From vapes to snus and nicotine pouches, we have a growing array of much safer substitutes for the combustible cigarettes that cost almost a half million lives each year in the United States.
That’s crucial, when individuals who switch from smoking have a variety of different needs. Some won’t find vaping helpful until they hit upon the right flavor, for example. To some, hand-to-mouth action and inhalation are essential elements for harm reduction products to replace; for others, it’s more about the nicotine, and oral products are more convenient.
But others still may prefer the smell and taste of tobacco, delivered over shorter periods—the harm reduction option that perhaps most closely replicates the cigarettes they’re trying to quit, only without the deadly smoke. And that’s why heated tobacco products have a vital role to play.
Heated tobacco products have a real-world track record of being linked with large-scale reductions in smoking.
Modern heated tobacco products (HTP) are devices that heat (but don’t burn) sticks of tobacco to produce vapor. The fact that they don’t produce smoke makes them much less harmful than cigarettes.
HTP also have a real-world track record of being linked with large-scale reductions in smoking—notably in Japan, where HTP were introduced a decade ago.
So what about the States? Regulatory requirements and court cases concerning copyright have greatly hindered HTP access here. But federal decisions over the next few years will be critical in determining how soon the country can make smoking obsolete. The evidence suggests it is time for the Food and Drug Administration (FDA) to lower barriers and allow more HTP to market.
While modern HTP are relatively new, the science behind heating tobacco is not. Researchers have understood since at least the 1970s that it is smoke (not nicotine) which causes most harms related to tobacco use. And ever since, manufacturers have sought to develop technologies that provide satisfying nicotine delivery for people who smoked, without those smoke-related harms.
HTP, in a very different form from later models, first entered the US market in the 1980s. First came Premier, which utilized a “small piece of charcoal-like carbon” to heat the tobacco. In 1994 the Eclipse HTP was introduced, later rebranded as “Revo.” Various factors severely limited any impact of these early models, whose harm reduction potential is disputed, on US smoking, although Eclipse is still authorized by the federal government to be offered for retail sale.
In 2009, the FDA was granted regulatory authority over tobacco products, and with that came a slew of strict restrictions and requirements to introduce new products to market. To date, the FDA has still authorized only two HTP for sale: Eclipse and IQOS.
Eclipse resembles traditional cigarettes, with each tobacco stick having a charcoal tip at the end to heat it, to be discarded after each use. But IQOS—which was the first HTP to be introduced in Japan—is an electronic device to which you attach a tobacco stick, with only the stick being discarded after use.
The products are also treated quite differently under federal regulations. The Eclipse was granted a “substantial equivalence” marketing order by the FDA in 2018, largely because the product was on the market prior to February 15, 2007.
But because IQOS was unlike any previously available product, it was subject to the FDA’s onerous premarket tobacco product application (PMTA) pathway to be authorized for sale.
The FDA granting a modified risk order was a significant step in acknowledging potential benefits of HTP—and of tobacco harm reduction more broadly.
In 2019, the FDA authorized the marketing of an earlier version of IQOS, deeming it “appropriate for the protection of public health” for producing “fewer or lower levels of some toxins than combustible cigarettes.” In 2020, the agency also granted a supplemental marketing authorization for the IQOS 3 model.
These PMTA applications, requiring reams of scientific evidence, cost more than any but the biggest manufacturers can afford. Newer products may also be subject to entirely new applications, depending on FDA decisions.
In 2020, IQOS additionally became the only HTP to date authorized under a different FDA pathway, as a modified risk tobacco product (MRTP). MRTP orders are issued to a “single specific product,” rather than the entire class (i.e, all HTP). To be granted an MRTP, a manufacturer must demonstrate to the FDA that “the product will or is expected to benefit the health of the population as a whole.”
That decision was a significant step in the FDA acknowledging the potential benefits of HTP—and of tobacco harm reduction more broadly.
But other parts of the world are moving much faster. In 2014, an estimated 100,000 HTP devices and 15 million heated tobacco sticks were sold worldwide. By 2021, nearly 30 million HTP devices and over 125 billion heated tobacco sticks were sold.
Increased HTP use has correlated with declines in smoking. In Japan, one report estimates that within five years of the introduction of HTP in 2014, cigarette consumption there decreased by an incredible 44 percent—the biggest decline the country had ever seen.
Even researchers at the American Cancer Society—no champion of tobacco harm reduction—have noted that, “The introduction of IQOS likely reduced cigarette sales in Japan.”
We need all the tools we can get, and inaction costs lives.
Now, three major HTP brands are available in the country. A 2023 study found dramatic increases in HTP use from 2015-18 among Japanese people who formerly smoked and those currently smoking (whether or not they intended to quit)—but not among people who had never smoked.
As of 2022, more than 30 million US adults were currently smoking. All of them deserve access to a wide range of harm reduction options, and the chance to find out what helps them to quit cigarettes and live a healthier life. For many, the best answer might be a heated tobacco product, but when only one recent HTP has been authorized, their chances are limited.
It’s down to the FDA to improve their chances. If the agency knows that one HTP can “benefit the health of the population as a whole,” this must surely apply to other, comparable products. We need all the tools we can get, and inaction costs lives.
Photograph of heated tobacco product and vapes by Vaping360 via Flickr/Creative Commons 2.0
The Influence Foundation, which operates Filter, has received unrestricted grants from Reynolds American, Inc. and Philip Morris International, which manufacture products mentioned in this article. The author’s employer, the Taxpayers Protection Alliance, previously made a one-off donation to The Influence Foundation to support travel to a harm reduction event. Filter’s Editorial Independence Policy applies.
Show Comments