[Federal Register Volume 60, Number 155 (Friday, August 11, 1995)]
[Notices]
[Pages 41453-41787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20052]
Federal Register / Vol. 60, No. 155 / Friday, August 11, 1995 /
Notices
[[Page 41453]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0253J]
Analysis Regarding The Food and Drug Administration's
Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco
Products
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; analysis regarding agency jurisdiction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is publishing a
document entitled ``Nicotine In Cigarettes And Smokeless Tobacco
Products Is A Drug And These Products Are Nicotine Delivery Devices
Under the Federal Food, Drug, and Cosmetic Act,'' and announcing the
availability of appendices to this document. FDA has conducted an
extensive investigation and has engaged in comprehensive analysis
regarding the agency's jurisdiction over nicotine-containing cigarettes
and smokeless tobacco products. The results of that inquiry and
analysis support a finding at this time that nicotine in cigarettes and
smokeless tobacco is a drug, and that these products are drug delivery
devices within the meaning of the Federal Food, Drug, and Cosmetic Act.
Nonetheless, because the agency recognizes the unique importance of the
jurisdictional issue as well as the factual justification for any
proposed rule in this area, the agency invites comment on these
matters. Comments submitted will receive full and serious
consideration.
DATES: Written comments by November 9, 1995.
ADDRESSES: ``Nicotine In Cigarettes And Smokeless Tobacco Products Is A
Drug And These Products Are Nicotine Delivery Devices Under the Federal
Food, Drug, and Cosmetic Act'' and its appendices may be purchased from
Superintendent of Documents, U.S. Government Printing Office (GPO),
Washington, DC 20402, 202-783-3238. ``Nicotine In Cigarettes And
Smokeless Tobacco Products Is A Drug And These Products Are Nicotine
Delivery Devices Under the Federal Food, Drug, and Cosmetic Act'' and
its appendices are available for public examination in the Dockets
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23,
12420 Parklawn Dr., Rockville, MD 20857, between 9 a.m. and 4 p.m.,
Monday through Friday.
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: The appendices referred to in the document
entitled ``Nicotine In Cigarettes And Smokeless Tobacco Products Is A
Drug And These Products Are Nicotine Delivery Devices Under the Federal
Food, Drug, and Cosmetic Act'' are available from GPO (address above).
Elsewhere in this issue of the Federal Register, the agency is
publishing a proposed regulation of nicotine-containing cigarettes and
smokeless tobacco products. The agency recognizes the unique importance
of the jurisdictional issue underlying this regulation as well as the
factual justification for any proposed rule in this area. The agency
invites comments on these matters. Comments submitted will receive full
and serious consideration.
The text of ``Nicotine In Cigarettes And Smokeless Tobacco Products
Is A Drug And These Products Are Nicotine Delivery Devices Under the
Federal Food, Drug, and Cosmetic Act'' follows:
BILLING CODE 4160-01-F
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Dated: August 8, 1995.
David A. Kessler,
Commissioner of Food and Drugs.
[FR Doc. 95-20052 Filed 8-10-95; 8:45 am]
BILLING CODE 4160-01-C