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more information to ascertain how you may be affected by PL 107-88, please visit
the Food and Drug Administration website at www.fda.gov.
Health
Warning Statement By
Adam Krautheim (202) 927-8140 The
Alcohol Labeling and Formulation Division (ALFD) has noticed an increase in the
number of ATF Forms 5100.31, Application for and Certification/Exemption of Label/Bottle
Approval (COLA), that fail to comply with the mandatory Health Warning Statement
requirements. As of November 1989, a predetermined warning statement was established
for all alcohol beverages containing 0.5% or more alcohol by volume. The implementing
regulations regarding the Health Warning Statement may be found in 27 Code of
Federal Regulations (CFR), Part 16. In
an effort to minimize the rejection of your COLA applications due to Health Warning
Statement problems, ALFD would like to call attention to a few common mistakes
found on COLA submissions. These inaccuracies include: - Illegibility:
Not clearly readable; lacks contrasting background.
- Compressed
Statement: The letters and/or words are compressed in such a manner that causes
the statement to be illegible.
- Not
separate and apart from all other information: Lacks a space or graphic line before
the beginning and after the end of the Health Warning Statement and all other
information.
- Contains
misspelled words, missing or added words or letters that change or confuse the
statement's meaning.
- Statement
is printed in type that is too small.
- The
words "GOVERNMENT WARNING" are not bold, capitalized, or are misspelled.
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We at ALFD hope
this information proves helpful in the preparation and submission of your label
applications. If you have any questions regarding this matter, please
contact
ALFD Customer Service at (202) 927-8140, toll free (866) 927-ALFD (2533) or by
email at alfd@atfhq.atf.treas.gov.
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Questions
or suggestions relating to the Alcohol & Tobacco Newsletter should be directed
to the Editor by fax at (202) 927-5611 or by mail at the following address: Bureau
of ATF, 650 Massachusetts Avenue, NW, Room 8110, Attention: Joette Brown, Editor,
Alcohol & Tobacco Newsletter, Washington, D.C. 20226. |