[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Rules and Regulations]
[Pages 17135-17136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7960]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 801, 803, 807, 820, and 897

[Docket No. 95N-0253]
RIN 0910-AA48


Regulations Restricting the Sale and Distribution of Cigarettes 
and Smokeless Tobacco to Protect Children and Adolescents; Revocation

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is revoking its 
regulations governing access to and promotion of nicotine-containing 
cigarettes and smokeless tobacco to children and adolescents. This 
action is being taken in response to the Supreme Court decision of 
March 21, 2000 in which the court held that Congress has not given FDA 
the authority to regulate tobacco products as customarily marketed. 
This action will result in the removal of the regulations.

DATES: This rule is effective March 31, 2000.

FOR FURTHER INFORMATION CONTACT: Anne Kirchner, Office of the 
Commissioner (HF-13), 5600 Fishers Lane, Rockville, MD 20857, 301-827-
0585.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 11, 1995 (60 FR 41314), We (FDA) 
issued proposed regulations to restrict the sale and distribution of 
cigarettes and smokeless tobacco to children and adolescents. In 
addition, we issued a jurisdictional determination that cigarettes and 
smokeless tobacco products are combination products consisting of a 
drug (nicotine) and device components intended to deliver nicotine to 
the body. We issued final regulations based on this proposal in the 
Federal Register of August 28, 1996 (61 FR 44398).
    On March 21, 2000, in Food and Drug Administration vs. Brown & 
Williamson Tobacco Corp., et al., the Supreme Court ruled that Congress 
has not granted FDA jurisdiction to regulate tobacco products as 
customarily marketed. In accordance with this ruling, we are hereby 
removing our regulations restricting the sale and distribution of 
cigarettes and smokeless tobacco to children and adolescents. 
Publication of this document constitutes final action under the 
Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)). We are also 
addressing the additional steps necessitated by the courts ruling, such 
as termination of state contracts to help enforce the age and photo 
identification requirements of the regulations.

List of Subjects

21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping 
requirements.

21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices, 
Reporting and recordkeeping requirements.

21 CFR Part 820

    Medical devices, Reporting and recordkeeping requirements.

[[Page 17136]]

21 CFR Part 897

    Advertising, Cigarettes, Labeling, Sale and distribution, Smokeless 
tobacco.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
801, 803, 807, and 820 are amended and part 897 is removed as follows:

PART 801--LABELING

    1. The authority citation for 21 CFR part 801 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.


Sec. 801.126  [Removed]

    2. Remove Sec. 801.126.

PART 803--MEDICAL DEVICE REPORTING

    3. The authority citation for 21 CFR part 803 continues to read as 
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
    4. Amend Sec. 803.19 by removing paragraphs (f) and (g).

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR 
MANUFACTURERS AND INITIAL DISTRIBUTORS OF DEVICES

    5. The authority citation for 21 CFR part 807 continues to read as 
follows:

    Authority: 21 U.S.C. 331, 351, 352, 360, 360e, 360c, 360i, 360j, 
371, 374.

    6. Amend Sec. 807.65 by removing paragraph (j).

PART 820--QUALITY SYSTEM REGULATION

    7. The authority citation for 21 CFR part 820 continues to read as 
follows:

    Authority: 351, 352, 360, 360c, 360e, 360h, 360i, 360j, 360l, 
371, 374, 381, 383.

    8. Amend Sec. 820.1 by removing paragraphs (e) and (f).

PART 897--[REMOVED]

    9. Remove part 897.

    Dated: March 28, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-7960 Filed 3-30-00; 8:45 am]
BILLING CODE 4160-01-F