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Three Ways to Obtain FDA Marketing Authorization

There are three methods to obtain marketing authorization from the FDA for tobacco and nicotine products. These pathways include:

Premarket Tobacco Product Application (PMTA)

Applies To: New tobacco products introduced after February 15, 2007.

Includes: E-Cigarettes, Heat-Not-Burn Devices, Oral Nicotine Pouches and Lozenges.

Substantial Equivalence (SE)

Applies To: New tobacco products that have a highly similar (“predicate”) comparison product that was sold prior to Feb. 15, 2007.

Includes: Combustible Cigarettes, Cigars, Snus Pouches, Moist and Dry Snuff, Chewing Tobacco, Loose-Leaf (Pipe) Tobacco.

Exemption from Substantial Equivalence (SE Exemption)

Applies To: New tobacco products that have been changed only by modifying the quantity of tobacco additive that was used in a highly similar (“predicate”) comparison product that was sold prior to Feb. 15, 2007.

May Include: Modified Combustible Cigarettes, Cigars, Snus Pouches, Moist and Dry Snuff, Chewing Tobacco, Loose-Leaf (Pipe) Tobacco.