E-Cigarettes, Snus Get a Wary Reception as Alternatives to Smoking

(Bloomberg) -- Makers of smoking alternatives hit some potentially major hurdles this week in their quest to create a rival to the almighty cigarette.

While Food and Drug Administration Commissioner Scott Gottlieb views tobacco products as a progression of risks, with cigarettes being the most harmful, his agency and its outside advisers dealt possible setbacks to products that deliver nicotine without cancer-causing smoke.

The dilemma underscores the difficult balance the FDA is attempting to maintain as it weighs support for new types of cigarette alternatives. Even as the agency wants to help smokers quit, Gottlieb said he worries that e-cigarettes may be luring kids who otherwise would avoid tobacco products. Separately, FDA advisers signaled uncertainty on Friday as to whether oral tobacco pouches are less likely to cause some diseases than smoking.

“These are the hard tradeoffs that we’re grappling with,” Gottlieb said about e-cigarettes.

The FDA panel of eight outside advisers gave British American Tobacco Plc’s Camel Snus pouches mixed reviews as to whether they are less risky than smoking cigarettes, showing the struggle the health community is having in describing any tobacco product as better than another.

Camel Snus contain smokeless, finely ground tobacco with labels like Frost and Winterchill, according to Reynolds American Inc.’s website. British American acquired Reynolds American Inc., the maker of Camel products, last year. Reynolds has sought FDA permission to market Camel Snus with advertising that would indicate smokers who switch to the pouches can reduce their risk of smoking-related diseases like lung cancer and heart disease.

The advisers said that smokers who switch to Snus can significantly reduce their risk of lung cancer and respiratory disease. But they were deadlocked over whether the pouches reduce the risk of oral cancer and heart disease. As a result, the panel had a hard time agreeing on wording that might convey a reduced risk.

While the advisers did agree on including in marketing the statement “No Smoke = Less Risk,” they didn’t back a proposal from Reynolds to specifically say Snus can significantly reduce health risks from smoking. They also were stuck on whether Camel Snus contain less harmful chemicals than cigarettes.

“I do think the details matter in terms of how it’s perceived,” said Deborah Ossip, a panel member and director of the Smoking Research Program at the University of Rochester Medical Center in New York. “I also would like to see less risk in more of a context because it’s not less risk for everything; it’s less risk in a certain context.”

Camel Snus do have lower levels of some potentially harmful ingredients, though they contain higher amounts of arsenic, cadmium and nicotine, according to FDA staff.

British American and Reynolds have invested $2.5 billion since 2012 to develop potential reduced-risk products, according to the company’s 2017 annual report.

FDA Threat

On Wednesday, the FDA threatened to prohibit sales of flavored e-cigarettes if tobacco companies such as Altria Group Inc., British American and relative newcomer Juul Labs Inc. don’t figure out how to stem what he called an epidemic of vaping by minors.

While shares of tobacco companies suffered last year when Gottlieb announced he may require lower nicotine levels, those same companies got a boost from the commissioner’s announcement on e-cigarette sales. Former smokers who vape may return to traditional cigarettes if the electronic versions aren’t available.

“This may create some obstacles for some adults who also enjoy e-cigs,” Gottlieb said. “But the youth risk is paramount. It’s now clear to me, that in closing the on-ramp to kids, we’re going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs.”

The FDA had attempted to ease regulations on the e-cigarette industry last year as a way to encourage development of more products that could help adults quit smoking. But critics said regulators didn’t do enough to prevent kids from using products like Juul, a pocket-sized device that resembles a USB drive and is popular with students.

Gottlieb said unpublished data the agency will release soon shows a “substantial increase” in youth vaping in the last year and that this made him change course.

The FDA hasn’t yet given any company the ability to market a cigarette alternative as less risky than smoking. The agency denied a request in 2016 from Swedish Match AB to ease warnings on its oral pouches. Philip Morris International Inc. is awaiting an FDA determination on whether the company can claim that its iQos tobacco-heating device cuts the risk of smoking-related diseases.

Advisers voted against Swedish Match and Philip Morris in previous meetings. The iQos device heats tobacco to a lower temperature than lighting a cigarette. The FDA takes into account votes by advisory panels when weighing whether to grant companies’ requests to market tobacco products as less risky but isn’t required to follow their advice.

©2018 Bloomberg L.P.