Pennsylvania has joined the growing group of states that condition ENDS sales on federal PMTA status. Enacted as Act 57 of 2025, House Bill 1425 adds Section 206-I to The Fiscal Code and directs the Pennsylvania Attorney General to maintain a directory of electronic cigarettes that may be sold in the Commonwealth. The law ties state market access to federal authorization status, but it does so through a fixed September 9, 2020 PMTA cutoff, recurring fees, a surety bond requirement, and a broad brand-family concept that will materially increase compliance costs for many manufacturers.
At the federal level, the PMTA pathway under Section 910 of the Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act, requires the U.S. Food and Drug Administration (FDA) to determine whether marketing a new tobacco product would be appropriate for the protection of the public health. For ENDS products, that process has yielded only a relatively small set of marketing granted orders and has generated years of litigation over marketing denial orders and review standards. States have responded by adopting directory and registry laws intended to keep products with no recognizable federal pathway off store shelves. Pennsylvania’s law fits squarely within that trend, but its scope and implementation details warrant close attention.
Scope, Definitions, and Product Eligibility
The statute reaches more broadly than the phrase “electronic cigarettes that contain nicotine” might imply. Section 202-I applies not only to products labeled, advertised, or marketed as containing nicotine, and to products that the Department of Revenue or the Attorney General determine contain nicotine, but also to products sold under the same brand name as a product determined to contain nicotine. Manufacturers, therefore, should not assume that nicotine-free products, including products formulated with nicotine analogs instead of nicotine, fall outside the law merely because they do not contain nicotine. Although those non-nicotine products are not subject to Pennsylvania’s PMTA-status documentation requirements, the Attorney General’s certification materials still impose separate obligations. Manufacturers must provide packaging images, certify that the products do not contain nicotine, and submit test results from a certified domestic laboratory for the e-liquid or other substance that generates the vapor or aerosol confirming the absence of nicotine.
The law also defines “brand family” broadly. It groups together all styles sold under the same trademark and differentiated by flavor, nicotine strength, size, capacity, or similar descriptors, and it also captures substantially similar combinations of words, logos, symbols, colors, and other identifying features. That matters because Pennsylvania imposes fees and supporting-document obligations at both the brand-family and brand-style levels. Companies with large portfolios or shared branding across multiple SKUs will feel that structure quickly. Eligibility for directory listing is limited to three categories. A product may qualify if it has received an FDA marketing granted order; if it is covered by a timely filed PMTA submitted on or before September 9, 2020 and accepted for filing, so long as the application remains under FDA review or is subject to a denial order that has been stayed, rescinded, or vacated; or if no additional PMTA was required because the product reflects only a change in name, brand style, or packaging from a product already covered by one of the first two categories. Later-filed PMTAs do not fit within the statute’s definition of a “timely filed” application and therefore do not provide an independent basis for listing.
Certification, Fees, and Supporting Materials
Each manufacturer selling covered products in Pennsylvania must certify to the Attorney General within 60 days of the law’s effective date and annually thereafter. The Office of Attorney General has set April 21, 2026 as the deadline for the initial certification, with annual recertifications due by April 21 thereafter, and has indicated that the initial directory will be published on June 20, 2026. Each certification must be made under penalty of perjury and must be supported by the applicable FDA order, acceptance letter, or documentation showing that a denial order has been stayed, rescinded, or vacated. Where a manufacturer relies on a name, brand-style, or packaging change that allegedly does not require a separate PMTA, it should expect to substantiate that position.
The statute also requires a surety bond payable to the Commonwealth in an amount fixed by the Attorney General of at least $50,000, and the Attorney General may demand a higher bond where warranted. Filing fees are assessed both by brand family and by brand style: $2,000 per brand family plus $200 per brand style for an initial certification, and $1,000 per brand family plus $100 per brand style for annual renewals.
In practice, the filing burden extends well beyond PMTA-status documents. The Attorney General’s certification portal calls for photographs and diagrams of manufacturing facilities, current USPTO trademark records, Pennsylvania tobacco-license materials where applicable, lists of Pennsylvania wholesalers, ownership and officer information, packaging images with UPCs, detailed brand lists, importer information and declarations for foreign-manufactured products, resident-agent materials, bond documentation, and product-specific FDA records. For manufacturers with complex supply chains, contract manufacturing arrangements, or shared branding across nicotine and non-nicotine lines, assembling that package may be a significant project in itself. Once the directory is live, the sales restrictions are real and fast approaching. The statute requires the Attorney General to update the directory at least monthly. Retailers will have 120 days from the initial publication date to sell through or remove unlisted inventory. Wholesalers will have 120 days from that same date to remove unlisted products from inventory intended for Pennsylvania retail sale. After that period, unlisted products are contraband subject to seizure, forfeiture, and destruction. The Attorney General has identified October 19, 2026, as the date after which products not appearing on the directory will be subject to seizure, with all associated costs borne by the responsible parties. In addition to seizure and destruction, retailers, wholesalers, and importers that sell or offer for sale non‑listed products face escalating civil penalties of up to $1,500 per product per day.
Pennsylvania’s ENDS directory law is therefore much more than a reporting obligation. It is a market-access regime backed by certifications, recurring fees, bonding, inspection authority, contraband treatment, and seizure risk. Manufacturers, importers, wholesalers, and retailers with Pennsylvania exposure should review product lines, branding, PMTA status, importer arrangements, and filing readiness well before the first certification deadline.
These issues, along with the broader patchwork of state nicotine product laws, will be a focus of discussion at Keller and Heckman’s 10th Annual E-Vapor, Nicotine, and Tobacco Law Symposium, to be held on May 4-5, 2026, in Las Vegas, Nevada. Additional information and registration details are available here.