FDA bans Juul vaping products and seeks to slash nicotine in cigarettes

ashtray-300x195Federal regulators have cracked down on Big Tobacco and its zealous, profit-seeking promotion of products that fuel some of the leading causes of preventable disease in this country: cigarette smoking and vaping.

The federal Food and Drug Administration ordered the maker of Juul, a pioneer in pushing so-called e-cigarettes and vape flavorings on the young, to pull its products off the markets.

Agency experts also made public their plans to order Big Tobacco to slash the nicotine in conventional cigarettes, a move designed to gut the addictive allure that is foundational to an estimated $95 billion-a-year industry.

Juul appealed the FDA ban and has won a temporary reprieve from it. But Altria — the company that now owns Juul and a multinational corporation formerly known as Philip Morris and the maker of Marlboro, already has taken a financial markets’ drubbing tied to the FDA actions.

The rulemaking to diminish nicotine in conventional cigarettes will take a while — years, perhaps, especially if the tobacco industry, as is expected, spends a huge war chest on lobbying the FDA, and, more importantly, Congress and influential members of the political parties.

Still, anti-smoking advocates mostly welcomed the newly aggressive FDA and its dual actions, especially given the shambolic way that the agency has failed to safeguard Americans health and gotten pushed around by corporate interests during the former pro-industry, anti-regulatory presidential administration.

Juul and other companies in recent years took advantage of a flat-footed FDA and its decision to pause oversight of the nascent vaping industry while the agency promised to scrutinize the role of nicotine in the pernicious, persistent health menace of smoking.

Positioning itself as tech entrepreneurs and not traditional tobacco hucksters, Juul created and became a youth sensation with its snazzy devices, nicotine-laden flavor pods, and a powerful exploitation of social media marketing and advertising. Young people, parents, educators, journalists, and anti-smoking advocates swiftly realized that Juul was running circles around the FDA, which seemed all but blind to the zeal with which vaping promoters were finding and targeting a new, youth market.

The FDA for months chased after the vaping industry, eventually imposing new regulation after new regulation to prevent underage, over the counter, and widespread sales of the wildly popular products. The agency, at one, point, grappled with hundreds of cases of patients hospitalized with vaping-related harms — later blamed on users inhaling tainted, street products. The agency had announced months ago a sweeping review of e-cigarette and vaping products, compelling their makers to submit detailed information about the safety, risks, and benefits of them. The agency decided Juul failed the review and in offering a reason to allow its products to be sold.

This, in part, was based on researchers fast finding that rather than providing an alternative to cigarette smoking, a whole new generation of consumers had been introduced through vaping to and gotten hooked on nicotine, and they were moving on to other products, including burning tobacco — items that medical scientists long ago showed to be causes of cancers, as well as other significant lung and heart ills. As the New York Times described the health issue with nicotine:

“Nicotine itself is not the cause of lung cancer and other deadly ills from smoking, but the drug is exceedingly addictive, making it difficult for smokers to quit despite the health risks. The adolescent brain is particularly susceptible to nicotine, which can affect memory, concentration, learning and self-control.”

The Wall Street Journal reported that scientists working with the FDA long have known about the problems that nicotine poses — in creating the high that makes users want to smoke combustible cigarettes or to vape. Even when the former administration wanted more studies of the substance, experts knew much about its detrimental effects and were developing a regulatory response. It could be rolling out soon — or relatively soon, given the too-often glacial pace at which oversight of tobacco often has occurred, the newspaper reported:

“The research, funded by the federal government and conducted by about a dozen universities over the past decade, has shown that when people use cigarettes with very low nicotine levels, they smoke fewer cigarettes, become less dependent on cigarettes, are exposed to fewer toxicants, and make more attempts to quit. Smokers of these cigarettes were more likely to quit or seek their nicotine fix from less-harmful alternatives such as e-cigarettes or gum compared with smokers who continued using regular cigarettes.”

The Biden Administration is working against a ticking clock with its Big Tobacco crackdown, the Washington Post reported:

“The [nicotine slashing] policy would fit with a major goal of the White House — to cut cancer deaths. As part of the White House’s retooled cancer moonshot announced this year, President Biden promised to reduce cancer death rates by 50% over 25 years. About 480,000 Americans die of smoking-related causes each year, and tobacco use remains the No. 1 cause of preventable death in the United States. The decision to pursue a policy to lower nicotine levels marks the first step in a lengthy process, and success is not assured. It could take at least a year for the Food and Drug Administration, which regulates cigarettes, to issue a proposed rule, experts say. After that, the FDA would have to sift through comments from the public before issuing a final rule. Opposition could delay or derail the effort — especially if the regulation is not completed before Biden leaves office. A president elected in 2024 could tell the FDA to stop work on an unfinished rule. The tobacco industry, which is sure to be fiercely opposed to such a drastic change in its products, could challenge a final regulation in court.”

The newspaper quoted Mitch Zeller, the recently retired director of the FDA’s Center for Tobacco Products and is a longtime advocate of reducing nicotine in cigarettes, saying this:

“The most important, game-changing policies take a long time, but it is worth the wait because, at the end of the day, the only cigarettes that will be available won’t be capable of addicting future generations of kids.”

The New York Times reported this reminder of the stakes, present and future, of the nation better controlling the choice by consumers of nicotine use, particularly among the young, by offering a bit of history:

 “By April 2018, the FDA announced a crackdown on the sale of [vaping] products, including Juul’s, to people under the age of 21. [But use] among young people had soared. In 2017, 19% of 12th graders, 16% of 10th graders and 8% of eighth graders reported vaping nicotine in the past year, according to Monitoring the Future, an annual survey done for the National Institute on Drug Abuse.”

In my practice, I not only see the harms that patients suffer while seeking medical services, but also the clear benefits they may enjoy by staying health and far away from the U.S. health care system. It is, according to research conducted in pre-coronavirus pandemic times, fraught with medical errorpreventable hospital acquired illnesses and deaths, and misdiagnoses.

If you don’t smoke, please don’t start. If you smoke, talk to your doctor, and make the challenging effort to stop. There are other ways to do so without taking up vaping. No one argues it is good for you — just that it is less harmful and another possible way to quit smoking. That’s a dubious health argument, akin to asking whether it’s “better” to die in a car or plane crash. Neither, thank you. After many months of battling a killer pandemic, does the nation need anything that can worsen people’s respiratory health, especially as smoking has been shown to inflict major damage on the lungs, heart, and other parts of the body with cancer and other terrible diseases? While the Juul ban is consequential, let’s also not forget that the company’s market share has dwindled, and the FDA has approved another e-cigarette and its Big Tobacco maker to push an increasingly popular product.

And, by the way, it always has been clear that marijuana smoking isn’t beneficial to the lungs.  Increasingly potent marijuana also is posing serious problems for young users.

We’ve got a lot of work to do to make ourselves, our loved ones, and our nation healthier, notably by dealing with avoidable or preventable causes of sickness and death.

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