[Federal Register Volume 63, Number 13 (Wednesday, January 21, 1998)]
[Notices]
[Pages 3146-3147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1344]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97D-0261]
Frequently Asked Questions About the New FDA Tobacco Regulations:
Draft Guidance; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration is announcing the
availability of a new section to the draft guidance entitled
``Frequently Asked Questions About the New FDA Tobacco Regulations.''
The draft guidance addresses the questions most frequently asked by
retailers, consumers and others about the age and photo identification
requirements of the final rule restricting the sale of cigarettes and
smokeless tobacco to protect children and adolescents. The new section
on enforcement procedures addresses questions raised by retailers and
others concerning the amount of penalties that FDA intends to seek for
third and subsequent violations of the age and identification
requirements.
DATES: Submit written comments on the draft guidance by April 21, 1998.
ADDRESSES: The draft guidance entitled ``Frequently Asked Questions
About the New FDA Tobacco Regulations,'' and the amendment are
available on the Internet at
http://www.fda.gov/, or a paper copy may be ordered free of charge by
calling 1-888-FDA-4KIDS.
Submit written comments on the draft guidance to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Mary M. Lyda, Office of Policy (HF-
11), Food and Drug Administration, 5600 Fishers Lane, rm. 14-101,
Rockville, MD 20857, 301-827-3360.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 28, 1996
(61 FR 44396), FDA issued a final rule to restrict the sale and
distribution of cigarettes and smokeless tobacco in order to protect
children and adolescents (21CFR part 897). The final rule covers three
general classes of nicotine-containing tobacco products: Cigarettes,
loose cigarette tobacco, and smokeless tobacco. The final rule applies
to manufacturers, distributors, retailers and importers who make,
distribute, sell, and import such products.
Since February 28, 1997, the final rule has prohibited retailers
from selling cigarettes, loose cigarette tobacco or smokeless tobacco
to persons under the age of 18, and has required retailers to verify
the age of customers under the age of 27 by checking an identification
(ID) card which contains the bearer's photograph and birth date.
The draft guidance answers questions most frequently asked by
retailers, consumers, and others concerning these requirements and the
agency's enforcement plans. To ensure that retailers are complying with
the requirements, FDA has commissioned State officials to conduct
compliance checks, during which adolescents, accompanied by State
officials, attempt to purchase cigarettes or smokeless tobacco from
retailers. The guidance
[[Page 3147]]
states that for a first violation of the age and identification
requirements, FDA will issue a letter notifying the retailer that it
was out of compliance and informing the retailer that FDA will schedule
a followup compliance check. The guidance explains that the second time
a retailer is out of compliance FDA will seek civil money penalties in
the amount of $250.00.
The new section that FDA is making available addresses questions
concerning the amount of penalties that FDA intends to seek for third
and subsequent violations of the age and photo ID provisions of the
regulation. FDA intends to seek $1,500.00 for a third violation,
$5,000.00 for a fourth violation, and $10,000.00 for a fifth violation.
The new section provides more information concerning the civil money
penalty process under which a retailer may pay the penalty or request a
hearing to contest it. Because some of the answers contained in the new
section represent FDA's current interpretation of new regulatory
requirements, the additions constitute guidance. Therefore, FDA is
publishing the new section in draft and is soliciting public comment.
FDA will review received comments and, if appropriate, revise the
document in response to comments.
The draft guidance does not create or confer any rights for or on
any person and does not operate to bind FDA or the public.
Interested persons may, on or before April 21, 1998, submit written
comments regarding this draft guidance to the Dockets Management
Branch, address above. Two copies of any comments are to be submitted,
except that individuals may submit one copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. The draft guidance and received comments may be seen in
the office above between 9 a.m. and 4 p.m., Monday through Friday.
Dated: January 12, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-1344 Filed 1-20-98; 8:45 am]
BILLING CODE 4160-01-F
