Attachment 12 Response to Public Comments to Federal Register Notice_Smokeless_0920-0338

Response to Public Comments to Federal Register Notice (FRN) Volume 77 No. 41, pp. 12595-12596
Questions and Comments Regarding “Annual Submission of the Ingredients Added to, and the
Quantity of Nicotine Contained in, Smokeless Tobacco Manufactured, Imported, or Packaged in the
U.S” OMB No. 0920-0338
1. [email protected] “Don’t need this anymore”
OMB-Comments (CDC) has deemed this comment as a non-substantive comment and replied with
CDC’s standard response.
2. Altria Client Services(ALCS) on behalf of Philip Morris USA, Inc. (PM USA) please see
Attachments 11 & 12
ALCS comments addressed three topics:
• Smokeless tobacco ingredient and nicotine reporting to CDC under CSTHEA
• Smokeless tobacco ingredient and nicotine reporting to FDA under the FSPTCA and related
requirements; and
• CDC should urge HHS to eliminate duplicative smokeless tobacco ingredient and nicotine
reporting.
CDC/OSH proposed response to ALCS on behalf of PM USA is as follows:
•

CSTHEA Public Law 99–252 requires annually of CDC's Office on Smoking and Health (OSH) to
collect, store, and analyze the list of ingredients added to cigarettes and smokeless tobacco
products.

•

CSTHEA requires, by March 31 each year, each person who manufacturers, packages, and/or
imports to report a list of all ingredients added to tobacco in the manufacture of smokeless
tobacco products with a specification of the quantity of nicotine contained in each product

•

Upon review and validation of each submitted annual report CDC/OSH provides the
manufacturer, packager and/or importer a Certificate of Compliance; which is required for
entities to be lawfully allowed to sell tobacco products in the U.S.

•

In June 2010, FSPTCA required manufacturers and importers to provide FDA within six months
of enactment of the FSPTCA a listing of ingredients, including tobacco, substances, compounds,
and additives that are, as of such date, added by the manufacturer to the tobacco, paper, filter,
or other part of each tobacco product by brand and by quantity in each brand and subbrand.

•

FSPTCA does not collect smokeless tobacco ingredient and nicotine data on an annual basis,
therefore, not providing State and local entities with accurate and sufficient data, in protecting
the public’s health concerns.

•

The Act requires that manufacturers to provide an ingredient listing under the following
circumstances: (1) prior to new brand style; (2) prior to changing an existing brand style of
smokeless tobacco product(s); (3) adding or increasing an additive as part of premarket review
of a new or modified brand style.

•

FSPTCA act does not meet the requirements of selling tobacco products in the U. S. The Act
does not provide States with compliance, instead, inspects and gives compliance to retailers, not
manufacturers, packagers and importers.

•

If ALCS’s request is permitted, the state and local tobacco control programs will not have full
disclosure to accurate tobacco product data and would depend upon year(s) old information.

•

CSTHEA provides manufacturers, packagers and importers with required certification to import
and sell tobacco products in the U.S.

Given the above, while similarities do exist in the nature of the information collected, key differences in
the scope and detail of the information make these collections non-duplicative. Aligning the
programmatic collection and sharing of information will improve the overall utility of data collected.
This will allow the agencies to verify the reliability and accuracy of the data, given CDC’s year-by-year
program and ability to serve as an annual quality assurance check for FDA monitoring of tobacco
product changes by manufacturers.
It would be beneficial if the Secretary would grant both HHS agencies the ability to share information
received under the FCLAA, CSTHEA, and FSPTCA legislations.