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FDA Requests More Time to Determine Ruling About E-Cigarettes

The Food and Drug Administration (FDA) asked for additional time before declaring the outcome of the final e-cigarette ruling, which ultimately determines whether or not e-cigarettes can remain on shelves in the United States. On the deadline date, the agency revealed that it had acted on 93 percent of the submitted applications. “However, there’s more work to be done to complete our remaining reviews and ensure that we continue taking appropriate action to protect our nation’s youth from the danger of all tobacco products,” the regulators said in a statement. 

Flavored E-Cigarettes Removed From Shelves

In total, more than 500 companies filed applications for some 6.5 million products by the September 9, 2020 deadline. The FDA’s official order is to authorize vaping products only if the manufacturing company can demonstrate the items are in the interest of public health. In other words, the FDA must compare the potential good of adult cigarette users switching to a less-dangerous option to the potential harm of young people getting addicted to nicotine.

Thus far, the FDA has ordered more than 946,000 flavored products be removed from shelves. For these vaping liquids, which include flavors like apple crumble and cinnamon toast cereal, the agency believes that manufacturers failed to provide sufficient evidence that the products benefit adult smokers enough to outweigh the potential appeal to young people.

The biggest e-cigarette manufacturer in the U.S. is JUUL. A spokesperson for the company said, “We respect the central role of the FDA and the required thorough science- and evidence-based review of our applications. We remain committed to transitioning adult smokers away from combustible cigarettes while combating underage use.”

Reshaping the Market with Final E-Cigarette Ruling

This sweeping review could reshape the e-cigarette market. If products are authorized to remain on the market, manufacturers should expect stricter controls on marketing. This sort on control has already proven beneficial: Youth vaping fell significantly last year after laws raised the legal purchase age to 21 and removed fruity-flavored e-cigarette cartridges from the market.

The agency hasn’t revealed when its review will be completed but did share that many applications are in the final stages of review.

For more information about the investigation into e-cigarettes, including JUUL products, contact us today.

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

FDA to Make Major Decision About Flavored E-Cigarettes

The Food and Drug Administration (FDA) is currently reviewing millions of applications from e-cigarette makers and must decide today if flavored e-cigarettes are “appropriate for the protection of public health.” 

Use of Flavored E-Cigarettes

A study from the Centers for Disease Control and Prevention (CDC) revealed that roughly 15 percent of adult smokers successfully quit smoking using e-cigarettes. Additionally, a study in the New England Journal of Medicine found that, of those smokers who quit, 18 percent remained cigarette-free after a year. 

Despite these positives, e-cigarettes have caused notable harm to public health. Lawmakers and public health advocacy groups focus on vaping’s appeal to teens and even children. A 2020 study from the CDC determined that nearly 20 percent of high school students and 5 percent of middle school students had vaped regularly. These users primarily partake in flavored e-cigarettes. 

Because of this usage by America’s youth, several lawmakers and state attorneys general have urged the FDA to ban all flavors, including menthol. The agency has already banned the sale of reusable flavored e-cigarettes sold by companies like JUUL, but it currently allows the sale of disposable flavored products. 

E-Cigarettes As A Cessation Device

Most public health experts agree that some kind of e-cigarettes should be available to help wean adults from cigarettes. However, anti-vaping advocates believe that flavors are unnecessary to sell e-cigarettes to individuals trying to quit smoking. After all, they are already familiar with tobacco-flavored products. 

Plus, many of these businesses don’t play by the rules. “No one has attempted to file applications or legally market these products [before now]. No one has filed applications to make modified risk claims legally,” explains Desmond Jenson, a lawyer at the Public Health Law Center at the Mitchell Hamline School of Law. “The whole idea that e-cigs are a cessation device — why has no company filed a drug application to say it’s a cessation device?”

