Star Scientific filed an application with the FDA for approval to market Ariva-BDL as a "modified risk" tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009.

Star Scientific, based in Glen Allen, Virginia, said it is the first company to apply for special approval from the Food & Drug Administration (FDA) to certify its tobacco product Ariva-BDL – a wintergreen-flavoured, dissolving tobacco lozenge – as a safer alternative to traditional tobacco products.
The "modified risk" classification certifies that a product is less harmful than traditional tobacco products. In order to make such a claim, the company must not only prove that its product will reduce tobacco-related harm for individuals, but also that it will benefit the overall health of the U.S. population. However, the FDA's recently set up 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.
Star Scientific, which calls itself "a technology company with a focus on reducing tobacco-related harm" says its Ariva lozenges is a much safer alternative to traditional smokeless tobacco products as toxin levels would be 1/1000th as great as moist snuff tobacco products. "Ariva-BDL is made with flue-cured tobacco that contains levels of tobacco-specific nitrosamines that are below detectable limits ("BDL") by most current standards of measure," stated the company in a press release. "Achieving this reduction, known within Star as "ZNT" or "zero-nitrosamine tobacco", was accomplished by new work on the StarCured(R) tobacco curing technology that originally was developed in the 1990s." (pi)