Puff Bar e-cigarettes, a popular single-use e-cigarette that uses flavored synthetic nicotine, could face scrutiny because the U.S. Food and Drug Administration has the power to regulate synthetic or lab-made nicotine products.

On March 11, a new federal spending bill was signed into law giving the FDA regulatory authority over synthetic nicotine, also known as tobacco-free nicotine. Previously, the FDA only had the authority to regulate products containing tobacco-based nicotine. Many e-cigarette makers, including Puff Bar, took advantage of this loophole to continue selling their nicotine-based products without direct FDA approval.

The FDA issued a warning letter to the maker of Puff Bar in July 2020, ordering the company to stop selling its single-use flavored e-cigarettes because it did not have the required premarket authorization. The agency cited its ongoing efforts to crack down on illicitly sold tobacco products, but Puff Bar has found a way around the ban.

In February 2021, Puff Bar announced that its products would begin manufacturing with synthetic tobacco-free nicotine. Now, Puff Bar and other e-cigarette makers could be hit with another round of warning letters from the FDA, ordering them to withdraw their products from the market.

Numerous clinical studies are needed to determine the exact dangers of synthetic nicotine, as the chemical is too new to allow any conclusive assessment of its health risks. However, there is some evidence that synthetic nicotine is more easily absorbed by the body than tobacco nicotine and therefore may be more addictive.

Nicotine addiction in teens and young adults is the main reason many parents and users have filed lawsuits against e-cigarette makers like Juul. More than 3,500 Juul lawsuits are currently pending as people who have suffered vaping-related injuries want to hold Juul and other vaping makers accountable for their products and misleading, youth-directed advertising.

A Puff Bar is a single-use e-cigarette with a limited number of uses of each e-cigarette, called a puff. Each Puff Bar disposable e-cigarette ranges from 400 to 3,500 puffs, depending on the size purchased. Puff Bar contains synthetic nicotine, a tobacco-free, lab-made addictive chemical.

Puff Bar Plus flavours include over 50 fruity, youth-friendly flavours such as Skittles, Pink Lemonade and Strawberry Ice Cream. In 2020, the FDA banned the sale of fruit-flavored e-cigarettes with refillable cartridges, but Puff Bar was able to bypass the ban because its products are single-use. The popularity of Puff Bar has soared, especially among students.

According to the 2021 National Youth Tobacco Survey, about 26 percent of high school students and 30 percent of middle school students report that the Puff Bar vape is their e-cigarette of choice.

There isn't enough research to determine whether Puff Bar is safe to use, especially with synthetic nicotine as the main ingredient. Despite its popularity, synthetic nicotine has been the subject of very little research and little is known about its health effects.

"Synthetic nicotine can alter neurotransmission in the brain in different ways than classic nicotine, but we don't yet understand that," said Sven-Eric Jordt, Ph.D., associate professor at Duke University.

As Jordt explained in the journal Tobacco Control, the difference between tobacco-based nicotine and synthetic nicotine is the molecule. About 99 percent of tobacco-based nicotine is the molecule S-nicotine, but synthetic nicotine contains equal amounts of S-nicotine and R-nicotine, mirror molecules that scientists know very little about.

In addition to Juul, several vaping brands are facing lawsuits for vaping-related injuries and knowingly marketing their products to teens.

As of April 15, there were 3,656 Juul lawsuits pending in California federal court. So far, there have been no separate vaping settlements or major verdicts, and lawyers expect litigation to continue to grow.

Many of those who filed Juul lawsuits claim their nicotine addiction developed or worsened after using the devices.

Parents suing on behalf of their teens claim Juul's marketing was deceptive, promoting products directly through social media and influencers, and hiding information about nicotine content.

In the first six months of the Juul device being sold, Juul's ads were apparently aimed at young people, according to Stanford researchers.

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