HCD Huachengda Analysis: Five compliance innovations that must be paid attention to in 2025 atomization technology under the new FDA policy

In 2025, the U.S. FDA (Food and Drug Administration) officially implemented a new policy for the field of atomization technology, and the regulatory framework was comprehensively upgraded from medical atomization equipment to e-cigarette products. The core of the new policy focuses on three dimensions: product safety, material environmental protection, and technical compliance, while opening up a green approval channel for innovative technologies. In this context, companies in the atomization industry chain need to simultaneously promote technological breakthroughs and compliance adaptation. HCD Huachengda combines policy trends, material innovation directions and typical corporate cases to analyze the five major compliance innovations in the field of atomization technology in 2025.

01.Policy interpretation: Three core regulatory elements of the FDA's new policy

1. Medical atomization equipment: clinical data and indications are bound
FDA requires all medical atomization devices to submit complete clinical trial data, especially for the verification of therapeutic effects for indications such as asthma and chronic obstructive pulmonary disease. For example, Changtai Pharmaceutical's Arformoterol Tartrate Inhalation Solution passed the FDA inspection with "zero defects" through dual reporting in China and the United States. The core lies in the clinical data support of nanocarrier sustained-release technology.
Compliance points: Enterprises need to establish a full-process data chain from laboratory to clinic to avoid "conceptual innovation".
2. E-cigarette regulation: nicotine upper limit and flavor ban
The new policy stipulates that the nicotine content of e-cigarette cartridges shall not exceed 2% (the limit in some states is 1.7%), and prohibits flavors such as fruits and desserts that attract teenagers. At the same time, disposable e-cigarettes have been banned in many countries due to waste pollution problems, forcing companies to turn to modular design.
Compliance points: Products must pass the FDA's PMTA (pre-market tobacco application), focusing on verifying harm reduction.
3. Full life cycle carbon footprint traceability
FDA requires the disclosure of the full-chain carbon footprint of atomization products from material procurement to waste treatment, and mandatory labeling of biodegradability. For example, the UK has clearly stated that it will ban non-degradable e-cigarette casings from June 2025.

02.Material Innovation: Technological Breakthrough of Biodegradable Materials

1. PLA fiber oil storage cotton: replacing traditional PET materials
Traditional electronic cigarette oil storage cotton mostly uses PET fiber, which is difficult to degrade. The PLA fiber oil storage cotton developed by Huachengda achieves a 90% biodegradability rate through molecular structure optimization while maintaining excellent oil absorption. The material has passed FDA food contact certification.
2. Process innovation of paper tube shell
The paper tube shell needs to solve problems such as waterproofing and dimensional accuracy. For example, ANDS Slix electronic cigarette uses a kraft paper inner tube + printed paper mounting structure. Huachengda controls the paper tube tolerance to ±0.05mm through mold optimization and develops waterproof coating technology.
3. Recyclable TPU and modular design
TPU (thermoplastic polyurethane) material is 100% recyclable. Huachengda applies it to parts such as cigarette holders. Combined with modular design, users can replace batteries and atomizer cores by themselves.

03.Huachengda Technology Reserve: A Practical Example of Compliance Innovation

As the global leader in atomizer cores, Huachengda has become a benchmark for compliance innovation through the "material-process-certification" trinity layout.
1. List of certifications passed International certifications: FDA (R&D and production system), ISO13485 (medical devices), RoHS/REACH (environmental protection). Industry certifications: French Design Award, Muse Design Award, Fog Valley Award. Material certification: 400+ R&D patents include core technology patents such as biodegradable materials and ceramic atomizer cores.
2. Core technology breakthrough COTTONX series atomizer core: adopts a double mesh design, alternating atomization reduces carbon deposition rate by 25%, and extends life. AX ceramic core: the world's first metal mesh and ceramic composite technology. Environmentally friendly production line: 5 major factories are equipped with dust-free workshops, and the five major factories are equipped with dust-free workshops and automated equipment to reduce artificial pollution.
3. Market data support Huachengda's atomizer core has a global market share of over 50%, serving 500+ brands, and its products are exported to 100+ countries. Its biodegradable material applications have covered electronic cigarette housings, oil storage cotton and other components.

04.Five major directions for compliance innovation of atomization technology in 2025

1. Medical atomization: precise delivery and intelligent monitoring
Combined with gene editing technology, develop targeted atomization drug delivery systems, such as the Chinese Academy of Sciences' "Regeneration Beauty and Youth" project to achieve anti-aging through atomized inhaled stem cell exosomes.
2. E-cigarettes: balance between harm reduction and user experience
Through the AXdual dual-net progressive heating ceramic core, while reducing the release of harmful substances, the taste restoration is improved.
3. Material Science: Biodegradable and Recyclable Technology
Promote materials such as PLA and PBS, and explore the application of marine degradable plastics in atomization equipment.
4. Intelligent Manufacturing: Full-process Data Traceability
Use blockchain technology to establish a full life cycle data chain from raw materials to finished products.
5. Carbon Neutrality: Green Transformation of the Supply Chain Huachengda covers 30% of production energy consumption through photovoltaic power generation and establishes an atomization core recycling system

Under the new FDA policy, compliance innovation in atomization technology has shifted from "single point breakthrough" to "systematic upgrade". Enterprises need to be policy-oriented, based on material science, and supported by intelligent manufacturing in order to gain an advantage in the global market. HCD Huachengda's practice shows that China's atomization industry is moving from "manufacturing" to "intelligent manufacturing" through deep technological development and compliance adaptation, leading the global industry transformation.

source：HCD华诚达

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