Category — FDA

Several tobacco product manufacturers and a retailer recently requested that the United States Supreme Court consider their challenge to FDA’s requirement for graphic warning labels on cigarette packages.  The tobacco companies are requesting that the Supreme Court reverse the Sixth Circuit Court of Appeals’ decision finding that the warning label requirement does not violate the First Amendment of the United States Constitution. [Read more →]

The New Jersey legislature recently introduced a bill that would ban “characterizing flavors” (except tobacco, clove or menthol) in cigars.  (The law’s ban on characterizing flavors in tobacco products currently extends only to cigarettes, thereby mimicking the federal ban.) [Read more →]

Troutman Sanders Tobacco Team Co-Leader Bryan Haynes was quoted in a recent article in Law360 regarding the D.C. Circuit Court of Appeals’ decision rejecting FDA’s graphic warning label requirements.  The article can be found here or by request at tobacco@troutmansanders.com.

For questions and/or comments, please contact Bryan Haynes, Troutman Sanders Tobacco Law Team Co-Leader, at 804.697.1420 or by email.

The US Court of Appeals for the District of Columbia today struck down the FDA graphic warning label requirement, which sets up a potential challenge before the US Supreme Court on this subject.  This result is opposite to an earlier ruling from another circuit, thus providing an opening for further appeal to the US Supreme Court. [Read more →]

Earlier this month, a federal court in the District of Columbia allowed a lawsuit, filed by Lorillard Tobacco and R.J. Reynolds and challenging the composition of FDA’s Tobacco Products Scientific Advisory Committee (TPSAC), to proceed. [Read more →]

Apparently frustrated with FDA’s delays in approving new tobacco products, Lorillard Tobacco Company has filed a citizen petition requesting that FDA exercise enforcement discretion to allow marketing of such products, so long as the manufacturer has submitted a report under Section 905(j) of the Tobacco Control Act at least 90 days before introducing the product. [Read more →]

A federal appellate court recently rejected the tobacco industry’s argument that restrictions imposed as part of a 2006 judgment should be set aside because Congress, in 2009, passed a law that imposed other restrictions on the industry and gave the Food & Drug Administration (“FDA”) the primary authority to regulate tobacco products.  [Read more →]

The US Food and Drug Administration issued a notice in the Federal Register yesterday, July 30, 2012 which seeks comments on proposed collection of Hazardous and Potentially Hazardous Constituents (“HPHCs”) in tobacco products, noting a proposal for data collection was sent to the Office of Management and Budget.   This notice gives new insights into FDA’s current thinking on testing and reporting HPHCs, and suggests strongly that FDA’s intent is to follow the testing regime described in the Draft Guidance issued March 30, 2012, particularly as to timing.  Yesterday’s notice in the Federal Register includes FDA’s current intention to exercise enforcement discretion for manufacturers who test for 20 rather than 93 constituents at this time, and adds that small tobacco manufacturers were given an additional three months, until December 22, 2012 to comply.  No Final Guidance has been issued by FDA.   

For questions and/or comments, please contact Nancyellen Keane, Troutman Sanders Intellectual Property Practice Group and Tobacco Law Team.

Last year, we reported on a bill that would exempt from FDA’s reach so-called “traditional” cigars — cigars wrapped in leaf tobacco, containing no filter and weighing at least six pounds per 1,000 count. [Read more →]

Pending before the New York legislature is a bill that would impose an outright ban on electronic cigarettes.  Opponents of  the bill note that FDA is on the verge of regulating e-cigarettes, and that a ban on the products is therefore unwarranted. [Read more →]