On this page:
- FDA Regulation of Dissolvables
- Manufacturing Dissolvables
- Nicotine Warning Statement for Newly-Regulated Dissolvables
- Retail Sales of Dissolvables
- Importing Dissolvables
- Reporting Adverse Experiences and Product Violations
Most dissolvable tobacco products dissolve in your mouth and do not require spitting or discarding of the product. Dissolvable tobacco products are noncombustible tobacco products.
Dissolvables 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.
Nationwide, an estimated 80,000 high school students used dissolvable tobacco in 2014.1
In 2009, the Family Smoking Prevention and Tobacco Control Act authorized FDA to regulate, among other things, smokeless tobacco products, the definition of which includes some dissolvables as well as products such as chewing tobacco and snus.
In 2016, FDA finalized a rule extending regulatory authority to cover all tobacco products, including dissolvables that do not fit the definition of smokeless tobacco products. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of all dissolvables. This includes components and parts but excludes accessories for dissolvables that are not considered smokeless tobacco products.
However, dissolvable 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. FDA recently proposed a rule clarifying the jurisdiction over tobacco products, drugs, and devices.
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import dissolvables, you must comply with the requirements for manufacturers.
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.
Beginning in 2018, all "covered" tobacco products* must bear the required nicotine addictiveness warning statement on product packages and advertisements. *Note: Cigars , which are also “covered” tobacco products, have additional required warning statements.
If you sell dissolvables, please read this summary of federal rules that retailers must follow.
You can find a list of retailer responsibilities for dissolvables in the final rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers more information on regulations, guidance, and webinars for retailers.
Tobacco products imported or offered for import into the United States must comply with all the applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act). You can find more information on the Importing and Exporting webpage.
You can also learn more about the importation process in the FDA Regulatory Procedures Manual, Chapter 9, Import Operations and Actions.
If you have questions about importing a specific tobacco product, please contact the FDA district into which your product will be imported.
If you have experienced an unexpected health or safety issue with a specific tobacco product, you can report your adverse experience to FDA. Knowledge about adverse experiences can help FDA identify health or safety issues beyond those normally associated with product use.
If you believe these products are being sold to minors, or you see another potential violation of the FD&C Act or FDA’s tobacco regulations, report the potential violation.
- Small Business Assistance for Tobacco Product Industry
- Selling Tobacco Products in Retail Stores
- FDA's Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products
1. Centers for Disease Control and Prevention (CDC). Tobacco product use among middle and high school students – United States, 2011-2014. Morbidity and Mortality Weekly Report. 2015; 64(14):381-385.