A complete analysis of global e-cigarette quality requirements: a guide for manufacturers
As the global e-cigarette market is booming, countries are also constantly strengthening the quality supervision of e-cigarette products to protect the health and safety of consumers. As an e-cigarette manufacturer, in-depth understanding of the quality requirements of different countries is the key to ensuring that products are listed in compliance and expanding the market. Today, we will comprehensively sort out the quality requirements of various countries for e-cigarettes.
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1. United States
The U.S. Food and Drug Administration (FDA) strictly controls e-cigarettes. Since 2016, all "electronic nicotine delivery systems" (ENDS) must comply with the same requirements as other tobacco products and must obtain "pre-market tobacco review" (PMTA) authorization before entering the U.S. market. When applying, eight materials must be submitted, including product health risk surveys, descriptions of ingredients and operating principles, production methods and control measures. In addition, each state also has detailed regulations, such as Massachusetts prohibiting the sale of e-cigarettes to minors and restricting online sales (except for certain low-concentration, flavorless products); Utah sets limits on e-cigarette nicotine concentrations and gradually tightens them over time.
2. Canada
In order to control the growth of young people smoking, the Canadian Ministry of Health issued a regulatory proposal in 2021, which will set the maximum nicotine concentration in e-cigarette products produced or imported and sold in Canada at 20mg/mL, and products exceeding the standard will be prohibited from packaging and sales. At the same time, the regulations on the labeling and packaging of atomizer products will be revised to be consistent with the nicotine limit requirements.
3. Australia
The Australian Therapeutic Goods Administration (TGA) stipulates that from October 1, 2021, consumers will need a doctor's prescription to import atomizer nicotine products. In addition, the TGA has also proposed a draft regulation to clarify the minimum quality and safety requirements for atomizer nicotine products, covering labeling (ingredient list, nicotine concentration, etc.), banned ingredients (such as 2,3-pentanedione, diacetyl, etc.) and packaging (in compliance with child safety protection requirements).
4. European Union
In the European Union, e-cigarettes are governed by the 2014/40/EU "Tobacco Products Directive". Although there is no pre-market review requirement, manufacturers and importers must inform local authorities of product information in the form of electronic documents six months before the product is put on the market, including manufacturer information, ingredient list, toxicology data, etc. At the same time, the EU also has clear requirements for the nicotine content, packaging, labeling, banned substances, etc. of e-cigarette products.
V. China
my country's regulation of e-cigarettes is becoming increasingly perfect. The mandatory national standard GB 41700-2022 "Electronic Cigarettes" issued in 2022 clarifies the definitions of terms such as e-cigarettes and atomizers, and stipulates e-cigarette design, raw material selection, technical requirements for smoking devices and atomizers, emission standards, product logos and instructions. For example, it is clear that e-cigarettes should not have flavors other than tobacco, and the atomizer should contain nicotine; a "white list" of 101 additives allowed for use is listed.
VI. Philippines
In 2022, the President of the Philippines signed a bill to regulate atomized nicotine and non-nicotine products (including e-cigarettes). The Department of Trade and Industry (DTI) stipulates that the nicotine content in atomized products shall not exceed 65 mg/ml, and refill containers must have child protection and other functions. From January 2024, e-cigarette products must pass BPS certification before they can be sold, and manufacturers and importers must register product information with DTI.
Faced with the complicated quality requirements of various countries, our e-cigarette manufacturers need to establish a strict quality control system, from raw material procurement, production process to product testing, every link must ensure that it meets the standards of the target market. Closely follow the changes in laws and regulations of various countries, and adjust product design and production processes in a timely manner, so that we can move forward steadily in the global e-cigarette market and provide consumers with safe, compliant and high-quality products.
