FDA Makes Giant Leap Forward in Tobacco Harm Reduction

FDA Makes Giant Leap Forward in Tobacco Harm Reduction
(AP Photo/Jacquelyn Martin, File)
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Across the U.S., tens of millions of smokers face a daily struggle to kick their deadly habit. Each traditional, combustible cigarette smoked poses multiple health risks ranging from lung cancer to heart disease to chronic obstructive pulmonary disease. Fortunately, smokers now have access to reduced risk technologies such as tobacco heating systems. Now, after more than three years of dithering, the Food and Drug Administration (FDA) allowed a tobacco harm reduction product called “IQOS” (which heats tobacco instead of burning it) to be marketed toward consumers as having “reduced exposure” to harmful chemicals. While this a large leap forward for consumer access to one healthier smoking alternative, there’s far more work to be done. For the sake of millions of smokers, the FDA must permit the sale and marketing of other reduced risk products such as vapes. Countless lives hang in the balance.

On July 7, after careful thought and consideration, the FDA announced that they had authorized the marketing of IQOS as a “modified risk tobacco product.” The FDA came to the decision after the producer demonstrated that, “because the IQOS Tobacco Heating System heats tobacco and does not burn it, it significantly reduces the production of harmful and potentially harmful chemicals compared to cigarette smoke.” The agency green-lit the sale of IQOS devices in April 2019, but without giving its producer the ability to market safety benefits to consumers. But now the FDA has realized the benefits of allowing consumers to make an informed choice that could very well save their lives.

FDA’s Center for Tobacco Products Director Mitch Zeller noted that, through the lengthy application and evaluation process, “the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable. Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.” And from day one, it was readily apparent that IQOS is a safer, healthier alternative to cigarette smoking.

In 2017, a team of researchers led by tobacco heating system skeptic Dr. Reto Auer of the University of Bern in Switzerland analyzed the carcinogenic content from an IQOS puff, compared to the traditional cigarette brand Lucky Strike.  The results spoke for themselves: levels of polycyclic aromatic hydrocarbons (PAH) found in IQOS aerosol were significantly lower than for cigarette smoke. IQOS aerosol was checked for thirteen PAHs, and only one such substance (Acenaphthene) was found to be present at levels comparable to cigarette smoke. In other words, the FDA’s “reduced exposure” finding was a no brainer because IQOS users are exposed to far fewer carcinogenic substances than cigarette smokers. And that’s a big deal, since devices such as IQOS are capable of delivering the smoking sensation that traditional cessation therapies cannot offer.

Harm reduction advocates, however, cannot be lured into complacency following this public health victory. The FDA continues to hold vaping products hostage to an onerous and confusing regulatory approval process, despite e-cigarettes being at least 95 percent safer than conventional cigarettes. The agency regularly yanks “unauthorized” products off the shelves, despite little evidence of harms posed to consumers. And bureaucrats continue to needlessly restrict flavored vapes, despite flavors playing a critical role in helping adult smokers transition away from tobacco.

It makes no sense for the FDA to strictly regulate e-cigarettes as “tobacco products,” since vapes contain no tobacco. Yet agency officials continue to enforce their strict rules with a heavy hand and restrict options for smokers trying to quit.

The FDA should double down on harm reduction and allow tobacco users an array of exit ramps off their deadly habits. Now is the time for action, not complacency. Millions of lives depend on continued reform and innovation.

Ross Marchand is the Vice President of Policy for the Taxpayers Protection Alliance.

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