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What is synthetic nicotine and what does it mean for the teen vaping epidemic?

What is synthetic nicotine and what does it mean for the teen vaping epidemic?

2022-06-10

Manufacturers of e-cigarettes and other nicotine products are using synthetic nicotine to take advantage of regulatory loopholes and continue to sell the sweet, fruity products that have made vaping popular among teenagers and continue to this day. Fortunately, this loophole is being closed.


Synthetic nicotine, which is made in a lab and not extracted from tobacco, is gaining popularity. A new article from Stanford University identifies six synthetic nicotine manufacturers and 98 brands that claim to contain synthetic nicotine.


Many e-cigarette makers that use tobacco-derived nicotine have recently switched to synthetic nicotine to avoid regulation by the U.S. Food and Drug Administration (FDA). For example, in July 2020, the FDA asked leading youth e-cigarette brand Puff Bar to stop selling its flavored tobacco-derived e-cigarette products. In March 2021, the company returned to the market with synthetic "smoke-free nicotine."


When the FDA reviews thousands of applications from e-cigarette manufacturers to determine whether their products can remain on the market, brands that claim to use synthetic nicotine, including Puff Bar, bypass the review process. Some brands have even returned to the market with synthetic formulation claims after the FDA rejected their application for tobacco-derived nicotine products and ordered them to stop selling them, according to Stanford researchers.


As the popularity of teen e-cigarettes continues, synthetic nicotine has the potential to exacerbate the teenage nicotine use crisis. Here's some important information about synthetic nicotine and how companies use it to try to evade federal oversight designed to protect teens.

Is synthetic nicotine regulated by the FDA?

Is synthetic nicotine regulated?

Now the short answer is yes. On March 11, 2022, Congress passed and the President signed a law requiring the FDA's Center for Tobacco Products to regulate synthetic nicotine products in the same way that nicotine products derived from tobacco are regulated. tobacco.


When these products first hit the market, some companies claimed that synthetic nicotine products did not have to be regulated by the FDA. While that's not accurate, the FDA has been slow to decide how to regulate these products, and it's unclear whether they'll be regulated as tobacco products or drugs. Products containing tobacco or tobacco-derived nicotine must be regulated by the Tobacco Products Center, which follows public health standards. Because synthetic nicotine isn't derived from tobacco, it's unclear whether they'll be regulated by the Center for Drug Evaluation and Research, which uses different standards for safety and effectiveness. As the law changes, it closes the regulatory gap around synthetic nicotine products and ensures that both synthetic nicotine and tobacco-derived nicotine products are regulated by the Tobacco Products Center using the same standards. (Note: Some products, such as nicotine replacement therapy, are considered to help people quit smoking, are regulated by the FDA Center for Drug Evaluation and Research, and must go through the FDA approval process. CDER approval for safety and efficacy).

Are products containing synthetic nicotine the same as "tobacco-free" products?

Synthetic Nicotine vs Tobacco Nicotine

Synthetic nicotine products are not alone in their prominent marketing as "tobacco-free" products. Products advertised as tobacco-free or "from tobacco" include Velo, on!, Rogue, Zyn and Lucy. These products are not synthetic because they use nicotine derived from tobacco, but are marketed in a similar fashion, including claims such as "clean" and "pure," which can mislead consumers. The increasingly popular oral nicotine products are often marketed as smoke-free alternatives to cigarettes with claims that may indicate lower risk and are not FDA-approved, according to a recent Truth Initiative analysis of direct mail advertising.


Both products are advertised as "smoke-free" because they do not contain tobacco leaves, but both contain nicotine, which we all know is bad for young brain development, regardless of its source.


Is synthetic nicotine safe?

It is too early to know whether synthetic nicotine has different health effects than tobacco-derived nicotine.


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