Harm reduction is the idea that public health policies should be created to lessen the negative consequences of human behavior as opposed to eradicating the behavior entirely. Examples in the public health space include safe injection sites or methadone prescriptions for drug users—even wearing a helmet while riding a bike.

Tobacco harm reduction operates similarly, acknowledging that many adult smokers may not be willing to stop using tobacco products entirely but would shift to less harmful alternatives. It’s a concept that has gained popularity with consumers, tobacco manufacturers and even some regulators and public health advocates over the past decade as new innovations in non-combustible products like electronic nicotine devices and spitless tobacco options have come onto the market.

“It’s the delivery mechanism” that causes harm, not nicotine itself, former FDA Center for Tobacco Products (CTP) director Mitch Zeller said while speaking at an American Legacy Foundation function in 2014. “We have to recognize some of these realities and figure out how they can impact regulatory policy.”

But the National Institute of Health (NIH) noted in a research paper that harm reduction “remains a controversial topic in tobacco control.” The NIH specifically called out marketing practices in the 1960s around low-tar or “light” cigarettes as a cause for doubt around tobacco harm reduction. The attention on youth vaping usage in 2019 only heightened the controversy.

Despite director Zeller’s seemingly supportive comments, the FDA has yet to acknowledge any vaping device as “modified risk” (the official pathway for marketing tobacco products as less harmful than cigarettes). Instead, the agency has banned flavors in electronic nicotine devices, removing a major incentive for smokers to switch. State and local governments have passed even more extreme regulations that, in some parts of the U.S., have all but stamped out the market for non-combustibles.

Yet consumer interest in harm reduction remains strong, as does the commitment of major tobacco and nicotine manufacturers to invest in this space. This begs the question: What is the future of harm reduction in the backbar?

Promise of Tobacco Harm Reduction

Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association Inc., said he could provide anecdotes about the willingness of adult smokers to try smoke-free options, but data from the Centers for Disease Control and Prevention (CDC) and other government agencies make the best case. “Really, you should look at the results,” he said.

CDC data shows that in 2015, 68% of adult smokers reported wanting to quit cigarettes. But success rates are low: In 2018, just 7.5% of the 55% of adult smokers who attempted to quit succeeded in doing so. The CDC noted that less than one-third of those smokers reported using cessation counseling or FDA-approved nicotine replacement therapies like nicotine patches or gum.

That’s where tobacco harm reduction comes in. These products give adult smokers the opportunity to switch to a less-harmful option rather than quit entirely.

Conley described vaping products as “central” to this switch. The 2022 National Health Institute Study showed that 41% of the 6.1 million vapers in the U.S. were former smokers.

“E-vapor has been the most successful category in the U.S. in transitioning smokers to alternative products,” said Jennifer Kelly, a spokesperson for Altria Group Distribution Company.

These products give adult smokers the opportunity to switch to a less- harmful option rather than quit entirely.

The problem is that in the United States, products like e-cigarettes or newer smokeless options like modern oral nicotine are not acknowledged by the FDA as—and therefore cannot be marketed as—less harmful than cigarettes. Other countries, however, have embraced this approach.

“In recent years, e-cigarettes have become a very popular stop smoking aid in the UK,” reads the National Health Service (the United Kingdom’s government healthcare system) website. “They’re far less harmful than cigarettes and can help you quit smoking for good.”

Meanwhile, the only way tobacco products can be marketed as less harmful than cigarettes in the United States is through the modified risk tobacco product (MRTP) pathway. To date, the FDA has denied MRTP status for electronic cigarette and vaping products and has only approved it for one snuff product, eight snus products, several heat-not-burn options that are currently unavailable in the United States and two low-nicotine cigarette products.

Regulatory Hurdles

Instead of taking a strategy closer to the UK’s, the FDA has taken many actions that advocates of a harm reduction approach argue have challenged the success of smoke-free products.

Particularly when it comes to flavors.

Responding to rising rates of youth vaping, the FDA issued an enforcement policy in January 2020 to limit the sale of cartridge or pod vaping products to only tobacco and menthol flavors unless the agency approved a flavored product through the premarket tobacco product application (PMTA) process. To date, the FDA has only approved tobacco-flavored vaping product PMTAs.

“While policing youth access is important, these regulations often overlook the potential public health benefits of transitioning adult smokers away from combustible cigarettes,” said Conley. “Flavor bans in particular undermine the appeal of safer alternatives. Flavors offer adult smokers a more appealing and satisfying alternative to the taste of traditional tobacco, increasing the likelihood of them making a permanent switch.”

As most retailers and consumers know, the market is filled with flavored disposable e-cigarettes (both those using traditional nicotine and synthetic nicotine). The question is what, if any, are legally allowed to be there under FDA purview.

