Understanding the FDA Ban on Sales of JUUL E-Cigarettes

PENSACOLA, FL (JULY 18, 2022) - On June 23, 2022, the U.S. Food and Drug Administration (FDA) announced its ban on the sale of JUUL e-cigarettes across the country. The FDA’s order meant that JUUL was required to stop selling and distributing its e-cigarette products. The order applied to all the company’s products marketed in the U.S. “In addition, those currently on the U.S. market must be removed, or risk enforcement action,” the FDA stated.

Although FDA stayed the marketing denial order on July 5, 2022, the temporary suspension does not mean the order has been rescinded. Rather, the ban represents a major win against a company that Pensacola-based national law firm Levin Papantonio Rafferty (LPR) has been fighting in court for the last three years. LPR Attorney Matt Schultz serves on the trial team for civil litigation currently happening in California. In his eyes, the FDA’s order strikes at the heart of a business model that effectively crippled the country with nicotine addiction.

“Cigarette manufacturers have long known that if people don’t begin smoking before age 18, they are extraordinarily unlikely to ever begin,” Schultz explained. “Because the industry eventually kills a substantial proportion of its customer base, and because virtually no one takes up nicotine after age 18, the industry has targeted youth going back to the 1920s.”

Schultz underscored his point by referencing the infamous 1978 memo sent from an area sales manager to the president of the Lorillard Tobacco Company: “The base of our business is the high school student.”

JUUL Labs Inc. (JLI)—the company that invented and began selling JUUL in 2015—imitated Big Tobacco’s nefarious practices to create a kid-friendly nicotine product that it rolled out with its youth-oriented “Vaporized” ad campaign. The marketing went viral. Youth e-cigarette use skyrocketed, and JLI made a bundle of cash, eventually attracting a $13 billion investment from tobacco titan Altria, which owns Phillip Morris, maker of Marlboro cigarettes.

FDA Commissioner Dr. Robert M. Califf stressed the agency’s commitment to ensuring that all e-cigarettes currentl being marketed to consumers meet the FDA’s public health standards. “The agency has dedicated significant resources to review products from the companies that account for most of the U.S. market. We recognize these make up a significant part of the available products and many have played a disproportionate role in the rise in youth vaping,” Califf said.

Electronic cigarettes (also known as e-cigarettes, e-cigs, and vaping products) are designed to look like cigarettes, writing pens, USB flash drives, and other common products. Although other companies manufacture e-cigarettes and vape products, JUUL was new and different when introduced in 2015. It eventually acquired more than 70% of this market, though its popularity fell when it discontinued its kid-friendly flavors after a public backlash against the company in 2018.

JUUL’s popular e-cigarettes consist of the JUUL device, which resembles a USB flash drive, and disposable pods containing flavored e-liquids laden with nicotine. Each pod delivers as much or more nicotine as a pack of traditional cigarettes, but it doesn’t burn out and can be used discreetly, as happened in thousands of middle and high schools across the country.

JUUL’s innovation was not limited to its flash drive appearance. Before JUUL came to market, all e-cigarettes used nicotine in its unprotonated or “freebase” form, which is harsh on the throat when inhaled and which served as a practical limit on the concentration of nicotine in existing e-cigarettes. JLI mixed its nicotine with benzoic acid, forming a nicotine “salt.” Not only is nicotine in its “salt” form less harsh when inhaled, but it also delivers deep into the lung, while the “freebase” nicotine in existing e-cigarettes was absorbed mostly in the mouth.

JUUL’s delivery of nicotine to the deep lung meant extremely fast delivery to the brain, enhancing the product’s addictive power. JLI’s manipulation of nicotine into its “salt” form thus generated a vapor that was smooth, mild, and easy to inhale. Because it was not as harsh as existing e-cigarettes, JLI could pack much more nicotine into its e-liquids than other products, and, in fact, it contained two to three times as much nicotine as all existing e-cigarettes while remaining easier to inhale and delivering nicotine deep into the lung where it is rapidly absorbed. JLI marketed this product in kid-friendly flavors like Mint, Mango, and Fruit Medley, coupled with an ad campaign that fueled what former FDA commissioner Dr. Scott Gottlieb called “an epidemic of e-cigarette use among teenagers.”

Besides the danger of lifelong nicotine addiction, FDA has identified other health risks linked to vaping. When heated, vape products can produce particles of heavy metals (cadmium, chromium, lead, manganese, and nickel) that can become lodged in lung tissue. All e-cigarettes deliver formaldehyde and other cancer-causing chemicals when inhaled.

In April 2018, the Journal of Pediatrics published a report about the carcinogenic effects of the chemicals used in vape juice to provide fruit flavors. These chemicals, which can cause the serious lung disease bronchiolitis obliterans (“popcorn lung”), include:

Levin Papantonio Rafferty represents individuals who became addicted to nicotine as a result of using JUUL. The JUUL lawsuits claim that JLI deceptively marketed its highly concentrated nicotine delivery system to teenagers and young adults, resulting in a new wave of nicotine addiction among youth at levels that had not been seen in nearly 40 years.

Multiple lawsuits and government agencies accuse JLI of targeting young people. The company built its marketing strategy on one overriding objective: to acquire a disproportionate share of of youth and thus attract investment from Big Tobacco, both of which happened.

