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This guide applies to products regulated by the FDA-CTP, including synthetic nicotine as well as products deemed to be a tobacco product including electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigarettes, cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. Requirements for data submission to FDA-CTP are defined and managed by FDA-CTP and are out of scope for this guide.

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