The Trump administration-led federal agency layoffs have extended to the US Food and Drug Administration (FDA) Tobacco Products Center. It is disclosed that the FDA recently fired a large number of probationary employees in the food, medical device and tobacco regulatory departments, including technical backbones responsible for the safety assessment of new tobacco products such as e-cigarettes. The elimination of these positions directly led to a sharp reduction in review resources, especially for the approval process of heated tobacco products such as IQOS and new atomization products.
At present, the FDA Tobacco Products Center faces the dual challenges of manpower shortage and technology gap. Taking e-cigarette products as an example, their pre-market tobacco product application (PMTA) needs to undergo complex toxicological analysis and clinical research evaluation, and layoffs have led to the loss of experts in related fields. It is expected that the average PMTA approval cycle will be extended by 3-6 months from the second quarter of 2025. The new IQOS series of products may face greater uncertainty in their review progress due to multiple technical iterations.
In view of the current situation of tight FDA review resources, VEEHOO can start cooperation with third-party laboratories 6-8 months in advance, complete the full set of toxicological tests and clinical data preparation required for PMTA, and lock the review standards through the pre-submission meeting to avoid repeated delays due to the process.
Build a modular declaration system: patent combination and data modular packaging of core atomization technology, e-liquid formula and other elements to achieve rapid declaration reuse of different product lines and shorten the compliance preparation cycle of a single product.
Multi-national certification is promoted simultaneously: while focusing on the US market, accelerate the acquisition of EU TPD, China’s electronic cigarette national standard and other certifications, and diversify policy risks through the “main attack + backup” market strategy. At present, VEEHOO’s three products that have passed the EU CE certification can be used as a springboard for rapid entry into the European market.
Establish an emergency logistics network: sign a priority cooperation agreement with local US warehousing service providers to ensure that when the product listing window changes due to review delays, stable channel replenishment capabilities can still be maintained.
Carry out consumer education programs: Take advantage of the FDA review window period to strengthen the dissemination of “technical safety” and “harm reduction characteristics” through social media and offline experience stores. For example, launch the disassembly display of the core components of the atomizer, the visual interpretation of the third-party test report and other content to consolidate the professional brand image. Targeted cooperation channel partners: Sign a priority shelf agreement with large chain convenience stores, promise to provide exclusive promotional support, and quickly fill the shelf vacancies when the competing products are not listed due to approval delays.
Although the Trump administration’s layoff policy has exacerbated short-term market uncertainty, it has provided well-prepared brands such as VEEHOO with an opportunity to reshape the industry landscape. Through the triple layout of technology, compliance and market, enterprises can not only resolve the risk of regulatory delays, but are more likely to establish a leading position in the industry reshuffle.
Tags: heated tobacco, ceramic atomizer core, Trump administration layoffs, veehoo vape