FDA seeks to make cig­a­rettes less ad­dic­tive

Shares of ma­jor to­bacco com­pa­nies tum­bled af­ter the an­nounce­ment

The Denver Post - - NEWS - By Jennifer Maloney

U.S. health of­fi­cials said Fri­day they are con­sid­er­ing new stan­dards that would re­quire to­bacco com­pa­nies to re­duce nico­tine in cig­a­rettes to non­ad­dic­tive lev­els, as part of a sweep­ing re­view of in­dus­try reg­u­la­tions.

Shares of ma­jor to­bacco com­pa­nies tum­bled on the move by the Food and Drug Ad­min­is­tra­tion. Marl­boro maker Al­tria Group Inc. was down more than 9% midafter­noon, while Bri­tish Amer­i­can To­bacco PLC, maker of Camel cig­a­rettes, was down 5%.

The agency said it was adopt­ing a harm-re­duc­tion strat­egy that seeks to bal­ance reg­u­la­tion of ex­ist­ing prod­ucts and en­cour­age de­vel­op­ment of “new prod­ucts that may be less dan­ger­ous.” It will ex­am­ine the role of men­thol and other fla­vors.

The FDA will con­sider an ex­emp­tion for pre­mium cigars, and al­low more time for mak­ers of re­duced-risk prod­ucts to sub­mit ap­pli­ca­tions un­der the agency’s rules, FDA Com­mis­sioner Scott Got­tlieb said. “Cig­a­rettes will likely re­main in­cred­i­bly toxic,” he said. “We may be able to reach a day when the most harm­ful prod­ucts will no longer be ca­pa­ble of ad­dict­ing our kids.”

Got­tlieb said the FDA’s new ap­proach would con­sider “a con­tin­uum of risk for nico­tine de­liv­ery,” from com­bustible prod­ucts such as cig­a­rettes to nico­tine-re­place­ment ther­a­pies such as nico­tine patches and gums. Cig­a­rette smoke, not nico­tine, is what causes can­cer, heart and lung dis­ease.

“The prob­lem is not just nico­tine, the prob­lem is the de­liv­ery mech­a­nism,” Got­tlieb said. Cig­a­rettes kill 480,000 peo­ple in the U.S. each year, ac­cord­ing to the Cen­ters for Dis­ease Con­trol and Pre­ven­tion.

E-cig­a­rettes and vap­ing de­vices for sale in Au­gust 2016 won’t be sub­ject to re­view un­til 2021 or 2022. The agency also will con­sider the po­ten­tial black mar­ket for cig­a­rettes.

Some an­ti­smok­ing ad­vo­cates and pub­lic health of­fi­cials have been urg­ing the FDA and CDC to pro­vide the pub­lic with in­for­ma­tion on the rel­a­tive risks of to­bacco prod­ucts. Un­til now, U.S. health of­fi­cials have stuck with a pub­lic ab­sti­nence-only mes­sage.

The FDA’s shift comes as the agency con­sid­ers whether to ap­prove mar­ket­ing claims for new heat-not-burn de­vices and smoke­less to­bacco. In April, Reynolds Amer­i­can, which was re­cently ac­quired by BAT, sub­mit­ted ap­pli­ca­tions for six styles of Camel Snus to­bacco pouches. Philip Mor­ris has ap­plied for a new de­vice that heats to­bacco in­stead of burn­ing it.

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