On this page:
- What Are Dissolvable Tobacco Products?
- Are You Looking for General Health and Safety Information Related to Dissolvable Tobacco Products?
- Are You a Manufacturer of Dissolvable Tobacco Products?
- Are You a Retailer of Dissolvable Tobacco Products?
Dissolvable tobacco products can be sold as lozenges, strips, or sticks, and some may look like candy. Like other tobacco products, dissolvable tobacco products contain nicotine and other harmful and potentially harmful constituents.
Most dissolvable tobacco products dissolve in the mouth and do not require spitting or discarding of the product. Dissolvable tobacco products are noncombustible tobacco products.
To protect people in the United States from tobacco-related disease and death, FDA provides information about tobacco products, including dissolvable tobacco products, and the dangers they pose to the public.
No tobacco product is considered safe. Using any tobacco product —including nicotine gel tobacco products—can harm your health. Different tobacco products, however, pose varying levels of health risk.
Learn more about print materials, web content, and social media posts available for free that help keep communities informed about tobacco-related issues.
If you have experienced undesired health or quality problems with any tobacco product, including dissolvable tobacco, 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.
FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of dissolvable tobacco products under the FD&C Act and its implementing regulations. This includes components and parts but excludes accessories for dissolvable tobacco products that are not considered smokeless tobacco products.
However, 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.
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.
Tools for Retailers
“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.
Did You Know?It is illegal for a retailer to sell any tobacco product – including cigarettes, cigars, smokeless tobacco, and e-cigarettes – to anyone under 21.