December 3, 2022

Volume XII, Number 337

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A Closer Look at China’s New E-Cigarette Regulations

With the implementation of the Management Rules of E-cigarettes and the forthcoming effective date for the GB Standard on E-cigarettes (October 1, 2022), China has been regularly updating its e-cigarette regulations. Following up on our recent articles on China’s GB Standard and manufacturer license requirements, below we summarize various e-cigarette regulations recently promulgated by the State Tobacco Monopoly Administration (STMA). Although these new regulations are mostly targeted at e-cigarettes sold in China, there are also many requirements that need to be met for e-cigarettes intended for export only (e.g., notification in the technical review management system and export and transportation notifications on the national trading platform).

Technical Review

E-cigarettes intended for sale domestically in China (including imported e-cigarettes) must first pass a technical review. The prerequisites for applying for technical review are (1) compliance with the GB Standard; (2) use of trademarks approved for registration in China; (3) compliance with the relevant regulations on e-cigarette packaging labels and warnings.

The application for technical review is submitted through the “Technical Review Management System for E-Cigarette Products.” Required materials include product formula and raw material reports, key production process descriptions related to safety, testing reports, safety assessment reports, etc. The applicant also is required to submit physical samples by mail. Imported e-cigarette products must additionally have certifications for production or sales approvals in the country of origin.

Notably, although e-cigarettes manufactured in China for export to overseas markets are not subject to technical review, notification through the technical review management system is required prior to export, with a written commitment to the product’s compliance with relevant regulations and standards.[1]

Warnings and Packaging

The Chinese GB Standard on E-cigarettes contains detailed labeling requirements for e-cigarettes. STMA has further developed a regulation on warning label requirements, which applies to e-cigarettes sold in China.

The warnings are divided into three groups.

  • Group 1: Smoking e-cigarettes is harmful to health. Do not smoke e-cigarettes in non-smoking places.

  • Group 2: Quitting e-cigarettes as soon as possible is good for health. Quitting e-cigarettes can reduce health risks.

  • Group 3: Discourage adolescents from smoking e-cigarettes. No e-cigarettes for primary and secondary school students.

The first group of warnings should always be used on the front (main visible panel), and the second and third groups of warnings are used alternately on the back. The regulation also makes detailed provisions on the location, area, font, etc., of the warning area.

Notably, e-cigarette labels are prohibited from containing “misleading and inducing” language, including efficacy-related terms like health, safety, environmental protection, smoking cessation, and quality-related terms like light, ultra-light, low tar, and low nicotine, as well as terms of flavorings that are easy to induce minors.

STMA also promulgated a packaging regulation, which stipulates detailed packaging specifications for e-cigarettes. For example, a single cartridge box must contain 1-3 cartridges, a single box set must contain 1 device and 1-3 cartridges, etc.

The box of an imported e-cigarette should be labeled with “only for sale within China.” While the box of an e-cigarette for export must meet the relevant requirements of the destination country, the serial number of China’s manufacturer license also must be labeled.

In another regulation on traceability management of e-cigarettes sold in China, STMA requires that a QR code must be labeled on the package of e-cigarettes sold in China. The QR code, used to trace information about e-cigarettes, must be generated from a national e-cigarette traceability platform established to unify traceability marks.

Quality Spot Checks

E-cigarette manufacturers or sellers are subject to spot checks on the quality of e-cigarettes, according to the STMA regulation on e-cigarette quality spot checks. The authority may not conduct more than two spot checks on the same products (of the same trademark and specifications, produced by the same manufacturer according to the same standard) within six months.

While quality spot checks generally only apply to products sold in China, this regulation will apply to e-cigarettes for export if the destination country does not have relevant regulations and standards. This is because when the destination country does not have relevant regulations or standards, e-cigarettes for export are required to comply with China’s e-cigarette regulations and the GB Standard.

Trading

The e-cigarette trading management regulation asks to establish a national unified e-cigarette trading management platform for domestic sales in China. E-cigarette manufacturers, wholesalers, retailers, and importers must trade on this platform. For imported e-cigarettes, e-liquids, and nicotine used in e-cigarettes, the importer should first file an import notification on the platform before trading. For those products for export, the manufacturer must file an export notification on the platform.

The platform is membership-based and was launched on June 15, 2022.

Logistics

The e-cigarette logistics regulation applies to the management of warehousing, sorting, transportation, and distribution of e-cigarettes. For e-cigarettes for export, it is required that they must be directly transported from the warehouse of the manufacturer to the place designated by the customs. If it is necessary to transfer these products from the warehouse of the manufacturer to other warehouses in China, the shipper must submit the warehouse and other information to the authority where the warehouse is located. The recipient must report the inventory quantity to the authority on a monthly basis.

Notably, the transportation of e-cigarettes (including e-liquid and nicotine for e-cigarettes) for export requires prior notification on the trading platform. After completion of customs declaration and clearance, relevant forms should be uploaded to the platform in a timely manner.


FOOTNOTES

[1] China’s Management Rules for E-Cigarettes require that e-cigarettes solely for export must comply with the regulations and standards of the destination country; when there are no relevant regulations and standards in the destination country, the product must comply with China’s regulations and standards.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 235
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About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

202.434.4230
Eric Gu, Keller Heckman, China, Shanghai, Food packaging lawyer, Additives regulations Attorney
Associate

Eric Gu advises domestic and foreign clients on the requirements and regulations for a variety of consumer products, including foods, food additives, food packaging materials, drugs, cosmetics, medical devices, and associated labeling, with a focus on China, Japan, Korea, Thailand, and other Asian countries.

Prior to joining Keller and Heckman, Mr. Gu worked as an attorney in law firms in Shanghai and New York and acquired deep understanding of both China and U.S. laws and practice. While attending the University of Wisconsin Law School, Mr. Gu...

86 21 6335 1000
David J. Ettinger, Keller Heckman, Partner, Food and Drug Corporation, International Trade Lawyer, Attorney, Shanghai, China
Partner

David Ettinger joined Keller and Heckman in 1999. Mr. Ettinger represents domestic and foreign corporations in the area of food and drug law.

Mr. Ettinger relocated to Keller and Heckman's Shanghai office in November 2012 to focus on the Asian market and counsel companies in the Far East on food, drug, and chemical regulatory matters. He has extensive experience counseling clients on product development and product protection of food and drug packaging in the United States, Europe, Asia, Canada, and South America. From 2006-2007, Mr. Ettinger...

86 21-6335-1000
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