FDA could crack down on va­p­ing ‘epi­demic’

Man­u­fac­tur­ers re­quired to sub­mit ‘ro­bust’ plans

USA TODAY International Edition - - NEWS - Jayne O’Don­nell USA TO­DAY

Food and Drug Ad­min­is­tra­tion Com­mis­sioner Scott Got­tlieb on Wed­nes­day de­clared youth va­p­ing an “epi­demic,” and said the agency will halt sales of fla­vored elec­tronic cig­a­rettes if the ma­jor man­u­fac­tur­ers can’t prove they are do­ing enough to keep them out of the hands of chil­dren and teens.

The FDA says it’s giv­ing man­u­fac­tur­ers of Juul, Vuse, MarkTen XL, Blu and Logic 60 days to sub­mit “ro­bust” plans to pre­vent youth va­p­ing. If the agency doesn’t think their plans go far enough, it could or­der their prod­ucts off the mar­ket. Those five brands make up more than 97 per­cent of the U.S. mar­ket for eci­garettes, FDA says.

The FDA is “re­con­sid­er­ing our over­all ap­proach” af­ter a re­view of pre­lim­i­nary data on youth va­p­ing, Got­tlieb told USA TO­DAY.

“Teenagers are be­com­ing reg­u­lar users, and the pro­por­tion of reg­u­lar users is in­creas­ing,” says Got­tlieb, a physi­cian. “We’re go­ing to have to take ac­tion.”

More than 2 mil­lion mid­dle school, high school and col­lege stu­dents use the bat­tery-pow­ered de­vices to heat liq­uid­based nico­tine into an in­hal­able va­por. E-cig­a­rettes are by far the most pop­u­lar tobacco prod­uct among teens: Nearly 12 per­cent of high school stu­dents and 3 per­cent of mid­dle school stu­dents used the de­vice in the past 30 days, ac­cord­ing to the 2017 Na­tional Youth Tobacco Sur­vey.

Some par­ents want the FDA to go far­ther.

Kelli Co­gan says her 15-year-old son was able to get free Juul car­tridges on­line last year by us­ing his fa­ther’s name and birth name and hav­ing them shipped to a dif­fer­ent ad­dress. The Rocky River, Ohio, woman says the com­pany of­fered to block her hus­band’s name from or­der­ing, but she didn’t think that was suf­fi­cient.

Juul spokes­woman Vic­to­ria Davis says the com­pany now re­quires an agev­er­i­fied sig­na­ture on de­liv­ery and has made other changes to pro­tect against dis­tribut­ing e-cig­a­rettes to chil­dren un­der the le­gal va­p­ing age in their states.

The FDA’s new ap­proach is much faster than the rule-mak­ing process the agency an­nounced in March. That was quickly crit­i­cized as too lit­tle, too late by pub­lic health ad­vo­cates.

The brands will no longer be largely im­mune from reg­u­la­tions sim­ply be­cause they were al­ready on the mar­ket in Au­gust 2016 when the FDA an­nounced e-cig­a­rettes would be reg­u­lated like other tobacco prod­ucts.

Com­pa­nies whose prod­ucts were or­dered off the shelves would have to show they have a net pos­i­tive pub­lic health ben­e­fit be­fore re­sum­ing sales.

The FDA also an­nounced the re­sults of its largest en­force­ment ef­fort yet against e-cig­a­rettes. The agency tar­geted more than 1,300 on­line and brickand-mor­tar re­tail­ers with warn­ing let­ters or civil penal­ties for sell­ing to mi­nors. Of­fi­cials said 131 of the re­tail­ers will have to pay penal­ties.

Got­tlieb told USA TO­DAY last month that the FDA was weigh­ing the ben­e­fits of e-cig­a­rettes in help­ing adults quit smok­ing against the risk to young peo­ple who be­come ad­dicted to tobacco through va­p­ing.

Many adults pre­fer fla­vored e-liq­uid when they are try­ing to quit. But Got­tlieb now says he’s pre­pared to make va­p­ing less at­trac­tive to adults if it re­duces the harm to teens.

Got­tlieb said the agency could also tar­get “car­tridge-based prod­ucts,” such as the USB-sized Juul, which is fa­vored by teens and sold in con­ve­nience stores. Adults tend to use bulkier “open tank” va­p­ing prod­ucts, he said.

A spokes­woman for Vapers United, a group that pro­motes va­p­ing as a way to quit smok­ing, said the FDA’s moves could send peo­ple back to cig­a­rettes.

“The FDA needs to be very cau­tious about the ad­verse ef­fects that fla­vor­ing bans or ex­cess reg­u­la­tion could have on this trend – smok­ers us­ing va­por as a way to stop con­sum­ing cig­a­rettes and move to­wards a health­ier lifestyle,” spokes­woman Liz Mair said.

The com­pa­nies tar­geted by FDA struck a con­cil­ia­tory tone.

JUUL Labs CEO Kevin Burns said the com­pany “will work proac­tively with FDA in re­sponse to its re­quest.”

“We are com­mit­ted to pre­vent­ing un­der­age use of our prod­uct, and we want to be part of the so­lu­tion in keep­ing eci­garettes out of the hands of young peo­ple,” he said in a state­ment.

A spokesman for Phillip Mor­ris par­ent Al­tria, maker of the MarkTen XL, said the com­pany wel­comed the FDA ac­tion.

We “look for­ward to shar­ing our thoughts about how to pre­vent and re­duce youth use, an is­sue we have fo­cused on for decades,” spokesman David Sut­ton said.

“We strongly be­lieve kids shouldn’t use any tobacco prod­ucts and take a num­ber of steps to pre­vent kids from get­ting ac­cess to all tobacco prod­ucts,” he said.

Anthony Hem­s­ley, Logic’s head of cor­po­rate af­fairs, said the com­pany will work with the FDA “to demon­strate that Logic mar­kets its prod­uct only to adults.”

R.J. Reynolds Va­por, maker of Vuse, said it sup­ports “elim­i­nat­ing youth us­age of all tobacco prod­ucts.”

The maker of Blu did not re­spond to a re­quest for com­ment.

The FDA said Wed­nes­day for the first time that some be e-cig­a­rettes might be on the mar­ket il­le­gally. Of­fi­cials said they’re in­ves­ti­gat­ing some man­u­fac­tur­ers for vi­o­lat­ing rules that re­quire reg­u­la­tors’ ap­proval to in­tro­duce new prod­ucts af­ter Au­gust 2016. They would not say which com­pa­nies they are in­ves­ti­gat­ing.

If you are in­ter­ested in con­nect­ing with peo­ple on­line who have over­come or are cur­rently strug­gling with health prob­lems men­tioned in this story, join USA TO­DAY’s ‘I Sur­vived It’ Face­book sup­port group.

“No one can look at the data and say there’s no prob­lem.”

Scott Got­tlieb Food and Drug Ad­min­is­tra­tion com­mis­sioner

Jack Cao, who co-owns a chain of vape shops, ques­tions whether a ban on the sale of fla­vored e-liq­uid would have much im­pact. JACK GRU­BER/USA TO­DAY

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