The Harm Reduction Race
The race is on for success in harm reduction: encouraging smokers to switch completely to reduced risk alternatives. Evidence of this rapidly evolving trend can be seen from all lanes — consumers, manufacturers, retailers, the government and even public health.
Citing the “2024 Surgeon General’s Report,” Kellsi Booth, chief legal officer for Black Buffalo, the Chicago-based maker of tobacco alternative chew and pouches, said: “Adult smoking and youth tobacco use are at all-time lows, which is a major public health milestone. The growing body of science and evidence around novel nicotine products supports the important role these products can play as acceptable alternatives for adult smokers to reduce the harm associated with current tobacco use.”
According to Booth, the widespread and growing availability of these products at retail has led to not only adult consumer awareness, but also interest and acceptance, as demonstrated by the rapid growth of the e-cigarette and modern oral categories in the United States. The modern oral (pouch) market has grown significantly over the past several years with some industry reports indicating a $1 billion increase in U.S. retail sales between 2022 and 2023.
Every major tobacco manufacturer — Altria Group Inc., Reynolds American Inc., ITG Brands LLC, Japan Tobacco International USA Inc. and Philip Morris International Inc. (PMI) — now has a reduced-risk tobacco/nicotine product strategy as a significant, if not primary, commitment that is immediately apparent upon a visit to their website home pages.
These reduced-risk strategies are playing out domestically through modern oral nicotine pouches and e-cigarettes (vapor). Globally, heat-not-burn devices are out in front in countries such as Japan, where smoking formerly dominated.
“Millions of adult smokers are seeking new options, including those that reduce risk, and their preferences are evolving rapidly,” Davien Anderson, a spokesperson for Altria, told Convenience Store News. “We believe it is our responsibility to create the conditions for harm reduction to succeed — through education, awareness and advocacy — as we build a strong portfolio of smokefree products that satisfy adult smokers’ evolving interests and preferences. We know that millions of adult consumers 21-plus are interested in completely switching from cigarettes to a smokefree tobacco product.”
At Reynolds American, its vision of “Building a Smokeless World” means becoming a predominantly smokeless business with 50% of its revenue from noncombustible products by 2035. “We have already started our transformation journey and year by year, we will continue to actively encourage adult smokers who are uninterested in quitting tobacco products altogether to transition to smokeless alternatives,” a company spokesperson said.
The U.S. Food and Drug Administration (FDA) and other public health experts agree that there is a broad continuum of risk among tobacco products, with cigarettes at the highest end of the spectrum and complete cessation at the lowest end.
“While there may be differences in risk profiles between specific smokefree products, it will take years of epidemiology to quantify those differences. The body of evidence does, however, indicate a profound risk differential between combustible and smokefree product categories,” Anderson stated.
The FDA authorizes reduced-risk alternatives via a limited number of premarket tobacco product application (PMTA) and modified risk tobacco product (MRTP) classifications.
On Jan. 16, for the first time ever, the FDA authorized the marketing of a nicotine pouch product. Following a scientific review, the agency approved 20 ZYN products through the PMTA pathway, giving the greenlight for them to be marketed in the U.S. ZYN is part of the Swedish Match portfolio, which is owned by PMI.
The FDA’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products — such as moist snuff and snus — the authorized products pose lower risk of cancer and other serious health conditions. The agency also noted that the company provided evidence from a study showing that a substantial proportion of adults who use cigarette and/or smokeless tobacco products completely switched to the newly authorized nicotine pouch products.
“To receive marketing authorizations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
More Action & Information Needed
Many in the industry want the FDA to move faster and say it’s necessary for true progress.
“We are seeing increasing interest in and pressure from lawmakers to expedite reviews for the hundreds of thousands of product applications that remain in process, which is crucial to get to a fully regulated and compliant diversified marketplace,” said Black Buffalo’s Booth.
Altria’s Anderson agrees. To make true harm reduction a reality, he believes there needs to be faster progress from the FDA in three key areas:
Authorizing smokefree products
Informing adult smokers about the benefits of switching to smokefree alternatives
Enforcing the law to eliminate illicit e-vapor products
“A strong course-correction is needed to protect the harm reduction opportunity for the 30 million adult smokers in the U.S.,” said Anderson, explaining that consumers are misinformed about the role of nicotine, for starters. “The FDA has authorized only a handful of smokefree products, woefully insufficient to meet the growing adult tobacco consumer demand. And the marketplace is being overrun by illicit disposable e-vapor products that are flouting FDA regulation and contributing to underage use.”
Some progress was made this past summer when the FDA, jointly with U.S. Customs and Border Protection, seized more than 50,000 unauthorized vapor products from China at the Chicago port of entry. In August 2024, the FDA issued a proposed rule requiring all imported vapor products to include a PMTA submission tracking number.
