In order for a tobacco product to be legally sold and marketed in America, the product needs to complete a “Premarket Tobacco Product Application” (PMTA) and get approved by the FDA.

A PMTA must provide scientific data that demonstrates a product is appropriate for the protection of public health.

In 2022, a slew of foreign countries sued the FDA for declining to approve their vapes for sale, and for providing sketchy guidance on what the requirements for a PMTA actually were.

Currently, only 23 Electronic nicotine delivery systems (ENDS) or “Vapes” have been approved for sale by the FDA.

So if vapes are technically illegal to sell in the U.S., why isn’t the FDA doing more to curb their distribution?

The FDA is Understaffed

The FDA is notoriously underfunded and understaffed. The FDA has stumbled from crisis to crisis over the past decade, including the baby formula shortage, food safety oversight failings, and foreign drug regulations.

However, with recent research underscoring the widespread use of vaping among young people, the FDA is beginning to take action by focusing on the products most popular with youth: flavored vapes.

The FDA recently announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes.

The FDA has taken multiple actions against large firms, including Chinese companies behind popular e-cigarette brands like Puff Bar, Breeze, Mr. Fog, and Esco Bars. According to the National Youth Tobacco Survey, these products have been among the most frequently used by U.S. youth in recent years.

Just some of their efforts include sending warning letters, inspection blitzes, product seizures, vape seizures, legal injunctions, and fines.

Actions taken against these companies include issuing warning letters to Dongguan Hengtai Biotechnology Co., Ltd. (makers of Mr. Fog) and Shenzhen Innokin Technology Co., Ltd. (makers of Esco Bars), as well as placing multiple manufacturers, including those producing youth-popular products like Elf Bar and Mr. Fog, on import alerts. These steps are part of a broader effort to address unauthorized tobacco products across the supply chain. For instance, in April, the FDA, in partnership with the DOJ, announced that the U.S. Marshals Service seized over $700,000 worth of illegal e-cigarette products from a California warehouse, which included brands like Puff Bar, Elf Bar, Esco Bar, and Smok. Additionally, in collaboration with U.S. Customs and Border Protection, more than $18 million worth of unauthorized e-cigarettes were seized at LAX last year, involving brands such as Elf Bar, Lost Mary, Funky Republic, RELX Pod, and IPLAY Max.

What Does The Future Hold For Vaping?

The FDA faces significant challenges in enforcing regulations on illegal vapes.

The vape industry is vast and constantly evolving. New products, formulations, and designs emerge rapidly, making it difficult for the FDA to keep up and enforce regulations on every new product. Manufacturers can alter packaging, ingredients, or branding to skirt regulatory actions, creating a “whack-a-mole” effect.

Many vape products come from overseas manufacturers, often based in countries with different regulatory standards. The FDA, working with agencies like Customs and Border Protection, can place certain products on import alerts, but the sheer volume of imports makes it difficult to catch every unauthorized product. Companies may also attempt to circumvent alerts with mislabeling or other tactics.

For these reasons, I think it’s unlikely that the FDA will be adequately equipped to regulate vapes in their entirety. But they are sending a strong message to manufacturers that vapes marketed to young people are on the top of their hit list.