[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Draft Guidance; Availability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availability of a new section to the draft guidance entitled 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The draft guidance addresses the questions most frequently asked by 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DATES: Submit written comments on the draft guidance by April 21, 1998.
ADDRESSES: The draft guidance entitled ``Frequently Asked Questions 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    Submit written comments on the draft guidance to the Dockets 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