14 Dec New FDA Guidance on Substantial Equivalent Process
This week the Food & Drug Administration (FDA) issued a revised guidance regarding the Substantial Equivalent (SE) application process that will impact the compliance requirements for many of IPCPR’s members. Specifically, the new guidance updates the definition of what qualifies as a “new tobacco product” and provides for a streamlined SE process under certain circumstances. A link to the full guidance is included below. For any questions or requests for additional information, please contact Daniel Trope, Director of Federal Government Affairs at firstname.lastname@example.org.
So what’s new?
Changes to labeling is not a “new product”
Under the guidance, modifications made to the labeling of existing tobacco products, including name changes, do not result in a “new product” in need of a SE application. This applies strictly to existing products where a modification to the label is the only change made. However, changes made to the quantity or composition of an existing product still qualify the product as “new” in the eyes of the FDA.
Quantity changes are new products, but have a “streamlined” SE process
The guidance provides for a streamlined SE application process in instances where modifications are made solely to the quantity of existing products. Changes in quantity include an increase or decrease in tobacco additive within the existing package. The streamlined application process, the “Product Quantity Change SE Application,” requires a reduced amount of information compared to a standard SE application.
Link to FDA Guidance: