October 17, 2021

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Is Synthetic Vape Nicotine Legal?

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Clever people in the vaping industry appear to be taking a page from a cannabis industry playbook in an attempt to skirt regulators.

You may be aware of Delta-8, a widely popular cannabis product that many regulators and lawmakers think should be illegal.

The gist of the controversy about Delta-8, which supposedly can create a mild high and provide pain relief, is that the product exists because of a legal loophole. Essentially, Delta-8 is the product of a synthetic laboratory process that marijuana laws don’t address.

Now the same sort of thing is happening in the vaping industry.

The federal government has been cracking down on e-cigarettes, saying that the tobacco-derived nicotine contained within vaping substances is a public health threat to young people. In response, savvy players in the vaping industry have turned to laboratory science and the creation of “synthetic nicotine” in an attempt to skirt government regulators.

Growing Popularity of E-Cigarettes

According to the Centers for Disease Control (CDC), 99% of the vaping products on the market contain nicotine derived from tobacco. The nicotine levels are usually lower than those in traditional cigarettes, prompting marketing claims that e-cigarettes are useful tools for adults who are trying to quit smoking. But in September 2020 the CDC reported that e-cigarette use in the U.S. grew by 300% over a three-year period, much of it due to the growing popularity of vaping among teenagers. The CDC found that nearly 20% of high-school students and 5% of middle-school students reported being regular vapers.

The Food and Drug Administration (FDA) has been empowered to regulate “tobacco products” since 2009, when President Obama signed the Family Smoking Prevention and Tobacco Control Act. But it took years for the FDA to consider vaping products to be under its regulatory umbrella.

In 2016, the FDA finally began to act when it required all manufacturers of e-cigarette products to submit “premarket tobacco product applications” for each particular product by Sept. 9, 2020. The purpose was to prove to FDA that their products were better for public health than traditional cigarettes.

The results for the vaping industry were not good.

On Sept. 9, the FDA said it issued marketing denial orders for more than 946,000 flavored vaping products because their applications “lacked sufficient evidence that they have a benefit to adult smokers sufficient to overcome the public health threat posed by the well-documented, alarming levels of youth use of such products.”

Looking for Backup Plans

By that time, the vaping industry apparently had already begun to see the handwriting on the wall and had begun to look for backup plans. That’s where synthetic nicotine comes in.

“Faced with the choice of removing their products from the market entirely or working in a regulatory gray area, some of those manufacturers are embracing uncertainty and pivoting to synthetic nicotine,” Time reported.

But is synthetic nicotine legal?

Some in the vaping industry argue that it is legal because it’s not derived from tobacco, thereby removing it from the regulatory umbrella.

But nobody knows. Marc Scheineson, a partner in at the Washington, D.C. law firm Alston & Bird, told Time that the issue is “definitely gray.” He said that although the FDA may not have the authority to regulate synthetic nicotine as a tobacco product, it may be able to regulate it as a drug. The agency would just need to show that synthetic nicotine alters the “structure or any function” of the body, which is one of the definitions the FDA uses to designate something as a drug.

What Might the FDA Do?

Legal experts believe that the FDA won’t be doing anything aggressive very soon – and that includes doing anything much about continued sales of products that received marketing denial orders.

Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law, told Filter, a nonprofit that focuses on drug policy, “FDA takes so little concrete action, especially in any newer or potentially controversial areas. They’ll probably wait until Congress orders them to take action, or some crisis appears, like … these companies start advertising in some say that creates youth initiation.”

In other words, vaping won’t be ending anytime soon.

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