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This guide applies to products regulated by the U.S. Food & Drug Administration (FDA) Center for Tobacco Products (CTP), including synthetic nicotine as well as products deemed to be a tobacco product to include electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco, and nicotine gels. This guide The TIG v1.0 does not address or define regulatory submission requirements. Requirements for data submission are defined and managed by regulatory authorities to whom data are submitted.