Week of June 16 Regulatory Intelligence Recap

Trade Press and Regulatory Summary:

• Swedish Match USA, Inc. Modified Risk Tobacco Product (MRTP) Applications for ZYN Products Enter Scientific Review - FDA

On June 17, 2025, FDA filed for substantive scientific review modified risk tobacco product (MRTP) applications from Swedish Match USA, Inc. for the following ZYN nicotine pouch products, each available in two strengths (3 milligrams and 6 milligrams): ZYN Chill, ZYN Cinnamon, ZYN Citrus, ZYN Coffee, ZYN Cool Mint, ZYN Menthol, ZYN Peppermint, ZYN Smooth, ZYN Spearmint, ZYN Wintergreen
The tobacco products in the applications are commonly referred to as nicotine pouches, which are small fiber pouches containing nicotine designed to be placed between a person’s gum and lip. Following an extensive scientific review of the premarket tobacco product applications (PMTAs) for these 20 ZYN nicotine pouch products, the FDA authorized them for sale in January 2025. (analysis below)

• How middlemen funnel illegal Chinese vapes into the United States - Reuters

The Chinese city of Shenzhen is the biggest source of vapes, both legal and illegal, coming into the United States. In 2024, China exported more than 26 billion yuan ($3.6 billion) in vapes to the U.S., according to Chinese customs data. But U.S. customs figures show only $333 million in Chinese vapes were officially received in the U.S. that same year.

Mismatches in custom data between the U.S. and its trading partners are not uncommon, but a 90% gap was unusual, two customs data specialists told Reuters.

Unauthorized vapes often arrive in the U.S. disguised as other items like shoes and toys, according to the FDA, which leads efforts to control the vape market.

Reuters used FDA and U.S. customs data, interviews with vape and tobacco industry insiders, and information from U.S. regulators and law enforcement to build a picture of how unauthorized vapes make their way onto U.S. shelves.

It found a group of middlemen based on U.S. soil - including some customs brokers and distributors - who played key roles in the vape supply chain, and sometimes take steps to avoid detection.

Trump Administration officials have promised a crackdown; FDA Commissioner Marty Makary has said the agency will stop illegal imports and distribution.

• Disposable vape ban spurs costly and wasteful misuse of prefilled pod kits - Vape Business

The UK’s ban on disposable vapes was intended to curb environmental damage, but online vape retailer WizVape has raised the alarm over a worrying trend it says undermines that goal, and leaves consumers out of pocket.

According to Saif Khan, director at WizVape, a growing number of consumers are now misusing prefilled pod kits — a category of vape products designed to be reused with replacement pods — by using them as if they were disposables.

“We are finding that many consumers are purchasing 5–10 devices at once and throwing the device away when the pod runs out, just as they would have done with disposables,” said Khan. “This shift raises significant issues on several fronts.”