Oral Nicotine Products at the Point of Sale

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What are “new” oral nicotine products, such as nicotine pouches?

The term “Oral Nicotine Products” refers to a class of products that includes nicotine pouches, lozenges, discs, chews, gum, sticks, and other non-combustible products containing nicotine that is absorbed in the mouth. Some of these products, such as pouches and many discs and chews, are placed between the lip and the gum, where the nicotine is then absorbed, after which the user removes and throws away the pouch. Other products are considered “dissolvable,” such as nicotine lozenges.

These products may contain nicotine that is derived from the tobacco leaf or nicotine that is declared as chemically synthesized (synthetic). Research has not shown any notable difference between nicotine derived from the tobacco leaf and synthetic nicotine as it pertains to the way the human body and brain react nor as it pertains to levels of addictiveness. [1]

Nicotine pouch style products are available in at least 22 markets globally. Some of the most widely known brands are owned by the largest tobacco corporations:

  • “ZYN”: Owned by Swedish Match, a subsidiary of Philip Morris International.
  • “Velo”: Owned by British American Tobacco.
  • “On”: Owned by Altria, the parent company of Philip Morris USA and U.S. Smokeless Tobacco.

Sales of nicotine pouch style products have skyrocketed in the last several years. These products are similar in design to the smokeless tobacco product “snus,” but they do not contain tobacco leaf. The Federal Trade Commission reported that sales of new oral nicotine products totaled $1.06 billion in 2022 with 5.63 billion nicotine lozenges, pouches or pucks sold, which is more than double their sales in 2020. Between late 2019 and early 2022, the overall sales of nicotine pouches rose from 126 million units to over 808 million units, which is an increase of nearly 700% in less than three years. Furthermore, sales of the higher nicotine concentration products rose more dramatically than lower nicotine concentration products. [2] In 2024, Philip Morris International declared that it had shipped 62% more cans of ZYN than in the year prior.

Health Considerations – What are the Concerns?:

Concerns related to these products span numerous areas of public health, particularly for youth, and include physiological and behavioral health impacts, ease of accessibility given their low cost and widespread distribution and sale, and targeted marketing of these products that research has shown appeal to adolescent youth. [3]

Ad for The nicotine concentrations of these products are high, and levels have been increasing since these products first hit the market. There are currently a wide variety of products sold at varying concentration levels. Nicotine pouch cans may have 15 pouches per tin, and each individual pouch can contains anywhere from 1.5mg – 12mg of nicotine. However, especially globally, some brands are now selling selling pouches containing up to 50mg nicotine per pouch. The body absorbs a significantly greater proportion of nicotine (about 50% through typical use of  these oral nicotine products than from inhalation of cigarette smoke (about 11%). [4,5] This means people who use these products may be absorbing two or three times more nicotine from one oral nicotine pouch compared to one cigarette.[6]

Furthermore, similar to many newer e-cigarettes, oral nicotine pouches contain nicotine salts. The tobacco company RJ Reynolds patented nicotine salts to increase the nicotine content of products but prevent what would otherwise cause more intense throat irritation if it were freebase nicotine of such concentration.[7] Validating this product formulation strategy, researchers have found study participants preferred salt-based nicotine over freebase nicotine, noting it was smoother and less harsh, with the greatest appeal among those who never smoked cigarettes.[7] Following RJ Reynolds’ patent, nicotine salts were re-structured by JUUL for use in their e-cigarette products in order to increase nicotine levels of their vaping products.[8] The high levels of nicotine in oral nicotine products are able to be sustained through the use of nicotine salts.

Along with the extremely addictive nature of nicotine and its intersection with mental health, youth use of nicotine can impair brain development, increase heart rate and blood pressure, and is associated with reproductive health impacts [9, 10, 11] While the health impacts of long-term nicotine exposure (without being paired with combustible tobacco) continues to be studied, it is important to note that acute symptoms of nicotine sickness can occur when consuming high nicotine levels, which include intense vomiting, nausea, headache, shallow breathing, increased heart rate and blood pressure, and dizziness and tremors.

Emerging research is finding out in markets around the world, half of oral nicotine pouches may contain some of the same cancer-causing chemicals that are in tobacco products, known as tobacco-specific nitrosamines (TSNAs).[12] The American Cancer Society has designated TSNA’s as the most dangerous cancer-causing substance that is found in smokeless tobacco products.

How are they being marketed at the point of sale?

Availability

Even though the FDA has not authorized the marketing of any currently sold types of new oral nicotine products, they are ubiquitous in shops across the country. This includes gas stations, convenience stores, grocery stores, and other types of retail establishments open to people of all ages.

