FDA May Seek New Law to Stop Synthetic Nicotine From Evading Regulation
Synthetic nicotine can be treated as an ingredient in vaping products, which would place such products under U.S. Food and Drug Administration regulation. Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency is concerned that s
Synthetic nicotine can be considered an ingredient in e-cigarettes, which would subject the product to regulation by the U.S. Food and Drug Administration (FDA). Mitch Zeller, director of the FDA's Tobacco Products Center, stated that the agency is concerned about the use of synthetic nicotine to evade regulation and enforcement and is considering options for addressing its use.
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On November 17, the first day of the TMA's "From Opportunity to Change" webinar, Zeller stated that the Tobacco Control Act defines tobacco products as any product made or derived from tobacco and intended for consumption. The FDA believes this also includes components (such as coils and batteries) and all ingredients contained in e-liquid (such as flavorings and vegetable glycerin), even if the product does not contain nicotine.<\/span><\/div>
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"This is an assessment we need to conduct on a case-by-case basis based on all the information we have," Zeller said.<\/span><\/div>
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According to Zeller, synthetic nicotine poses a challenge for the FDA as it becomes increasingly difficult to distinguish it from naturally sourced nicotine. "Historically, this has not been an issue," he said. "Now it is not a problem, but it may become a challenge for us moving forward."<\/span><\/div>
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Zeller explained that nicotine consists of two isomers: R and S. Tobacco-derived nicotine is 99% S, while early synthetic nicotine had a 50-50 ratio between R and S isomers. However, newer versions of synthetic nicotine have a higher proportion of S isomer (purity up to 99.9%), making it difficult to distinguish synthetic nicotine from natural nicotine. The quality of tobacco-derived nicotine is also improving.<\/span><\/div>
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"From a purity standpoint, tobacco-derived nicotine is now provided at a higher quality... pharmaceutical grade. With this, we may find it harder to see chemical fingerprints, if you will, whether it's tobacco DNA or tobacco-specific nitrosamines," he said. "We can view this as a future issue. Additionally, some companies are doing this with the explicit intent to evade FDA regulation... we are concerned about what this means for product regulation, public health, and what it means for products like Puff Bar that proudly claim to use synthetic nicotine, which is the first brand used by young people."<\/span><\/div>
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In the short term, Zeller stated that the FDA is internally discussing how best to address the increasing use of synthetic nicotine to evade FDA regulation. He mentioned that the agency is also responding to questions from Congress regarding synthetic nicotine and providing technical assistance to members when asked.<\/span><\/div>
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"Many companies take pride in complying with the rules. They have every right to expect a fair competitive environment. This is where we work with compliance and enforcement agencies," Zeller said. "We agree that one of the most important things we can do is to use our compliance and enforcement tools to ensure a fair competitive environment and let our actions [in the e-cigarette field] serve as a deterrent. Aside from the investigations we are conducting, I have nothing to say about synthetic nicotine from a compliance enforcement perspective."<\/span><\/div>
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