R.J. Reynolds apparently feels that its dissolvable tobacco products will receive automatic FDA approval under the new FDA/tobacco regulation because of their "equivalency" to the Star Scientific Ariva and Stonewall products that have been on the market for many years:
FDA regulates tobacco
So this is good news for the availability of harm-reduced products and current smokers, but it's not good news for Star. Star just lost a patent suit against RJR for what Star says was a novel and patentable way to cure tobacco for lower (very low) nitrosamine levels. These reduced nitrosamines are the key to the low risk of Star dissolvables. Star is appealing the decision, and I would think will have to win this suit to compete with RJR. I would also think that RJR would have to demonstrate that their nitrosamine levels are as low as those in the Star products to demonstrate equivalency. After the court decision, Star stock (STSI) lost about 80% of its value.
FDA regulates tobacco
So this is good news for the availability of harm-reduced products and current smokers, but it's not good news for Star. Star just lost a patent suit against RJR for what Star says was a novel and patentable way to cure tobacco for lower (very low) nitrosamine levels. These reduced nitrosamines are the key to the low risk of Star dissolvables. Star is appealing the decision, and I would think will have to win this suit to compete with RJR. I would also think that RJR would have to demonstrate that their nitrosamine levels are as low as those in the Star products to demonstrate equivalency. After the court decision, Star stock (STSI) lost about 80% of its value.