Was your tobacco product commercially marketed in the United States as of February 15, 2007? If so, you will be required to provide evidence of this to FDA. You should take the time to protect and collect documents supporting grandfathered status for each brand.
The agency is asking for comments its draft Guidance, which contains the current thinking on what documents will establish this status. The Draft suggests that information including the following dated documents must be provided to FDA: (i) copies of advertisements, (ii) catalog pages, (iii) promotional material, (iv) trade publications, (v) manufacturing documents, (vi) bills of lading, (vii) freight bills, (viii) waybills, and/or (ix) complete copies of other supporting information.
Contributor: Nancyellen Keane