FDA's jurisdiction under the Tobacco Control Act extends to products made or derived from tobacco. Products made entirely from non-tobacco plant materials with no nicotine derived from tobacco may fall outside FDA CTP's authority, but the regulatory boundary is not always clear-cut. Importers should obtain a legal opinion on FDA jurisdiction before importing, particularly for novel substitute materials, to avoid potential enforcement action.

Federal excise tax on tobacco products applies to articles that meet the statutory definition of cigarettes, cigars, or other tobacco products. Whether a tobacco-substitute product triggers excise tax depends on its composition and how TTB classifies it. Importers should request a TTB ruling or consult a licensed customs broker with tobacco expertise before assuming these products are excise-tax-exempt.