Star Scientific wants FDA approval to market its dissolvable lozenges as ‘modified risk’ items

Company asks FDA to say new items cut tobacco risk

RICHMOND, Va. — Star Scientific Inc., which sells tobacco products that dissolve in the consumer’s mouth, is asking the Food and Drug Administration to certify them as less harmful than other forms of tobacco.

Star Scientific said Monday it asked the FDA Friday to approve its wintergreen-flavored dissolvable tobacco lozenges called Ariva-BDL as a “modified risk” product under the 2009 law that gave the FDA authority over tobacco.

The Glen Allen, Va., company said the lozenges contain “below detectable levels” of certain cancer-causing chemicals found in tobacco and its smoke. The letters BDL in the product’s name refer to the regulatory term.

The tablets contain tobacco’s most addictive component, nicotine.

Star Scientific has sold varieties of smokeless dissolvable tobacco products since 2001 under the Ariva and Stonewall brands. It said the product would be marketed to adult smokers as “a useful alternative — with greatly reduced toxin levels.”

Tobacco companies are focusing on cigars, snuff, chewing tobacco and other cigarette alternatives for growth as demand for cigarettes continue to decline.

The FDA this month asked Star Scientific and Reynolds American Inc. to produce research and marketing information about dissolvable tobacco products, saying they could be particularly appealing to kids and young adults.

The FDA’s Center for Tobacco Products has not yet solidified its guidelines for the application and approval process for “modified risk” products. Draft guidelines suggest the FDA could take nearly a year to review an application.