Source: https://www.federalregister.gov/documents/2000/03/31/00-7960/regulations-restricting-the-sale-and-distribution-of-cigarettes-and-smokeless-tobacco-to-protect
Timestamp: 2018-04-21 09:01:26
Document Index: 751021124

Matched Legal Cases: ['art 897', 'ART 807', 'ART 897', 'arts 801', 'art 897', '§\u2009801', '§\u2009801', 'art 803', '§\u2009803', 'art 807', '§\u2009807', 'art 820', '§\u2009820', 'art 897']

Federal Register :: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Revocation
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents; Revocation
This rule is effective March 31, 2000.
65 FR 17135
Docket No. 95N-0253
0910-AA48
00-7960
21 CFR Part 897
PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL DISTRIBUTORS OF DEVICES
PART 897—[REMOVED]
https://www.federalregister.gov/d/00-7960 https://www.federalregister.gov/d/00-7960
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.
Anne Kirchner, Office of the Commissioner (HF-13), 5600 Fishers Lane, Rockville, MD 20857, 301-827-0585.
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.
Imports, Medical devices, Reporting and recordkeeping requirements.
Medical devices, Reporting and recordkeeping requirements. Start Printed Page 17136
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:
§ 801.126
2. Remove § 801.126.
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 § 803.19 by removing paragraphs (f) and (g).
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 § 807.65 by removing paragraph (j).
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 § 820.1 by removing paragraphs (e) and (f).
9. Remove part 897.
[FR Doc. 00-7960 Filed 3-30-00; 8:45 am]