In 2025, the U.S. FDA (Food and Drug Administration) officially implemented new policies for the atomization technology field, comprehensively upgrading the regulatory framework from medical atomization devices to e-cigarette products. The new policies focus on three core dimensions: product safety, material environmental friendliness, and technological compliance, while also opening a green channel for innovative technologies. Against this backdrop, companies in the atomization industry chain need to simultaneously advance technological breakthroughs and achieve compliance adaptation. HCD Huachengda, combining policy trends, material innovation directions, and typical company cases, analyzes five key compliance innovation points in the atomization technology field in 2025.
- Policy Interpretation: The Three Core Regulatory Elements of the FDA's New Policy
1. Medical Nebulization Devices: Clinical Data and Indications Linked
The FDA requires all medical nebulizers to submit complete clinical trial data, especially verification of their therapeutic effects for indications such as asthma and COPD. For example, Changtai Pharmaceutical's tartaric acid afortrol inhalation solution passed the FDA inspection with "zero defects" after being submitted for dual applications in China and the United States. The core of this success lies in the clinical data support provided by its nanocarrier sustained-release technology.
Compliance guidelines: Companies need to establish a complete data chain from laboratory to clinical practice to avoid "conceptual innovation".
2. E-cigarette regulation: Nicotine caps and flavor bans
The new regulations stipulate that the nicotine content of e-cigarette cartridges must not exceed 2% (with some states limiting it to 1.7%), and prohibit flavors that appeal to teenagers, such as fruits and desserts. Meanwhile, disposable e-cigarettes have been banned in many countries due to waste pollution issues, forcing companies to shift towards modular designs.
Compliance requirements: Products must pass the FDA's PMTA (Premarket Tobacco Application), with a focus on verifying harm reduction.
3. Full life-cycle carbon footprint traceability
The FDA requires the disclosure of the carbon footprint of vaping products throughout the entire supply chain, from material procurement to disposal, and mandates the labeling of biodegradability rates. For example, the UK has explicitly banned non-degradable e-cigarette casings from June 2025.
- Materials Innovation: Technological Breakthroughs in Biodegradable Materials
1. PLA fiber oil-absorbing cotton: a substitute for traditional PET materials
Traditional e-cigarette oil absorbers are mostly made of PET fiber, which is difficult to degrade. Huachengda's PLA fiber oil absorber, through molecular structure optimization, achieves a 90% biodegradability rate while maintaining excellent oil absorption. This material has obtained FDA food contact grade certification.
2. Technological innovation in paper tube outer shell
The paper tube outer shell needs to address challenges such as waterproofing and dimensional accuracy. For example, the ANDS Slix electronic cigarette uses a kraft paper inner tube + printed paper mounting structure. Huachengda has optimized the mold to control the paper tube tolerance to ±0.05mm and developed waterproof coating technology.
3. Recyclable TPU and modular design
TPU (thermoplastic polyurethane) material is 100% recyclable. Huachengda uses it in components such as mouthpieces, and combined with modular design, users can replace the battery and atomizer core themselves.
- Huachengda's Technology Reserves: A Practical Example of Compliant Innovation
As a global leader in atomizing cores, Huachengda has become a benchmark for compliant innovation through its integrated approach of "materials-processes-certification".
1. List of Certifications Approved
International certifications: FDA (R&D and manufacturing system), ISO13485 (medical devices), RoHS/REACH (environmental protection).
Industry certifications: French Design Award, Muse Design Award, Fog Valley Award.
Material Certification: Among the 400+ R&D patents, there are core technology patents such as biodegradable materials and ceramic atomizing cores.
2. Breakthrough in core technologies
COTTONX series atomizer coils: feature a dual-mesh design, alternating atomization to reduce carbon buildup by 25% and extend lifespan.
AX Ceramic Core: The world's first composite technology combining metal mesh and ceramic.
Environmentally friendly production lines: The five major plant areas are equipped with dust-free workshops and automated equipment to reduce human pollution.
3. Supported by market data
Huachengda atomizer cores hold over 50% global market share, serving more than 500 brands, and its products are exported to over 100 countries. Its biodegradable materials are used in components such as e-cigarette casings and oil reservoirs.
Five key directions for compliance innovation in atomization technology by 2025
1. Medical Nebulization: Precise Delivery and Intelligent Monitoring
By combining gene editing technology, targeted atomized drug delivery systems can be developed. For example, the Chinese Academy of Sciences' "Regenerative Beauty and Youth" project achieves anti-aging through atomized inhaled stem cell exosomes.
2. E-cigarettes: Balancing Harm Reduction and User Experience
The AXdual dual-network progressive heating ceramic core reduces the release of harmful substances while improving the accuracy of taste reproduction.
3. Materials Science: Biodegradable and Recyclable Technologies
Promote materials such as PLA and PBS, and explore the application of marine degradable plastics in atomization equipment.
4. Intelligent Manufacturing: End-to-End Data Traceability
Establish a data chain covering the entire lifecycle from raw materials to finished products using blockchain technology.
5. Carbon Neutrality: Green Transformation of Supply Chains
Huachengda covers 30% of its production energy consumption through photovoltaic power generation and has established an atomizer core recycling system.
Under the new FDA policy, compliance innovation in atomization technology has shifted from "single-point breakthroughs" to "systematic upgrades." Enterprises need to be policy-driven, grounded in materials science, and supported by intelligent manufacturing to gain a competitive edge in the global market. HCD Huachengda's experience demonstrates that China's atomization industry is leading global industry transformation by deepening its technological expertise and adapting to compliance, moving from "manufacturing" to "intelligent manufacturing."