Placement and Packaging

While the tobacco corporations that make these oral nicotine products may instruct the retailer to store these products behind the counter, there is not uniform standards or robust federal direction on this issue as the Tobacco Control Act created for cigarettes and other forms of smokeless tobacco. These products are often packaged and labeled in ways reminiscent of ordinary candy, gum, and mints, which may lead consumers or retailers to believe these products are in the same product category as regular retail snacks and candy. [13]

Promotion

As has become widely covered in the media, by public health officials and organizations, and by policy-makers in Congress, youth are being targeted for these oral nicotine products – in many of the exact same ways that e-cigarettes have targeted youth. From a wide variety of flavors to alarmingly low prices, to younger people depicted in advertisements, to promotions that remark on the products’ “discreet” qualities and ability to hide from others, this marketing appears to intentionally appeal to youth and resembles many forms of e-cigarette and cigarette ads.[14] These products are marketed with the words “freedom,” denoting the ability to use these products in all various settings.[15]  Findings have confirmed that these marketing tactics have appealed to minors, with those 13-20 years of age being more likely to purchase Zyn if there was content about appealing flavors and social comfortability.[16]

These products have also been marketed as “tobacco free” or containing “food grade ingredients” or “pharmaceutical-grade nicotine,” even though no health difference has been found between nicotine sources. Furthermore, while the FDA does generally note that smokeless products are lower on the spectrum of risk than cigarettes, none of these new oral nicotine products have been granted a modified risk tobacco product (MRTP) designation. In fact, the FDA has sent warning letters to certain manufacturers of new oral nicotine products, declaring them in violation of federal law for implying or explicitly stating that their product is lower risk. These warnings have also formally documented the absence of nicotine health warning statements with which these products are required to be labeled.

Oral nicotine products, particularly the nicotine pouch brand of ZYN, has recently received significant media attention and congressional attention.[17] In part, this has been due to the rise of social media influencers posting about their oral nicotine product-use on social media outlets that are frequented by youth. These individuals are colloquially termed “zynfluencers,” as they are increasing product exposure and product normalization for youth and young adults. It seems evident that the marketing and accessibility of oral nicotine products has effectively drawn in youth and young adults.

In addition, Phillip Morris International is even launching a “rewards program” for ZYN brand products, which is akin to similar rewards programs that have a long history in cigarette marketing. This rewards system encourages individuals to trade in ZYN-brand pouch cans for items such as valuable tech products, Amazon gift cards, and hair styling products.

Rather than serving as a medicinal cessation aid for people who currently smoke to eventually stop use of nicotine products, this promotional style may incentivize continuous and increased use by offering goods and merchandise for increased purchases.

Pricing

Zyn advertisement with $2.99 per can when you buy 2; Save $1.50The average price for a can of 15 Zyn nicotine pouches is around $4 to $5. This is half the price of a pack of cigarettes in many states and one-third the price of a pack of cigarettes in other states. These new oral nicotine products are exempt from certain states’ tobacco excise taxes and evade many restrictions on coupons and discounts, employing many “buy one get one”-style pricing strategies. 

Increased price is one of the most impactful determinants in reducing tobacco use, particularly in price-sensitive populations such as youth, and maintaining low prices is a key strategy to growing and maintaining the tobacco industries’ bases of consumers. Exemption from state tobacco excise taxes and the ability to offer a wide range of in-store and online promotions and discounts helps to keep the price of these oral nicotine products low for consumers. Coupling low price points with a myriad of flavor options are two marketing strategies that have made tobacco products most appealing and accessible to youth, and tobacco companies seem to be using the same playbook to promote new oral nicotine products as well.

Regulation

Federal Regulation:

In 2021, certain manufacturers of nicotine products began to increasingly claim that their nicotine was synthetically derived. At that time, the FDA stated it did not possess the ability to extend tobacco product regulations to these synthetic nicotine products. In response, in March 2022, the U.S. Congress passed a bill that expressly clarified and permitted the FDA to regulate nicotine from any source. This law amended the Family Smoking Protection and Tobacco Control Act (TCA) by updating the definition of “tobacco product” to specifically encompass products containing nicotine from any source. Learn more in the Public Health Law Center’s summary: What’s the Deal with Synthetic Nicotine? Taking effect in April 2022, the FDA has since referred to and regulated these synthetic nicotine products as “Non-Tobacco Nicotine” (NTN) products.

This means that, presently, the Tobacco Control Act of 2009 and the 2016 FDA Deeming Rule together regulate all cigarettes, smokeless, e-cigarettes, hookah, pipe tobacco, cigars, smokeless tobacco, and products containing nicotine from any source that is intended for human consumption. All such products, including new oral nicotine products containing nicotine from any source, are subject to premarket tobacco product application requirements. It is important to note all such products that are marketed without FDA marketing authorizations are, in fact, being marketed illegally.

As of April 2024, the FDA has only authorized the marketing of four types of new oral nicotine products – none of which are currently sold on the market today. These include Verve Discs Blue Mint, Verve Discs Green Mint, Verve Chews Blue Mint and Verve Chews Green Mint. As of May 2024, this means that all other new “oral nicotine products” on the market are currently in violation of federal law.

