) e-cigarettes. It’s more complicated than that, of course, and FDA has taken some actions against e-cigarette companies. Still, the marketing of new tobacco products should be accompanied by some level of FDA review, but that isn’t the case for many new tobacco products on the market today.

You also should know that one other HTP has successfully undergone FDA premarket review, but it traversed a less rigorous pathway and hasn’t yet been marketed in the U.S. The successful review of IQOS under the PMTA pathway required a finding that the product is “appropriate for the protection of public health.” Such a finding isn’t supposed to translate to “FDA approved” or “safe for use,” but having that FDA “appropriate for the protection of public health” finding is likely to lend some favorable perception about the product to the public. And that’s before FDA even makes a decision on the modified risk tobacco product (MRTP) application for IQOS. I wrote a short piece about the MRTP concept here, but suffice it to say that favorable/less risky product perceptions are associated with using the products. This is only a good thing for people who smoke conventional cigarettes, the most harmful of tobacco products, and only if they can’t or won’t quit and switch to exclusively using the new, potentially reduced risk product.

That brings me to my disappointment about the FDA’s balancing of the risks and benefits under the PMTA “appropriate for the protection of public health” standard. It minimized concerns about youth uptake of the product, dual use of the HTP with conventional cigarettes, the role of menthol flavoring in other tobacco products that make them appealing to a variety of especially vulnerable groups, and patterns of use and resulting harms when there is wide availability of e-cigarettes. Introduction of HTPs to a rapidly evolving U.S. e-cigarette market where people are already confused about where various products along the continuum of risk stand may exacerbate existing misperceptions about risk and dilute efforts to effectively target accurate relative risk communications.

I understand the agency had to make a judgment call based on existing data and projecting how uncertainties might play out, but their calculus seems to ignore warning signals from the past about an industry not to be trusted. I’d like to believe current representations by Juul and other major multinational tobacco companies engaging in reduced risk product development that the elimination of conventional cigarettes really is their goal, but it’s also hard to take them seriously when they continue to promote the very product they say they’re working against (or partner with companies that do) and undermine effective tobacco control policies that would reduce the use of conventional cigarettes.

So now I get to have my cake and eat it, too. Yes, I’m disappointed that we’ll soon be seeing more widespread use of HTPs in the U.S., but I also hope that the new variety of tobacco products along the “continuum of risk” that tobacco harm reductionists have so badly wanted will now bolster what tobacco control efforts have for so long been about and help us all really focus on what everyone says the real problem is: conventional cigarettes. There are no more excuses that strong policies to reduce, and eventually eliminate, conventional cigarettes will leave smokers without options.  

Posted in FDA, Food and Drug Law, Non-Communicable Diseases, Tobacco ; Tagged: , , .

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The views reflected in this blog are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.

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