FDA Panel Comes Out Against Swedish Match's Modified-Risk Bid

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FDA Panel Comes Out Against Swedish Match's Modified-Risk Bid


SILVER SPRING, Md. — A federal panel voted down a move by Swedish Match to classify its General snus products as less harmful than cigarettes. 

The Food and Drug Administration's (FDA) Tobacco Products Scientific Advisory Committee (TPSAC) said on Friday that Swedish Match should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes.

In June, Swedish Match submitted a Modified Risk Tobacco Product (MRTP) application to the FDA for eight sub-brands in its General snus product line. The company also proposed a new warning emphasizing that snus is less risky than smoking: "No tobacco product is safe, but this product presents substantially lower risks to health than cigarettes," as CSNews Online previously reported.

The eight-member TPSAC committee voted unanimously that the company's application does not show that snus lack the same risks of gum diseases and tooth loss as other smokeless tobacco products, according to The Associated Press.

As for a new warning label, panelists said the company's language oversimplifies the issue, since some snus users also smoke, exposing themselves to negative health effects from both products. Panelists voted unanimously that the company's language does not adequately describe the health risks of snus, including pregnancy complications such as early delivery and stillbirth.

"I did not think the warning was clear, it did not adequately convey the health risks that are relevant," said Dr. Philip Huang, committee chair and an official with the health department of Travis County, Texas.

A day earlier Swedish Match representatives presented findings suggesting that Swedish uptake of snus has helped reduce diseases linked to cigarettes there. But panelists pointed to key differences between the U.S. and Sweden, including Sweden's ban on tobacco advertising and a population that is less diverse racially, economically and culturally than the United States, the AP reported.

The FDA is not required to follow the advice of the panel. The tobacco panel held a two-day meeting to discuss the application on April 9 and 10.