FDA elec­tronic cig­a­rette reg­u­la­tions loom­ing

Modern Healthcare - - THE WEEK AHEAD - Steven Ross John­son

Long-awaited rules reg­u­lat­ing the pro­duc­tion and mar­ket­ing of elec­tronic cig­a­rettes could be a breath away, Food and Drug Ad­min­is­tra­tion Com­mis­sioner Dr. Mar­garet Ham­burg told a Se­nate sub­com­mit­tee last week.

A pro­posed rule is cur­rently be­ing an­a­lyzed by the White House Of­fice of Man­age­ment and Budget, she said. She pre­dicted the rule will be is­sued “very soon.”

Pro­po­nents and crit­ics of e-ciga- rettes have been wait­ing for years for the FDA to deliver rules for the de­vices. Sup­port­ers say e-cigs could help mil­lions of Amer­i­cans quit smok­ing reg­u­lar cig­a­rettes. But anti-smok­ing groups ar­gue that not enough is known about the in­gre­di­ents and health ef­fects of ecigs, which use a bat­tery to heat a liq­uid nico­tine so­lu­tion that is in­haled.

The agency at­tempted to ban e-cigs in 2009 on the grounds the prod­ucts were “an un­ap­proved drug-de­vice com­bi­na­tion” un­der the Food, Drug, and Cos­met­ics Act. But a federal ap­peals court in 2010 ruled in fa­vor of man­u­fac­tur­ers who said they were not med­i­cal de­vices, and should be reg­u­lated as tobacco prod­ucts, al­low­ing wide-open mar­ket­ing and sales. Since then, the FDA, which be­gan over­see­ing tobacco prod­ucts in 2009, has worked on rules that some pre­dict will im­pose re­stric­tions on mar­ket­ing and sales of e-cigs to mi­nors.

At the hear­ing, Sen. Jeff Merkley (DOre.) crit­i­cized Ham­burg and the FDA for de­lays in is­su­ing a pro­posed rule, say­ing the mar­ket­ing of e-cigs is a ma­jor pub­lic health haz­ard. “Let’s not let an­other month pass with this thing gath­er­ing dust in some bu­reau­crat’s closet,” he


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