FDA Fact Sheet (1995)
Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Proposed Rules ]
[Page 41313-41375]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Part 801, et al.
Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco Products To Protect Children and Adolescents;
Proposed Rule
Analysis Regarding FDA's Jurisdiction Over Nicotine-Containing
Cigarettes and Smokeless Tobacco Products; Notice
[Page 41314]]
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
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing new
regulations governing the sale and distribution of nicotine-containing
cigarettes and smokeless tobacco products to children and adolescents
in order to address the serious public health problems caused by the
use of and addiction to these products. The proposed rule would reduce
children's and adolescents' easy access to cigarettes and smokeless
tobacco as well as significantly decrease the amount of positive
imagery that makes these products so appealing to them.
THE PROPOSED RULE:
Specifically, 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 sales of tobacco, especially verification that the
purchaser is at least 18 years of age before a tobacco sale is made.
Finally, 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 aimed at children and adolescents to counter the
pervasive imagery and reduce the appeal created by decades of pro-
tobacco messages and thus to help reduce young people's use of tobacco
products. The objective of the proposed rule is to meet the goal of the
report ``Healthy People 2000'' by reducing roughly by half children's
and adolescents' use of tobacco products. If this objective is not met
within seven years of the date of publication of the final rule, the
agency will take additional measures to help achieve the reduction in
the use of tobacco products by young people. FDA is requesting comment
regarding the type of additional measures that would be most effective.
DATES: Written comments and recommendations by November 9, 1995.
ADDRESSES: Submit written comments and recommendations 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 Chao, Office of Policy (HF-23),
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20857,
301-827-3380.