Walking into an unfamiliar convenience store can be a bit of an unexpected assault on the senses, especially if you venture into the section featuring tobacco products. It’s a riot of colors and shapes, with items ranging from vapes (e-cigarettes) to dip to nicotine pouches. For many, this can provide the first contact with a brand they’d never heard of before. Haven’t these companies ever heard of marketing their products?
As a recently filed (and dropped with the intent to file it again elsewhere soon - it’s complicated) lawsuit shows, companies with new tobacco products have to jump through a few hoops for the U.S. Food and Drug Administration (FDA) before gaining permission to market their wares. The Premarket Tobacco Product Application (PMTA) process, part of 2009’s Family Smoking Prevention and Tobacco Control Act (TCA), requires the FDA’s review of all tobacco products before marketing authorization is given.
Such is the case for Fontem US, which has taken its battle with the FDA over a Refuse-To-File (RTF) marketing denial order for its nicotine pouch product Zone to federal court. Originally filed in a U.S. District Court in the Northern District of Texas, the suit was transferred to South Carolina before Fontem US decided to drop that version and refile in the District of Columbia, which may provide a more amenable venue for the plaintiffs.
Why can Zone, one of the best-selling nicotine pouches in the country, be seen on the side of a NASCAR vehicle but not on a billboard? Lacking FDA premarket review approval leaves companies scrambling to advertise and market their tobacco products to retailers and customers. The nicotine pouch manufacturer’s suit joins others in the industry in alleging that the FDA’s review process lacks uniformity and violates the Administrative Procedure Act (APA).
Nicotine Without Smoking, Chewing, or Spitting
Nicotine pouch application allows those seeking the effects they may have gotten from a different form of tobacco to do so without smoking, vaping, or dipping. First available in 2016, the pouches are placed between a user’s lip and gum. They contain nicotine that is either synthetic or derived from tobacco (although the pouch does not contain any actual tobacco-leaf). Like vaping products, they are available in a variety of flavors.
Under federal law set out in the TCA, all tobacco products are subject to extra scrutiny by certain government agencies to assess their potential impact on public health. Manufacturers of new tobacco products must submit a PMTA to receive FDA authorization before marketing can commence. Originally just for cigarettes, the requirement was expanded in 2016 to include e-cigs and other products for adult smokers, which resulted in an unexpected 6.5 million PMTAs being filed. In 2022, Congress amended the TCA to include FDA regulation for all tobacco products that contain nicotine.
Companies like nicotine pouch maker Zyn, which received approval for its PMTA in 2025, market the product as a healthier alternative to other forms of tobacco use. The Centers for Disease Control (CDC) states that while scientific reviews are still being conducted, it considers all nicotine products, including pouches, to be unsafe and to contain a dangerously addictive product. To receive PMTA approval, the FDA’s Center for Tobacco Products must have evidence that the new product offers greater benefits to population health than risks. While Zyn’s pouches still contain nicotine, the delivery system offers significantly less exposure to carcinogens than other tobacco products.
If Zyn’s nicotine pouches were approved for marketing, why was Zone denied? As evidenced by the pending lawsuit, Fontem US would like to know that answer.
Oh, Say Can D.C.?
According to the now-pulled lawsuit, Fontem US submitted a PMTA for its Zone products in May 2022. Despite a statutory 180-day deadline for granting or denying the PMTA, the FDA finally responded on December 16, 2025. Instead of providing an approval or a denial, it issued a Refuse-To-File letter, claiming that Fontem US’s PMTA was missing necessary information. The agency agreed to reconsider the PMTA, but returned the same RTF on March 12, 2026.
Left with no other administrative option to exhaust, Fontem US filed suit in Texas the following day, seeking a stay, preliminary and permanent injunctive relief, and vacatur of the FDA’s decision. It claims that the FDA's lack of a uniform standard for PMTAs falls short of the responsibilities Congress has placed on the agency. After being shown that the missing information causing the first RIF was in fact not missing, it accused the FDA of changing the rationale for the second rejection to questions about “bridging” used for data on harmful and potentially harmful constituents (HPHCs).
After the suit was moved from Texas to South Carolina, Fontem US withdrew the complaint. The company plans on refiling in the District of Columbia, which has a history of being more business-friendly. While Zone lacks FDA approval for marketing, that doesn’t preclude it from being available on the shelves of smoke shops, drug stores, and bodegas. Unless it wins in federal court, Fontem may have to rely on word-of-mouth to keep Zone’s sales buzzing along.
Related Resources
- Is Synthetic Vape Nicotine Legal? (FindLaw’s Law and Daily Life)
- Chewing Tobacco and Smokeless Tobacco Injuries (FindLaw’s Product Liability Law)
- Synthetic Food Dyes Targeted by U.S. Health Officials (FindLaw’s Law and Daily Life)
