Please note that this is not a complete list of all grandfathered products because manufacturers are not required to seek a grandfathered determination from the FDA.
Products Receiving Substantial Equivalence Marketing Orders. Certain deemed tobacco products, including cigars and pipe tobacco products, have received Substantial
Equivalence Marketing Orders. A substantially equivalent tobacco product is either a tobacco product commercially marketed (other than for test marketing) in the United States as of Feb. 15, 2007, or a tobacco product that the FDA has previously determined to be substantially equivalent and in compliance with the requirements of the Food Drug & Cosmetic Act. These products can be legally marketed and are not subject to FDA’s enforcement discretion. FDA’s website is updated from time to time but may not include all Substantial Equivalence marketing orders issued by FDA. To visit the FDA’s website page on Substantial Equivalent marketing orders, click here.
Products Receiving Substantial Equivalence Exemption Orders. Certain deemed tobacco products, including cigars and pipe tobacco products, have received Substantial
Equivalence Exemption Orders. A new tobacco product may be considered for an exemption from Substantial Equivalence (SE) if FDA determines that: (1) the new tobacco product is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive; the proposed modification is minor and to a legally marketed tobacco product; an SE Report is not necessary; and an exemption is otherwise appropriate. These products can be legally marketed and are not subject to FDA’s enforcement discretion. FDA’s website is updated from time to time but may not include all exemption orders issued by FDA. To visit the FDA’s website page on substantial equivalence exemption, click here.
The FDA also notes that the lists of deemed products provides information only as of a specific date. The FDA webpage states that the lists were updated as of April 5, 2021. Since the agency plans to update the lists regularly, industry members should check the FDA lists from time to time for additional applications posted to the lists.
You can view the full list of deemed tobacco products with timely filed PMTAs by clicking here. For all the latest news from the National Association of Tobacco Outlets, visit natocentral.org.
