FDA Stifles Cloud of Electronic Cigarette and Vaping Products But Delays Big Decision | Patrick Malone & Associés PC | DC Personal Injury Lawyers

The Federal Food and Drug Administration has launched a scheduled showdown over e-cigarettes, delaying a decision to allow Juul and other dominant companies in the market to continue selling trendy ‘smoke-free’ devices while banning millions vaping products from other manufacturers, mostly smaller. .

The agency argued defensively and defiantly that it acted on 6.5 million deposits and 93% of approval requests to market e-cigarette and vaping-related products, rejecting most (including including millions of erroneous requests from a single requestor).

But the FDA said it needed more time – how much it didn’t say – to assess the evidence from the big e-cigarette makers who have more than 40 percent of the market. They claim that the benefits of their products in helping adults quit smoking tobacco, especially killer cigarettes, outweighs the harm they do to young people, possibly increasing the health-damaging nicotine in new generations. and opening a door to the consumption of tobacco and marijuana.

Anti-smoking groups, which had sued the FDA to get it to step up its oversight of vaping and e-cigarettes, were enraged by the agency ignoring a court-ordered September 9 deadline for dealing with Juul and d ‘other manufacturers. Matthew Myers, president of the Campaign for Tobacco Free Children, told Stat, the medical and science news site, this:

“Although the FDA said it has ruled on 93% of the applications, it has not ruled on the products that have led to the e-cigarette epidemic among young people. Every day that these products remain on the market, our children remain at risk. It is very frustrating that this problem has been allowed to fester for over a decade. There has to be a resolution and a resolution quickly.

The FDA has not said 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 whether and when to go to court for potentially ask for other remedies to bring the agency to action.

It has also been left open as to when or how the FDA might enforce its regulatory ruling against vendors and small manufacturers of vaping products now sold in stores across the country. The FDA has said its enforcement powers allow it to suspend sales anytime and anywhere of vaping products it has banned – the uncertainty of that happening has parties concerned upset. Gregory Conley, chairman of the American Vaping Association advocacy group, told Stat:

“It is absolutely absurd that the same agency that found the time to ban over 6 million vaping products made by small companies is now saying it needs more time to review products with market share massive. “

Anti-smoking groups have pushed the FDA for years to stop the rise of alternatives to tobacco use, with the Obama administration – with considerable effort – poised to implement a crackdown on e-cigarettes. But before that surveillance could take place, officials in the Trump administration had taken office. And then FDA commissioner Scott Gottlieb argued for a different approach. He said more studies were needed to disrupt the potent addictive nature of nicotine, saying if this could happen it would likely lead to a reduction in smoking, a proven and leading cause of illness and death in this country.

As Gottlieb ended the crackdown on e-cigarettes and planned for more nicotine research, San Francisco-based Juul caught the FDA completely off guard, not only launching a new generation of nifty little devices, but also relentlessly using social media and other sales and marketing channels. to make vaping a fashionable trend among young people. Juul insisted that its devices were a less harmful way of delivering nicotine to users, also claiming that its product was intended for adults.

The company’s pitches and products have shown how it targets young people and how it increases the potency of its high nicotine devices. But for months, the company and other major manufacturers edged out increasingly frantic efforts by Gottlieb and the FDA to regulate what educators and parents saw as a significant threat to the health of young people.

A growing body of research has shown that vaping, contrary to manufacturers’ claims, can be a gateway to smoking. As the nation battled a deadly crisis worsened by opioid abuse and drug overdoses, FDA officials and many adults were also dismayed at studies showing vaping and its devices also offered a new extremely popular way for marijuana users to get high.

Just before the coronavirus pandemic broke out, the FDA found itself in the throes of a nightmare in which dozens of previously healthy young people were hospitalized with serious lung problems after vaping. Authorities finally tracked down what they believed to be the culprit: the sharp increase among vapers in the use of contaminated street products that were often either less expensive or presented as more potent.

Now, with vaping and e-cigarettes ingrained and a fury likely to guarantee, whatever the decision of the agency’s experts, what is the way forward for the FDA? Can the agency reverse the popularity of a practice and its devices by decree? Can regulators keep ‘trendy’ products out of the hands of young people, while only supplying them to adults (see history of alcohol and dirty magazines, please)?

Maybe the FDA is going out of its way and listening to the health promotion advocates of Americans and trying something that hasn’t been done in decades – getting rid of e-cigarettes, vaping products (including flavors and except menthol), and while we’re at it, crack down on menthol cigarettes and other flavored tobacco products?

In my practice, I see not only the harms patients experience when seeking medical services, but also the obvious benefits they can enjoy by staying healthy and away from the American healthcare system. It is riddled with medical errors, preventable hospital illness and death, and misdiagnosis. Dealing with doctors or being in the hospital are some of the last places one might want to be in 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 an effort to quit. There are other ways to do this without starting to vape. No one is saying it’s good for your health, just that it’s less harmful and that it’s another possible way to quit smoking. It is a questionable health argument, which amounts to asking whether it is “better” to die in a car or plane crash. Neither, thank you. Amid a deadly coronavirus pandemic, does the nation need anything that can worsen people’s respiratory health, especially since smoking has been shown to inflict major damage on people? lungs, heart and other parts of the body with cancer and other terrible diseases. And, by the way, it has always been clear that smoking marijuana is not good for the lungs.

We have a lot of work to do for ourselves, our loved ones, and our healthier nation, including addressing the preventable or preventable causes of illness and death. Staying on top of Big Tobacco is no easy task. Once again, Mr. President, perhaps the FDA procrastinating on e-cigarettes and vaping is a sign, as well as the damage with the sketchy approval of the Alzheimer’s drug Aduhelm, and the clamor at the subject of agency surveillance on vaccines. The FDA needs a permanent full-time leader and it is high time the Biden administration appointed one and the Senate gave its advice and consent.

About Margaret Shaw

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