De­layed FDA rule on e-cig­a­rettes draws fire

Modern Healthcare - - NEWS - By Steven Ross John­son

While e-cig­a­rette sup­port­ers say the Food and Drug Ad­min­is­tra­tion’s pro­posed rule to reg­u­late elec­tronic cig­a­rettes will ham­per ef­forts to get smok­ers to aban­don deadly tobacco cig­a­rettes, many pub­lic-health ad­vo­cates fear the new rules don’t go far enough to reg­u­late these new prod­ucts whose health ef­fects are still un­known.

The long-awaited rule, is­sued last week, would ban the sale of e-cig­a­rettes to any­one un­der 18, re­quire pro­duc­ers to stop giv­ing free sam­ples, and re­quire warn­ing la­bels stat­ing that nico­tine is ad­dic­tive. Man­u­fac­tur­ers would have to dis­close in­gre­di­ents and could not say their prod­ucts are safer than tobacco prod­ucts.

Both e-cig­a­rette sup­port­ers and crit­ics agree the pro­posed rules are merely a first step rather than the govern­ment’s fi­nal word. Some ob­servers say the FDA chose to move cau­tiously be­cause of le­gal and po­lit­i­cal pres­sures and be­cause of how lit­tle is known about the prod­ucts.

The agency’s ac­tion has been de­layed for years by le­gal bat­tles that be­gan in 2009 when it first at­tempted to reg­u­late e-cigs as a drug-de­liv­ery de­vice un­der the Food, Drug, and Cos­metic Act. E-cig­a­rette mak­ers sued to chal­lenge that des­ig­na­tion, say­ing e-cigs should be con­sid­ered tobacco prod­ucts, not med­i­cal de­vices. In 2010, a federal ap­peals court sided with e-cig­a­rette man­u­fac­tur­ers.

Since then, e-cig sales have taken off, with no reg­u­la­tory over­sight. As many as 200 brands are now sold. E-cig­a­rette sales reached nearly $2 bil­lion in 2013. In­dus­try an­a­lysts pre­dict sales will eclipse the $80 bil­lion-a-year tobacco-cig­a­rette mar­ket by 2040.

The pro­posed rule did not im­pose re­stric­tions on TV ad­ver­tis­ing, on­line sales, or fla­vored e-cig­a­rettes, which crit­ics say ap­peal to mi­nors. Stan­ton Glantz, a pro­fes­sor at the Cen­ter for Tobacco Con­trol Re­search and Ed­u­ca­tion at the Univer­sity of Cal­i­for­nia, San Fran­cisco, said the agency likely faced pres­sure from the Obama ad­min­is­tra­tion to pro­ceed cau­tiously. “This is re­ally not the FDA’s rule, it’s Pres­i­dent Obama’s rule,” Glantz said. “The Of­fice of Man­age­ment and Budget sat on this for months.”

Dr. D. Kyle Hog­a­rth, med­i­cal di­rec­tor at the Univer­sity of Chicago Med­i­cal Cen­ter’s Pul­monary Re­ha­bil­i­ta­tion Pro­gram, said the pro­posed rules are too timid. He scoffed at ar­gu­ments that e-cig reg­u­la­tions should be lighter be­cause the prod­ucts can help tobacco users kick their deadly habit.

“If this was re­ally a prod­uct de­signed to re­place the (tobacco) cig­a­rette, then this thing would have been to­tally geared only for adults,” he said. But the com­mer­cials, he added, are fre­quently tar­geted to young people, and the fla­vored prod­ucts are geared mainly to mi­nors.

E-cig­a­rette sup­port­ers crit­i­cized the rule’s re­quire­ment that pro­duc­ers seek FDA ap­proval be­fore mak­ing claims that their de­vices are less haz­ardous than tobacco cig­a­rettes. They say the process to get such des­ig­na­tion would prove too timely and costly for smaller man­u­fac­tur­ers. “We don’t claim it is a stop-smok­ing de­vice,” said Thomas Kik­las, co­founder and chief fi­nan­cial of­fi­cer of the Tobacco Va­por Elec­tronic Cig­a­rette As­so­ci­a­tion, a trade group. But, he said, ev­i­dence is mount­ing that e-cigs, which heat a liq­uid nico­tine so­lu­tion to form a va­por that is in­haled, are in fact a safer al­ter­na­tive to the es­ti­mated 4,000 chem­i­cals known to be pro­duced when a tobacco cig­a­rette is smoked.

Some physi­cians agree. “There’s no ques­tion in my mind that these prod­ucts are safer than cig­a­rettes,” said Dr. Michael Siegel, a pro­fes­sor of com­mu­nity health sci­ences at Bos­ton Univer­sity. “To not al­low these com­pa­nies to tell the truth doesn’t make any sense to me.”

Still, many health ex­perts ar­gue that too lit­tle is known about e-cig­a­rette in­gre­di­ents to judge their safety or ef­fec­tive­ness as a tobacco-ces­sa­tion aid, and they say the draft rule does not go far enough to re­duce the use of e-cigs among young people. The num­ber of mid­dle-school and high-school stu­dents who re­ported us­ing an e-cig­a­rette dou­bled from 3.3% in 2011 to 6.8% in 2012, ac­cord­ing to the Cen­ters for Dis­ease Con­trol and Preven­tion.

The FDA will ac­cept pub­lic com­ment on the pro­posed rule over the next 75 days. Once the fi­nal rule goes into ef­fect, com­pa­nies would have up to two years to sub­mit ap­pli­ca­tions to the FDA to get ap­proval to con­tinue sell­ing cer­tain ex­ist­ing and new prod­ucts. But com­pa­nies can con­tinue sell­ing their de­vices dur­ing the re­view process.

Glantz said he’s pes­simistic that the FDA will strengthen the rule based on pub­lic com­ments. It would have been bet­ter for the agency to start from a strong reg­u­la­tory po­si­tion and then wa­ter down the rules based on com­ments, rather than start­ing with what he called a “tepid” rule. “My ex­pec­ta­tion is the fi­nal rule is go­ing to pretty much be what (the pro­posed rule) is,” he said.

A cus­tomer picks out a smok­ing tip for an elec­tronic cig­a­rette at a Mi­ami store.

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