FDA sets glacial pace
No decision has been reached on the first Modified Risk Tobacco Product (MRTP) application to be presented to the US Food and Drug Administration, even though the application process is believed to have started more than five years ago.
The FDA says that it doesn’t have anything additional to share in respect of the timing of a decision.
In January 2011, Swedish Match North America (SMNA) started the formal process of making an MRTP application and, on August 27, 2014, it became the first company to complete such an application.
The application involved the submission of something of the order of 1,000 pages of evidence with about 120,000 pages of supporting documents, some of which related to studies that pre-dated the start of the application.
On July 31, 2015, at the request of the FDA, SMNA supplied additional information.
SMNA made the application because it wanted to be able to modify, for 10 products within its General snus brand, the health warnings currently applied to all smokeless products sold in the US and to advertising for those products. These warnings declare: this product can cause mouth cancer; this product can cause gum disease and tooth loss; this product is addictive; and this product is not a safe alternative to cigarettes.
The company would like to see the first two warnings dropped, the third warning about addictiveness left in place, and the fourth warning replaced with one reading: no tobacco product is safe, but this product presents substantially lower risks to health than cigarettes.
SMNA made the warning labels the target of its application because research had indicated that consumers were confused by, on the one hand, seeing dire warnings on snus packs, while, on the other, reading third party reports of studies showing that the consumption of snus was less risky by a factor of 90 percent and upwards than was the consumption of cigarettes. However, the current application calls for no suggestion on warning labels of orders of magnitude of reduced risk.
The US Congress made provision for companies to make MRTP applications to the FDA when it passed the Tobacco Control Act in 2009.