To date, there are no NTN products that have received approved marketing orders from the FDA. Akin to the e-cigarette product types and other tobacco-derived products that do not have FDA marketing authorizations, all such NTN products are being marketed illegally. Even so, many types of new oral nicotine products are widely available and sold at retail establishments and online. There remain significant gaps in federal regulation of these products, both in ensuring compliance with the FDA’s tobacco product standards policies as well as federal regulation in the placement and promotion of these products at the retail establishment.

Furthermore, the FDA has recognized illegal sales of these products to youth under the minimum legal sales age (MLSA) of 21. The FDA issued over one hundred warning letters in April 2024 to brick and mortal retailers that engaged in underage sales of flavored nicotine pouch products. These violations occurred during inspections taking place within only a five-month period (October 2023 to February 2024). Three online retailers of flavored nicotine pouch products were also issued warning letters due to illegal underage sales.

In addition, a potentially confusing and concerning practice is the marketing of FDA-registered NRT products alongside other nicotine products that are not approved for smoking cessation by the FDA.[18] The products, which may be produced by the same manufacturer, are marketed, branded, and sold in similar manners to each other, potentially muddling the important distinction between products that are FDA-approved smoking cessation aids and those that are not. This seems to blur the lines between a retail product broadly marketed and a targeted product outreach as a nicotine cessation medication – to aid eventual cessation rather than prolong nicotine dependence.

oral nicotine pouches under a
Oral nicotine pouches placed under a “smoking cessation” sign in a pharmacy

State Regulation:

Product proliferation and sales may benefit from the fact that these oral nicotine products are excluded from numerous state-level definitions for tobacco products. This means that these products evade many state level policies established to protect youth from new or prolonged addiction or deleterious health effects. This may include exemption from regulations around retailer licensing, density or proximity restrictions to schools, flavored product sales restrictions, taxation, and the time, place, and manner of advertising and promotions.

sandwich board sign advertisement for Zyn In practice, particularly if excluded from many state regulations, this can mean these cheap products may be sold in a wide variety of flavors across many types of all-age accessible stores. They can be found marketed, labeled, branded, and shelved similarly to many other food products. They can be offered with discounts, coupons, and promotions.

State regulators attempting to address youth nicotine dependence and youth access to these products have faced increased difficulties, particularly because there are no nicotine concentration restrictions imposed by the FDA and nearly all new oral nicotine products are being marketed in an illegal fashion without FDA marketing authorization. Similar to relatively recent e-cigarette industry practices, these products are promoted either through direct advertisements or indirect product sponsorships, skirting many of the advertising and marketing restrictions that exist for cigarettes and becoming extremely different for state regulators to monitor, survey, and address.

Key Policy Considerations: 

To ensure a holistic and cohesive approach to tobacco and nicotine product regulation, it is important for jurisdictions to appropriately consider how these new oral nicotine products may be unintentionally excluded in state or local regulatory frameworks.

Significant ambiguity can come from existing definitions of “tobacco” or “nicotine” products that may be overly narrow or those that rely upon the terminology of “tobacco-derived” or of “tobacco leaf.” Accordingly, in alignment with the action taken by Congress, local leaders may want to ensure that state statute and local ordinances appropriately regulate tobacco products containing nicotine from any source. Note that FDA approved nicotine replacement therapy (NRT) is expressly excluded from the definition of “nicotine products.”

Individual Level Treatments vs Population-Level Policies:

Many of the oral nicotine product manufacturers state that their products are intended for and marketed solely to adult populations who currently use combustible tobacco. Knowing that combustible tobacco use is the leading cause of preventable death, oral nicotine product use may be a relatively lower-harm alternative if people who smoke stop smoking all together. However, for people who are not currently smoking, oral nicotine product use can lead to nicotine dependence, and a growing number of studies around use of nicotine products have found that nicotine dependence may be predictor of lifelong tobacco use and addiction as well as dual use of combustible tobacco and other forms of nicotine.[19]

Accordingly, similar to the marketing efforts of e-cigarette companies, it is clear through promotional efforts by the tobacco companies selling oral nicotine products that they are incentivizing continued and uninterrupted use of their product in perpetuity – and gaining significant appeal from youth who may not currently smoke, thereby potentially initiating or prolonging nicotine and tobacco dependence.

Communities may benefit from considering place-based, point-of-sale policies to help protect youth and adults from targeted marketing by tobacco corporations. Knowing that nicotine is used as a coping mechanism, and that youth of color, LGBTQ+ youth, and youth from lower-socioeconomic status communities face disproportionately greater stressors and barriers to health resources, it is important to implement policies rooted in health equity. Examples of policies may include:

Additional Resources 

Last updated July 11, 2024

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