U.S. FDA could start regulating cigars as soon as June 2011..







December 27, 2010 - (abstract on proposed rule below)

WASHINGTON -- A brief posting in the December 20, 2010, issue of the Federal Register, the Department of Health and Human Services suggests cigars could come under regulation by the Food and Drug Administration as soon as June 2011.

The Federal Register published the agency's semi-annual "Regulatory Agenda," which provides a forecast of numerous rulemaking actions under development that the agency expects to undertake in the foreseeable future. The FDA is a part of the Department of Health and Human Services.

In the published notice, Sequence Number 325 lists a proposed rule titled "Cigars Subject to the Family Smoking Prevention and Tobacco Control Act," according to a recent newsletter from the National Association of Tobacco Outlets. This act is the law that granted the FDA the authority to regulate tobacco products.

The notice includes the abstract on this proposed rule, which states that "[t]his proposed rule would deem cigars to be subject to the Tobacco Control Act and include provisions to address public health concerns raised by cigars."

To date, cigars have remained separate from the act, although many in the industry assumed they would eventually fall under the FDA’s regulation. In the notice, a possible action timetable for a proposed rule on cigars is June 2011.

Federal Register /Vol. 75, No. 243 /Monday, December 20, 2010 /Unified Agenda 79765
HHS - Food and Drug Administration—Proposed Rule Stage
325 Cigars Subject to the Family Smoking Prevention and Tobacco Control Act .............................................................. 0910–AG38


325. CIGARS SUBJECT TO THE
FAMILY SMOKING PREVENTION AND
TOBACCO CONTROL ACT
Legal Authority: 21 USC 301 et seq,
The Federal Food, Drug, and Cosmetic
Act; PL 111–31, The Family Smoking
Prevention and Tobacco Control Act
Abstract: The Family Smoking
Prevention and Tobacco Control Act
(the Tobacco Control Act) provides
FDA authority to regulate cigarettes,
cigarette tobacco, roll-your-own
tobacco, and smokeless tobacco.
Section 901 of the Federal Food, Drug,
and Cosmetic Act, as amended by the
Tobacco Control Act, permits FDA to
issue regulations deeming other tobacco
products to be subject to the Tobacco
Control Act. This proposed rule would
deem cigars to be subject to the
Tobacco Control Act and include
provisions to address public health
concerns raised by cigars.
Timetable:
Action Date FR Cite
NPRM 06/00/11
Regulatory Flexibility Analysis
Required: Yes
Agency Contact: May Nelson,
Regulatory Counsel, Department of
Health and Human Services, Food and
Drug Administration, 9200 Corporate
Boulevard, Rockville, MD 20850
Phone: 877 287–1373
Fax: 240 276–3904
Email: may.nelson@fda.hhs.gov
RIN: 0910–AG38"Agenda" suggests agency could take on additional tobacco category as soon as June, CSP (Convenience Store / Petroleum) Daily News, 12/27/2010.
Reference: Cigars Next for FDA Regulation, CSP (Convenience Store / Petroleum) Daily News, 12/27/2010.

1 comments:

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