U.S. Shortcomming fda tobacco regulations only applies to cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco ..

March 24, 2011 - The FDA's determination that Ariva-BDL(TM) and Stonewall-BDL(TM) are not tobacco products that are currently regulated under Chapter IX of the FDCA clears the way for Star to proceed with marketing these products. Star Scientific Inc said U.S. health regulators informed the company that two of its products do not come under a federal law that restricts the sale of tobacco products, clearing the way for Star to market them.

The notices from Lawrence Deyton, MD, MSPH, Director of the FDA Center for Tobacco Products (CTP), state, in part, "Not all tobacco products are currently subject to Chapter IX of the FDCA [Federal Food Drug & Cosmetic Act]. At this time, only cigarettes, cigarette tobacco, smokeless tobacco and roll-your-own tobacco are subject to Chapter IX FDCA Section 901(b). Based upon the information in your submission, [ARIVA-BDL(TM) and Stonewall-BDL(TM) are] not currently subject to Chapter IX requirements."

"It is clear from the notices we received that the Center for Tobacco Products does not believe these products are subject to regulation under FDC Act Chapter IX at this time," Star said.

References: Star Scientific Receives Notices from FDA: Ariva-BDL(TM) and Stonewall-BDL(TM) Not Subject to Regulation Under FDC Act Chapter IX, PRNewswire via COMTEX/, SOURCE Star Scientific, Inc., 3/213/2003..-

UPDATE 1-Star Scientific says 2 products outside tobacco law, shares rise, Reporting by Esha Dey in Bangalore; Editing by Gopakumar Warrier, Reuters, 3/23.2011..


Some related Star Scientific news briefs:
Star Scientifc - filed application with U.S. FDA for approval to market a moist-snuff product.;
Star Scientific, Inc. - U.S. patent office grants request to re-examine patents (2)..;
Star Scientific - developed a moist snuff tobacco product that has extremely low levels of carcinogens -- even lower than snus products..;
Star Scientific - date for oral arguments in patent infringement lawsuit set..;
Star Scientific - U.S. patent Patent and Trademark Office To Consider Reopening Patent Examination..;
Star Scientific asks FDA to certify Ariva-BDL lozenges as less harmful than traditional forms of tobacco..;
Star Scientific - Star Scientific q1 2010 financial report..;
Star Scientific - continue incurring losses on its smokeless-tobacco products..;
Star Scientific asks FDA to certify lozenge less harmful..;
Star Scientific denied new trial in patent infringement - files appeal..;
Star Scientific - NASDAQ trading symbol changed to CIGX..;
Star Scientific - new product (in 2010) to help adult smokers maintain a nicotine-free metabolism..;
Star Scientific - will use its low-nitrosamine tobacco curing process to formulate smokeless tobacco dissolvable smokeless products..
Star Scientific - q2 2009 report..;
Star Scientific - Filing patent for zero-nitrosamine tobacco curing process..;
Star Scientific - 2008 annual report/Stonewall vs other OTC NRTs..;
Star Scientific Corporate Study Stonewall Lozenge in NRT..;
Star Scientific Files Third Quarter Financial Report..;
Star Scientific wants to augment sales of their tobacco lozenges..;
Star Scientific , second quarter 2008, sales down 23.6%..;
Star Scientific Applauds Recent State Legislation - Banning Smoking in Cars with Children..

The Stonewall Lozenge..
Click on image to enlarge..
Stonewall Hard Snuff Packaging - front..



Click on image to enlarge..
Stonewall Hard Snuff Packaging - back..