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FDA committee recommends moving forward with Camel Snus review

FDA committee recommends moving forward with Camel Snus review


R.J. Reynolds Tobacco Co.’s bid to market Camel Snus as a modified-risk tobacco product took a significant step forward Friday.

A scientific advisory committee of the Food and Drug Administration approved advancing the applications for six Camel Snus styles to the agency. The styles are Frost, Frost Large, Mellow, Mint, Robust and Winterchill.

Snus, which became popular first in Sweden, are teabag-like pouches of loose tobacco that users stick between their cheek and gum, but that don’t require spitting. They are marketed in part for use in places where smoking is prohibited.

Reynolds submitted its applications in April 2017, which included more than 450,000 pages of data and extensive scientific research. The committee began its review in December and held a two-day public presentation that concluded Friday.

If any application is approved by the FDA, Reynolds would be able to market the snus styles as posing less risk for smokers who stop smoking and use the products in place of cigarettes.

In a separate modified risk development, the FDA accepted Friday for substantive scientific review a modified-risk application from U.S. Smokeless Tobacco Co., an Altria Group Inc. subsidiary, for the Copenhagen moist snuff style known as fine cut.

The committee’s Camel Snus recommendation comes two days after FDA Commissioner Dr. Scott Gottlieb announced a potentially game-changing campaign to limit the use of electronic cigarettes by youths.

At the forefront: The FDA said it would consider banning the sale of flavored e-cigs if the manufacturers can’t prove they are doing enough to limit youth consumption of the products.

The brands cited are: top-selling Juul; Vuse, made by R.J. Reynolds Vapor Co.; MarkTen XL, made by Altria Group Inc. subsidiary NuMark LLC; blu Cigs, made by Imperial Brands Plc subsidiary Fontem Ventures; and Logic.

Camel Snus has been the dominant snus product in the U.S. since its 2006 debut.

The FDA said in a statement the committee’s role is providing “independent, expert advice to the agency on a range of complex scientific, technical and policy issues.”

“This includes questions related to the development and evaluation of products regulated by the FDA.

“There are a valuable resource and make an important contribution to the agency’s decision-making process … the FDA makes the final decisions.”

Reynolds said in a statement the committee “recognized that the available science supports that switching completely from cigarettes to Camel Snus can significantly reduce smokers’ risk of lung cancer and respiratory disease.”

The manufacturer cautioned that the committee “was evenly divided on claims regarding oral cancer and heart disease.”

“The (committee) also recognized that switching to snus means less risk for smokers of cigarettes, and that no smoke equals less risk.”

A key element in the process was Reynolds submitting, and the committee reviewing, proposed marketing and advertising materials. The committee offered recommendations to the company and the FDA on those materials.

“We appreciate the committee’s thoughtful and robust discussion of the specific language that should appear in modified-risk advertising for Camel Snus and are pleased it agrees with some of our proposed messages,” said James Figlar, executive vice president of research and development for Reynolds.

“The committee’s insight should be of great value to the FDA, and we look forward to working with the FDA as it evaluates our applications.”

Figlar said the FDA approving of the Camel Snus styles as modified-risk tobacco products “would be a scientifically sound step toward reducing the harm caused by cigarettes and is consistent with the FDA’s vision to put in place a comprehensive regulatory framework based on tobacco harm reduction.”

Gottlieb called in July 2017 for a sweeping regulatory “road map” on tobacco and nicotine products.

That included easing some regulations for product innovations, and extending the application deadline for FDA regulatory review for new products, such as e-cigs and vaporizers, from late 2018 to as far out as August 2022. Gottlieb said Wednesday the FDA is reconsidering shifting the August 2022 deadline to a shorter timeframe.

Scott Ballin, past chairman of the anti-smoking alliance Coalition of Science or Health, spoke before the committee in support of the modified-risk recommendation.

“I gave a forceful statement that 30 million addicted smokers deserved to have alternative products available to them, and that there needed to be improved truthful labeling and marketing,” Ballin said Friday.

“We have waited far too long, and 480,000 premature deaths from cigarette smoking is not acceptable.”

Although Ballin acknowledged the advisory role of the committee, he said “I would expect that the FDA Center for Tobacco Products would have a tough time not being able to accept that harm reduction is hopefully here to stay.”

Which group carries the more persuasive recommendation, the committee or an FDA staff report, could be the deciding factor on Camel Snus, said David Sweanor, an adjunct law professor at the University of Ottawa and the author of several electronic-cigarette studies.

Sweanor said Friday he is concerned the FDA staff has been overly negative to the Camel Snus application considering it said Reynolds’ submitted clinical studies “did not demonstrate” that smokers reduced their overall risk of lung and oral cancer, respiratory diseases and heart disease by switching products.

“Given the overwhelming evidence that cigarette smoking is not just more hazardous than snus, but massively so, such (an FDA staff) conclusion … protects cigarettes, keeps consumers misinformed and undermines Gottlieb’s commitment to moving smokers down the continuum risk,” Sweanor said.

“The mental calisthenics necessary to reach such conclusions furthers the overall assault on truth and attack on reason presently seen in the U.S.” 336-727-7376 @rcraverWSJ

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