[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices ]               
[Page 41453-41787]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]


      


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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