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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

Lung Injuries in Teens Linked to Vaping Marijuana

A recent study reveals that teens are nearly twice as likely to report “wheezing or whistling” in the chest after vaping marijuana than after smoking cigarettes or e-cigarettes. While we know that cigarettes and e-cigarettes are unhealthy and damaging to the lungs, it appears that vaping marijuana has even worse health implications. 

Study author Carol Boyd, co-director of the Center for the Study of Drugs, Alcohol, Smoking & Health at the University of Michigan in Ann Arbor, was surprised by these results. “We thought we would find more negative respiratory symptoms in both cigarette and e-cigarette users,” she explains. “I recommend parents treat all vaping as risky behavior (just like alcohol or drug use).”

Vaping marijuana is also associated with a newly-identified lung disease called EVALI, which stands for e-cigarette or vaping product use-associated lung injury. This dangerous illness was first identified in August 2019 by the U.S. Centers for Disease Control and Prevention (CDC) after seemingly-healthy young people from around the country were hospitalized for severe and even fatal lung infections. 

A link between the condition and vaping was soon discovered with blame being placed on the use of vitamin E acetate. This sticky oil substance, which is added to thicken or dilute the oil in cartridges, is most often used in vaping products with THC, the primary psychoactive compound in marijuana. “According to the CDC, 84 percent of the EVALI cases were associated with cannabis-containing products,” Boyd says. 

Vaping and Juul
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