January 2011
 |
AMENDMENTS TO GENERAL REGULATIONS OF FOOD AND DRUG ADMINISTRATION RELATED TO TOBACCO PRODUCTS
Source: Federal Register /Vol. 75, No. 229
On November 30, 2010, the Food and Drug Administration (FDA) published a final rule in the Federal Register to amend certain of its general regulations, for example labeling and penalty provisions, to include tobacco products, where appropriate, in light of FDA’s authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. This final rule is effective April 14, 2011.
Read the Federal Register Notice
On this same date, the FDA published a companion proposed rule to establish a procedure to finalize this rule in the event they receive significant adverse comment and withdraw this direct final rule. Comments are due by February 14, 2011.
Read the Federal Register Notice
PRELIMINARY INJUNCTION GRANTED REGARDING CIGARETTE-MAKING MACHINES
On Monday, November 15, 2010, the United States District Court for the Northern District of Ohio temporarily enjoined the Department of the Treasury, the Alcohol and Tobacco Tax and Trade Bureau (TTB) and "their agents, servants, employees, successors, representatives and assigns, and all others in active concert and privity with them who receive actual notice" from enforcing the provisions of Chapter 52 of the Internal Revenue Code dealing with manufacturers of tobacco products against retailers who maintain commercial cigarette-making machines on their premises for use by consumers to facilitate the manufacturing of cigarettes, as interpreted in TTB Ruling 2010-04. On December 14, 2010, the temporary restraining order was replaced with a preliminary injunction ordering that pending final resolution of this matter, the U.S. Treasury Department, TTB, and their agents, servants, employees, successors, representatives and assigns, and all others in active concert and privity with them who receive actual notice of the Injunctive Order by personal service or otherwise are immediately restrained from enforcing the TTB Ruling and all requirements set forth therein.
As a result of this preliminary injunction, TTB is not taking enforcement action at this time under the Internal Revenue Code of 1986 (IRC), relative to the TTB Ruling and all requirements set forth therein. TTB has alerted all Bureau employees of the preliminary injunction that, at this time, TTB is enjoined from enforcing the TTB Ruling or authorizing others to enforce the TTB Ruling. Please note that the preliminary injunction does not rescind the TTB Ruling, but enjoins TTB from enforcing it. Accordingly, the preliminary injunction does not waive any valid tax liability or other IRC obligations that may arise during the pendency of this litigation and which would be resolved at such time as TTB is no longer subject to a court-ordered restraint or completion of the litigation.
To download a PDF file, you must have Adobe Acrobat Reader software installed
on your system. To download a free copy of Adobe Reader, click here.