For a number of years, the U.S. Food and Drug Administration signaled that it would exercise enforcement discretion with respect to companies selling e-cigarettes that otherwise lack authorization from the agency to be sold, which included prioritizing enforcement against some unauthorized e-cigarettes over others. This has fostered the development of a misperception that the FDA continues to allow some unauthorized products to be sold. Now the agency is emphasizing that it has only authorized 39 e-cigarette products for sale and that all others are illegal.

When Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009, the law originally covered many tobacco products but did not regulate e-cigarettes. E-cigarettes could therefore initially be sold without federal regulation. However, the Tobacco Control Act gave the FDA authority to assert jurisdiction over additional products, and the agency “deemed” e-cigarettes and other products made or derived from commercial tobacco to be under its regulatory authority in 2016. This meant that companies would be required to submit e-cigarettes for premarket review and receive authorization before marketing the products for sale.

Since many e-cigarettes were already on the market when the FDA asserted authority over them, the agency stated in the Deeming Rule that it would allow companies with products on the market as of the rule’s effective date of August 8, 2016 to continue to sell them while their applications remained under review. In this way, the FDA allowed some unauthorized e-cigarettes to stay on the market from the outset, though only for a limited period of time.

Despite granting that initial short-term period for newly deemed products to remain on the market without affirmative authorization, the agency then issued a guidance in 2017 that announced its intent to delay the premarket review requirement for years. In response, public health groups sued to compel the FDA to comply with the Tobacco Control Act’s premarket review requirements in 2018. As a result of this litigation, the court required all manufacturers with products on the market as of August 8, 2016 to submit applications by September 9, 2020 in order to continue to market the products while the FDA reviewed their applications. This case thus again allowed some products to remain on the market without a marketing granted order.

The FDA issued an additional guidance that explained its enforcement priorities in 2020, a guidance that may have been construed to suggest that the agency might continue to allow some products to remain on the market even though they lacked authorization. In the guidance, the FDA specifically identified its intent to prioritize enforcement against flavored, cartridge-based e-cigarettes, products with inadequate measures to prevent youth access, products with marketing appealing to youth, and products offered for sale after September 9, 2020. While the industry could have taken this guidance to mean that products not falling into one of the prioritized categories could be sold without a marketing granted order, more accurately it suggested that e-cigarettes without such an order that did not fall into one of those categories may simply have been lower enforcement priorities. It did not mean that deprioritized products would see no enforcement from the FDA.

That implied message that the FDA might not enforce against certain types of unauthorized e-cigarettes is now the basis for a number of state laws. Many of the laws undergirding the industry driven rise of state registries for e-cigarettes, for instance, permit the sale of e-cigarettes if they were on the market as of August 8, 2016 and submitted applications by September 9, 2020, even if they lack a marketing granted order. By using that date range, such state laws allow numerous unauthorized products to be sold. What is more, these bills and laws do not address flavored products and seem market protective for a legacy e-cigarette industry.

Recently, though, the FDA has been stressing a new prioritization. Rather than categorizing some unauthorized products as higher enforcement priorities than others, the agency is instead underscoring that it has only authorized 39 tobacco- and menthol-flavored e-cigarette products to date, along with 20 nicotine pouches. The FDA Commissioner recently announced that educational materials will be sent out to several hundred thousand retailers nationwide, for example, materials that include the list of e-cigarettes that the agency has authorized, implying that all others are unauthorized. In addition, the FDA’s website providing this list states that “[t]hese are the only e-cigarettes that may be lawfully sold in the United States.” The agency retains broad discretion over enforcement, but it also must abide by the requirements of the Tobacco Control Act, and its current stance towards unauthorized products seems more in line with what that law requires.

Thousands of e-cigarettes other than the ones on the FDA’s list pervade the market—some with submitted applications and others without, and it is now apparent that the agency considers it illegal to sell all of them. And with companies like Altria and R.J. Reynolds about to market new products despite knowing that they lack authorization, it is worth emphasizing that having a product application under review does not grant a company safe harbor, as public health groups have recently reminded the FDA.

Luke Haqq, Staff Attorney
October 14, 2025