Synthetic nicotine can be regarded as an ingredient of e-cigarettes, which will make the product subject to the supervision of the U.S. Food and Drug Administration.

Mitch Zeller, director of the US FDA's Tobacco Products Center, said the agency is concerned about the use of synthetic nicotine to evade regulation and law enforcement, and is considering options for dealing with its use.

On November 17, the first day of TMA’s "From Opportunity to Change" webinar, Zeller said that the Tobacco Control Act defines tobacco products as any product made or derived from tobacco and used for consumption.

The FDA believes that it also includes parts (such as coils and batteries), as well as all the ingredients (such as flavoring and vegetable glycerin) contained in the production of e-liquid, even if the product does not contain nicotine.

"This is a case-by-case evaluation based on the overall situation of all the information we have." Zeller said.

According to Zeller, synthetic nicotine is a challenge for the FDA because it is increasingly difficult to distinguish from natural sources of nicotine. "Historically, this is not a problem, but it may become a challenge for us to move forward."

Zeller explained that nicotine is composed of two isomers: R and S. 99% of tobacco-derived nicotine is S, and the ratio of R isomer to S isomer in the early synthesized nicotine is 50-50. However, newer versions of synthetic nicotine have a higher proportion of S isomers (up to 99.9% purity), so it is difficult to distinguish synthetic nicotine from natural nicotine. The quality of tobacco-derived nicotine is also getting higher and higher.

"From a purity point of view, tobacco-derived nicotine is now available in higher quality pharmaceutical grade. With this, it may be more difficult for us to see chemical fingerprints, whether it is tobacco DNA or tobacco-specific nitrosamines if you wish. ."He said. "We can see it as a future problem. In addition, some companies are doing this to evade the clear intention of FDA regulation... We are worried that this will affect product regulation, public health, and people like Puff Bar who proudly claim to use synthetic nicotine. What does the product mean, and it’s the number one brand used by young people.”

In the short term, Zeller stated that the FDA is internally discussing how to best address the increasing use of synthetic nicotine to circumvent FDA regulation of products. He said that the agency is still answering questions about synthetic nicotine raised by Congress and providing technical assistance to members in a timely manner when asked.

"There are many companies that take pride in complying with the rules. They have every right to expect that the playing field is fair. This is where we cooperate with compliance and law 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 level the playing field and let our actions in the field of e-cigarettes, hoping to act as a deterrent. Except we are Outside of the investigation, from the perspective of compliance and enforcement, I have nothing to say about synthetic nicotine.”

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