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What Are Nicotine Pouches?

“Nicotine pouches” are a type of tobacco product. They are small fiber pouches that, unlike some other types of oral tobacco products, can be used without the need for the person using them to spit. During use, these pouches are typically placed between the gum and upper lip, where the nicotine is absorbed into the body. Nicotine pouches are not intended to be heated or burned (combusted).

Nicotine pouches contain nicotine in the form of either nicotine powder or nicotine salts, which is chemically synthesized or extracted from tobacco leaf. However, they do not contain cut, ground, powdered, or leaf tobacco itself. Nicotine pouches can also contain such other ingredients as fillers like microcrystalline cellulose (a term for refined wood pulp), sweeteners such as xylitol or maltitol, other flavors, and preservatives.

What Are Nicotine Gels?

Nicotine gels are a type of tobacco product that are rubbed or placed on the skin, where it is absorbed. Nicotine gels are not intended to be heated or burned (combusted).

Nicotine gels contain nicotine, either added directly or as part of a tobacco extract. They can also contain humectants such as propylene glycol, preservatives, binders like xanthan gum, and permeation enhancers.

What Are Dissolvable Tobacco Products?

Dissolvable tobacco products include lozenges, oral use strips, or sticks, and some may look like hard candy. Most dissolvable tobacco products dissolve in the mouth and do not require spitting or discarding of the product. Dissolvable tobacco products are not intended to be heated or burned (combusted).

Dissolvable tobacco products can be made with or without cut, ground, powdered, or leaf tobacco. Those dissolvable tobacco products made with cut, ground, powdered, or leaf tobacco would be considered smokeless tobacco products for the purposes of FDA’s regulation.

Dissolvable tobacco products contain nicotine. They also often contain added ingredients such as fillers, sweeteners, and other flavors.

Are You Looking for General Health and Safety Information Related to Tobacco Products?

To protect people in the United States from tobacco-related death and disease, FDA provides information about tobacco products and the dangers they pose to the public.

Tobacco products contain nicotine. Nicotine is why tobacco products are addictive and this addiction is why most people find it difficult to stop using tobacco products once they have started. Tobacco and tobacco products also contain thousands of other chemicals. The mix of chemicals is what causes serious death and disease.

Health Effects of Tobacco Use

No tobacco product is considered safe. Using any tobacco product —including nicotine pouches, nicotine gels, and dissolvable tobacco products—can harm your health. However, different tobacco products can pose varying levels of health risk.

Resources in the FDA Tobacco Education Resource Library

Learn more about print materials, web content, and social media posts available for free that help keep communities informed about tobacco-related issues.

See Tobacco Product Resources

Report a Tobacco Product Problem or Violation

If you have experienced undesired health or quality problems with any tobacco product, you can report it to FDA. Knowing more about adverse experiences can help FDA identify concerning trends and causes or contributors for particular incidents or health or quality problems beyond those normally associated with tobacco product use. You can read some tobacco-related adverse experience reports on the Tobacco Product Problem Reports page.

If you believe these products are being sold to minors, or you see another potential violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or FDA’s tobacco regulations, report the potential violation.

Are You a Manufacturer of Tobacco Products?

FDA regulates the manufacture, sale, and distribution of tobacco products under the FD&C Act. This includes components and parts but, for deemed products, excludes accessories.

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import any tobacco product, then you are considered a tobacco product manufacturer. Importers of finished tobacco products are regulated as tobacco product manufacturers, distributors, or both. If you are a tobacco product manufacturer, find out more information on complying with FDA’s tobacco products regulation on CTP’s Manufacturing webpage.

CTP’s Office of Small Business Assistance can answer specific questions about requirements of small businesses and how to comply with the law. This office also provides online educational resources to help regulated industry understand FDA regulations and policies.

Note: Nicotine pouches, nicotine gels, and dissolvable tobacco products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by FDA through the Center for Drug Evaluation and Research (CDER) as drugs. In 2017, FDA published a rule clarifying when products made or derived from tobacco are regulated as tobacco products, drugs, and/ or devices.

Are You a Retailer of Tobacco Products?

Tools for Retailers

It is illegal for a retailer to sell any tobacco product – including roll-your-own tobacco, cigarettes, cigars, and e-cigarettes – to anyone under the age of 21.

“This is Our Watch” is an education program with resources to help tobacco retailers better understand and comply with FDA tobacco regulations. Tobacco retailers play a direct role in protecting kids from nicotine addiction and the deadly effects of tobacco use. Learn what tobacco retailers need to do to comply with the rules designed to prevent our nation’s youth from becoming the next generation of people to die prematurely from tobacco-related disease.

Retail Sales of Tobacco Products offers more information about federal rules that retailers must follow as well as information on regulations, guidance, and tools to help retailers comply.



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