FDA gives re­prieve to e-cig­a­rette mak­ers

Miami Herald - - FRONT PAGE -

Elec­tronic-cig­a­rette mak­ers won a ma­jor re­prieve last week when the Food and Drug Ad­min­is­tra­tion de­layed reg­u­la­tions that could have re­moved many of their prod­ucts from the mar­ket and opened the door to en­dors­ing e-cig­a­rettes as a means to get smok­ers to quit.

The FDA com­mis­sioner, Dr. Scott Got­tlieb, an­nounced the de­lay as part of a broad plan to re­duce to­bacco deaths in the United States, which now num­ber about 480,000 a year. That strat­egy will in­clude steps to push mak­ers of to­bacco cig­a­rettes to re­duce the lev­els of nico­tine in their prod­ucts to make them less ad­dic­tive, he said. Fed­eral law gives the agency the au­thor­ity to re­quire lower lev­els of nico­tine in to­bacco prod­ucts, FDA of­fi­cials said, and the an­nounce­ment was a step to­ward that.

Got­tlieb, in a con­fer­ence call with re­porters, said the FDA would en­cour­age eci­garette com­pa­nies to talk to the agency about gain­ing ap­proval of their prod­ucts as smok­ing ces­sa­tion aids if that is their in­tent.

In a later in­ter­view with The New York Times, Got­tlieb sounded no­tably more open to e-cig­a­rettes than many other fed­eral pub­lic health of­fi­cials, who have op­posed the de­vices as a gate­way to nico­tine ad­dic­tion and even­tu­ally to the smok­ing of to­bacco cig­a­rettes. Although Got­tlieb said he was con­cerned about chil­dren’s use of e-cig­a­rettes and would con­sider reg­u­lat­ing fla­vors de­signed to ap­peal to them, he also noted the po­ten­tial ben­e­fits to ad­dicted cig­a­rette smok­ers of prod­ucts ca­pa­ble of de­liv­er­ing nico­tine with­out hav­ing to burn to­bacco.

“We do think there’s a po­ten­tial op­por­tu­nity for eci­garettes to be a lower-risk al­ter­na­tive to smok­ers who want to quit com­bustible cig­a­rettes,” he said. “We still have to fig­ure out if they are a way to get peo­ple off com­bustible cig­a­rettes. We don’t fully un­der­stand.”

The an­nounce­ment thrilled the e-cig­a­rette in­dus­try, which was fac­ing a dead­line of next year for mak­ers to seek ap­proval to sell any prod­uct that en­tered the mar­ket af­ter Feb. 15, 2007.

Mak­ers of to­bacco cig­a­rettes were warier be­cause the FDA said it would seek pub­lic in­put on a move to lower nico­tine lev­els in com­bustible cig­a­rettes to non­ad­dic­tive lev­els. Shares of cig­a­rette mak­ers tum­bled af­ter the morn­ing an­nounce­ment.

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