Key Points:
·The Retail Industry Alliance pressures the Trump administration: The National Association of Convenience Stores (NACS) has joined forces with four major industry associations to write to the Trump administration, demanding immediate action to address the widespread problem of illegal e-cigarette imports from China.
·The FDA faces harsh criticism from the industry: a backlog of thousands of e-cigarette applications has been pending for up to four years, leading to market confusion. The agency has failed to provide clear compliance guidance to retailers.
·The Trump administration is urged to take emergency measures: the FDA must expedite the approval of all pending applications. Customs must strengthen inspections of Chinese e-cigarette imports. The Department of Justice should initiate criminal prosecutions against violators.
·The political timing is sensitive: the letter specifically mentions the recent swift handling of the JUUL case by the Trump administration. Equal efficiency is demanded in addressing the issue of Chinese e-cigarettes.
【2Firsts News Flash】According to a report by NACS on July 18, this week, the National Association of Convenience Stores (NACS) sent a letter to the Trump administration requesting action to address the crisis of the illegal proliferation of Chinese e-cigarettes in the convenience store and travel center industry.
The NACS, in collaboration with the American Energy Marketing Association, the National Association of Tobacco Outlets, NATSO representing travel plazas and truck stops, and the leading fuel marketer SIGMA, emphasized that illegal e-cigarette products have flooded the American market for years, severely impacting law-abiding retailers' businesses.
This letter calls on the Center for Tobacco Products (CTP) to drive change and seek assistance from federal law enforcement agencies to implement regulation.
“Over the past four years, thousands of product applications have been in regulatory limbo at the CTP, leading to a continued influx of illegal e-cigarettes into the U.S. market. During this time, the agency has consistently refused to provide clear market entry standards to retailers. The current administration has the opportunity to swiftly process all pending applications, like they did with the Juul case, to provide long-awaited clarity for retailers and crack down on the sale of illegal products.”
Anna Blom, strategic consultant for the NACS Government Relations team, stated.
NACS and collaborating organizations propose the following solutions:
·Demand for CTP to approve all pre-market applications: CTP should expedite the approval process. Many products awaiting approval are highly similar to those that have already been approved and should be fast-tracked. However, a clear approval process is always better than being left in limbo. Even if a decision is negative, it can at least initiate legal challenge procedures until a final ruling is reached.
·Demand for increased transparency from CTP: CTP must be required to accurately disclose rejected products (not limited to manufacturers), products that are still in legal gray areas, and details of timely submitted applications. Most businesses in the US do not have the resources to interpret official terms and need CTP to provide clear and concise information.
·Strengthening interagency task forces: After establishing clear product regulatory standards, a federal interagency task force led by the FDA and the Department of Justice should be formed by June 2024 to take the strongest civil and criminal enforcement actions against serious offenders to deter illegal activities. All seized illegal products should be confiscated. The FDA has direct authority to regulate the distribution chain and should fully exercise this power.
·Demand for increased enforcement by Customs and Border Protection (CBP): CBP should prevent the illegal entry of Chinese e-cigarettes by strengthening supply chain targeted inspections, expanding the use of risk-based analysis tools, and holding individuals accountable for fraudulent import declarations through civil and criminal actions.
2Firsts Highlights Key Points from the Joint Letter:
I. Core Demands (Four Key Requests)
1.Urge the FDA to Expedite PMTA Decisions
a. The agency should either approve or reject submitted applications without indefinite delays.
b.Nearly five years of inaction has created regulatory uncertainty and a compliance vacuum.
2.Disclose the Review Status of PMTA Products
a. FDA should clearly identify which products have been rejected, which remain under review, and which are subject to legal challenges.
b. It should also clarify the legal status of products at different stages for policy and trade purposes.
3.Reinforce Multi-Agency Enforcement
a. A task force led by the FDA and Department of Justice should step up efforts to dismantle illegal distribution networks.
b. Civil and criminal penalties should be pursued against serious violators, with all illicit products seized.
4.Tighten Customs Controls on Illegal Chinese E-Cigarettes
a. Customs and Border Protection (CBP) must enhance risk monitoring, increase inspection frequencies, and crack down on false declarations.
b. The letter warns Chinese manufacturers are exploiting regulatory loopholes to expand exports to the U.S.
II. Core Criticisms of the FDA’s Center for Tobacco Products
·“Approve or Reject” Stalemate Fuels a Gray Market: The FDA’s reluctance to make decisions to avoid legal challenges has created enforcement blind spots.
·Lack of Transparency: The agency discloses only manufacturers of rejected products, not specific names, leaving retailers unable to verify which products are legal.
·Compliance Marginalized: Law-abiding retailers are losing market share as unreviewed, unregulated products dominate sales.
III. Associations’ Position and Industry Role
·The signatories represent the U.S. compliant retail ecosystem—including convenience stores, gas stations, and tobacco retailers—with:
a. Annual sales of $837.4 billion
b. Over 95% small, independent businesses
c. These businesses handle 165 million daily transactions but are losing competitiveness due to regulatory ambiguity.
IV. Background
a. To date, the FDA has authorized only 39 e-cigarette products—far below market demand.
b. Thousands of applications remain pending, while many Chinese products have not applied at all.
c. This regulatory gap allows illegal Chinese e-cigarettes to flood the U.S. market, undermining fair competition.
Previously, the Vapor Technology Association (VTA) launched a million-dollar ad campaign urging the Trump administration to distinguish between illegal youth-targeted products and adult cessation tools. The ads—running on major networks and at Trump golf clubs—called for streamlined regulation, support for independent vape businesses, and protection of consumer choice. (Read more: U.S. Vape Tech Association Launches Million-Dollar Ad Campaign Accusing FDA and CBP of Breaking Trump’s Industry Rescue Promise)
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