By Marina Murphy

With its new pilot program, the U.S. Food and Drug Administration is signaling a potential shift towards faster reviews for nicotine pouches, a move that could accelerate market entry and foster product innovation. 

Until now, consumers have been forced to wait years, sometimes up to five years, for new products to gain authorization. The result in the case of the e-cigarette sector is that almost 87 percent of the current market is unauthorized or illicit, something we don’t want to see in the nicotine pouch market. 

Nicotine pouches, smokeless, spitless, and tobacco-free, represent a lower toxicant alternative to combustible cigarettes, and they are more similar in terms of their toxicant profile to medicinal nicotine products. Research shows that these products are predominantly used to help adult smokers transition away from combustible and vaporized tobacco and nicotine products.    

This matters because cigarette smoking is still the leading preventable cause of death and disease worldwide. Smoking has claimed over 175 million lives in the last three decades. Smokers need alternatives, but manufacturers have been unable to innovate at the speed required because, despite a congress-mandated 180-day review window, FDA authorizations for new products are typically taking four to five years, by which time the product is massively out of date relative to international markets.  Indeed, warning letters issued by the FDA to retailers over unauthorized products increasingly reflect the presence of international innovation within US borders.

We have seen the results of this failure to act in the e-cigarette market, where nine out of ten products used by consumers are unauthorized. Since theTobacco Control Act was applied to e-cigarettes in 2016, the FDA has authorized a small number of e-cigarette products. Meanwhile, the non-authorized marketplace and technology have raced ahead, leaving FDA-authorized products looking prehistoric when they hit shelves. A recent Tobacco Control study found that in 2024, only 13.8% of e-cigarette sales came from FDA-authorized products, up from just 3.3% in 2023 – meaning that nearly 87% of products sold to consumers have not been reviewed by the FDA. 

With the launch of the pilot program for nicotine pouches, the FDA appears to have learned from the mistakes in the e-cigarette market. This program will expedite reviews, standardize requirements, and ensure the authorization process keeps pace with innovation rather than stifling it.

Right now, the situation for pouches is even more restrictive than it was for vapes. This lack of diversity, combined with enforcement, has the potential to impact consumer choice and slow innovation. Millions of smokers who might benefit from switching will have fewer “FDA authorized” options.

Access matters.  Global evidence shows that when  smokeless products are widely available, smoking rates fall. When they are restricted by bans, red tape, or prescription-only policies, black markets thrive, and smoking rates stagnate. Australia’s criminalization of nicotine vapes, for example, has fueled illicit trade, increased criminal activity, and slowed progress in smoking reduction. By contrast, in countries like Sweden, open access to smokeless products like snus or nicotine pouches is driving real progress towards smoke-free goals.

The Youth Access Prevention Question

Some advocate restricting access to reduced-risk nicotine products to prevent unintended youth use. It’s a legitimate concern, but evidence shows that new technology, combined with enforcement,  can tightly control access. In fact, U.S. youth smoking and vaping rates are at historic lows. At Nicokick, we’ve invested heavily in robust online age-verification and compliance systems. Our experience shows it is possible to effectively age gate the online purchase of nicotine products for adults who might otherwise continue to use more harmful products.

The FDA’s pilot represents a smarter approach: requiring the right level of evidence to support different categories of novel products. A standardized but adaptable review process can both protect consumers and accelerate access to  alternatives to smoking.

It is an opportunity to modernize how the U.S. approaches public health regulation. If successful, it will show that scientific rigor and innovation do not have to be at odds. For the sake of smokers, responsible companies, and public health itself, this pilot should not be the exception. It should be the new standard.

Dr. Marina Murphy is the Senior Director of Scientific Affairs at Haypp Group and its subsidiary Nicokick.com.