South Korea announced today (Feb. 3) that it will extend full tobacco regulatory controls to synthetic nicotine liquid e-cigarettes from April 24, bringing them in line with conventional tobacco products following amendments to the Tobacco Business Act and National Health Promotion Act. The measures require manufacturers and distributors to include graphic health warnings on packaging and restrict advertising to limited channels, while banning promotional content targeting women or minors or highlighting flavors. The revised framework also prohibits the use of all tobacco and nicotine products, including e-cigarettes and heated tobacco, in designated smoke-free areas, with violations subject to fines of up to 100,000 won ($69). The regulatory expansion, the first major update to the tobacco definition since 1988, aims to close loopholes that previously allowed synthetic nicotine products to be marketed and sold with fewer controls, particularly amid concerns around youth access and public health risks.
Tag: syntethic nicotine
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Nicotine Alternatives Under Scrutiny
Photo: Alexey Stiop Nicotine alternatives, such as 6-methyl nicotine, may be more potent and addictive than nicotine itself, reports Reuters, citing U.S. Food and Drug Administration scientists and independent researchers.
Traditional nicotine found in many vapes and pouches is extracted from tobacco leaves; 6-methyl nicotine, in contrast, is made in a laboratory.
While chemically similar to nicotine, the synthetic substances are not subject to U.S. tobacco and vaping regulations, allowing manufacturers to sell vapes with nicotine analogues without seeking FDA authorization.
Tobacco and vape companies have criticized that the FDA product authorization process is costly and time-consuming. Only a handful of applications have been approved.
In response to questions from Reuters, the FDA said it was reviewing the available data on nicotine alternatives to inform potential actions.
Three academic researchers told the news agency that current studies of 6-methyl nicotine are too limited to draw definite conclusions on the health impact or to what degree it is addictive.
The limitations of existing research, the researchers said, included that some papers were industry funded while others focused on the short-term impact on animals or cells and were insufficient to understand 6-methyl nicotine’s effects on human bodies.
The FDA has yet to approve any flavored vape using traditional nicotine for sale in the United States, saying companies have not been able to show that the health benefits they offer to smokers outweigh the known risks to young people, who may be more attracted by the flavors.
The Spree Bar vaporizer, which uses a 6-methyl nicotine solution branded as “Metatine,” notes on its website that Metatine “may have a toxicity profile similar to nicotine.”
Sven Jordt, a professor at Duke University who has authored papers on products like Spree Bar, said 6-methyl nicotine could me more addictive and toxic than its traditional cousin.
“Do we want to have such a chemical as a recreational product, available to anyone?” he asked. “That’s really questionable.”
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VTA and FDA Discuss Synthetic Nicotine
Photo: pressmaster The Vapor Technology Association (VTA) met with officials of the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP) on May 2 to help clarify issues relating to synthetic nicotine. Premarket tobacco product applications (PMTAs) for synthetic products are due on May 14.
“We presented a thoughtful case for synthetic nicotine products that, to our knowledge, had not yet been made to any policy maker,” the VTA wrote in a press note.
During the meeting, scientists explained how synthetic nicotine is manufactured and how it differs from tobacco-derived nicotine. Expert speakers included Bill Jackson, (organic chemistry), David Johnson (physical analytical chemistry), Ray McCague, (organic chemistry), and Willie McKinney (inhalation toxicology).
This is the VTA’s second meeting with the FDA following the signing into law of new legislation governing synthetic nicotine. While pleased with the level of engagement from the CTP, the VTA stressed its work continues.
“These meetings, and the additional meetings that we are working on, are just part of VTA’s multi-pronged strategy to ensure the proper and full assessment of synthetic nicotine PMTAs,” the VTA wrote.
“If your company is manufacturing products containing synthetic nicotine and is serious about regulatory compliance, or if your retail operation wants the ability to continue to diversify its retail offerings with synthetic nicotine products, or if you want to have continued access to innovative products containing synthetic nicotine, you should strongly consider being engaged in our strategic efforts.”