As regulatory landscapes evolve and public health priorities shift, companies developing alternative nicotine delivery systems are navigating increasingly complex environments. Among these innovators is SENO, a company founded by Jason Zhao, an experienced Silicon Valley engineer, bringing engineering precision and user-centric design to a traditionally regulated industry, with a focus on rethinking how nicotine products are delivered and regulated for adult consumers.
SENO’s primary area of exploration is oral film technology, a format designed to dissolve on the tongue and deliver nicotine through the oral mucosa. SENO’s oral films deliver nicotine in a fast, smoke-free and residue-free format, offering adult users a cleaner alternative to traditional nicotine products. While not the first to experiment with non-combustible delivery systems, SENO represents a cohort of emerging ventures seeking to align new product formats with regulatory expectations, manufacturing standards, and regional compliance frameworks.
Development Through a Regulatory Lens
From the outset, SENO positioned regulatory compliance as central to its product development process. In the United States, nicotine products fall under the jurisdiction of the Food and Drug Administration (FDA), which mandates that new tobacco products, including alternative delivery systems, undergo rigorous evaluation before being marketed legally.
As of September 2025, SENO submitted a Premarket Tobacco Product Application (PMTA) for its nicotine oral film product. A PMTA is not an approval, but a regulatory submission that initiates a detailed review by the FDA to determine whether a product meets the necessary public health standards. The review process assesses various factors including ingredients, manufacturing practices, toxicology, and the potential impact on public health.
This approach demonstrates a willingness by SENO to engage with formal regulatory channels rather than seeking rapid, unvetted market entry, a notable stance in an industry often characterized by fast-moving product cycles and patchy oversight.
Manufacturing and Oversight
SENO’s products are developed in collaboration with Shenzhen Xinnuo Technology Co., Ltd., a manufacturing partner based in China. According to SENO, the facilities have obtained FDA Establishment Registration and certifications such as the Material Safety Data Sheet (MSDS) and Air Transport Safety documentation (as well as GMP (good manufacturing practice, important!)).
While such registrations and certifications suggest procedural alignment with international standards, it’s important to note that they do not equate to product approval. However, they do represent a level of operational transparency that regulators typically require when assessing supply chain integrity and product safety in tobacco and nicotine-related filings.
Global Considerations and Market Positioning
SENO reports activity in multiple international markets, including Europe, North America, the Middle East, and Australia. Each region brings its own regulatory frameworks and consumer expectations. In many jurisdictions, oral nicotine delivery products whether in the form of pouches, lozenges, or films are subject to specific packaging, labeling, and retail regulations. Companies operating in these markets must align with both national policies and broader public health goals, which increasingly emphasize harm reduction and youth access prevention.
The company’s operational model includes IP filings across several categories. These include design patents for packaging and trademarks in Class 34 (tobacco and smoking articles). Such filings suggest a long-term strategy for brand and format differentiation. While intellectual property protection does not influence product approval, it can play a role in how companies defend their innovations and control market entry across regions.
Navigating a Shifting Regulatory Landscape
The landscape for nicotine products continues to evolve rapidly. Governments and health authorities have intensified efforts to regulate flavored products, marketing strategies, and distribution channels particularly those that may inadvertently appeal to non-smokers or younger audiences.
For instance, regulators in the European Union and Canada have proposed or enacted restrictions on certain flavors, packaging designs, and sales methods. In the United States, the FDA has increased scrutiny of non-combustible nicotine products, especially those introduced without premarket authorization.
SENO’s regulatory focus appears to be a direct response to these broader trends. The company has stated its intention to prioritize transparency and documentation, which are increasingly viewed as essential for companies attempting to enter regulated nicotine markets.
Looking Forward
As the global market for alternative nicotine delivery systems continues to diversify, companies like SENO face both opportunity and challenge. While there is growing interest in reduced-risk products and smoke-free alternatives, the bar for regulatory compliance is high and rising.
SENO’s strategic focus on oral film technology, manufacturing oversight, and regulatory filings positions it as a participant in the next phase of nicotine innovation. Nevertheless, the company’s future success will depend not only on technological development but also on sustained engagement with regulators, public health stakeholders, and evolving consumer expectations.
While it’s too early to predict the long-term role of oral film nicotine delivery systems in the broader market, ventures like SENO represent a shift toward greater accountability and structure within an industry under increased scrutiny. For regulators and industry watchers alike, the path of companies adopting a compliance-first approach will be worth observing as the nicotine landscape continues to transform.