“The largest challenge to the future of these innovative nicotine product categories is the proliferation of largely illegal disposable vapor products pouring across our borders,” said Matt Domingo, senior director of external relations at R.J. Reynolds Tobacco Company.

Domingo described illegal disposable products as being those without either a marketing granted order or a pending PMTA application with the FDA or those that market to kids. “These illicit vapor product manufacturers are flouting FDA regulations,” he said.

Because of the lack of clarity of what is and isn’t legal—and a near-total lack of enforcement—retailers aren’t just dealing with products not allowed by FDA but products that are outright counterfeits.

Then there are state and local governments that have taken the regulations even further.

Jigar Patel, CEO of FASTIME and vice president of the Strategic Alliance of Affiliated Store Owners of America (SAASOA), described being contacted about what seemed to be brand of disposable e-cigarettes he was already selling. He was given the opportunity to get a much lower rate than his wholesaler charged if he bought directly from the manufacturer. He later discovered what was being offered “directly” was in fact a fake.

“My eyes were opened,” Patel said. “This could actually hurt somebody.”

Then there are state and local governments that have taken the regulations even further.

Peter Brennan, executive director for the New England Convenience Store & Energy Marketers Association (NECSEMA), pointed to Massachusetts. The state didn’t just ban flavored vaping products in 2020: it was the first state to ban all flavored nicotine products, including menthol, including snus, including modern oral nicotine.

“Since then, we’ve have lost approximately $337 million in tax revenues,” Brennan said. “The black market’s thriving.”

Taxes are another form of regulation that makes it less appealing for smokers to switch to a non-combustible alternative. For example, in Minnesota, vaping products and modern oral nicotine are taxed at a record-high 95% of their wholesale price. That’s the exact same rate the state taxes combustible cigars.

Current States of Harm Reduction

Despite the regulatory challenges, these alternatives are managing to survive and even thrive thanks to polyusage and an increase in adult smokers moving to other forms of nicotine, said Domingo. “Non-combustible nicotine products are the fastest growing products in the nicotine space.”

Not surprisingly, the success of harm reduction products often comes down to the state (or city) in which a retailer operates.

Lonnie McQuirter, director of operations for 36 Lyn Refuel Station, operates in the regulatory-heavy city of Minneapolis. Due to the combination of the high excise taxes and a law that bans flavors in convenience stores but permits flavors in adult-only locations like tobacco shops and liquor stores, the vaping market is “virtually non-existent for convenience retailers without a separate adult-only store inside.”

Patel, on the other hand, operates in the more regulatory-friendly southeastern United States, as do most of the retailers that make up SAASOA.

“For us, the vape category is actually growing,” he said, noting that SAASOA represents retailers in 13 states with 5,000 stores, and not a one has complained about a reduction in vapor sales. “It’s quite profitable and it’s helping compensate for the loss of margins in other categories, namely cigarettes.”

How modern oral nicotine or nicotine pouches—another popular harm reduction option—are doing also seems to depend on the region, the store or even the customer. Brennan described it as an exciting and growing segment, making up as much as 8% of backbar sales for retailers in New England. Patel said these products were “hit or miss” based on any given store. “I think the demographics where people are able to spend more money, it’s doing better there.”

Major manufacturers have expressed a firm commitment to harm reduction.

Whether it’s electronic nicotine devices, nicotine pouches or new innovations in non-combustible options, major manufacturers have expressed a firm commitment to harm reduction.

“Transformation is at the core of Reynolds and its operating companies,” said Domingo. “We are making significant investments in innovative non-combustible nicotine products and engaging with stakeholders and policymakers to develop a regulatory environment that supports and promotes tobacco harm reduction.”

Altria’s vision “is to responsibly lead the transition of adult smokers to a smoke-free future,” said Kelly, referencing Altria’s commitment to “moving beyond smoking” and the company’s recent acquisition of the NJOY vapor brand.

Reynolds and Altria are hardly alone: ITG Brands, Swedish Match, Swisher, JTI, Philip Morris International and more have all invested heavily in non-combustible products.

Retailers are caught in a tougher spot. Consumer demand may be there, and manufacturer support certainly is, but how much space in a crowded backbar can retailers spare if the local and federal regulations don’t support harm reduction but instead outright stymie its success?

“As combustibles are further criminalized, people are going to turn to other products. We want to be there to fill those needs,” said Brennan. “But it’s tough how much shelf space you can give to these products in such an uncertain regulatory environment.”

It’s a question that remains to be answered.

“Given the current regulatory landscape,” said Conley, “uncertainty is all that is guaranteed in the tobacco harm reduction space.”