The U.S. FDA regulates tobacco and nicotine products and has established a comprehensive framework for regulation. This framework acknowledges that nicotine can be delivered on a continuum of risk, with combustible products on one end being the most dangerous and lethal, and nicotine replacement therapies such as gums and patches being the least harmful. The framework contemplates that products which deliver nicotine without burning tobacco can pose much lower levels of individual risk than combustible cigarettes.
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and for the first time conferred on FDA regulatory authority over tobacco products. The law, among other critical oversight and regulatory features, established premarket-review requirements for new tobacco products, including through Premarket Tobacco Product Applications (PMTAs). The PMTA, in particular, is a rigorous science- and evidence-based process to evaluate new tobacco products, such as vapor products, and determine whether they are appropriate for the protection of public health.
Through the Tobacco Control Act and review of PMTAs, FDA also has authority to impose sales and distribution restrictions as part of a product’s specific marketing authorization. Further, FDA will have continuing oversight over a product that receives a PMTA marketing order and will monitor the product’s impact in the market to determine whether it remains appropriate for the protection of public health.
Juul Labs respects FDA’s oversight role of our category, and we are currently preparing our PMTA based on rigorous scientific research. Our PMTA will explain the actions we have and are taking to restrict underage access to and limit underage appeal of our products.
While the PMTA process is underway, Juul Labs recognizes the important role state and local policymakers can play to combat underage use and support FDA’s actions to establish national policy. Initiatives such as raising the age of purchase to 21 to comply with federal requirements, strengthening age and identity verification at retailers, and creating a licensing framework are critical steps to preventing underage access and use.
In addition, state and local policymakers must help provide alternatives for adult smokers by ensuring that all products that are in domestic commerce consistent with FDA policy may be marketed and sold consistent with FDA’s policies. In general, we believe that public policy should reflect the continuum of risk for nicotine delivery, and should encourage adult smokers to transition toward potentially less harmful noncombustible products. This belief informs the following positions we hold on public policy questions surrounding vapor products.
In the United States, the Tobacco Control Act provides federal regulatory oversight of tobacco products, including vapor products. State governments play a critical role in augmenting that regulatory oversight with laws designed to promote public health and safety consistent with national tobacco policies.
Data from the CDC in 2018 and 2019 showed rising and unacceptable rates of underage access to vapor products in the United States. In December 2019, the federal government established 21 years of age as the minimum-purchasing age for the sale of all tobacco products, including vapor products. We strongly support this policy change. For decades, the vast majority of Americans have lived in states where the minimum-purchasing age was under 21 years, usually 18 years of age. This meant that 18-year old high school seniors could legally buy these products, and then share them with, or sell them to, their younger classmates. According to National Youth Tobacco Surveys 2017-2019, this type of “social sourcing” accounts for 65-85% of all underage use. While the federal law has changed to reflect 21 as the new legal age of purchase, we believe it is important that all 50 states do so as well to ensure state governments have enforcement authority in this critical area.
In addition to requiring a minimum-purchasing age of 21 years, Juul Labs believes it is appropriate to require all tobacco product purchases, whether at retail or online, be made with advanced age and identity verification. All tobacco product purchases, including vapor products, should automatically verify that the purchaser is at least 21 years of age and that his or her government-issued ID is valid. At retail, this may include the use of technology that prevents the sale of vapor products unless a valid, 21+ ID is electronically scanned at the point-of-sale. It may also be appropriate to require that a customer’s information be automatically validated against publicly available records and/or other data sources, where feasible.
Juul Labs believes that vapor products should be available in retail locations where combustible cigarettes are sold to provide an alternative for adult smokers. Therefore, we oppose proposals to restrict vapor products to tobacco specialty stores or to 21+ establishments where cigarettes are not subject to the same restriction. We support requiring advanced age and identity verification at all points of sale, regardless of the retail location.
The U.S. market has been flooded by tens of millions of illegal black market vape products, such as counterfeit devices and pods as well as unauthorized compatible pods designed to be used with authentic JUUL Devices. These products are produced with unknown quality standards and ingredients, often appear specifically marketed to underage people, and are often sold online without adequate age verification. FDA actively enforces against these illegal products. State governments can also play a critical role by requiring that any retailer selling vapor products be licensed to do so, and by establishing a product registry to assist enforcement efforts.
Juul Labs believes, and evidence demonstrates, that flavored vapor products can play an important role in helping adult smokers transition away from combustible cigarettes. At the same time, the National Youth Tobacco Survey (NYTS) in the United States has shown that underage use of vapor products disproportionately tracks to certain flavors, and rising rates of underage access demonstrate that the U.S. vapor category requires a comprehensive, uniform, and nationwide approach to regulating flavored vapor products.
The Food and Drug Administration has prohibited the sale of cartridge-based vapor products in any flavors other than tobacco and menthol, unless specifically authorized through the Agency’s PMTA process. Juul Labs fully supports and is complying with this federal policy, which provides adult smokers with the same flavor choices for vapor products that are available for cigarettes. In fact, prior to the issuance of the guidance, we proactively suspended the sale and distribution of all flavored JUUL products other than tobacco and menthol.
FDA is the appropriate body that will determine which vapor products will be available in the U.S. marketplace in the future. We will not reintroduce any other flavored product unless and until it goes through FDA’s premarket-review process.
We do not want any non-nicotine users, especially those underage, to try our products as they exist only to transition the world’s one billion adult smokers away from combustible cigarettes. We believe smokers should first and foremost quit. Those who have not successfully quit should completely switch to potentially less harmful alternative nicotine products.
As a part of FDA’s Comprehensive Plan for Tobacco and Nicotine Products, the Agency has said that “Envisioning a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources, needs to be the cornerstone of our efforts.”
As a number of public health experts have observed: to transition adult smokers completely, vapor products must sufficiently appeal to smokers, provide a satisfying nicotine experience, and be lower in toxicity and harm.
Many early vapor products did not appeal to large numbers of current adult smokers because they failed to provide a nicotine experience in an amount and manner that is satisfactory. Products with nicotine that more closely resembles the experience of smoking have helped make vapor devices more satisfying for adult smokers and have facilitated complete switching. According to these public health experts, “some new innovations in e-cigarettes do begin to occupy this sweet spot because some smokers have found an e-cigarette with sufficient appeal for them to sustain use and quit smoking.” For this reason we believe that vapor products should be permitted to convey a nicotine experience comparable to that of combustible cigarettes.
FDA, through its authority granted under the Tobacco Control Act provides federal regulatory oversight of tobacco and nicotine products, including vapor products. FDA can regulate nicotine content and delivery of vapor products both through the PMTA process and/or product standards.
Juul Labs believes FDA is the appropriate body to determine which tobacco and nicotine products will be available in the U.S. marketplace.
We believe that tax policy should reflect the continuum of risk for nicotine delivery, and should encourage adult smokers to transition toward potentially less harmful products. Taxes for this category should be levied on the volume of e-liquid, and should be less than, and certainly no more than, taxes levied on combustible cigarettes.
Juul Labs was founded and is based in the United States, and its affiliates operate in countries across the globe, in order to pursue our mission of transitioning the world’s billion adult smokers away from combustible cigarettes, eliminating their use, and combating underage usage of our products. To accomplish that mission, we are committed to working with governments, regulators, and other stakeholders in all our markets to create a responsibly regulated and adequately safeguarded vapor category. To view our international policies, click here.