FDA Grants First-Ever Modified Risk Orders to Tobacco Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) approved Swedish Match's bid to market its General Snus smokeless tobacco products as less harmful.

On Oct. 22, the agency announced it authorized Swedish Match U.S. Division's amended Modified Risk Tobacco Product applications (MRTP) for eight varieties of General Snus.

The FDA's decision makes General Snus the first tobacco product to secure the modified risk designation and right to market the product as a less harmful alternative to cigarettes.

"Today's decision is a huge accomplishment for public health in the U.S. and another step toward realizing our vision of a world without cigarettes," said Gerry Roerty, vice president and general counsel, Swedish Match U.S. Division. 

The modified risk status classifies General Snus as a tobacco product that is sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products, according to the company.

The FDA also cleared Swedish Match's claim that using General Snus instead of cigarettes puts users at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis, it added.

Swedish Match was also the first to receive FDA approval for its Premarket Tobacco Application for General Snus in November 2015.

According to the FDA, the agency authorized Swedish Match's MRTP after reviewing scientific evidence submitted by the company. In an effort to help prevent youth access and exposure, the agency also placed advertising and promotion restrictions on the products, including a requirement to restrict advertising to adults.

In addition, the products' packaging and advertising must also include the warning statements required for all smokeless tobacco products.

While the decision permits the eight General brand snus smokeless tobacco products to be sold in the U.S. with a modified risk claim, it does not mean these products are safe or "FDA approved," the agency added.

The modified risk orders are product-specific and limited to five years.

"Today's action demonstrates the viability of the pathway for companies to market specific tobacco products as less harmful to consumers, but only following a thorough scientific evaluation by the FDA," said Acting FDA Commissioner Ned Sharpless. "Our team of scientific experts examined these applications to ensure that the tobacco products meet the public health standards in the law. While we are authorizing 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."

"In addition to stringent restrictions to limit youth access and exposure to advertising, this time-limited authorization comes with a number of postmarket requirements that will allow us to keep a close watch on the marketplace," he added. "Should any information lead us to determine that the marketing of these products as posing less risk no longer benefits the health of the population as a whole, the agency would consider withdrawing this authorization."

An Analyst's Take

The FDA's authorization "a huge positive," according to Bonnie Herzog, managing director of tobacco, beverage and convenience store research at Wells Fargo Securities LLC.

"We view this as very good news for the broader tobacco/nicotine industry as it demonstrates the FDA's commitment to a 'continuum of risk' strategy and provides a viable pathway/process for manufacturers," she explained.

The move also increases Wells Fargo Securities' confidence that IQOS, Philip Morris International's heat-not-burn tobacco product, will also receive MRTP authorization. Altria Group Inc. is commercializing IQOS in the United States.

"The ability to make a modified risk claim in tobacco/nicotine is a real game changer, in our view, not just from a consumer perception point of view, but also in terms of potential tax favorability down the line since it's logical that a tobacco product that is less harmful to public health should be taxed less onerously than a higher-risk product," Herzog said.