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.
FDA to Take Action on Cigars?
Posted in FDA
On March 28, 2011, Representative Henry Waxman, the architect of the Tobacco Control Act giving the FDA authority to regulate tobacco products, sent a letter to FDA Commissioner Margaret Hamburg suggesting that the FDA extend the ban on flavored cigarettes to flavored cigars that have purportedly been designed to “circumvent” the flavored cigarette prohibition.
Distributors — Have Your Suppliers Complied with the FDA’s Registration and Filing Requirements?
Posted in FDA
Since the 2009 passage of the Tobacco Control Act, the Troutman Sanders Tobacco Practice has been helping our clients comply with the many new Food & Drug Administration requirements for tobacco companies. These requirements include FDA registration and other filing requirements.
More recently, the Troutman Sanders Tobacco Practice has been working around the clock to help our clients file their “substantial equivalence” reports due on March 22nd. This requires reports to the FDA regarding products that were first sold after February 2007, or products that have changed since then.
FDA Considers Ban on Menthol Cigarettes
Posted in FDA
On March 18, the FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) suggested that the FDA consider banning menthol cigarettes. TPSAC argued that menthol makes people more likely to start smoking and less likely to quit.
Smokeshop Magazine’s February Edition of Regulation Focus
Posted in Articles and Publications, FDA
In the latest edition of Smokeshop magazine, our Tobacco Practice is featured in their Regulation Focus section titled, “FDA’s New Product Approval Process: An Innovation Chill?”