Reynolds Starts ‘Modified-Risk’ Designation Through FDA

The tobacco firm submitted six styles of Camel Snus, including robust, winterchill and mint.

December 20, 2017

WASHINGTON – This week, six styles of Camel Snus entered the U.S. Food and Drug Administration’s (FDA) review process, as Reynolds American Inc. seeks to have the products listed as having a modified-risk status, the Winston-Salem Journal reports.

The applications for substantive review are for winterchill, robust, mint, mellow, frost large and frost camel snus styles. The review process could last 12 months, and began with a public comment period that opened on Monday.

If ultimately approved by the agency, Reynolds could market the snus styles as less risky for those who replace smoking with snus, a teabag-like pouch containing loose tobacco that users insert between cheek and gum. Unlike chewing tobacco, no spitting is necessary. Reynolds launched Camel Snus in 2006.

James Figlar, senior vice president for scientific and regulatory affairs with RAI Services Co., said that the agency moving the applications forward represents “an important step forward in fulfilling Reynolds’ commitment to collaborative leadership in the transformation of the tobacco industry. … We believe the science and our proposed advertising to be compelling and accurate.”

“The true test here is whether the FDA is able to follow through on its commissioner’s proclamation of the importance of moving smokers to the low-risk end of nicotine’s continuum of risk,” said David Sweanor, an adjunct law professor at the University of Ottawa who studies electronic cigarettes. “The success of product substitution with snus in Sweden, vaping in the UK, and now the dramatic success of heat-not-burn products in driving down cigarette sales in Japan could be not just replicated but accentuated in the United States.”

Other tobacco companies are also seeking approval for modified-risk products, such as British American Tobacco’s heat-not-burn glo and R.J. Reynolds Tobacco Co.’s similar product, Eclipse.

Advertisement
Advertisement
Advertisement