Photo by Truth Initiative

Article by Truth Initiative

As the youth e-cigarette epidemic continues with about one in five high school students using e-cigarettes in 2020, a new type of flavored nicotine product is gaining popularity and raising public health concerns.

Oral nicotine pouches and lozenges are a new category of tobacco product that includes brands such as Zyn, On! and Velo and they come in many flavors. The use of flavoring in tobacco products has been proven to appeal to youth, and sales data show that nicotine pouches are increasing in popularity. According to Nielsen data reported in an industry news article, Zyn nicotine pouch dollar sales in convenience stores increased 470% in the first half of 2020. Truth Initiative has also observed a concerning number of young people reporting use of oral nicotine products. For example, Truth Initiative tracking shows that 13% of 15-24 year olds surveyed in Fall 2020 were past 30-day users of pouches. Enrollees in This is Quitting, a text message quit vaping program for young people from Truth Initiative, are also reporting use of nicotine pouches when they sign up for the quit program.

Oral nicotine products are used similarly to snus – a type of smokeless tobacco pouch that does not produce saliva, making it spit-less – but, unlike snus, they do not contain leaf tobacco. The products are still derived from tobacco and contain nicotine, which is harmful to young people in any form, but due to the absence of tobacco leaf, the Food and Drug Administration does not classify it is a smokeless tobacco product.

While official data on youth use do not yet exist because they are not included in national surveys, Truth Initiative has submitted recommendations that federal agencies include oral nicotine pouches and lozenges like Zyn, On! and Velo in future surveys. As more information emerges, here are some important things to know about these products.

Levels of nicotine and toxicants vary significantly across different types of products. For example, in Zyn products, nicotine levels can be as high as 6 milligrams per pouch.

Nicotine use during adolescence can disrupt the formation of brain circuits that control attention, learning, and susceptibility to addiction. Research has shown early age of nicotine use and pleasurable initial experiences are correlated with daily use and lifetime nicotine dependence.

Oral nicotine products come in an array of youth-friendly flavors such as mango, cinnamon, honey lemon, citrus burst, black cherry and many types of mint and menthol flavors.

The availability of sweet, fruity and candy-like flavors is troubling because, as pod-based e-cigarettes like JUUL face federal flavor restrictions in response to the youth vaping epidemic, young people are switching to other products that still offer flavors. For example, disposable e-cigarettes, which were exempted from the partial flavor restrictions FDA enacted in January 2020, have skyrocketed in popularity. Sales of menthol-flavored e-cigarettes, which were also exempted, experienced a drastic, immediate rise in sales with an increase of almost $60 million and its market share more than doubling.

Flavors play a significant role in drawing youth to tobacco products – more than 80% of youth who have used tobacco report that they began with a flavored product. In a study among youth, non-cigarette users who had used a product in the last 30 days, a large majority cited flavoring as a primary reason they used the products.

Oral nicotine products are, as yet, not regulated as tightly as smokeless tobacco products or combustible tobacco in the U.S. The FDA places some regulations on these products, including requirements that manufacturers submit certain information to the agency, use nicotine warning labels and comply with some basic marketing restrictions. No current regulations exist that prevent or restrict flavored nicotine pouches and the marketing restrictions on these products are not as strict as those on smokeless or combustible tobacco products. 

Manufacturers of products like Zyn were required to submit applications to the FDA in for pre-market review by September 9, 2020. The FDA is charged with determining if the products are “appropriate for the protection of public health” and authorizing tobacco products for sale in the U.S. As of today, if an oral nicotine product has not submitted a pre-market application, it is subject to removal from the market by the FDA. Additionally, to date, no oral nicotine product like Zyn has been authorized for sale by the agency.

While specific health effects of nicotine pouches like Zyn remain unknown, youth use of nicotine in any form is unsafe. While these products are not technically categorized as smokeless tobacco, they have many similarities to smokeless products, which carry serious health risks.

Chronic use of smokeless tobacco can result in nicotine addiction and there is evidence that smokeless tobacco use leads to cigarette use. According to nationally representative data published in National Center of Biotechnology Information, non-tobacco using youth who try smokeless tobacco are more willing to try cigarettes and e-cigarettes one year later.

Truth Initiative strongly urges the FDA to remove all unauthorized oral nicotine products from the market, including Zyn, that the agency has not authorized for sale. In order to prevent youth from using these products, eliminating all flavors, including menthol, from all tobacco products is crucial, as well as instituting marketing restrictions on these products to prevent youth exposure to them.