Troutman Pepper Locke Tobacco Practice

Was your tobacco product commercially marketed in the United States as of February 15, 2007? If so, you will be required to provide evidence of this to FDA. You should take the time to protect and collect documents supporting grandfathered status for each brand.

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.

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.

A bill is currently pending before the Nebraska legislature that would impose significant new requirements for nonparticipating manufacturers to the MSA and relating to tribal sales.  Legislative Bill 590, which was introduced on January 19, 2011 and reported from the legislature’s revenue committee (as amended) on April 7, 2011, also would impose stringent new requirements regarding the taxation and sale of tobacco products.  The bill appears to be spearheaded by the Nebraska Attorney General, who is co-chair of the National Association of Attorneys General Tobacco Committee.

With respect to nonparticipating manufacturers, the Nebraska bill: