In an August 27, 2012 letter to FDA Commissioner Margaret Hamburg, Representative Henry Waxman (the architect of the Tobacco Control Act giving FDA regulatory authority over tobacco products) again urged FDA to assert jurisdiction over cigars and pipe tobacco. Representative Waxman complained that the 2009 increase on federal excise taxes for tobacco products resulted in many manufacturers relabeling and/or reconfiguring their products from little cigars to large cigars, and from roll-your-own cigarette tobacco to pipe tobacco.
Troutman Sanders Tobacco Practice Quoted on Cigarette Warning Label Decision
Troutman Sanders Tobacco practice partner 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,
Appeals Court Ruling on Cigarette Graphic Warnings Sets Up Potential Challenge before US Supreme Court
Posted in FDA, Significant Cases
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.
Federal Court Allows TPSAC Challenge to Proceed
Posted in FDA, Significant Cases
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.
Takeaways From the IPCPR Trade Show
Posted in Conferences and Events, FDA
We enjoyed seeing many friends and meeting new ones at the IPCPR trade show in Orlando.
Lorillard Pursues FDA Citizen Petition to Obtain Approval of New Tobacco Products
Posted in FDA
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.
Big Tobacco Loses Appeal in Racketeering Case
Posted in FDA, Significant Cases
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.
FDA Notice Language Supports HPHCs Draft Guidance
Posted in FDA
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.
Bill Exempting Cigars From FDA’s Reach Gains Opposition
Posted in FDA, Legislation
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.
New York Legislature Considers E-Cigarette Ban
Posted in FDA, Legislation
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.