Synthetic Nicotine May be Subject to Regulation

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    Synthetic nicotine could be considered a component of e-cigarettes, which would allow for the product to be regulated by the U.S. Food and Drug Administration. Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the agency was concerned about the use of synthetic nicotine to avoid regulation and enforcement and is considering its options in dealing with its use.

    On Nov. 17, the first day of TMA’s “From Chance to Change” webinar, Zeller said that the Tobacco Control Act defines tobacco products as anything that is made or derived from tobacco and is intended for consumption. The FDA believes that it also includes components and parts (such as coils and batteries) and all the ingredients included in producing e-liquids (such as flavorings and vegetable glycerin) even if the product does not contain nicotine.

    “That’s an assessment that we need to make on a case-by-case basis based upon the totality of all the information that we have,” said Zeller.

    According to Zeller, synthetic nicotine represents a challenge for the agency because it is increasingly difficult to differentiate from naturally derived nicotine. “Historically, that hasn’t been a problem,” he said. “It’s not a problem now, but it could become a challenge for us going forward.”

    Zeller explained that nicotine is comprised of two isomers: R and S. Tobacco-derived nicotine is 99 percent S, and early synthetic nicotine had a 50-50 split between R isomers and S isomers. However, newer versions of synthetic nicotine have much higher proportions of S isomers (as high as 99.9 percent pure), making it harder to tell synthetic nicotine apart from natural nicotine. Tobacco-derived nicotine is also becoming higher in quality.

    “Tobacco-derived nicotine is now being made available at a higher quality … pharmaceutical grade from a purity standpoint. And with that, it may be harder for us to see that chemical fingerprint, if you will, whether it’s tobacco DNA or tobacco-specific nitrosamines,” he said. “We could see this as a problem going forward. Coupled with the clear intent of certain companies to do this to evade FDA regulation … We are concerned about what this means for product regulation, for the public health, and a product like Puff Bar proudly proclaiming its use of synthetic nicotine [and] being the No. 1 brand used by youth.”

    In the short term, Zeller said the FDA is talking internally about how to best address the growing number of products that are using synthetic nicotine to skirt FDA regulation. He said the agency is also responding to questions from Congress about synthetic nicotine and providing technical assistance to members when asked.

    “There are a lot of companies out there that pride themselves on playing by the rules. They have every right to expect that the playing field is going to be level. That’s where we come in with our compliance and enforcement authorities,” Zeller said. “We agree that one of the most important things that we can do, using our compliance and enforcement tools, is to level the playing field and to have our actions [in the e-cigarette space], hopefully, serve as a deterrent. There’s nothing that I can say from a compliance enforcement standpoint on synthetic nicotine other than we have ongoing investigations.”