New Tobacco Review Process Could Require Clinical Trial Data For Products

Posted: January 6, 2011

A new tobacco approval process that mimics device 510(k) clearance procedures could also require that industry supply clinical trial data and other information as the agency implements a mandate from the 2009 law that brought tobacco regulation under FDA’s purview. The equivalence review process, issued Wednesday, will likely lead to new data requirements for an industry that is not accustomed to FDA’s regulatory environment, especially because the agency is still learning about the products, an industry attorney said.

Menthol’s Future Is Looking Brighter

A new  FDA rule will force tobacco companies to disclose any changes they’ve made to their wicked products in the last four years. Hassle! Interference! Big government out of flavor country! But there is some great news for Newport smokers.

Yesterday we told you about the FDA panel that will soon recommend whether or not to ban menthol cigarettes altogether. Well, yesterday Dr. Gregory Connolly, the “dominant antitobacco voice” on the panel, resigned in disgust. Says the NYT:

Contraband cigarettes seized, official says

By OMER GILLHAM World Staff Writer
Published: 12/15/2010  2:30 AM
Last Modified: 12/15/2010  4:22 AM

BIXBY – State troopers stopped a tribal truck in Bixby on Tuesday, seizing more than $150,000 in contraband cigarettes, an official said.

The Oklahoma Highway Patrol pulled over a delivery van believed to be owned by the Muscogee (Creek) Nation, said Paula Ross, spokeswoman for the Oklahoma Tax Commission.

Ross said the van was carrying cigarettes without an Oklahoma state tax stamp.

“The cigarettes are deemed contraband because they are not part of the MSA (approved) list of cigarettes for sale in Oklahoma,” Ross said.

Menthol cigarettes may be harder to quit

BY RANDY W. FULK AND BARRY JENKINS

 Stakeholder is a word used to describe a person or group that can affect – or be affected by – another organization. Any way you look at it, workers in the tobacco industry are surely among the stakeholders in the U.S. tobacco industry. That’s why it was perplexing when the Food and Drug Administration excluded tobacco workers from a stakeholder meeting earlier this week in Raleigh.

The issue is vitally important because the FDA is now at work to implement the powerful new federal tobacco law. As part of that effort, the FDA created a scientific advisory committee to consider banning menthol cigarettes, which comprise one-third of the cigarettes sold today in the United States.

Happy Birthday Wishes to the Data Quality Act

December 21, 2010 marks the tenth anniversary of the Data Quality Act (DQA), also known as the Information Quality Act, 44 U.S.C § 3516, note.

The DQA has deep roots developed over nearly a half-century as the result of a seed planted during the Johnson Administration which germinated in the Nixon Administration, was watered by the Carter Administration and whose product was harvested by the Reagan Administration, made available to the public in the Bush I Administration and subsequently enhanced by the Clinton Administration and promoted by the Bush II and Obama Administrations. See: http://thecre.com/ombpapers/SystemsAnalysisGroup.htm and http://thecre.com/quality/20010924_fedinfotriangle.html