FDA Will Fast Track Nicotine Pouch Pilot Program
While RFK Jnr’s start as Secretary of Health and Human Services has been marked by controversy, his support for nicotine pouches could lead to progress. As reported by Reuters this morning, the FDA has announced the launch of a fast-track pilot program to accelerate the review process for nicotine pouches. Let’s take a look.
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FDA fast track
Starting September 8th, the FDA will begin a fast-track program for nicotine pouch products from four brands: Philip Morris International, Altria, Reynolds American (a subsidiary of British American Tobacco), and Turning Point Brands.
While the announcement is a big deal, it’s perhaps not the most notable part of the story. Instead, the aspect that really stands out is that the FDA aims to conclude the process by December 2025. This timeline stands in stark contrast to the years-long wait companies previously faced for product approvals.
What products will form part of the trial?
The fast-track pilot covers products such as:
- Zyn Ultra (Philip Morris)
- on! Plus (Altria)
- Velo mini (Reynolds)
- Fre and Alp (Turning Point Brands).
The FDA’s streamlined review will focus on scientific and manufacturing data, such as:
- Product characterization (i.e., ingredients, nicotine strength, size, form, and the way nicotine is delivered to the user)
- Stability (shelf life, risks of byproducts from storage and normal use)
- Consistency (Do production processes yield products that are uniform from batch to batch?)
- Abuse liability (Assess whether the new product presents greater, lesser, or similar risks of nicotine “addiction”, especially in comparison to cigarettes or e-cigarettes.)
The program’s goal is to provide clarity on the legal status of these products, particularly those already sold without formal FDA authorization. If a product receives FDA approval, it gains an explicit legal status to be marketed. What’s more, FDA approval shields nicotine pouch manufacturers and sellers from potential legal and regulatory penalties.
Who is driving this seachange?
During his recent presidential campaign, Donald Trump promised to “save vaping”. While these grand promises are yet to be realised, news outlets like Reuters credit his administration with fast-tracking this process to expedite tobacco and tobacco-derived product approvals.
Pouches are the fastest-growing tobacco category in the US, and if these products are approved, we might see him claim that he’s “saved pouches” sometime next year.
Is there precedent for approval?
In January 2025, the FDA approved 20 ZYN nicotine pouch products. However, the agency’s first approval of nicotine pouches came on the back of an exhaustive and lengthy scientific review process that took over five years from submission to authorization.
That marketing authorization meant Zyn could advertise and sell these pouches, but they were
prohibited from making claims that the products are safer or reduce health risks compared to cigarettes or other tobacco products. To do that, the FDA must grant a “modified risk” designation.
ZYN has submitted Modified Risk Tobacco Product (MRTP) applications that provide convincing scientific evidence supporting those claims. However, the pilot programs do not cover these MRTP but only standard product authorization.
Final thoughts
The Trump administration is putting pressure on the FDA to make decisions about the authorisation of nicotine pouches. The glacial pace that characterised the FDA approval process is finally coming to an end, which will delight both manufacturers and consumers.
RFK Jnr has called nicotine pouches “probably the safest way” to consume nicotine while promising in other interviews to crack down on flavored vapes with bright, candy-like imagery because of their alleged appeal to youth. If Trump wants to come good on his election promises to save vaping, he needs to start with his own Health Secretary.
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