October 22nd, 2012
CSD Staff
The agency has requested a hearing before all eight judges on the U.S. Circuit Court of Appeals for the District of Columbia
The U.S. Food and Drug Administration (FDA) is fighting back after a three judge panel with the U.S. Circuit Court of Appeals for the District of Columbia, on Aug. 24, barred the FDA’s implementation of graphic cigarette warnings, the National Association of Tobacco Outlets (NATO) reported.
October 13th, 2012
Food and Drug Law Institute
Mark Greenwold
In this issue of the Policy Forum (Volume 2, Number 18, September 26, 2012) Mark Greenwold, Senior Consultant for the Campaign for Tobacco-Free Kids, discusses the Tobacco Control Act of 2009. Specifically, he addresses the Act’s novel regulatory structure requiring that “new tobacco products” must be found to be “appropriate for the protection of the public health” before they can be marketed. Greenwold explores an exception to this requirement for tobacco products marketed after February 15, 2007 that are alleged to be “substantially equivalent” to a product sold prior to February 15, 2007. If the new product was marketed before March 23, 2011 and a substantial equivalence application was filed before that date, the new product can continue to be marketed indefinitely unless FDA denies the substantial equivalence application. Greenwold recommends that in evaluating substantial equivalence applications, FDA place the burden on manufacturers to prove that the product is substantially equivalent to an earlier product. This is the most effective way to ensure that public health is protected under the statute, Greenwold concludes.
October 10th, 2012
News Tribune
Mark Huffman of ConsumerAffairs
Ever since e-cigarettes came on the scene, offering smokers a tobacco-free alternative to smoking, health advocates have raised questions.
Earlier this month Greek researchers suggested using the device, which delivers nicotine in water vapor, could still be harming the lungs. Now, an anti-smoking group says e-cigarettes are just as obnoxious to non-smokers as real cigarettes.
Criticizes marketing
Americans for Non-Smokers Rights is slamming the marketers of e-cigarettes, claiming they are using press releases and social media to tout the benefits of their product, despite a lack of independent peer-reviewed scientific evidence demonstrating the safety or effectiveness.
