Heno Bio Achieves FDA Submission and Registration Milestone, Setting a New Industry Standard for Compliance

On February 20, 2025, Heno Bio, a global leader in natural nicotine production, announced that it has successfully completed the submission and registration of its Tobacco Product Master File (TPMF) under U.S. FDA regulations, with support from 2Firsts compliance solutions. The company has been assigned a TPMF STN (Submission Tracking Number), signifying that Heno Bio’s TPMF documentation has passed the FDA’s formatting and preliminary scientific review.

On January 9th, Heno Bio held a joint press conference with 2Firsts, announcing their collaboration to advance compliance efforts in the U.S. market. Just one month later, Heno Bio achieved a major milestone, further solidifying its position as a leading player in the global natural nicotine industry and setting a benchmark for compliance excellence.

From “Heno's Compliance Professionalism” to “Heno's Compliance Efficiency,” Heno Bio sets a global benchmark for excellence

Currently, compliance is the most critical factor influencing the development of the global NGP industry and market. Awareness and emphasis on compliance, strategic planning in the compliance field, along with a specialized team and efficient execution, now represent the three key elements that define a new tobacco enterprise’s compliance competitiveness.

In response to the changing global competitive landscape, 2Firsts launched its 2Firsts Compliance Solutions in September 2024. By integrating global compliance resources, it offers businesses more cost-effective and efficient compliance solutions, while continuously hosting various compliance exchange events to advance the industry’s compliance development. 2Firsts’ advocacy for compliance aligns perfectly with Heno Bio’s philosophy. As a global leader in natural nicotine manufacturing, Heno Bio has always regarded compliance as the foundation of its business development and has adhered to this from the company’s inception. In order to expand its international presence and better support global clients, Heno Bio formed a strategic partnership with 2Firsts, focusing on U.S. market compliance as a starting point to jointly promote compliance progress.

Through the joint efforts of both parties, from establishing the partnership to determining the compliance exhibition, and finally obtaining the TPMF STN number, the entire process took just over one month. According to relevant experts, this speed is more than 50% faster than the industry’s typical timeline.

Li Jiang, Co-founder and Vice General Manager of Heno Bio, stated: “From establishing the partnership to organizing the expert team for the compliance application, the entire process went very smoothly. The successful submission of the technical documents not only highlights Heno Bio’s strength, but also better supports the development of our international clients.”

The high importance placed on compliance reflects Heno Bio’s commitment to excellence in compliance; its professionalism and efficiency in compliance actions demonstrate the company’s expertise and execution capability. From “Commitment to Compliance” to “Excellence in Compliance,” Heno Bio has set an excellent benchmark for global NGP companies.

TPMF and TPMP have become key entry points for an increasing number of NGP supply chain companies in U.S. compliance efforts.

Previously, compliance efforts in the U.S. market were largely focused on the product level, initiated mainly by brands or manufacturers, with upstream supply chain companies providing support. However, as global competition intensifies and compliance becomes an increasingly vital competitive advantage, upstream supply chain companies are also proactively engaging in compliance strategies.In the U.S. market compliance landscape, the compliance models represented by TPMF and TPMP are gradually being adopted by a growing number of supply chain companies.

The U.S. FDA uses the PMTA (Pre-market Tobacco Product Application) to regulate the market entry of NGPs, while TPMF (Tobacco Product Master Files) and TPMP (Requirements for Tobacco Product Manufacturing Practice) serve as the compliance “interfaces” within the PMTA system for supply chain companies.

Guo Xiaoyu, Co-Founder and COO of 2Firsts, commented, “The successful interim outcome of Heno Bio’s TPMF application in such a short period of time not only reflects Heno Bio’s long-standing investment in compliance and expertise but also serves as an inspiration for global supply chain companies—supply chain enterprises can proactively embrace compliance, rather than waiting passively as was the norm before.”

Heno Bio’s successful acquisition of the TMPF STN number marks the first step in the strategic compliance collaboration between Heno Bio and 2Firsts. The two parties will continue to work closely together, advancing global compliance efforts, including in the U.S. market, contributing to the compliant development of the global NGP industry.

About HENO

Hubei Heno Biological Engineering Co., Ltd. is one of the first batch of natural nicotine production enterprises in the country to obtain the "Tobacco Monopoly Production Enterprise License", and the first domestic enterprise to apply for the raw material production permit with the natural nicotine extraction process route. It has obtained the "Drug Production License" issued by the Hubei Provincial Drug Administration, is a national-level specialized, refined, unique and innovative giant enterprise, a nicotine production enterprise with CANS laboratory nicotine testing capabilities, and a customs advanced certification (AEO) enterprise. 

The company has drafted the "Production, Processing and Technical Control Specifications for (1-Methyl-2-(3-pyridyl)pyrrolidine)", filling the global standard gap in the production, processing and technical control of natural nicotine. The company has built a safe, environmentally friendly, green and 5G smart park in Baiyangping Industrial Park Chemical Zone in Enshi, Hubei, with an annual capacity to process more than 60,000 tons of tobacco waste and a nicotine production capacity of more than 600 tons.

For inquiries regarding 2Firsts Compliance Solutions and U.S. PMTA applications, please contact: info@2firsts.com.