If a predicate product existed prior to February 15, 2007, applicants can apply via the Substantial Equivalence (SE) regulatory pathway.
On May 10, 2016, the US FDA finalized its "deeming" rule, subjecting additional products to scrutiny under the Federal Food, Drug and Cosmetic Act as amended by the Family Smoking Prevention and Tobacco Control Act.
Substantial Equivalence exemptions have a total compliance period of 24 months and an enforcement deadline of August 8, 2017.
Substantial Equivalence applications have a total compliance period of 30 months and an enforcement deadline of February 8, 2018.
Premarket tobacco applications have a total compliance period of 36 months and an enforcement deadline of August 8, 2018.