FDA snuffs out cloud of e-cigarette and vaping products but delays big ruling

vaper9112021-220x300The federal Food and Drug Administration punted on a scheduled showdown over e-cigarettes, delaying decisions on whether to allow Juul and other market-dominating firms to keep selling trendy “smokeless” devices while also banning millions of vaping products from other, mostly smaller manufacturers.

The agency argued with a defensive and defiant tone that it had acted on 6.5 million filings and 93% of the requests for approval to market e-cigarette and vaping-related products, rejecting most (including millions of flawed  applications from a single applicant).

But the FDA said it needed more time — how much it didn’t say — to weigh evidence from big e-cigarette makers who hold sway over 40% of the market. They claim their products’ benefits in helping adults stop smoking tobacco, especially killer cigarettes, outweighs the harms they cause to young people, likely addicting new generations to health-damaging nicotine and opening a gateway to tobacco and marijuana consumption.

Anti-tobacco groups, which had sued the FDA to get it to stiffen its oversight of vaping and e-cigarettes, were incensed by the agency ignoring a court-ordered Sept. 9 deadline to deal with Juul and other manufacturers. Matthew Myers, president of the Campaign for Tobacco Free Kids, told Stat, the medical and scientific news site, this:

“While FDA has said it has ruled on 93% of the applications, it hasn’t ruled on the products that have driven the youth e-cigarette epidemic. Every day those products remain on the market, our kids remain in jeopardy. It is very frustrating that this problem has been allowed to fester for more than a decade. There needs to be a resolution and a resolution quickly.”

The FDA did not say when it will rule on Juul and other major e-cigarette makers, and opponents of the devices and their use in vaping were still deciding if and when to return to the courts to potentially seek further remedy in getting the agency to act.

It also was left up in the air as to when or how the FDA might enforce its regulatory decision against the vendors and smaller makers of vaping products now sold in stores across the country. The FDA said its enforcement powers allow it to shut down sales at any time and in any place now of vaping goods it has banned — with the uncertainty of this occurring upsetting the affected parties. Gregory Conley, president of the American Vaping Association advocacy group, told Stat this:

“It is absolutely absurd that the same agency that found time to ban over 6 million vaping products manufactured by small businesses is now indicating they need more time to review products with massive market shares.”

Anti-smoking groups have prodded the FDA for years to stop the rise of alternatives to tobacco use, with the Obama Administration — with considerable effort — ready to put in place an e-cigarette crackdown. But before that oversight could occur, officials with the Trump Administration had taken office. And then-FDA Commissioner Scott Gottlieb argued for a different approach. He said more study was needed to disrupt the powerful addictive nature of nicotine, arguing that if this could occur, it likely would lead to reductions in tobacco smoking, a proven and leading cause of illness and death in this country.

While Gottlieb halted the e-cigarette crackdown and planned for more nicotine research, San Francisco-based Juul caught the FDA totally off guard, launching not only a new generation of small, slick devices but also using relentless social media and other sales and marketing channels to make vaping a hot trend among the young. Juul insisted that its devices were a less harmful way to deliver nicotine to users, also asserting that its product was aimed at adults.

The company’s pitches and products showed how it targeted the young and how it amped up the potency of its devices with high nicotine levels. But for months, the company and other major makers raced ahead of increasingly frantic efforts by Gottlieb and the FDA to regulate what educators and parents saw as a sweeping menace to the health of young people.

A growing body of research showed that vaping, contrary to makers’ claims, could act as a gateway to tobacco use. As the nation battled a worsening and lethal crisis with opioid abuse and drug overdoses, FDA officials and many grownups also were aghast the studies showed that vaping and its devices also offered a new and hugely popular way for marijuana users to get stoned.

Just before the coronavirus pandemic erupted, the FDA found itself in the throes of a nightmare in which dozens of previously healthy young people were hospitalized with serious lung conditions after vaping. Authorities eventually tracked down what they believed to be the culprit: the sharp rise among vapers of using tainted street products that often were either less costly or promoted as more potent.

Now, with vaping and e-cigarettes entrenched and a furor likely to ensure no matter what agency experts decide, what’s the path forward for the FDA? Can the agency reverse the popularity of a practice and its devices by fiat? Can regulators keep “hip” goods out of young people’s hands, while providing them to adults only (see the history of the likes of booze and dirty magazines, please)?

Maybe the FDA goes all out and listens to advocates advancing Americans’ health and tries something that hasn’t been done in decades now — get rid of e-cigarettes, vaping products (including flavors and not excepting menthol), and while we’re at it, clamp down on menthol tobacco cigarettes and other flavored tobacco products?

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 fraught with medical errorpreventable hospital acquired illnesses and deaths, and misdiagnoses. Dealing with doctors or being in the hospital are among the last places anyone may want to be for the foreseeable future with the coronavirus pandemic.

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. In the midst of a killer coronavirus 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. And, by the way, it always has been clear that marijuana smoking isn’t beneficial to the lungs.

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. Staying on top of Big Tobacco is no easy task. Once more, Mr. President, maybe the FDA dithering on e-cigarettes and vaping is a sign, along with the messes with the sketchy approval of the Alzheimer’s medication Aduhelm, and the clamor about the agency oversight on vaccines. The FDA needs a fulltime, permanent chief and it is long overdue for the Biden Administration to name one and for the Senate to advise and consent.

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