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Companies may receive marketing authorization through one of the three pathways: Premarket Tobacco Product Applications (PMTA) Substantial Equivalence (SE) Reports. Exemption from Substantial Equivalence Requests (EX REQ)
On August 8, 2016, FDAs tobacco authorities were extended to all deemed tobacco products (except for accessories of deemed tobacco products), such as e-cigarettes, cigars, hookah tobacco, pipe tobacco, nicotine gels and certain dissolvables.
The Deeming Rule extends the FDAs authority to regulate tobacco products to include electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels.
Tobacco products encompass varieties of products including cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, electronic cigarettes, cigars, hookahs, pipe tobacco, nicotine gels, and dissolvables.
A covered tobacco product is any tobacco product deemed under the deeming final rule to be subject to chapter IX of the Federal Food, Drug, and Cosmetic Act, but excludes any component or part that is not made or derived from tobacco.
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There is no safe form of tobacco use. All forms contain nicotine and can cause addiction and health problems. Chew- see Smokeless Tobacco. Cigarettes. Cigars, Cigarillos and Little Cigars. Dip- see Smokeless Tobacco. Electronic cigarette or E- cigarette (nicotine delivery system) Hookah. Kreteks. Pipe.
Tobacco products encompass varieties of products including cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, electronic cigarettes, cigars, hookahs, pipe tobacco, nicotine gels, and dissolvables.
The Deeming Rule also prohibits the sale of covered tobacco products to individuals under the age of 18, prohibits vending machine sales unless sold in adult-only facilities, and requires warning labels on packages and advertisements.

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