“Closing this loophole is something for which we have long advocated,” Anderson said, adding that Altria provided comments in support of the rule and encouraged additional action, such as extending the rule to cover nicotine pouch products.
Booth pointed out that the FDA has an excellent model in Sweden, which declared itself officially “smokefree” in November, with fewer than 5% of its adult population using combustible cigarettes. “This landmark is a direct result of the Swedish government [being] focused on harm reduction rather than prohibition, by employing adult-focused advertising that increases awareness and encourages uptake, as well as enacting a proportionally lower tax on risk-reduced products to drive adoption,” Booth said.
New Zealand and the United Kingdom also have seen significant declines in smoking rates thanks to successful harm reduction strategies, according to Chris Howard, executive vice president of external affairs and new product compliance for Swisher, which operates Swisher Sweets Cigar Co., Helme Tobacco Co., Hempire, Rogue Holdings and Drew Estate.
Howard told CSNews that research has solidified the role of lower-risk products such as e-cigarettes and heated tobacco devices in reducing smoking prevalence. “Public Health England and organizations such as the Society for Research on Nicotine and Tobacco have highlighted that these alternatives are significantly less harmful than smoking. For instance, vaping is estimated to be 95% less harmful than combustible tobacco,” he said.
Future Factors
Convenience store operators looking to stay ahead of the harm reduction trend should keep in mind that the term is evolving. “In sum, it now encapsulates not only the use of safer alternatives, but also the broader framework of innovation, public health policy and greater access to less harmful nicotine products,” Howard explained.
Despite the fact that U.S. markets are “still hampered by the FDA’s regulatory scheme and the long delays from submission of PMTAs to market order,” he maintains that the future of reduced harm products is encouraging. “Both domestically and internationally, the tobacco industry continues to make significant investments in reduced harm products,” he said.
The launch of heat-not-burn devices in the U.S. by PMI in October 2024, as well as the expanded consideration of other tobacco harm products internationally, will factor into the future success of harm reduction, Booth stated.
“These are important developments because every adult consumer has different needs and subjective preferences, and we must meet them where they are, both in their risk reduction journey and in the places and occasions that require this widened scope of products,” she said.
Within the next few years, Reynolds expects to see a correction of the public misperceptions around the health effects of nicotine and potentially reduced risk products.
“We know that sustained and lasting changes to adult consumer behavior requires access to evidence-based information concerning alternative products. Our focus will be to correct these misperceptions by educating and engaging key stakeholders on the benefits of potentially reduced products, which is supported by scientific evidence,” the company’s spokesperson said.
- A Sprint or Marathon for Retailers?
The backbar has become somewhat of a mirror to the harm reduction movement as the typical convenience store offering has evolved to include more space for noncombustible products. But how can tobacco category managers be more strategic and proactive in the harm reduction race? Are there specific steps they should they be taking now?
According to Greg Schmidt, vice president of business analytics for Swisher, increasing alternatives to combustible cigarettes and shifting consumer preferences to emerging segments may necessitate reevaluation of product assortment and pricing strategy.
“Retailers can expect to see continuous new market entrants, especially in modern oral. This will drive a need to balance innovation with consistency to support a positive consumer experience, minimize shelf disruptions and avoid oversaturation,” he advised, noting that Swisher recommends retailers consider item productivity and exclusivity in awarding shelf space from combustible cigarettes to other tobacco products (OTP) to achieve the broadest consumer appeal.
“Delighting consumers in OTP with a variety of products can capture incremental margin opportunities with rotating seasonal or limited-time products from trusted manufacturers,” said Schmidt. Additionally, he challenges retailers to consider partnerships with manufacturers that are investing incrementally in innovation and product roadmaps, along with trial-driving initiatives aimed at accelerating transitions to noncombustible alternatives.
Forward-thinking convenience retailers in the harm reduction race also must anticipate portfolio shifts that align with regulatory changes. “Be prepared for item swaps, new item intros and item runouts to be more prevalent in the future,” Schmidt added.
Vetting for compliant products and manufacturers is another must, according to Kellsi Booth, chief legal officer for Black Buffalo. “The illicit market continues to thrive, including illegal importation of unauthorized e-cigarettes and nicotine pouches, as well as black market sales of banned products. Retailers can and should check that they are working with manufacturers of compliant products with demonstrated commitment to responsible marketing practices,” she stated, noting that the U.S. Food and Drug Administration’s Center for Tobacco Products has issued guidance and education materials to assist retailers.
Booth also emphasized that retailers play a critical role in preventing youth access and appeal, which she asserts will be of paramount importance to the success of emerging novel nicotine products. At a minimum, c-store retailers should ensure they are following the FDA’s recently released final rule increasing the minimum age for certain restrictions on tobacco sales, she said. Additionally, retailers may want to implement mandatory ID checking and/or scanning for all transactions to eliminate any guesswork from the equation.