Request for Additional Information

«Date»
Form Approved
OMB# 0920-0210
Expiration Date: 02/28/2014

«Name»
«Company»
«Address_1»
«Address_2»
«City_State_Zip»
Dear «Salutation»:
This letter is to notify you that the Centers for Disease Control and Prevention (CDC) has begun
processing the Ingredient Reports submitted by you on «Date», on behalf of «Company» for the
brands of cigarettes. As you know, 15 U.S.C. §1335a(a) of the Federal Cigarette Labeling and
Advertising Act (FCLAA) provides in part that each person who manufactures, packages, or
imports cigarettes shall annually provide the Department of Health and Human Services with a
list of the ingredients added to tobacco in the manufacture of cigarettes. The CDC, Office on
Smoking and Health (OSH) has been delegated the responsibility of implementing these
provisions.
An initial review of the submission reveals that the Ingredient Report contains errors as
summarized in the attached document. Federal Register notice 50 FR 49617, December 3, 1985,
specifies that the ingredient submission “shall be provided reporting each ingredient by chemical
name and chemical abstract service (CAS) registry number.” Please correct the errors and
provide a written update within 60 business days. Upon receipt of your corrected Ingredient
Report, CDC will complete its review of your submission and provide a final determination
regarding compliance.
If you require additional assistance please contact Ruth L. Hayes, (770) 488-5743.
Sincerely yours,

Tim A McAfee, MD, MPH
Director
Office on Smoking and Health
National Center for Chronic Disease Prevention and
Health Promotion
Enclosure: (1)
Public reporting burden of this collection of information is estimated to average 6.5 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not collect or sponsor and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to CDC/ATSDR Reports Clearance Officer,
1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-0210).