Recent amendments to China’s Tobacco Monopoly Law present an opportunity for responsible companies to demonstrate how alternative high-quality products are an important and appropriate element of tobacco harm reduction, according to Broughton.
Writing on the website of the contract research organization, Broughton’s head of regulatory affairs, Lloyd Smart, and regulatory consultant Xiangyin Wei summarize China’s tobacco monopoly law changes and explain what they means for electronic nicotine delivery systems (ENDS).
On Nov. 26, 2021, China’s State Council amended the country’s tobacco law, giving the State Tobacco Monopoly Administration jurisdiction over e-cigarettes. Next-generation products will now be managed in the same way as combustible cigarettes.
Among other things, this means that ENDS companies, including exporters, will need to apply for a license. A single transaction platform will be implemented for product distribution and all products must comply with a new national standard. Regulation of products likely to be introduced following an initial transition period of between three and five months, during which no new products may be brought to market. Products with synthetic nicotine will be banned in China.
According to Broughton, the recently announced changes to e-cigarette regulation in China offer an excellent business opportunity for companies that want to build consumer trust by showcasing their product’s high quality and safety standards.
“As with all regulatory requirements, the most important initial step is to understand fully what’s needed—to provide reassurance or identify gaps that need to be addressed. And to act quickly; seizing the opportunity while making sure you don’t get left behind as the market changes,” write Smart and Xiangyin.