The Food and Drug Administration (FDA) will now have authority to regulate synthetic nicotine under provisions included in the federal omnibus spending bill recently passed by Congress and signed into law today (March 15) by President Joe Biden. This new authority will expand the FDA’s existing authority to regulate tobacco plant-based nicotine in vaping products to include nicotine made in labs.
Disposable vaping products using synthetic nicotine such as those marketed under the Puff Bar label have emerged in recent years as leaders in the vaping market because they escaped FDA regulatory authority banning sweet and fruit-flavored products. Among high school and middle school current users, i.e., those who reported using vaping products within the past 30 days, the Puff Bar brand was the most commonly used by a wide margin, according to a 2021 Centers for Disease Control and Prevention analysis of the National Youth Tobacco Survey.
Although the FDA issued warning letters in July 2020 ordering Puff Bar to remove its disposable, plant-based nicotine products from the market, Puff Bar and other brands pivoted to synthetic nicotine, which was beyond the reach of the FDA to regulate until now. The new law will require makers of synthetic nicotine products to file applications seeking authorization to market their products within 60 days of the law’s enactment. Synthetic nicotine products currently on the market will become illegal absent FDA authorization within 120 days of the law’s enactment.
Until last year, the FDA had never authorized any vaping product for the market. However, in Oct. 2021 the agency authorized the Vuse Solo Power Unit and two accompanying tobacco-flavored e-liquid pods. The FDA denials have consistently indicated that the applications “lacked sufficient evidence that they [vape products] have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”
For more information on this topic, including our updated infographic on youth vaping, visit our Vaping Updates & Insights page.