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

FDA Removes 55,000 Flavored Vaping Products From Market

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

FDA Removes 55,000 Flavored Vaping Products From Market

Last week, the Food and Drug Administration (FDA) ordered three small e-cigarette makers to pull their products from the market, signifying the beginning of a larger agency crackdown on vaping products. JD Nova Group LLC, Great American Vapes, and VaporSalon must pull 55,000 existing or future flavored products from stores. These products include flavors like Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal. 

FDA Crackdown Against Flavored Vaping Products

According to regulators, the companies failed to provide “sufficient evidence” that their products offer a net public health benefit for adult smokers when compared to the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes. These FDA orders mark the agency’s first marketing denials for e-cigarettes. “We know that flavored tobacco products are very appealing to young people, therefore assessing the impact of potential or actual youth use is a critical factor in our decision-making about which products may be marketed,” Janet Woodcock, acting commissioner of the FDA, said in a statement.

Of course, the agency’s orders come during a broader fight against the future of vaping. Public health advocates believe that e-cigarettes, especially flavored ones, have spurred an epidemic of nicotine-addicted youth rather than helping adults quit smoking. The FDA will determine the future of about two million vaping and other non-cigarette tobacco products by September 9th. 

Vaping advocates, however, are alarmed at the FDA’s decision and shared a warning that the broader industry is in danger. As one tweet stated, “FDA bans 55,000 flavored e-cigarette products, crippling three vape companies. FDA clams applicants failed to demonstrate they are a net benefit to public health. No worries though, people can just switch back to smoking! #publichealth”

E-Cigarettes and America’s Youth

The focus here lies in potential danger to America’s young people. As the FDA prepares to rule on JUUL and other major companies, a regulator stressed that the agency would be carefully considering the potential risk to children. “Companies who want to continue to market their flavored [e-cigarette] products must have robust and reliable evidence showing that their products’ potential benefit for adult smokers outweighs the significant known risk to youth,” Mitch Zeller, director of the FDA’s Center for Tobacco Products, said.

For more information about the investigation into flavored vaping products, contact us today.

Additional Reading:

Judge Advances Bellwether Lawsuit Against JUUL for Deceiving Marketing Tactics

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Judge Advances Bellwether Lawsuit Against JUUL for Deceiving Marketing Tactics

E-cigarette company JUUL is facing a bellwether lawsuit that argues its top executives intentionally deceived customers about the addictive qualities of vaping products. Specifically, the suit blames the company’s founders and board members as well as their biggest investor, Altria, of using marketing campaigns to target young people and create a new generation of nicotine addicts.

Active Case

Plaintiff Claims in E-Cigarette Bellwether Trial

At the end of July, U.S. District Judge William Orrick III refused to throw out most of the claims filed by 19 bellwether plaintiffs from 14 states in the multi-district class action lawsuit. Ultimately, he advanced both conspiracy and fraud claims, bringing the lawsuit closer to trial.

The plaintiffs are between the ages of 15 and 27 with some claiming they got hooked on e-cigarettes as young as 12 years old. They say that the e-cigarette company failed to warn consumers that their products were highly addictive. Allegedly, JUUL even falsely claimed in ads and on product labels that the pods contained 5 percent nicotine (that same amount in a pack of cigarettes) when, in truth, the levels are much higher. Additionally, they believe that JUUL marketed its vaping products as a “safer alternative” to cigarette smoking.

The Response of JUUL’s Top Executives

JUUL founders and top executives James Monsees and Adam Bowen asked the federal judge to dismiss claims of fraud, negligence, negligent misrepresentation, strict product liability, and medical monitoring, arguing that they were not personally involved in the testing, design, marketing, or sale of the vaping products. However, Judge Orrick rejected their claims, believing that the plaintiffs “adequately alleged that both Monsees and Bowen engaged in acts that had the intent and impact of misleading the public and plaintiffs about the dangers of JUUL.” 

The judge also refused to let three board members — Nicholas Pritzker, Hoyoung Huh, and Riaz Valani — off the hook for fraud and negligence, finding them to have a direct role in the alleged wrongdoing. 

