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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, but that authority only extended to tobacco products that contain nicotine made or derived from tobacco. 

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. This law gives FDA authority over products made with NTN, including synthetic nicotine, 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. 

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. 

All applications submitted by May 14 have been processed, and more than 97 percent have been reviewed to determine if they meet the minimum requirements to be accepted for further review. As of Oct. 17, FDA has issued refuse-to-accept (RTA) letters for more than 897,000 products in applications submitted by May 14 that do not meet the criteria for acceptance. FDA has also accepted over 1,800 applications, with the vast majority being for e-cigarette or e-liquid products. This acceptance is not a determination about the products’ authorization status. Accepted applications then enter further review, which ensures certain criteria are met for applications to proceed forward for further evaluation. 

Currently, no NTN products have received marketing authorizations.

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

FDA continues to pursue enforcement action as swiftly as possible. 

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.

As of Oct. 31, FDA has issued a total of over 60 warning letters to manufacturers and over 450 warning letters to retailers for violations in relation to their sale of non-tobacco nicotine products. Failure to promptly correct violations can result in further action such as civil money penalties, seizure, and/or injunction. Eighteen retailers have received civil money penalties for sales of NTN products to underage purchasers.

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