Congress Calls for New FDA Regulation of Synthetic Nicotine Fueling Teen Vaping Addictions

New legislation is being consider by Congress, which would expand the authority of the U.S. Food & Drug Administration (FDA) to regulate synthetic nicotine products, in the face of continuing concerns about the long-term risks associated with teen vaping addiction.

A provision proposed in new bipartisan legislation would redefine tobacco products to include those that contain nicotine from any source, tobacco-derived or synthetic. This redefining of tobacco would effectively close the “loophole” that some lawmakers, as well as anti-tobacco and anti-vaping advocates, claim is being used by manufacturers of synthetic nicotine, allowing them to sell their products to teenagers and fuel teen vaping addictions while evading government regulation.

The popularity of e-cigarettes like Puff Bar among today’s youth led Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and other Senators to push for new provisions that allow the FDA to regulate synthetic nicotine, as part of a massive $1.5 trillion must-pass government funding bill (PDF) introduced this week.

“Over the last few years, FDA has taken important steps to crack down on the flavored vaping products that fueled the dramatic rise in tobacco use among kids and teens,” Pallone states in a press release. “Unfortunately, some bad actors have attempted to avoid FDA regulation by pivoting to using synthetic nicotine in their products. That ends with passage of this bill, which will close this loophole and clarify FDA’s authority to regulate all tobacco products, including those containing synthetic nicotine.”

If passed, the new legislation would require makers of synthetic nicotine products to file an application with the FDA seeking authorization to sell their products. Applications would need to be submitted within 60 days of enactment of the law. Any synthetic nicotine product not authorized by the FDA within 120 days of enactment would become illegal.

The FDA currently regulates products containing nicotine extracted from tobacco plants, including traditional cigarettes and cigars, e-cigarettes with refillable cartridges, disposable vape products, and flavored liquids. Of the nearly 6 million premarket approval applications submitted to the FDA by makers of vaping products, only three have received the agency’s approval to date.

Synthetic Nicotine Concerns

Also known as tobacco-free nicotine, synthetic nicotine is not derived from tobacco plants. It is instead fully synthesized in a laboratory using a chemical or enzymatic process. The resulting compound is odorless, tasteless, and mimics the sensation that nicotine users desire. It is also just as addictive and potentially harmful as the tobacco-based version.

It is the very synthetic nature of the compound that has thus far allowed certain makers of e-cigarettes to skirt FDA regulation, claiming it is not a tobacco-based product and therefore does not fall under the jurisdiction of the regulatory body.

The odorless and tasteless quality of synthetic nicotine makes it easier for producers of certain brands of e-cigarettes to offer them in a variety of what anti-tobacco advocacy organizations like the Campaign for Tobacco Free Kids refers to as “Kid-friendly” flavors making products like Puff Bar appealing to teenagers.

Puff Bars are disposable, single-use e-cigarettes that contain high levels of synthetic nicotine. They are available in flavors like Sour Apple, Menthol, O.M.G (Orange, Mango, Guava), Mango, and Lemonade that are often attractive to teens, yet they are not subject to FDA regulation under current laws. A recent 2021 survey conducted by FDA and the Centers for Disease Control and Prevention (CDC) found that Puff Bars have become the most popular brand of e-cigarette among teenagers, surpassing JUUL vaping pods, which were widely marketed to minors and prior non-smokers in recent years.

While scientists are still discovering the long-term health effects of e-cigarettes overall, the effects of nicotine exposure during adolescence are well documented. According to the CDC, nicotine can harm the developing adolescent brain well into the early to mid-20s and lead to addiction.

There are active lawsuits against e-cigarette makers that cite the rise in their popularity among teens is due to specific marketing strategies that target minors to develop life-long customers. The lawsuits also claim the use of e-cigarettes led to seizures, strokes, serious lung injuries, and disease. Many of the lawsuits have been filed against JUUL Labs, Inc.

Introduced in 2015, the JUUL vape pens quickly became popular among teens and have been blamed for sparking the teen vaping addiction crisis in the U.S. JUUL devices have a USB charging dock at the end, making them closely resemble an ordinary USB drive. This alleged the vape pen to be hidden from parents, as an ordinary tech tool. A reusable vaping device the disposable and interchangeable JUULpods that contain the nicotine-based e-liquid were available in “kid-friendly” fruit flavors similar to the ones now sold by Puff Bar.

More than 4,500 JUUL lawsuits are now being pursued in courts nationwide, citing child-focused marketing strategies and physical harm.

Unlike Puff Bar, the nicotine used in the JUUL Pods is extracted from tobacco plants making it fall securely under FDA regulation. However, the JUUL product, unlike millions of other similar e-cigarettes, is still available for sale as the FDA has yet to provide an official ruling on the product.