White Smoke Review
Perhaps one of the most controversial gadgets today is the electronic cigarette. These electronic cigarettes, or also more commonly referred to as e-cigarettes or e-cigs, are considered to be by some as the best alternative to smoking.
The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.
CSPnet.com
In the Jan. 8, 2013, Tobacco E-News bulletin, NATO reported that the Food and Drug Administration had released its annual Regulatory Agenda, which states that the agency intends to issue a proposed rule to regulate other tobacco products sometime by April of 2013. While the FDA stated its intention to release proposed regulations on other tobacco products by April of this year, there are various steps that a federal agency needs to follow in drafting, proposing, obtaining public feedback and finalizing a new regulation.
NPR
It’s been only a few years since Congress granted the federal government the power to approve how tobacco products are made and sold in the U.S.
The Food and Drug Administration’s new Center for Tobacco Products, established under a 2009 law that gives the agency jurisdiction over tobacco, must review all new cigarettes or smokeless tobacco, as well as any changes to existing brands.
But the agency has yet to clear any products under the new system, and some cigarette makers are frustrated by the backlog of applications.
U.S. District Court Judge Richard Leon has allowed a lawsuit seeking an injunction by R.J. Reynolds and Lorillard Tobacco to proceed against the Tobacco Products Scientific Advisory Committee. It alleges a conflict of interest on the scientific panel responsible for regulating tobacco products.
FDA officials asked Judge Leon to deny the request but the judge rebuffed their claim, noting in his ruling “the limited number of viewpoints on these issues” and “the scientific as opposed to the political nature of those viewpoints, and the distinct responsibilities of the committee.”