Durbin: FDA’s Weak Limits on E-Cigarettes Endanger Children

The proposed regulations would ban the sale of the products to minors, but they do not crack down on candy-flavored versions.

MIAMI, FL - FEBRUARY 20: Julia Boyle enjoys an electronic cigarette at the Vapor Shark store on February 20, 2014 in Miami, Florida. As the popularity of E- cigarettes continue to grow, leading U.S. tobacco companies such as Altria Group Inc. the maker of Marlboro cigarettes are annoucing plans to launch their own e-cigarettes as they start to pose a small but growing competitive threat to traditional smokes. (Photo by Joe Raedle/Getty Images)
National Journal
Clara Ritger
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Clara Ritger
April 24, 2014, 7:27 a.m.

For the first time, the Food and Drug Ad­min­is­tra­tion has ex­ten­ded its to­bacco-over­sight au­thor­ity to e-ci­gar­ettes, ci­gars, and pipe to­bacco, but an­t­i­s­moking ad­voc­ates say the reg­u­la­tions don’t go far enough.

The FDA pro­posed Thursday a ban on the sale of e-ci­gar­ettes and oth­er newly reg­u­lated products to per­sons un­der 18. It also re­quired the products to carry warn­ing la­bels about the ad­dict­ive nature of nicot­ine. E-ci­gar­ettes, ci­gars, and pipe to­bacco would be treated like tra­di­tion­al com­bust­ible ci­gar­ettes un­der the new rules. E-ci­gar­ettes va­por­ize nicot­ine, dif­fer­ent from tra­di­tion­al com­bust­ible ci­gar­ettes which burn to­bacco, a pro­cess known to re­lease car­ci­no­gens.

Sen. Dick Durbin, an Illinois Demo­crat who has been among those in Con­gress push­ing the FDA to reg­u­late the e-ci­gar­ette mar­ket, called the FDA’s an­nounce­ment “a polit­ic­al com­prom­ise” with the to­bacco in­dustry.

“Pro­hib­it­ing sales to kids but do­ing noth­ing to pro­tect chil­dren from candy-flavored mar­ket­ing in chil­dren’s ven­ues is an aw­ful out­come,” Durbin said in an email. “Par­ents across Amer­ica lost their best ally in pro­tect­ing their kids from this in­si­di­ous product.”

Al­though the agency has had the power to set guidelines for the e-ci­gar­ette mar­ket since 2009, when Con­gress passed the To­bacco Con­trol Act, years of meet­ings with in­dustry lob­by­ists and an­t­i­s­moking ad­voc­ates led to Thursday’s reg­u­la­tions, seen by many as a “first step” in de­term­in­ing just how the FDA should as­sert its power over the grow­ing e-ci­gar­ette in­dustry.

“There’s so much po­ten­tial for e-ci­gar­ettes to be safer,” said Dav­id Ab­rams, ex­ec­ut­ive dir­ect­or of the Schroeder In­sti­tute for To­bacco Re­search and Policy Stud­ies at the Leg­acy Found­a­tion, an an­t­i­s­moking non­profit de­voted to to­bacco con­trol. “If people switch to good-qual­ity, reg­u­lated e-ci­gar­ettes, we could see a drop in the death and dis­ease rates caused by tra­di­tion­al com­bust­ible ci­gar­ettes.”

The new reg­u­la­tions set the stage for the FDA to be­gin test­ing products on the mar­ket to de­term­ine their im­pact on pub­lic health. They also al­low the FDA to mon­it­or for qual­ity con­trol the mar­ket that was once de­scribed by Com­mis­sion­er Mar­garet Ham­burg as the “Wild, Wild West.”

Makers would have to re­gister their products with the FDA and dis­close in­gredi­ents. New to­bacco products could only be mar­keted after FDA ap­prov­al. Claims of products hav­ing a re­duced risk of death and dis­ease could only be mar­keted with sci­entif­ic evid­ence.

“To­bacco-re­lated dis­ease and death is one of the most crit­ic­al pub­lic-health chal­lenges be­fore the FDA,” said Mitch Zeller, dir­ect­or of the FDA’s Cen­ter for To­bacco Products, in a press re­lease. “The pro­posed rule would give the FDA ad­di­tion­al tools to pro­tect the pub­lic health in today’s rap­idly evolving to­bacco mar­ket­place, in­clud­ing the re­view of new to­bacco products and their health-re­lated claims.”

The pro­posed rule sets in mo­tion a 75-day com­ment peri­od. Fi­nal reg­u­la­tions could take up to a year, an­t­i­s­moking ad­voc­ates say.

One in­dustry lobby group, the To­bacco Va­por Elec­tron­ic Ci­gar­ette As­so­ci­ation, said the FDA’s move will add ne­ces­sary over­sight to the e-ci­gar­ette mar­ket.

“This will help the in­dustry thrive as it will de­mand that those ir­re­spons­ible play­ers ad­here to rules and reg­u­la­tions that the re­spons­ible in­dustry already abides by,” the group wrote in a let­ter pos­ted on­line. “This will not just be­ne­fit the e-cig in­dustry but ul­ti­mately the end user, as they will now get a re­li­able and con­sist­ent product that has been man­u­fac­tured with the highest de­gree of over­sight and con­trol.”

But an­t­i­s­moking ad­voc­ates, while pleased that the FDA had as­ser­ted its au­thor­ity after a long wait, said what was miss­ing from the pro­pos­al was wor­ri­some.

The FDA did not pro­pose re­stric­tions on ra­dio and tele­vi­sion ad­vert­ising, or lim­it­a­tions on candy-flavored products, which rep­res­ent­at­ives from the Amer­ic­an Can­cer So­ci­ety’s Can­cer Ac­tion Net­work said were used by to­bacco com­pan­ies to hook youth.

“We think it’s crit­ic­al that the FDA move as quickly as pos­sible to ad­dress the ad­vert­ising strategies and the design of the products that are clearly de­signed to be at­tract­ive to kids,” said Gregg Haif­ley, AC­SCAN’s as­so­ci­ate dir­ect­or of fed­er­al re­la­tions.

The FDA also pro­posed ex­empt­ing premi­um ci­gars from over­sight.

“There are health con­sequences as­so­ci­ated with to­bacco products, and we don’t think any should be ex­empt from reg­u­la­tion by the FDA,” Haif­ley said.

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