FDA approves marketing of 8 smokeless tobacco products in US

Using General Snus instead of tobacco cigarettes can cut risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis, claims Swedish Match 

By DTE Staff
Published: Wednesday 23 October 2019

In a first, the United States Food and Drug Administration (FDA) has authorised the marketing of a brand of smokeless tobacco as “reduced risk” to the harmful cigarettes in the country.

Swedish Match was, on October 22, 2019, granted permission to sell and advertise eight of its snus smokeless tobacco products, under the brand name ‘General’. The approval is based on scientific evidence of reduced risk submitted by the company.

“Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis,” claimed the company.

However, this does not mean these products are safe or FDA approved, the regulator said, adding that all tobacco products are potentially harmful and addictive. But, General Snus lowers the risk relative to cigarette smoking.

While the modified risk has a five-year time limit, the product will be continually monitored by the FDA. The regulator has also placed stringent advertising and promotion restrictions on the sale of the products. It has asked Swedish Match to carry mandatory warning statements — that smokeless tobacco products can cause mouth cancer, gum disease and tooth loss — on the products’ packaging and advertisements.

“Our team of scientific experts examined these applications to ensure that the tobacco products meet the public health standards in the law,” said acting FDA Commissioner Ned Sharpless, in a statement.

“While we are authorising these specific modified risk tobacco products, it’s important for the public to understand that all tobacco products — including these — pose risk. Anyone who does not currently use tobacco products, especially youth, should refrain from doing so,” Sharpless added.

The FDA had, in 2015, authorised the products for sale in the US without the modified risk claims, after Swedish Match filed premarket tobacco applications (PMTAs).

Snus is a moist powdered smokeless tobacco product, which comes in a small tea-bag like pouches. It is inhaled by placing it under the upper lip. It is not fermented, but contains nicotine. The byproduct is swallowed and not spit out like chewing tobacco.

Various studies have claimed that use of snus limits the use of cigarettes. Sweden is believed to have had the lowest lung and oral cancer rates in men in Europe, due to the extensive use of snus, while it decreased smoking rates among young women in Norway.

Meanwhile, health advocacy groups has expressed dissatisfaction at the approval.

The American Lung Association, along with other organizations including the American Academy of Pediatrics, the American Heart Association and the Campaign for Tobacco-Free Kids had, in May, written to the FDA arguing insufficient evidence on reduced risk of General snus.

“The Lung Association is disappointed with FDA's announcement today,” Erika Sward, assistant vice president of national advocacy at the American Lung Association, was quoted as saying by CNN.

“The FDA seems to fundamentally not understand that their consumer and top priority is the public health — not the tobacco industry,” Sward added.

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