Did FDA just let Big Tobacco put another burn on Americans’ health?

iQOS-300x240Federal regulators appear to be getting caught flat-footed yet again as Big Tobacco’s harms metastasize before their very eyes. The federal Food and Drug Administration has given a qualified go-ahead to Philip Morris International to sell a device that heats but does not burn tobacco, a process that appears to expose users to fewer harmful toxins.

Still, the iQOS gadget packs the same wallop of highly addictive nicotine as does a standard, tobacco-burning cigarette. And the FDA decided it would be regulated just as cigarettes are, thereby restricting its sales and marketing to young people.

Big Tobacco executives talked up iQOS (eye-kos) as yet another way for smokers of their proven and deadly burned tobacco cigarettes to get unhooked from them and to lessen their health harms.

Isn’t this just a variant of the argumentative fog that Big Tobacco used on Scott Gottlieb, the former FDA commissioner who delayed tough rules on vaping and e-cigarettes while studying if they could reduce tobacco use and damage? While the FDA dawdled, the e-cigarette Juul became a youth phenomenon, snatching up a huge market share and, as the agency and Gottlieb conceded, addicting millions of young people to nicotine — a substance in itself harmful and which had been the focus of the commissioner’s grand plan to slash smoking.

Big Tobacco foes assailed the conditional approval for iQOS gadgets, noting they are a dodge and damage users health, no matter the claim that this may be less than what occurs with burning tobacco cigarettes. The New York Times quoted Erika Sward, an assistant vice president of the American Lung Association, as saying: “Inhaling chemicals and toxins into one’s lungs always poses risks. Lungs are on the front line — and have been showing immediate results of being exposed to chemicals — whether in the workplace, using tobacco products or outdoor air pollution.”

Philip Morris has introduced and sold iQOS elsewhere, with the product failing to gain the public attention in Japan or Italy that e-cigarettes have in the United States. The devices will be sold domestically with Marlboro Heatsticks, Marlboro Smooth Menthol Heatsticks, and Marlboro Fresh Menthol Heatsticks. They will be sold in 500 of so stores, including Circle K, Murphy USA, QuikTrip, RaceTrac, Speedway, and other retailers.

The American distributor for iQOS will be Altria, a firm that should be familiar to anti-tobacco advocates, because it is the corporation that holds a 35% stake in Juul, which holds 70% of the U.S. vaping and e-cigarette market. Further, Altria is a $1.8 billion investor in a Canadian cannabis concern.

While Philip Morris has expressed concern that its iQOS product hasn’t gotten the attention or shelf space of, say, Juul devices (which have faced a major FDA crackdown), Altria now finds itself at the center of a web of substance-inhaling devices and products. The company has pledged to focus its powerful marketing on selling e-cigarettes to adults and not to the youth market it now dominates. But even as it talks up vaping curbs among kids in Washington, D.C., it has dozens of lobbyists in state capitols pushing a different view.

The firm’s activity on multiple fronts should be a concern to parents, politicians, and regulators, new research from the independent, nonpartisan RAND Corporation suggests. As the think tank reported:

Studying a group of young adults from California, researchers examined the many different ways that cannabis and tobacco or nicotine products are used together—a byproduct of the introduction of new vaping devices and other delivery methods. Among those surveyed, young adults who used cannabis and tobacco or nicotine together in some way (either using one right after the other or by mixing the products together) tended to consume more marijuana and tobacco or nicotine products, and report poorer functioning and more problematic behaviors compared to those who did not use both products together. … ‘There is growing concern that as more states legalize marijuana, there also will be an increase in tobacco use because the two substances may be used together,’ said Joan Tucker, lead author of the study and a senior behavioral scientist … ‘Co-use of cannabis and tobacco could reverse some of the progress made on reducing rates of tobacco use.’

This is not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the terrible toll that tobacco abuse has inflicted on tens of millions of Americans. As the New York Times reported, “Although smoking rates have declined, cigarettes still kill about 480,000 people every year.” Smoking is a proven cause of several kinds of cancer and it damages the heart, lungs, skin, and other tissues.

Americans recorded important health gains when officials stuck to a simple, direct message: Big Tobacco and its products must be avoided because they are harmful. It’s unacceptable that this evidence-based position has been eroded and corrupted by messaging too clever by half. Don’t believe this? Researchers say they’re struggling to study the epidemic of vaping and e-cigarettes, partly because of language confusion: Young people may not be giving them accurate information because they call their habits with a different term: “Juul-ing.”

How did we lose the clarity of this message: Inhaling smoke or vapor from catalyzed substances is bad for your lungs, as is taking in addictive nicotine. Focusing on nicotine alone was misguided, and just reducing its consumption isn’t a full-on deterrence strategy. It’s crazy that regulators get giddy, too, about less- and not zero-product harm. It’s unacceptable to allow sales of a device on this basis — that warmed tobacco is OK because it is less lethal than if it is burned? Would we allow a machine that only lopped off arms but didn’t kill its users? In dealing with Big Tobacco, the FDA isn’t exercising nanny state oversight — it’s acting more like a lot of ninnies. If the agency can’t stop rolling over to the industry, folks in Congress need to ask why and fix this, stat.

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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