FDA’s Marketing Denial Orders: JUUL
July 7, 2022 | Napoli Shkolnik News
On June 23, 2022, the FDA issued Marketing Denial Orders to JUUL Labs, maker of the popular JUUL e-cigarettes, covering all their products currently marketed in the United States.
JUUL immediately filed an appeal, and on June 24 the US Court of Appeals for the District of Columbia put a hold on the order while JUUL proceeds with its appeal.
Given the harm that nicotine-containing products do, the FDA’s jurisdiction over companies that produce these products includes the extraordinary power to remove them from the stream of commerce if they don’t meet consumer safety guidelines.
JUUL, along with other e-cigarette companies, has come under fire in recent years for marketing its products to minors—even going so far as to produce flavored e-liquid (or “juice”) intended to appeal to younger smokers.
Although JUUL stopped selling all its flavors except tobacco and menthol, it remains the most popular brand among young people. And as the standard-bearer for e-cigarettes in general, it’s received special scrutiny.
In the case of the Marketing Denial Orders, JUUL argues that this extra scrutiny, especially by members of Congress, has led the FDA to take actions it wouldn’t take under normal circumstances.
That includes not providing a “winding down” period that would allow the company can at least sell the products currently in the commercial stream.
But the fact remains that e-cigarettes, which have been shown to cause unique harms such as popcorn lung as well as carrying the risks of nicotine addiction, have been marketed broadly as a safer alternative to traditional cigarettes.
That has caused millions of Americans to vape even when they wouldn’t otherwise smoke—both adults who believed that they weren’t harmful and teenagers who were drawn in by flavored juices and didn’t think they carried the same risks as cigarettes.
That means JUUL and other e-cigarette companies have caused significant damage to individual Americans’ health.
To make matters worse, the June 23rd Marketing Denial Orders weren’t triggered by JUUL’s marketing, but rather by conflicting evidence in the scientific reports for its products.
Regardless of whether political pressure influenced the severity of the action, the Administration’s concern stemmed from the data it provided, suggesting that JUUL was either not exhaustive in its research or intentionally omitting data from the information provided to the FDA.
So what does this mean to those who have been harmed by e-cigarettes produced by JUUL or other companies?
Areas of Harm
Since the e-cigarette was introduced as an alternative to traditional tobacco cigarettes, vaping has been shown to cause several kinds of harm, leading personal injury lawyers to file a rash of lawsuits over the past several years.
JUUL alone has been sued over 2,000 times, and the number is only growing.
The most common complaints are:
Although e-cigarettes contain nicotine and are more addictive than traditional cigarettes, JUUL and other companies have been accused by thousands of plaintiffs, as well as public agencies including the FDA, of targeting minors with their advertising and product selection.
That’s led to a dramatic rise in youth vaping, which can be attributed to the companies’ actions.
Nicotine forms an extremely potent addiction. Because it’s not intoxicating, and because it has a long cultural history, nicotine is generally seen as a “less bad” addiction than other drugs.
But being addicted to any substance is, itself, a health problem that requires treatment and can lower an individual’s quality of life.
In 2019, a swarm of reports revealed that users of e-cigarettes experienced a wide variety of breathing problems, ranging from limited lung capacity to severe injuries like bronchiolitis obliterans organizing pneumonia, which can have a long-term impact on quality of life, especially among teens.
Seizures and Strokes
Nicotine toxicity—which occurs when an individual receives an “overdose” of nicotine—is known to cause seizures and strokes, most often when young children accidentally chew on nicotine gum or patches.
In April of 2019, the FDA reported that vaping products may also increase the risk of seizures.
Most incidents of poisoning related to e-cigarettes stem from an individual ingesting e-liquid, resulting in an overdose.
Although vaping products carry labels warning of the poisoning risk, labels are often not read and heeded—especially among teenagers.
Poisoning from ingesting e-liquid is severe and can be fatal.
The e-liquids used in e-cigarettes can contain toxic chemicals, including volatile organic compounds and heavy metals, such as nickel, tin, and lead.
When e-cigarette manufacturers fail to ensure that their supply chains, designs, and manufacturing processes are safe, dangerous concentrations of those chemicals can lead to injury or illness.
In addition to the harms listed above, e-cigarettes including those manufactured by JUUL have caused injuries due to product defects, such as battery explosions.
Thousands of these injuries have occurred in recent years, and they can be severe: in one well-publicized case a teenager’s jaw was blown open when his e-cigarette exploded in his mouth.
The Market Denial Orders
Although the FDA asserted that it has not received clinical information suggesting that either the JUUL device or JUUL pods present an immediate health risk, the Marketing Denial Orders were triggered by conflicting and insufficient data related to genotoxicity and the potential for harmful chemicals to leach from the company’s e-liquid pods.
In the FDA’s view, that made it impossible to reach a determination about the product’s toxicity. In other words, although the FDA didn’t say JUUL products were immediately harmful, it said the company had not provided the evidence to support its claim that they were not.
This is especially relevant in light of the dangers e-cigarettes pose—namely, the risks of toxicity and other injuries.
For those who have been injured, the FDA’s ruling validates the theory that the company has made insufficient scientific effort to ensure that its products are free of toxins and will operate safely.
And while there may indeed have been pressure on the FDA to act, the severity of the move reflects a sober view among regulators of JUUL’s corporate responsibility and governance.
If You’ve Been Injured
There are likely to be numerous appeals in JUUL’s case, so the final outcome remains to be seen.
However, the process itself will likely move significant amounts of information into public court filings, making it available to attorneys fighting for those who have been injured by JUUL and other e-cigarettes.
That, along with the allegations made in the Market Denial Orders, is good news for injured parties seeking relief.
With thousands of cases already moving their way through the legal system, JUUL faces an uphill battle to defend itself.
If you’ve been injured, the FDA encourages you to report any unexpected health problems through the Safety Reporting Portal.
In addition, speaking with a qualified personal injury attorney will help you understand the process of filing a suit and the strength of your case.
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