Under the Family Smoking Prevention and Tobacco Control Act (2009), the U.S. Food and Drug Administration (FDA) was given one of the strongest tools to address the harm caused by commercial tobacco product use: premarket review. With its premarket review authority, the FDA acts as a gatekeeper to the marketplace. This means that the FDA has the ability to determine which products are available for sale in the United States and which are not. However, since the passage of the Tobacco Control Act in 2009, the FDA has repeatedly failed to implement premarket review in a timely or public-health focused manner.
Current Status of Premarket Review Process - Missed Deadline
After years of delays, the premarket review process has finally begun for e-cigarettes, nicotine pouches, cigars, waterpipe tobacco, and other products that were entirely unregulated until 2016. The process began only after public health groups successfully sued the FDA .
The court established deadlines: all manufacturers were required to submit applications by September 9, 2020, to be able to continue to sell their products while the FDA reviewed the applications. Additionally, the court ordered that only products that received authorization from the FDA by September 9, 2021, could remain on the market legally beyond that date. Leading up to that deadline, the FDA did deny or otherwise reject approximately two-thirds of all product applications. However, to date, only twenty-five products have received authorization from the FDA (more on this below). This means that all other products that have not received authorization (approximately 850,000 products - including brands popular with youth, like Juul), are illegally being sold in violation of the court’s order.
While this is legally true, the FDA is also the agency tasked with enforcing the court’s order. To date, the FDA has sent no warning letters or taken any other enforcement action to remove these products from the market. Essentially, the FDA is allowing these products to remain on the market past the deadline while it continues to review applications. In November of 2021, the plaintiffs requested that the court modify its order to specifically direct the FDA to adhere to the deadline. The FDA responded by asking the court to deny the plaintiff’s request and by pointing out the progress that has been made and the litigation burden of defending its decisions in court. As of January 2022, the court has not provided a decision.
Currently Authorized Products
To date, the FDA has authorized twenty-five products: The first authorizations in 2021 (four flavors of VERVE discs, the Vuse Solo e-cigarette device and two varieties of tobacco-flavored pods for that device) have raised many concerns:
- The FDA stated that it intended to approach authorizations by addressing products with the largest market share first. That has not happened. Phillip Morris, maker of VERVE discs, no longer markets these products at all and has stated in industry-focused publications that it does not intend to sell these products anytime soon. Although Vuse is generally a popular e-cigarette brand, its most popular device is a Juul-like device: Vuse Alto, not Vuse Solo. Neither of these authorizations indicate that the FDA is taking a market share approach to authorizations.
- The authorized Vuse Solo cartridges have an alarmingly high nicotine content. Each cartridge has a nicotine concentration of 57.4 mg/mL. This is much higher than the maximum allowed in other countries. The European Union, Canada, and the United Kingdom all currently restrict nicotine levels in vape products to 20/mg/mL.
- The FDA chose to neither deny nor authorize menthol products. While the FDA denied authorization for most of the flavored Vuse cartridges, the agency decided to not make a decision on Vuse menthol cartridges. This is despite the FDA’s assertion that it intends to move forward with a rule to prohibit menthol in cigarettes.
- The FDA has caused considerable confusion and frustration in how it has communicated about these authorizations, which has been further exacerbated by the media coverage of the authorizations. Many headlines improperly claim that the FDA had “approved” these products for sale, when the correct term is “authorized,” and some even improperly state that Vuse Solo was “approved” as a cessation device. The FDA uses the term “approved” when it grants an application to market a drug or delivery-device. To the average consumer, this means that the FDA has given its “stamp of approval” that the product is “safe and effective” – the legal standard to sell a drug or device. Recognizing that commercial tobacco products could never be “safe and effective” for consumers to use, the Tobacco Control Act, instead establishes a process of “authorization.” This means that Vuse Solo is NOT “safe and effective,” is NOT a cessation product, and does NOT have the FDA’s “approval.” The FDA has merely determined that the marketing of the product will not cause additional harm to public health, hardly a determination that connotes “approval.”
While the FDA is careful to use the term “authorization” rather than “approval” in its communications regarding Vuse, it continues to cause confusion by also stating in bold typeface, “the manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals.” This is contrary to the non-industry data that exists demonstrating that e-cigarettes do not lead to cessation. It was irresponsible of the FDA to make such bold claims, while ignoring evidence to the contrary, and inappropriate for the FDA to make unfounded claims on behalf of a tobacco product manufacturer.
Impact on State, Local, and Tribal Regulation
Many state, local, and Tribal regulations have adopted definitions of e-cigarettes (and sometimes tobacco products) that exclude any product that is “approved” or "authorized" by the FDA as a drug or device. These exemptions are intended to allow legitimate medical products to avoid policies such as tobacco product taxation. It’s important to note that Vuse Solo – or any other product the FDA's Center for Tobacco Products may give premarket authorization to in the future – are not approved as cessation drugs or devices and are not exempt from the definition of e-cigarettes or tobacco products in our sample definitions.
Additionally, some communities have previously adopted language that prohibits the sale of any e-cigarette that has not received premarket review authorization from the FDA. Most notably, San Francisco took this approach in 2019. Other communities have followed and adopted similar provisions. In those communities that tied the prohibition of sale of e-cigarettes to FDA premarket review authorization, Vuse Solo (and other more recently authorized e-cigarettes) can now most likely be sold. If those communities wish to continue with a total sales prohibition of e-cigarettes, they would likely need to amend their ordinances to disentangle the prohibition from premarket authorization. Those communities should also ensure that any flavor restrictions and other restrictions in the current ordinance will still apply to e-cigarettes that have received premarket review authorization.
Finally, some states and communities would like to ensure that their laws and regulations mirror the current federal landscape regarding premarket review. Each state and community is unique, but one approach would be to adopt a law that would prohibit the sale of any tobacco product that has received a Marketing Denial Order (or MDO) from the FDA. Communities that wish to take this approach are encouraged to reach out to the Public Health Law Center for assistance.
By Natalie Hemmerich, Lead Senior Staff Attorney for California Technical Assistance
May 16, 2022