In an earlier court decision from April, Judge Orrick ruled that Altria and JUUL’s board members could potentially be held liable under the Racketeer Influenced and Corrupt Organizations Act. These claims are the result of the belief that the defendants treated JUUL like an illegal enterprise and conspired to target young people and create a generation of nicotine addicts, omit necessary information about nicotine content, and mislead government regulators in an effort to continue selling to children. 

For more information about the investigation into JUUL, contact us today.

Additional Reading:

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

JUUL Settles North Carolina Youth Vaping Case for $40 Million

At the end of June, Attorney General Josh Stein announced that JUUL settled with North Carolina for $40 million. The state alleged that the e-cigarette company aggressively marketed its products to young people through social media advertisements and other outlets, leading to a notable increase in youth vaping. 

Active Case

Underage E-Cigarette Use and Marketing Tactics

“For years, JUUL targeted young people, including teens, with its highly addictive e-cigarette,” Stein shared in a statement. “It lit the spark and fanned the flames of a vaping epidemic among our children — one that you can see in any high school in North Carolina.”

Under the consent order, JUUL must adhere to several marketing restrictions, including little to no social media advertising, no outdoor advertising near schools, and no sponsorships of sporting events and concerts. While the e-cigarette company has voluntarily adhered to many of these rules, it’s now considered the law in North Carolina. The company also agreed to stop the sale of sweet and fruity flavored e-cigarettes in the state unless given permission by the Food and Drug Administration (FDA).

Youth Vaping Across the Country

Although North Carolina is the first state to reach a settlement with JUUL, an additional 12 states and Washington D.C. have also sued the company. From a national perspective, Stein encouraged the FDA to prohibit all non-tobacco flavors, including menthol, in e-cigarettes; to limit the level of nicotine in e-cigarette products; and to impose strict marketing guidelines to prevent attracting young people.  

Youth vaping has been on the rise since 2017, with JUUL at the center of the e-cigarette controversy from the beginning. In fall 2019, the company stopped selling flavored vaping pods, excluding tobacco and menthol. 

Even so, the e-cigarette manufacturer denies any wrongdoing and liability. In a statement, spokesperson Josh Raffel said that the agreement with the state of North Carolina “is consistent with our ongoing effort to reset our company and its relationship with our stakeholders, as we continue to combat underage usage and advance the opportunity for harm reduction for adult smokers.”

For more information about the investigation into JUUL, contact us today.

Additional Reading:

North Carolina Takes Legal Action Against JUUL

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

North Carolina Takes Legal Action Against JUUL

North Carolina Attorney General Josh Stein recently filed a lawsuit against e-cigarette company JUUL for its marketing tactics towards young people. Stein argues that these practices have played a role in creating “an epidemic among minors.” This statement is supported by, among other evidence, a 2017 report that revealed 17 percent of all North Carolina high school students had used an e-cigarette within the last 30 days. 

Stein’s investigation, which began last fall, hopes to show that JUUL failed to highlight the potency and danger of nicotine. If found guilty, the e-cigarette company would be in violation of North Carolina’s Unfair and Deceptive Trade Practices Act. 

Notable Increase in E-Cigarette Usage

“JUUL’s business practices are not only reckless — they’re illegal,” Stein shared. “We cannot allow another generation of young people to become addicted to nicotine.” He also revealed that the average potency of a JUUL pod is nearly three times the concentration allowed for sale  for people of all ages in countries around the world. 

Within the last year, e-cigarette use has increased among high schoolers across the country by 78 percent and middle-schoolers by 48 percent. North Carolina is the first state to come forward with allegations against JUUL. 

For more information about the investigation into JUUL, contact us today.

Additional Reading:

JUUL Labs Faces “Substantive Scientific Review” from the FDA

E-Cigarette, Vaping, and Juul Bans

Juul and Vaping Side Effects

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