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FDA Regulates Synthetic Nicotine

Time: 2022-03-23

Views: 462

U.S. House E&C chair questions e-cigarette companies' marketing of synthetic nicotine products to teens

The E&C chairman of the U.S. House of Representatives Energy and Commerce Committee expressed concern about the role of four companies in the rise of teen vaping after legislation authorizing the FDA to regulate synthetic nicotine passed.


In the wake of recently enacted federal legislation clarifying the Food and Drug Administration's (FDA) authority to regulate all tobacco products, including those containing synthetic nicotine, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) wrote Letter to four leading e-cigarette companies selling synthetic nicotine products requesting information on the health and safety of their products. The chairman also asked each company about their plans to comply with federal regulations, details of their marketing practices, and their role in promoting e-cigarette and nicotine use among children and teens.


In the letter, Pallone noted that the companies appear to be targeting younger audiences when marketing their products. For example, an ad for Puff Bar advertises itself as "...perfectly free from...parents' text; 7 Daze has released a line of fruit flavors that use synthetic nicotine salts; VaporSalon recently for anyone (including those under 21) Advertise an in-store pizza party; a post on Daddy's Vapor's Instagram states that music education can improve test scores, and its hashtag is only related to vaping."


“Given the well-established health consequences of nicotine addiction, I am concerned about the proliferation of synthetic nicotine products like yours, as the specific consequences of using them are poorly understood. I am also deeply concerned about the apparent impact of your products on teen e-cigarette use. Disturbed," Pallone wrote. "The rapid increase in youth use of these products is worrying and is similar to earlier strategies by other tobacco companies that contributed to the emergence of the youth vaping epidemic."


Pallone also raised concerns that the four companies appear to be trying to circumvent agency oversight by selling so-called tobacco-free synthetic nicotine products, rather than tobacco-derived nicotine, until legislation clarifies the FDA's authority to regulate synthetic nicotine products.


In the letter, Pallone noted that Puff Bar co-CEO Patrick Beltran claimed that the synthetic nicotine, which is known to be outside the FDA's control, and that VaporSalon posted on its company Facebook page, switched to synthetic tobacco.


"As the FDA continues to work to ensure that products on the market are authorized to protect public health, it appears that your company has been deliberately circumventing regulators by using synthetic nicotine rather than tobacco-derived nicotine," Pallone continued. "In light of the recent clarification of the FDA's regulatory authority for all tobacco products, including those containing synthetic nicotine, and addressing the issues I outlined above, please provide the requested information below along with a briefing by April 5, 2022. "


Since the start of the COVID-19 pandemic, the proportion of young people using single-use vaping products has risen alarmingly.


According to the Centers for Disease Control and Prevention's 2021 National Youth Tobacco Study (NYTS), more than 2 million high school and middle school students reported using e-cigarettes in the past 30 days, with more than half using single-use devices. Flavored e-cigarettes are a major driver of teens switching to single-use vaping products. In 2020, about 85% of teens who use e-cigarettes use only flavored products, and these numbers remain largely unchanged in 2021.


Pallone has long been an advocate for protecting teens from tobacco use. As chair, Pallone leads committee efforts to address the youth vaping crisis, including: August 2019 inquiry into the impact of e-cigarettes on youth; February 2020 hearing on the public health impact of e-cigarette manufacturers; Legislation on the youth tobacco epidemic, including language clarifying the FDA's authority over synthetic nicotine, passed the House of Representatives in February 2020.


Last week, President Biden signed into law H.R. 2471 (Bipartisan and Bicameral Omnibus Appropriations and Supplements for Ukraine), which contains provisions advocated by Pallone that clarify the FDA's authority to regulate synthetic nicotine products.


As part of the investigation, Chairman Pallone asked to answer a series of questions, including:


Does your company intend to continue to market its products and submit a Premarket Tobacco Application (PMTA) for products containing synthetic nicotine? If yes, please indicate which products are for. If your company does not intend to file a PMTA for all of its products containing synthetic nicotine, please describe the steps the company will take to ensure that these products are no longer available for sale 60 days after the omnibus Act is enacted.


What federal regulatory agencies does your company comply with to ensure the safety of its products and restrict their use to adults over the age of 21?


What research has your company conducted on its products, including the health effects of its products on teens, the appeal of its flavored products to teens, the evidence that these products are essential for adults to quit smoking, and the effects of social media on teens What is your product? user?


What is your company's annual breakdown of paid marketing, including the use of sponsored content, social media influencers, or paid celebrity endorsers?


What age verification strategies does your company use to prevent the sale of minors to minors in-store and online?


Has your company ever run targeted online advertising, and if so, to which specific groups?



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WhatsApp:+86 13871529372

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WhatsApp:+86 13871529372


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