Recently, Rep. Denny Rehberg (R-Montana) proposed an amendment to the 2012 agriculture appropriations bill that would, among other things, curb FDA’s authority to regulate tobacco products by limiting the factors FDA can consider in regulating these products.
FDA Says Restrictions on Free Samples Inapplicable to Cigars and Pipe Tobacco
In March, FDA released Draft Guidance for the Industry advising that it will not regulate cigars, little cigars, and pipe tobacco under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
#3 Cig Manufacturer Sees Volume Growth
While cigarette tobacco volumes are somewhat declining across the industry, and majors are looking at or entering alternative markets such as smokeless and cigars, Lorillard has made it clear that for the time being they are going to concentrate on their core products–Newport, which has approximately 35% of the menthol market, and a non-menthol Newport, recently introduced in view of the FDA’s advisory panel’s review of the impacts of menthol cigarettes.
FDA Requests Tours of Tobacco Farms and Factories
FDA has asked tobacco companies to allow the agency to tour farms and factories that grow or process tobacco. Specifically, FDA would like to tour large and small cigarette factories, a smokeless tobacco plant, tobacco farms, a rolling-paper factory, and a tobacco warehouse.
FDA Will Regulate E-Cigarettes as Tobacco Products
On April 25, FDA announced that it will regulate smokeless electronic cigarettes as tobacco products and not as drug-delivery devices, which are subject to more stringent regulation.
E-Cigarettes Regulated as Tobacco Products
FDA announced yesterday that it will not appeal the December 2010 court decision that determined e-cigarettes will be regulated as a tobacco product rather than as a drug-delivery device.
Establishing Grandfathered Brands
Was your tobacco product commercially marketed in the United States as of February 15, 2007? If so, you will be required to provide evidence of this to FDA. You should take the time to protect and collect documents supporting grandfathered status for each brand.
FDA Allows Marketing of Modified Risk Tobacco Product
Star Scientific — manufacturer of the dissolvable tobacco products Ariva and Stonewall — has announced that it is poised to market these products as modified risk. To our knowledge, Star Scientific was the first company to submit an application to FDA to market its products as having a lower risk of heath ailments resulting from the use of tobacco.
FDA to Take Action on Cigars?
On March 28, 2011, Representative Henry Waxman, the architect of the Tobacco Control Act giving the FDA authority to regulate tobacco products, sent a letter to FDA Commissioner Margaret Hamburg suggesting that the FDA extend the ban on flavored cigarettes to flavored cigars that have purportedly been designed to “circumvent” the flavored cigarette prohibition.
General Tobacco Appeal Rejected by Arkansas Supreme Court
On March 31, 2011, the Arkansas Supreme Court rejected an appeal by General Tobacco regarding its payment obligations under the MSA.