The guidance document provides information on how a manufacturer may establish that a tobacco product was commercially marketed in the United States as of February 15, 2007. A grandfathered tobacco product is not considered a new tobacco product and thus is not subject to the premarket requirements of the FD&C Act. A grandfathered tobacco product may also serve as the predicate tobacco product in a section 905(j) report (intended to be used toward demonstrating substantial equivalence) for a new tobacco product (section 905(j)(1)A)(i) of the FD&C Act( 21 U.S.C. 387e(j)(1)(A)(i))). FDA interprets the phrase "as of February 15, 2007," as meaning that the tobacco product was commercially marketed in the United States on February 15, 2007. The guidance associated with this collection of information recommends that the manufacturer submit information adequate to demonstrate that the tobacco product was commercially marketed in the United States as of February 15, 2007. Examples of such information may include, but are not limited to, the following: dated copies of advertisements, dated catalog pages, dated promotional material, and dated bills of lading.
The latest form for Establishing That a Tobacco Product Was Commercially Marketed in the United States As of February 15, 2007 expires 2022-08-31 and can be found here.
Document Name |
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Justification for No Material/Nonsubstantive Change |
Justification for No Material/Nonsubstantive Change |
Supporting Statement A |
No material or nonsubstantive change to a currently approved collection | 2024-10-25 | ||
Approved without change |
No material or nonsubstantive change to a currently approved collection | 2023-08-15 | |
Approved without change |
Extension without change of a currently approved collection | 2022-05-12 | |
Approved without change |
Extension without change of a currently approved collection | 2019-06-05 | |
Approved without change |
Revision of a currently approved collection | 2016-05-12 | |
Approved without change |
New collection (Request for a new OMB Control Number) | 2014-07-15 |