RFK Jr.'s FDA Signals A New Direction for Nicotine Pouches

The U.S. nicotine landscape seems to be shifting fast—but it has actually been a decade in the making.

What began with ZYN’s quiet arrival back in 2014 has evolved into a defining test of how the Food and Drug Administration (FDA) handles nicotine alternatives. Ten years later, the first major regulatory approvals are finally here, and they’re already reshaping how Americans might approach nicotine.

When ZYN first appeared in a handful of Colorado stores in 2014, it was a curiosity: a tobacco leaf-free pouch with pharmaceutical-grade nicotine, no smoke, and little fanfare.

By 2019, the product had been launched nationally and quietly built a following among adult smokeless tobacco users and smokers looking for a different way to use nicotine. But there was a catch: no nicotine pouch had ever been authorized for sale under the FDA’s stringent Premarket Tobacco Product Application (PMTA) process.

ZYN’s manufacturer submitted its applications in March 2020, ahead of the September 2020 deadline imposed by the FDA. What followed was nearly 5 years of scientific review, stretching across multiple administrations and layers of scrutiny. The redacted technical document shows the depth of that process, from toxicology and chemistry to behavioral science and youth-risk analysis.

On January 16, 2025, after nearly a decade on the market and half a decade under review, the FDA authorized the marketing of 20 ZYN nicotine pouch products. It was the first full federal authorization of its kind, and it set the benchmark for how all future pouch applications will be judged.

The decision came with both praise and caveats (all quoted text from the FDA):

• Extremely low toxicant levels: Of 42 tested toxicants, “36 were too low to be quantified.”
• No detectable tobacco-specific nitrosamines: ZYN does “not contain measurable quantities of the carcinogenic tobacco-specific nitrosamines…or the carcinogenic polycyclic aromatic hydrocarbon B[a]P.”
• Encouraging switching data: In a 10-week study, “nearly one-quarter of participants…switched completely from other tobacco products and reported exclusive use” of ZYN.
• Flavor classification: “Due to added ingredients such as sweeteners and cooling agents, FDA has determined that all new products have a non-tobacco characterizing flavor.”
• Child safety packaging: The review determined that the products “are packaged in certified child-resistant polypropylene cans and safety lids, which can reduce the risk of accidental exposure in children."
  

Ultimately, the FDA found ZYN “appropriate for the protection of the public health,” provided strict marketing controls and youth safeguards were in place.

Soon after that landmark authorization, newly appointed U.S. Health Secretary Robert F. Kennedy Jr. began reframing nicotine policy around relative risk. In an August interview, he called nicotine pouches “probably the safest way to consume nicotine,” placing vapes second and underscoring the need to move away from cigarettes.

He also highlighted that the U.S. costs due to smoking-related disease are $640 billion a year. His remarks and demeanor reflect a growing consensus: combustion, not nicotine itself, causes most tobacco-related harm. They also symbolize a broader policy pivot: toward regulation that distinguishes between high- and low-risk nicotine products.

In September 2025, the FDA announced a new pilot program to streamline review of nicotine pouch applications—effectively a “fast track” for this product category. The program aims to reduce paperwork, focus on the most relevant scientific questions, and deliver faster decisions without compromising public health standards. Manufacturers are closely watching, eager to move through the same process in months rather than years.

This new pilot program could mark a stark shift from the current long slog. It is designed to preserve rigor while eliminating bottlenecks. Only a few products from 4 manufacturers will be included in this round, but a broader change could finally legitimize the pouch category in the U.S. market.

Despite decades of anti-smoking campaigns, roughly 11.6% of U.S. adults (about 28.8 million people) still smoke cigarettes. The burden isn’t evenly distributed: smoking rates are higher among adults who are older, have lower incomes, live with disabilities, or are veterans.

• The age group with the highest rate of smoking (15.1%) is among adults aged 45-64.
• The only age group to see an increase in smoking prevalence was U.S. adults ≥65 (+0.3%, corresponding to an additional 600,000 people).
• Approximately 18.3% of adults in low-income households smoke, compared to 6.7% in high-income households.
• The smoking rate among adults with a disability is 18.6%, compared to 10.9% among adults without a disability.
• More than 1 in 5 veterans smoke—nearly twice the national average.

These are the groups most likely to benefit from lower-risk nicotine options. For people who have smoked for decades, nicotine pouches offer a practical path to reduce harm without requiring total abstinence.

With FDA signaling a faster review process, the implications for the rest of the pouch market are substantial:

• A regulatory template now exists. Manufacturers can model their PMTAs on the existing precedent.
• Timelines could shrink dramatically. The multi-year review process may be replaced by 1-year or even 6-month evaluations under the new pilot.
• Scientific expectations remain high. The FDA made clear that reduced toxicants aren’t enough: behavioral, youth, and long-term studies remain essential.
• Competition could expand the category. Faster reviews may open the door for new formulations, different nicotine levels, and flavors designed for adults who smoke.
• Youth prevention will be the fault line. If flavored products or sleek packaging appeal to teens, the fast-track program could face political backlash and reversals.

The ZYN authorization shows that a nicotine pouch product can clear the highest scientific bar. But it also highlights how complex that path remains. Hopefully the FDA’s new program will make the path more clear.