Tobacco Products

Dissolvable Tobacco Products

Dissolvables

Most dissolvable tobacco products dissolve in your mouth and do not require spitting or discarding of the product.

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

 

FDA Regulation of Dissolvables

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 our regulatory authority to cover all tobacco products, including dissolvables that do not fit the definition of smokeless tobacco products. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of all dissolvables. This includes components and parts but excludes accessories for newly-regulated dissolvables that are not considered smokeless tobacco products.

However, products marketed for therapeutic purposes (for example, marketed as a product to help people quit smoking) are regulated by the 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.


Manufacturing Dissolvables

If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import dissolvables, you must comply with these 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.


Nicotine Warning Statement for Newly-Regulated Dissolvables 

Beginning in 2018, the product packages and advertisements of all newly-regulated covered tobacco products must bear the following warning statement:
 

“WARNING: This product contains nicotine. Nicotine is an addictive chemical.”


If the tobacco product manufacturer submits a self-certification statement to FDA that the newly-regulated tobacco product does not contain nicotine (and that the manufacturer has data to support such assertion), then an alternate statement must be used on product packages and advertisements::
 

“This product is made from tobacco.”


You can find more information about nicotine warning statements in Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.  


Retail Sales of Dissolvables

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 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act. In addition, our website offers more information regulations, guidance and webinars for retailers.


Importing Dissolvables

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 (PDF - 406 KB).


Reporting Adverse Experiences and Product Violations

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.


1. Centers for Disease Control and Prevention. Tobacco Product Use Among Middle and High School Students - United States, 2011 -2014. Morbidity and Mortality Weekly Report 2015; 64: 381-5.


 

Page Last Updated: 06/27/2017
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