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Regulation and Enforcement of Non-Tobacco Nicotine (NTN) Products

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What Are Non-Tobacco Nicotine (NTN) Products?

NTN is the term used to describe nicotine that did not come from a tobacco plant. NTN includes “synthetic” nicotine, which is made in a lab and has a similar molecular makeup as naturally-occurring nicotine.

Nicotine is naturally present in tobacco plants. Most tobacco products, including cigarettes, cigars, and smokeless tobacco, contain nicotine derived from tobacco plants. 

The “e-liquid” in e-cigarettes usually contains nicotine derived from a tobacco plant. Recently, a growing number of companies, including manufacturers of some of the e-cigarette brands most popular with youth, began using NTN in their products.

Is Non-Tobacco Nicotine Addictive?

Yes. Regardless of the source, nicotine is addictive, including NTN. 

Tobacco products are addictive because they contain nicotine. Nicotine keeps people using tobacco products, even when they want to stop. 

No tobacco product is safe. Young people have a higher risk of becoming addicted to the nicotine in tobacco products than adults because their brains are still developing. Nicotine exposure during adolescence can also disrupt normal brain development. If you’re an adult who currently doesn’t use tobacco products, you should stay tobacco-free. If you’re an adult who currently uses tobacco products, there are resources to help you quit.

Does FDA Regulate Non-Tobacco Nicotine Products?

Yes, FDA regulates NTN products. Since passage of the Family Smoking Prevention and Tobacco Control Act (commonly called the Tobacco Control Act) in 2009, FDA has regulated the manufacturing, distribution, and marketing of tobacco products. In 2016, the Deeming Rule extended FDA's tobacco product authorities to more tobacco products, including e-cigarettes. 

In response to the increase of NTN in popular tobacco products, Congress passed a federal law which went into effect on April 14, 2022, clarifying FDA’s authority to regulate tobacco products containing nicotine from any source, including synthetic nicotine. This law makes FDA's authority clear, and imposes requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for manufacturers, importers, retailers, and distributors of NTN products. 

Manufacturers of NTN products who wish to market their products are required to submit a premarket application and obtain FDA authorization, or they will be subject to FDA enforcement.

In July 2022, FDA announced its first warning letters to manufacturers and retailers illegally selling NTN products. In August 2022, FDA provided an update on FDA review and enforcement of NTN products.

Is it Legal to Sell Non-Tobacco Nicotine Products?

NTN products can only be legally marketed in the United States if it received premarket authorization from FDA. Without marketing authorization from FDA, a product is in violation of the FD&C Act and is subject to FDA enforcement.

This means that manufacturers of products containing NTN are now held to the same public health standards implemented for other tobacco products. This includes many of the same requirements to prevent youth access to these products, as well as the requirement to submit a premarket application and obtain authorization from FDA to sell their products to consumers in the United States.  

What is the Status of FDA’s Review of Submitted Non-Tobacco Nicotine Applications?

A substantial number of applications were submitted by May 14, 2022 – nearly one million from more than 200 separate companies. FDA has been actively engaged in the necessary work to prepare for, process, and review the applications since the new law was passed. 

Since then, FDA has completed acceptance review of 100% of the non-tobacco nicotine applications submitted by May 14, 2022. FDA accepted over 9,500 applications, with the vast majority being for e-cigarette or e-liquid products. Importantly, acceptance is not a determination of the product’s authorization status; these applications will proceed forward to more substantial review. FDA also issued refuse-to-accept (RTA) letters for more than 926,000 products in applications submitted by May 14 that do not meet the criteria for acceptance. As of October 2023, FDA has made determinations on over 98% of the applications received.

Currently, no NTN products have received marketing authorizations. Additional information about actions taken on premarket applications can be found on the Tobacco Product Applications: Metrics & Reporting webpage.

How Does FDA Enforce Against Illegal Non-Tobacco Nicotine Products?

FDA continues to pursue enforcement action as swiftly as possible. Since Congress clarified FDA's authority to regulate non-tobacco nicotine products, FDA has issued:

Failure to promptly correct warning letter violations can result in further action such as civil money penalties, seizure, and/or injunction.

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