On April 25, FDA announced that it will regulate smokeless electronic cigarettes (“e-cigarettes”) as tobacco products and not as drug-delivery devices, which are subject to more stringent regulation. FDA said it will propose rule changes to treat e-cigarettes the same as cigarettes and other tobacco products. While FDA regulation is coming into focus, uncertain issues involve how state and local governments will regulate e-cigarettes. It is critical that e-cigarette manufacturers and vendors gain an awareness of this rapidly changing regulatory landscape.
FDA Announces New Cigarette Health Warnings
Posted in FDA
This week, the FDA announced the nine new cigarette health warnings that, as of September 2012, must be placed on the top fifty percent of both the front and rear panels of each cigarette package. The new warnings are larger, more prominent and include images that correspond to each warning. The new warnings must also be placed in the upper portion of each cigarette advertisement, occupying at least 20 percent of the area of the advertisement.
Proposed Legislation Weakens FDA’s Ability to Regulate Cigarettes
Posted in FDA, Legislation
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
Posted in FDA
In March, FDA released Draft Guidance for the Industry advising that it will not regulate cigars, little cigars, and pipe tobacco under the Family Smoking Prevention and Tobacco Control Act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
Posted in FDA
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
Posted in FDA
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
Posted in FDA
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
Posted in FDA, Significant Cases
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
Posted in FDA
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
Posted in FDA
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.