[Federal Register Volume 60, Number 199 (Monday, October 16, 1995)]
[Proposed Rules]
[Pages 53560-53561]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25670]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801, 803, 804, and 897

[Docket No. 95N-0253]


Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco Products to Protect Children and Adolescents; 
Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to January 
2, 1996, the comment period for the proposed rule that appeared in the 
Federal Register of August 11, 1995 (60 FR 41314). The document 
proposed new regulations governing the sale and distribution of 
nicotine-containing cigarettes and smokeless tobacco products in order 
to protect children and adolescents. As a result of this extension, the 
agency is providing a comment period of more than 140 days on the 
notice, and a comment period of more than 90 days from the date that 
additional documents that the agency considered were placed on display. 
This action is being taken in response to several requests for an 
extension of the comment period.

DATES: Written comments by January 2, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr., 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 11, 1995 
(60 FR 41314), FDA issued a proposed rule that would govern the sale 
and distribution of nicotine-containing cigarettes and smokeless 
tobacco products in order to protect children and adolescents. The 
proposed rule would reduce easy access to these products by children 
and adolescents and decrease the amount of imagery that makes these 
products attractive to children and adolescents. The proposed rule 
would establish 18 years of age as the Federal minimum age of purchase 
and would prohibit cigarette vending machines, free samples, mail order 
sales, and self-service displays. It would also require that retailers 
comply with certain conditions regarding tobacco sales, such as 
verifying the purchaser's age. The proposed rule would limit 
advertising and labeling to which children and adolescents are exposed 
to a text-only format; ban the sale or distribution of branded, non-
tobacco items (such as hats and tee shirts); restrict sponsorship of 
events to the corporate name only; and require manufacturers to 
establish and maintain a national public education campaign. The 
proposed rule would also require cigarette advertising to carry a brief 
statement stating, ``About one out of three kids who become smokers 
will die from their smoking;'' the agency stated that it would perform 
focus group testing to evaluate the content and format of the brief 
statement and other statements to determine whether the warnings are 
communicated effectively.
    In response to the proposed rule, the Tobacco Institute; Brown & 
Williamson Tobacco Corp.; Liggett Group, Inc.; Lorillard Tobacco Co.; 
Philip Morris, Inc.; R. J. Reynolds Tobacco Co.; the Smokeless Tobacco 
Council, Inc.; Conwood Company, L. P.; Swisher Tobacco Co.; National 
Tobacco, L. P.; Pinkerton Tobacco Co.; and the United States Tobacco 
Co. requested a 180-day extension of the comment period. These parties 
requested additional time on the grounds that some references in the 
proposed rule were not available and that the regulatory issues were 
complex and controversial. They sought a 180-day comment period 
starting on the date when all documents and other material (including 
information reviewed, but not relied upon by FDA) are available for 
public display. The parties also requested that FDA extend the comment 
period to give interested persons sufficient time to review and comment 
on the methodology and results of focus group studies and proposed 
warning statements.
    Additionally, the Cigar Association of America, Inc., requested a 
9-month extension of the comment period to permit it to review and 
analyze the proposed rule and relevant technical materials. The Food 
Marketing Institute requested a 90-day extension of the comment period 
to permit it to develop information and data to respond to the proposed 
rule.
    The agency has carefully considered the requests. The agency 
published the proposed rule on August 11, 1995. On August 16, 1995, the 
documents referred to in the proposed rule were placed in the public 
record. Thus, the proposed rule and the documents cited by the agency 
in support of the rule have been on public display since August 16, 
1995. On September 29, 1995, FDA placed additional documents that the 
agency considered on public display at the Dockets Management Branch. 
Accordingly, FDA is extending the comment period to January 2, 1996. A 
deadline of December 28, 1995, would provide a comment period of 90 
days from the date on which the agency placed additional documents that 
the agency considered on public display. Because, December 28, 1995, is 
a Thursday and January 1, 1996, is a holiday, the agency does not 
anticipate that it will be able to undertake significant work on the 
comments until January 2, 1996. Therefore, the agency is extending the 
comment period until January 2, 1996.
    FDA will also provide a 30-day period to review and comment on the 
results of any focus group studies that it conducts. The agency will 
announce the dates for comments on the focus group studies in a future 
issue of the Federal Register. Otherwise, because of the public health 
importance of this matter, the agency advises that it does not 
anticipate granting further extensions of the comment period beyond 
January 2, 1996. In order to assure consideration by the agency, 
comments are to be filed by that date.
    Interested persons may, on or before January 2, 1996, submit to the 
Dockets Management Branch (address above) written comments regarding 
the proposed rule. Four 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. Received comments may be seen in the office 

[[Page 53561]]
above between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 11, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-25670 Filed 10-12-95; 1:38 pm]
BILLING CODE 4160-01-F