Unclear Labeling of Nicotine Products Poses Risks to Consumers

Labeling of emerging commercial nicotine products—including electronic cigarettes (e-cigarettes) and new non-tobacco oral nicotine products—is insufficient for the protection of public health. Changes to labeling practices and federal requirements are urgently needed in order to convey the risks associated with nicotine use, to ensure that all individuals are aware that a given product contains nicotine, and to protect from accidental ingestion of nicotine.

While all nicotine products sold in the United States are required to carry warning labels in at least 12-point font size, if the product’s packaging is too small to accommodate the required label, the label may be affixed to outer packaging using a wrapper or tag.¹ Unlike cigarettes, outer packaging of emerging commercial nicotine products is often quickly discarded after purchase, leaving the consumer with no further exposure to the warning label after purchase. For example, Figure 1 presents a popular brand of e-cigarette in the package in which it is sold (including the warning label), and after the outer packaging has been discarded (as the product is used after purchase). This may be especially problematic for young people, who may receive little to no exposure to warning labels indicating the harms of e-cigarettes, either because they purchase and discard the package with the warning label or because they obtain e-cigarettes from friends² and therefore never see the product’s original packaging with the warning label. One study found that 87% of e-cigarette ads in the United States carried the required nicotine warning label, suggesting relatively strong compliance³; however, less than half of U.S. high school students who use e-cigarettes reported high exposure to warning labels on product packaging.⁴ Graphic warning labels on nicotine products may be an additional strategy to increase knowledge of the harms of non-cigarette nicotine products. Exposure to graphic warning labels has been shown to be highly effective in increasing knowledge of the harms of cigarettes, promoting smoking cessation among adults, and preventing smoking initiation among youth.⁵ Canada implemented graphic warning label requirements on cigarette packaging and subsequently experienced a steeper decrease in smoking prevalence than did the United States.⁶ Along with pictorial warnings, textual messages on each principal display area are important components of warning label best practices for cigarettes.⁷ With e-cigarettes, a recent study found that nicotine warning statements on product packaging increased perceived harm of e-cigarette products and decreased intentions to use e-cigarette products among young people.⁸

Figure 1.

A popular e-cigarette in its box with a warning label (left) and as typically carried (right).

In addition to warning labels, all nicotine products should be clearly labeled as containing nicotine. Such labeling is necessary for proper identification when the product has been removed from its package. Insufficient labeling presents danger of accidental ingestion or over-ingestion of nicotine from e-cigarettes and new non-tobacco oral nicotine products (eg, gums, gummies, lozenges, tablets, pouches). Young people have reported becoming “nic-sick” from e-cigarettes, referring to experiencing symptoms of nicotine over-ingestion (eg, nausea, headache, dizziness).⁹ Accidental ingestion and over-ingestion can cause serious illness. In 2021, United States poison control centers handled over 5000 cases related to e-cigarettes and liquid nicotine.¹⁰ While some e-cigarettes have the nicotine concentration printed directly on the device, many do not. For example, the e-cigarette in Figure 1 (without the package) contains no indication that the product contains nicotine. The reference to “5%” (denoting 5% nicotine) is insufficient for clear messaging that this is a nicotine product.

Non-tobacco oral nicotine products also carry risk of accidental ingestion or over-ingestion due to related concerns regarding insufficient labels about the product’s nicotine content. Many oral nicotine products bear a striking similarity to ordinary food products. Figure 2 shows a non-therapeutic nicotine gum alongside a popular brand of ordinary gum. When the outer packaging is removed, the products are almost indistinguishable, and it is unclear that the product on the left contains nicotine. Youth and adults alike may mistake nicotine gum for ordinary gum and unintentionally consume nicotine. A popular brand of non-therapeutic nicotine gum does not explicitly mention nicotine on the product’s outer packaging, which simply states, “4 mg per piece”.¹¹ Youth may take advantage of the similarity in appearance to conceal nicotine products from teachers and caregivers. There is an apparent need for clear labeling of nicotine products to prevent accidental ingestion or over-ingestion among both youth and adults. Products that resemble food products, like gum, may carry an especially high risk of accidental ingestion.

Figure 2.

Gum with (panels A, B) and without (panels C, D) nicotine, with outer packaging removed.

As the nicotine marketplace evolves, labeling requirements should be updated to ensure that: (1) warning labels are conspicuous even when the product is removed from its outer packaging, and (2) products are clearly labeled as containing nicotine. First, warning labels clearly stating that the product contains nicotine, an addictive chemical, should be required on the smallest component of the packaging, such as on e-cigarette devices (Figure 1) and blister packs (eg, for non-therapeutic nicotine gum; Figure 2). The required font size (ie, 12-point) could be reduced when necessary to affix the label directly to the package. Warning labels should also be required on accessories that would conceal a warning printed on the nicotine/tobacco product itself. The U.S. Food and Drug Administration (FDA) has regulatory authority over tobacco product components, parts, and accessories¹² such as “skins”, which are decorative covers for popular e-cigarette devices. Warning labels on decorative skins would convey ­information about the product’s harms. Second, nicotine content should be clearly printed on products that contain nicotine, including disposable e-cigarettes, e-cigarette cartridges, and the innermost packaging of oral nicotine products (eg, blister packs of gum). Consumers need to be aware of a product’s nicotine content even when it has been removed from its outer packaging.

In sum, warning labeling for alternative nicotine/tobacco products needs to both identify the product as a nicotine product and warn users that nicotine is an addictive chemical. Labeling outer packaging is insufficient for products that are typically carried and used without their outer ­packaging. Nicotine/tobacco product packaging and accessories are within FDA’s regulatory authority, and regulatory action should be taken to strengthen labeling requirements.

Funding

Research reported in this publication was supported by grant U54CA180905 from the National Cancer Institute (NCI) at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) Center for Tobacco Products (CTP), grant R01CA229617 from NIH/ NCI, and grant K01DA042950 from the National Institute for Drug Abuse at NIH. The funders had no role in the preparation, review, or approval of the manuscript.

Declaration of Interests

The authors have no conflicts of interest to declare.