Pennsylvania’s Vape Directory Law Survives Federal Court Challenge

A final judgment

On October 14, Judge Julia K. Munley of the US District Court for the Middle District of Pennsylvania rejected the challenge brought by MMA Group 1 Inc., which operates Tobacco Hut stores, and several other vape businesses against Attorney General Dave Sunday and Revenue Secretary Patrick Browne.

The ruling is not a preliminary decision. The plaintiffs had filed suit on May 20, 2026, and asked for a preliminary injunction the next day. After an evidentiary hearing, the judge chose to decide the preemption question on the merits, and converted the request into a motion for summary judgment. Her order grants summary judgment to the state and closes the case. The plaintiffs can still appeal to the Third Circuit.

A sales ban, not premarket review

The plaintiffs argued that Act 57 was a “backdoor” form of premarket review, an area the Family Smoking Prevention and Tobacco Control Act (TCA) reserves to the FDA. The judge partly agreed: because eligibility for the directory depends on the FDA’s premarket review, the law does fall within the TCA’s preemption clause.

But that clause is framed by two others. The first preserves states’ authority to adopt rules stricter than federal ones, including sales bans. The second, known as the savings clause, exempts from preemption any requirement relating to the sale, distribution or possession of tobacco products, or to information reported to the state. Since Act 57 attaches its prohibitions and penalties to the sale of unlisted products, the court ruled that it is a sales ban, which fits within this exception.

The judge acknowledged that the plaintiffs’ criticisms of the reasoning used by other courts were “well taken”, but reached the same conclusion from the text of the TCA.

No federal enforcement by proxy

The plaintiffs also argued that only the federal government can enforce the Food, Drug, and Cosmetic Act. The court disagreed: to enforce Act 57, the state only has to show that an unlisted product was sold or offered for sale, not that federal law was violated. A manufacturer can also be excluded from the directory for purely state-law reasons, such as failing to pay fees or post a bond, while remaining compliant with federal law.

The memorandum also notes that unauthorized vapes remain widely available because the FDA has opted for deferred, case-by-case enforcement, a situation that led states to adopt directory laws. The agency has since eased its enforcement approach further.

What is at stake for retailers

According to the court’s summary of the record, the plaintiffs make, distribute and sell e-cigarettes that have neither an FDA marketing order nor a pending application. Tobacco Hut employs 150 to 180 full-time staff and draws 60% of its profits from e-cigarettes. As of June 2, it held $2 million worth of products subject to seizure under Act 57. Its stores sell 200 to 300 different unauthorized vapes, including the Hut Bar, made by co-plaintiff Nova Distro.

What Act 57 requires

Under Act 57 of 2025, signed in December 2025, nicotine e-cigarettes can only be sold if they appear in a directory kept by the Attorney General. Manufacturers must certify each product annually, under penalty of perjury, and show that it meets one of three conditions:

• it has received a marketing granted order from the FDA;
• it is covered by a timely filed PMTA that is still under review, or whose denial order has been stayed, rescinded or vacated;
• it only differs from such a product by its name, brand style or packaging.

According to the Attorney General’s FAQ, a PMTA is timely filed only if the product was on the market on August 8, 2016, and the application was submitted by September 9, 2020, and accepted for filing by the FDA. Manufacturers must also post a surety bond of at least $50,000 and pay $2,000 per brand family and $200 per brand style in the first year, then $1,000 and $100 annually.

The directory was first posted in June with no products listed, the FAQ states. The Attorney General’s website still lists 22 manufacturer certifications as under review.

Seizures and fines from October 19

Retailers and wholesalers had 120 days after the directory’s publication to sell off or remove unlisted products. From October 19, those products become contraband and can be seized and destroyed at the holder’s expense. Consumers who made a bona fide purchase are exempt from both seizure and penalties.

The penalties apply to retailers, wholesalers and importers, and the law defines “each product” as each individual e-cigarette, regardless of whether units share the same SKU:

• first violation: $500 per product, which can be negotiated down to the cost of destruction if the business complies within 30 business days;
• second violation within 12 months: $750 to $1,000 per product per day, and a license suspension of at least 14 days;
• third violation within 12 months: $1,000 to $1,500 per product per day, and revocation of the license.

Manufacturers whose unlisted products are sold in the state face $1,000 per product. In an October 8 statement, Dave Sunday said the law aims at “keeping harmful products out of the hands of both children and adults”. His office plans targeted enforcement and will provide compliance education during inspections.

A string of defeats

The ruling follows a series of appellate decisions rejecting the same preemption arguments, all cited by the court: the Seventh Circuit for Wisconsin, the Eighth Circuit for Iowa and the Fourth Circuit for North Carolina. According to the memorandum, at least 16 states now have some form of e-cigarette directory law.

Their conditions remain tied to federal authorization status, at a time when the FDA plans to replace its 2021 PMTA rule.