Tag: Shenzhen

  • SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK Files Appeal of FDA’s Marketing Denial Orders

    SMOK’s factory

    One of the oldest MOD makers in the vaping industry has filed an appeal of the U.S. Food and Drug Administration’s marketing denial orders for six of the company’s open-system vaping devices.

    China-based Shenzhen IVPS, the parent to SMOK brand vaping devices, filed the appeal after with the New Orleans, Louisiana-based U.S. Court of Appeals for the Fifth Circuit, and was joined in the suit by a Dallas, Texas-based distributor of the SMOK products that were denied marketing.

    The FDA claimed that it had issued the MDOs for the premarket tobacco product applications (PMTAs) for the SMOK products because the applications “failed to provide sufficient data to characterize constituent delivery, product stability, and product abuse liability.” The agency also stated that SMOK failed to provide a specific e-liquid and consumers could use any e-liquid in the devices.

    Shenzhen IVPS strongly challenges those assertions, as the company “invested more than $30 million in its applications, which totaled well over 600,000 pages in all, and collaborated with the world’s leading laboratories to conduct robust harmful and potentially harmful constituent aerosol testing, in vitro toxicology testing and toxicological analysis, accelerated and 24-month storage and stability testing, and rigorous clinical pharmacokinetic studies to test the products’ potential abuse liability profiles,” according to a press release.

    Welfer Ouyang, Shenzhen IVPS CEO, said he was “very concerned” that the agency issued marketing denial orders on open-system devices that are sold without any nicotine-containing e-liquid.

    “FDA is using isolated data from testing of the devices with e-liquid formulations that the products’ instruction manuals specifically warn are not compatible with these devices, and ignoring the overwhelmingly positive toxicological and safety profile of these products,” said Ouyang.

    On Jan. 3, the U.S. Court of Appeals for the Fifth Circuit ruled that the FDA acted “arbitrarily and capriciously” in rejecting PMTAs of Wages and White Lion Investments, doing business as Triton Distribution, and Vapetasia for approval to sell their products in the United States.

    The 9-5 decision by the New Orleans-based 5th U.S. Circuit reversed a July 2022 decision by a three-judge panel of that court.

    The agency “sent manufacturers of flavored e-cigarette products on a wild goose chase,” telling them what would be needed to approve their products, and then denying all applications, the court said in an opinion by Judge Andrew S. Oldham. The FDA “never gave petitioners fair notice that they needed to conduct long-term studies on their specific flavored products,” Oldham wrote.

  • Shenzhen Gets Shut Down Due to Hong Kong Covid Surge

    Shenzhen Gets Shut Down Due to Hong Kong Covid Surge

    A drone aerial view of the shenzhen city

    China’s health authorities have locked down Shenzhen to prevent the spread of Covid-19 from Hong Kong, which is experiencing a surge of the virus.

    Shenzhen is a significant manufacturer of consumer electronics, including vapor hardware, for the global market. The city houses tech powerhouses, such as iPhone manufacturer Foxconn, and more than 170,000 vaping-related businesses. The local vapor industry employs more than 3 million people and supplies more than 90 percent of the vapor hardware used around the world, according to some estimates.

    The Shenzhen lockdown will last for at least seven days. All nonessential workers must stay home, adults must take PCR tests and public transportation is being halted.

    A lockdown in Shenzhen might further disrupt global supply chains because Shenzhen has one of the world’s largest ports. An outbreak in Shenzhen in late spring of last year held up port operations and caused a steep spike in global shipping rates that helped drive up prices for imported goods in the United States and elsewhere.

    According to The New York Times, Hong Kong has reported nearly 3,780 Covid-19 deaths and nearly 700,000 new cases since late January. Shenzhen reported 66 new cases in a population of 17 million on Sunday.

  • China’s IECIE Vapor Industry Trade Show Expands for 2021

    China’s IECIE Vapor Industry Trade Show Expands for 2021

    The world’s largest vapor and e-cigarette trade is expanding for its 2021 event. The 7th annual IECIE Shenzhen eCig Expo is scheduled to be held on September 3-5 at the Shenzhen Convention and Exhibition Center.

    Credit: Timothy S. Donahue

    Organizers say the show will be restructured to include three new, independent exhibition halls. Those halls will include a seperate Supply Chain Expo, Heat Not Burn hall and a Future New Retail Digital Solutions & Future Shop Expo. The goal of the expansion is to “fulfil the in-depth and horizontal expansion of the vape industry, IECIE will continue to promote the evolution of the industrial structure and the sublimation of the value of the IECIE Shenzhen eCig Expo,” according to IECIE organizers.

    The 2021 IECIE Supply Chain Expo will include 15,000 square meters of new tobacco products including upstream and downstream supply chain manufacturers. Organizers say there will also be an industry forum covering new technologies and concepts from various industry providers. “It is expected to attract 300 companies from various supply chains in the industry as well as attracting more than 80,000 professional visitors,” a press release states.

    The Future New Retail Digital Solutions & Future Shop Expo is designed to better serve the brick-and-mortar retailers by showcasing digital services, and creating a one-stop offline retail solution, this time IECIE specially teamed up with Future Shop, an organization with more than 17,000 store solution providers.

    The new Heat Not Burn Hall is 7,500 square meters and it is expected to attract 100 heat-not-burn and low-temperature herbal exhibitors, including China Tobacco Guizhou, China Tobacco Yunnan, China Tobacco Henan, China Tobacco Jiangxi, China Tobacco Sichuan, and China Tobacco under Shandong China Tobacco.

    For more information contact IECIE.official@informa.com

  • Shenzhen Shuns Vapor Product Sales Near Schools

    Shenzhen Shuns Vapor Product Sales Near Schools

    One of China’s most adamantly anti-smoking cities has vowed to stop selling e-cigarettes near schools and reduce children’s exposure to secondhand smoke at home as part of a new “smoke-free communities” campaign.

    In a more focused update to its “smoke-free city” campaign launched in 2018, the southern metropolis of Shenzhen pledged Saturday to strictly prohibit the sale of not only tobacco products but also e-cigarettes within 50 meters of primary and middle schools, according to Sixth Tone’s sister publication The Paper.

    The city is also aiming to reduce primary and middle schoolers’ exposure to secondhand smoke at home to below 20% while raising the proportion of “smoke-free families” to at least 50% in three years — though it’s unclear how the success rates will be measured. Some doctors believe that, because secondhand smoke can cause a variety of diseases in children, from asthma and pneumonia to lung cancer and sudden infant death syndrome, it is equivalent to child abuse.

    The smoke-free communities campaign, jointly announced by Shenzhen’s civilization and tobacco control offices, will be enforced alongside the city’s official smoking control regulation, last updated in July 2019. While other Chinese cities have also taken steps to curb smoking and vaping, Shenzhen’s are widely regarded as the most comprehensive in the country.