2. What goes into tobacco products?
2.1 What are the main tobacco products?
The vast majority of smokers use cigarettes. Most are manufactured. Other ways of smoking, including cigars, pipes and waterpipes are less common. Like roll-your-own cigarettes, they also use blends of tobacco. In waterpipes, tobacco is heated over charcoal and the smoke filtered through water before being inhaled. The smoke from these tobacco products has different characteristics. Waterpipe smoke, for instance, is cooler and tends to be inhaled into the lungs, while cigar smoke typically remains in the mouth.
Together, tobacco products used for smoking lead to about 500,000 deaths per year in the EU. Smokeless tobacco products, such as snuff or chewing tobacco, can also be harmful to health. Very recently, electronic cigarettes have been marketed. These are battery-powered devices that produce an inhalable vapour of nicotine and other chemicals. They have been marketed to help people stop smoking and as a way of taking in nicotine in smoke-free zones. Their risks are as yet little studied.
2.2 How are they made?
Cigarettes are carefully designed “nicotine delivery devices”. Fine-cut tobacco leaves are processed, wrapped, and often filter tipped. The final product delivers a mix of smoke-borne chemicals which depends on the tobacco type and blend, and how it is cured, on the precise engineering of the tube, and on the properties of additives incorporated during manufacture. They are included to affect how fast the tobacco burns, how much nicotine is released, and the flavour and harshness of the smoke. The whole process is closely monitored to deliver a standardised product which has the characteristics smokers recognise in “their” brand.
Burley tobacco, a light air-cured leaf widely used in cigarette blends, can absorb up to 25 per cent of its weight in additives. Humectants and flavourings can be added to the blend at various stages but flavourings are most often added to already blended tobacco near the end of processing. They are often mixed with alcohol before application. Other additives, such as menthol, may also be added via the filter or the cigarette paper.
As well as additives, the technology of tobacco production is evolving. The industry has developed genetically modified (GM) tobacco plants, to alter nicotine levels. Some smoking cessation aids use GM tobacco which contains little or no nicotine.
2.3 What is added?
Tobacco additives were little used before 1970. Since then, their use has increased and US-style cigarettes now contain about 10 per cent of additives by weight. As reported by the tobacco industry, approximately 600 substances are used as cigarette additives. The main additions to tobacco are sugars, which are also present naturally in tobacco leaves, and moisture retaining compounds (humectants), such as glycerol and propylene glycol. There are ingredients which are part of the cigarette paper, the filter, if used, and the glue which holds a cigarette or cigar together.
Other items on the list include preservatives and numerous flavourings. The latter include cocoa, liquorice, menthol and lactic acid. Most others are only used in small amounts. They may be chemical flavouring agents, plant extracts and oils. Cigars, pipe tobacco and smokeless tobacco usually contain fewer additives. Waterpipe tobacco tends to be high in water and sugars.
Tobacco industries in the EU have to report the full list of additives in tobacco products, including the exact amount, to the competent authorities.
Tobacco Additives 2. What goes into tobacco products? 2.1 What are the main tobacco products? The vast majority of smokers use cigarettes. Most are manufactured. Other ways of smoking,
U.S. Food and Drug Administration
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Pipe tobacco is generally loose leaf tobacco burned in a traditional smoking pipe with a bowl. Pipe tobacco is a combustible tobacco product.
Nationwide, 1.4 percent (an estimated 190,000) of high school students currently smoke pipes. 1
FDA Regulation of Pipe Tobacco
In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including pipe tobacco. FDA regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of pipe tobacco. This includes components and parts such as pipes, but excludes accessories such as lighters.
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“Components” or “parts” include, among other things, software or an assembly of materials intended or reasonably expected to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or to be used with or for the human consumption of a tobacco product. Accessories of deemed tobacco products are not regulated. For a full definition of components, parts, and accessories, please read Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act.
Manufacturing Pipe Tobacco
If you make, modify, mix, manufacture, fabricate, assemble, process, label, repack, relabel, or import pipe tobacco, 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.
Warning Statement Requirements
The United States District Court for the District of Columbia recently issued an order vacating the health warning requirements for cigars and pipe tobacco set forth in 21 CFR §§ 1143.3 and 1143.5 and remanding the Final Deeming Rule’s warning requirements for cigars and pipe tobacco back to the Agency. See Order, Cigar Ass’n of Am. v. U.S. Food & Drug Admin., No. 1:16-cv-01460 (D.D.C. September 11, 2020). Although the requirement has been vacated, cigar and pipe tobacco firms may choose to voluntarily comply with these health warning provisions. FDA will continue to enforce the other requirements it was already enforcing for cigars and pipe tobacco under the FD&C Act and its implementing regulations, such as not selling these products to individuals under 21 years of age or marketing them as modified risk tobacco products without an FDA order.
All “covered” tobacco products, including pipe tobacco, must bear required warning statements and additional required statements on product packages and advertisements. For more information, see:
Retail Sales of Pipe Tobacco
Note: On December 20, 2019, the President signed legislation to amend the Federal Food, Drug, and Cosmetic Act, and raise the federal minimum age of sale of tobacco products from 18 to 21 years. It is now illegal for a retailer to sell any tobacco product – including cigarettes, cigars and e-cigarettes – to anyone under 21. FDA will provide additional details on this issue as they become available, and the information on this page will be updated accordingly in a timely manner.
You can find a list of retailer responsibilities for pipe tobacco 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.
Importing Pipe Tobacco
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.
Reporting Adverse Experiences and Product Violations
If you experience 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
1. Centers for Disease Control and Prevention (CDC). Tobacco use among middle and high school students – United States, 2011-2016. Morbidity and Mortality Weekly Report. 2017; 66(23):597-603.
Find facts and figures about pipe tobacco and an overview of FDA's regulation of pipe tobacco.