“We are representing thousands of plaintiffs who have developed an addiction or some kind of injury as a result of using these JUUL products,” said LPR Attorney Sara Papantonio. “Most of these plaintiffs are young kids who got swept away in JUULs misleading advertisement scheme and fell victim to their products.”

In 2016, FDA deemed e-cigarettes to be tobacco products, so e-cigarettes came under FDA regulatory authority for the first time. Unfortunately, the FDA was slow to act, and e-cigarette products, including JUUL, were allowed to remain on the market while the manufacturers drafted and submitted their applications for permanent FDA authorization.

In the meantime, “JUUL took over the e-cigarette market with a product that looked cool, was easily concealable, featured kid-friendly fruit and mint flavors, was smooth and easy to inhale, and packed a nicotine punch that could easily exceed cigarette deliveries for daily users,” Schultz explained. While the FDA had authorized the marketing of other e-cigarettes over the past several months, it denied JLI’s application and declared that JUUL could be sold no longer in the United States. Although the FDA’s marketing denial order is not released publicly, an accompanying press announcement cited a lack of needed evidence regarding certain toxic chemicals in JUUL’s e-vapor.

The product was small and sleek—the so-called “iPod of e-cigarettes” —and consuming the nicotine produced no offensive odor—traits that strongly catered to the teen mindset.

“By 2019, one in three high school students reported ever using an e-cigarette, and the same was true for one out of every seven middle school students,” Schultz said.

JUUL’s low-hanging fruit strategy ended up backfiring. All those fruity and minty flavors had succeeded in addicting millions of kids to nicotine. When JUUL discontinued these flavors in response to public outrage, sales plummeted, while nicotine-addicted-flavor-seeking kids switched to other brands that still offered “kid-friendly” flavors. These companies anticipated an FDA crack-down, so they started marketing products with synthetic nicotine, arguing that they were not subject to FDA’s jurisdiction because nothing in their products is derived from tobacco.

“Synthetic nicotine is an idea cooked up in the labs of vaping companies as a way to sink their deadly hooks of addiction even deeper, quicker, and more pleasurably,” explained Chris Paulos, another LPR attorney who handles the firm’s JUUL cases.

In March 2022, President Biden signed a law aimed at thwarting the growing synthetic nicotine industry’s attempts to further addict youth. Vaping companies have until July 13, 2022, to get FDA authorization for synthetic nicotine or risk the product being banned under the new law.

“The fact that FDA will now address the dangers, known and unknown, of synthetic nicotine simply means that it’s supposedly doing its job. Let’s hope it’s not asleep at the switch like it has been so many times before,” Paulos commented.

“FDA now faces the challenge of keeping pace with companies that are moving at breakneck speed to flood the market and get their hooks in consumers,” Paulos added. “Yet the revolving door relationship between FDA and Corporate America has neutered the government so it cannot move quickly or decisively.

“If and when FDA rolls out the results of its review of these synthetic products, one can only hope the process hasn’t been too polluted by industry influence and that sound public health-protective and precautionary measures were used.”

Although the FDA banned the marketing of JUUL on June 23, JLI appealed the order to a federal court in Washington, D.C. The FDA announced on July 5 that JUUL could continue in the marketplace while the company’s appeal moves forward. The federal court may defer to the FDA’s ruling, in which case JUUL will be removed from the market permanently.

Alternatively, the court could overrule the FDA’s decision; or send the matter back to the FDA for further consideration. According to Schultz, the whole process likely will take several months. Meanwhile, lawsuits over JUUL’s defective product and youth marketing tactics continue in consolidated litigation before Judge William Orrick in San Francisco.

“We were on the eve of our first trial when FDA’s marketing denial order was issued,” Schultz explained. “Although that trial was postponed, it appears we will try a case on behalf of the San Francisco Unified School District starting in November. Regardless of how the FDA issue pans out, we intend to hold those behind the rise of JUUL accountable before a jury of everyday folks.”

Levin Papantonio Rafferty has been battling the tobacco industry for years. Most notably, Attorney Fred Levin, now deceased, rewrote Florida’s Medicaid Third-Party Recovery Act, permitting the state of Florida to sue the tobacco industry for Medicaid costs in treating smoking-related illnesses. LPR attorneys Matt Schultz and Bobby Loehr have been litigating cases against cigarette manufacturers since 2006 and have won numerous jury verdicts for the victims of Big Tobacco’s decades-long deceptive practices.

The Levin, Papantonio, Rafferty law firm has been representing the injured people of Pensacola and the world since 1955. The firm has gained national recognition as one of the most successful personal injury firms in the country and has been featured on CNN, NBC, ABC, CBS, and Fox, as well as The Wall Street Journal, The New York Times, Time Magazine, Forbes, and National Law Journal.

The law firm’s attorneys handle lawsuits throughout the country involving prescription drugs, medical devices, medical malpractice, car accidents, and business litigation. Levin Papantonio Rafferty has earned more than $4 billion in jury verdicts and settlements, litigating against some of the largest corporations in the world.

For questions about the firm’s legal practice, call 1 (800) 277-1193.

To interview Matt Schultz or Chris Paulos, email Sara Stephens at sstephens@levinlaw.com or call 281-744-6560.