The U.S. FDA established a framework that 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).
Juul Labs respects the original intent of the TCA and the framework that acknowledges a continuum of risk for potentially less harmful alternatives for adult smokers. The company has submitted multiple PMTAs to be reviewed by the FDA to expand viable, science-based alternatives for adult smokers to transition and completely switch them from combustible cigarettes, while continuing to combat underage use with novel and tested technological solutions.
We believe that once FDA does a complete review of all of the science and evidence presented in the applications, without political interference, as required by law, we should receive marketing authorization for our products.
Juul Labs recognizes the important role state and local policymakers can play to combat underage use, particularly with enforcement to prevent the proliferation of illicit and potentially harmful disposable vapor products. The companies manufacturing and distributing these illicit products completely disregard the law, and many use irresponsible marketing and flavors that appeal directly to youth. Data from the CDC’s National Youth Tobacco Survey shows that these disposables are the top brand being used by those underage. Furthermore, they have unknown ingredients and manufacturing practices that could pose serious risks to adult smokers looking for a potentially less harmful alternative. These disposable products threaten the opportunity for adult smokers to maintain access to potentially less harmful alternatives that abide by the rules and regulations of the United States.
State and local policymakers must help provide potentially less harmful alternatives for adult smokers by ensuring that products sold are in accordance with federal regulation. 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, while combating underage use. This belief informs the following positions we hold on public policy questions surrounding vapor products.
Illicit Products
The largest threat to providing adults with potentially less harmful alternatives is the massive proliferation of illicit products that are coming into the United States–mainly from China. Only 11 percent of the products sold in the U.S. have been authorized by FDA. These illegal products now account for approximately $9 billion per year, representing over two-thirds of U.S. e-vapor sales.
The vast majority of these products are illegal for sale in China, but are being sold freely in the U.S. The Chinese manufacturers of these products have profited billions by evading FDA regulation, misbranding and mislabeling their products, and engaging in marketing tactics that attract youth. What the country has experienced is an out of control market filled with illegal products that have questionable ingredients and increase underage use.
To bring law and order to the U.S. market, the federal government should demand the Chinese government immediately stop all exports of these illegal products to the U.S., and stop the importation of all illicit products at our borders. In addition to stemming the tide of this wave of illegal products, the FDA must enhance enforcement action. Juul Labs commends the steps taken by the agency thus far, but it is clear that its efforts are far too small to combat this problem. Continuing the status quo will only enrich Chinese companies, increase the prevalence of underage use, and harm the opportunity for adult smokers to switch to potentially less harmful alternatives that have undergone the proper scientific review.