The Food and Drug Administration (FDA) is conducting an ongoing review of e-cigarettes, cigars and other tobacco products that contain nicotine to determine if meet the standards set by the 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). As a result, all flavored e-cigarette products (with the glaring exception of menthol) have been ordered off the market. However, vape and e-cigarette companies found a loophole around the law by claiming to use synthetic nicotine in their products because the 2009 Tobacco Control Act only gave FDA authority over tobacco products that got their nicotine from tobacco plants. However, Congress acted and in March 2022, closed what the Lung Association refers to as the “Puff Bar loophole.”

What is synthetic nicotine?

Synthetic nicotine is created in a laboratory rather than from tobacco leaves. Though synthetic nicotine has been around for some time, it has only recently started being used in products such as e-cigarettes as the production costs have gone down. It is produced as a liquid, which is how it has found its way primarily into vape products.

One brand that claims to use synthetic nicotine is Puff Bar, which is the top vape brand used by young people. In July 2020, FDA told Puff Bar to stop selling their flavored e-cigarettes—a huge win for helping teens stop vaping. However, in March 2021 the company debuted their new “tobacco-free nicotine” or synthetic, products on the market, evading FDA’s oversight.

Closing the synthetic nicotine loophole

After some debate, in March 2022, Congress passed and the President signed a law updating the Tobacco Control Act that says products containing nicotine of any kind can be regulated by FDA’s Center for Tobacco Products and set out a timetable for that to happen.

This provision took effect in April 2022 and includes requirements such as:

  • Not selling synthetic nicotine products to people under the age of 21, in person or online;
  • Not advertising these products as being less harmful without FDA authorization; and
  • Requiring manufacturers to submit their products for review by FDA before they are legally allowed to be sold.

Despite Congress being quite explicit in requiring FDA to halt the sale of all synthetic e-cigarettes whose manufacturers that did not sufficiently prove to FDA that the product is “appropriate for the protection of public health,” FDA has failed to remove these products from the marketplace. This puts the nation’s youth at risk, as Puff Bar continues to attract and addict our nation’s youth.

Risks of using synthetic nicotine

Just because synthetic nicotine is not made from tobacco does not mean that it is not harmful. Scientists are beginning to study the health effects of this product, and it is already known that flavor ingredients can cause negative health effects.

Additionally, synthetic nicotine is still nicotine—a highly addictive substance that research suggests is as addictive as heroin, cocaine or alcohol. Nicotine is especially harmful to adolescents, as it impacts brain development. A young person’s memory, attention levels and ability to learn are all negatively affected by nicotine.

Products containing synthetic nicotine will not help you quit smoking like nicotine replacement therapies (NRT) and other quit smoking products can. Products such as the NRT patch, NRT gum and NRT lozenge are approved by FDA to help smokers quit and are designed to provide much lower levels of nicotine to help tobacco users end their nicotine addiction. Products that use synthetic nicotine, on the other hand, have the same or similar amounts of nicotine in them as tobacco-derived products.

What you can do

The use of synthetic nicotine in e-cigarettes and other vape products threaten to addict more kids and teens. If you are a parent, talk to your child about the dangers of vaping.

To learn more and find support about stopping use of tobacco and nicotine products, visit Lung.org/quit-smoking.

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