Australia's TGA announces TGO 110 compliance for e-cigarette products for the first time
On March 1, 2022, the Australian Therapeutic Goods Administration (TGA) website announced for the first time that since the TGO 110 standard came into effect 5 months ago, its laboratory has tested the compliance test results of 214 electronic cigarette products currently on the market or being imported. It also emphasized that compulsory measures should be taken against products that do not meet the requirements, which sounded the alarm for suppliers of non-compliant products.
This issue introduces you to the product compliance requirements worthy of attention in publicity cases.
For the first time, the official publicized 214 e-cigarette products, of which 190 are nicotine-containing products and must meet the requirements of the TGO 110 standard; there are also 24 zero-nicotine products, which are not suitable for TGO 110 control. This time, 190 nicotine-containing products were used as valid samples to analyze product compliance.
TGA main inspection items
a. E-cigarette product label compliance inspection;
b. Detection of 8 banned ingredients in e-cigarette liquid;
c. Detection of nicotine concentration in e-cigarette liquid.
a. All 190 e-cigarette product labels did not meet the TGO 110 label requirements, and the failure rate was 100%;
b. 66 electronic cigarette products were tested to contain prohibited ingredients specified in TGO 110, and the failure rate was 34.7%;
c. The nicotine concentration test results of 182 electronic cigarette products have not yet been updated, but 3 of the 8 products whose results have been announced exceed the nicotine concentration specified in TGO 110, with a failure rate of 37.5%.
The TGA had earlier announced that from October 1, 2021, all commercially available nicotine vaping products (e-cigarettes) will be regulated as prescription drugs under the Drugs Act 1989 - Schedule 4 of the Toxic Standard, with its " Therapeutic Articles (Standard for Nicotine Pumping Products (TGO 110)) also came into force at the same time. This standard specifies the most basic safety and quality requirements for nicotine vaping products marketed in Australia. Please click the link below to view the product requirements in the standard.
The TGA electronic cigarette product compliance announcement marks that the implementation of the Australian TGO 110 standard has entered the stage of landing supervision. Electronic cigarette manufacturers interested in the Australian market should earnestly fulfill the compliance obligations of electronic cigarette products, understand the country's control requirements as soon as possible, and promptly Prepare documents required for customs clearance for use by relevant parties in the supply chain.
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