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 burden for this collection
of information is expected to increase by 4,235 reporting hours. We
attribute this adjustment to an updated number of submissions
received through this approval and the number of submissions
expected in the next 3 years. The estimated number of respondents
and annual responses will increase by 847 (from 153 to 1,000).