Juul warned over claims e-cig­a­rette safer than smok­ing

The Oneida Daily Dispatch (Oneida, NY) - - Front Page - By Matthew Perrone

WASH­ING­TON >> Fed­eral health au­thor­i­ties on Mon­day blasted va­p­ing com­pany Juul for il­le­gally pitch­ing its elec­tronic cig­a­rettes as a safer al­ter­na­tive to smok­ing and or­dered the com­pany to stop mak­ing un­proven claims for its prod­ucts.

The Food and Drug Ad­min­is­tra­tion also upped its scru­tiny of a num­ber of key as­pects of Juul’s busi­ness, telling the com­pany to turn over doc­u­ments about its mar­ket­ing, ed­u­ca­tional pro­grams and nico­tine for­mula.

The FDA ac­tion in­creases the pres­sure on the na­tion’s best-sell­ing va­p­ing com­pany, which has been be­sieged by scru­tiny from state and fed­eral of­fi­cials since a re­cent surge in un­der­age va­p­ing. Fed­eral law bans sales to those un­der 18. The FDA has been in­ves­ti­gat­ing Juul for months but had not pre­vi­ously taken ac­tion against the com­pany.

A Juul spokesman said the com­pany “will fully co­op­er­ate” with the FDA.

In a sternly worded warn­ing let­ter, the agency flagged var­i­ous claims made by Juul rep­re­sen­ta­tives, in­clud­ing that its prod­ucts are “much safer than cig­a­rettes.” Cur­rently no va­p­ing prod­uct has been fed­er­ally re­viewed to be less harm­ful than tra­di­tional to­bacco prod­ucts, and that won’t hap­pen for a while.

In the past year, Juul has tried to po­si­tion its e-cig­a­rettes as a tool to help adult smok­ers stop smok­ing, us­ing the tagline “Make the Switch.” In a sep­a­rate let­ter to the com­pany’s CEO, the FDA said it is “con­cerned” that the ad­ver­tis­ing cam­paign sug­gests “that us­ing Juul prod­ucts poses less risk or is less harm­ful than cig­a­rettes.”

“JUUL has ig­nored the law, and very con­cern­ingly, has made some of these state­ments in school to our na­tion’s youth,” said FDA act­ing com­mis­sioner Ned Sharp­less, in a state­ment.

The agency’s warn­ing let­ter high­lights an in­ci­dent re­counted by two New York high school stu­dents dur­ing a con­gres­sional hear­ing in July. The stu­dents told House law­mak­ers that a representa­tive from Juul was in­vited to ad­dress the school as part of an as­sem­bly on men­tal health and addiction is­sues. Dur­ing the pre­sen­ta­tion, the stu­dents said the representa­tive told them the com­pany’s prod­uct was “to­tally safe.” The representa­tive also showed stu­dents a Juul de­vice and claimed the FDA “was about to come out and say it was 99 per­cent safer than cig­a­rettes.”

Juul says it dis­con­tin­ued its school pro­grams — which were in­tended to dis­cour­age un­der­age use — last Septem­ber. Juul and sim­i­lar small, dis­crete eci­garettes have be­come a scourge in U.S. schools na­tion­wide.

FDA warn­ing let­ters are not legally bind­ing, but reg­u­la­tors can take com­pa­nies to court if they don’t com­ply with their re­quests. Juul has 15 busi­ness days to re­spond with a plan for fix­ing the prob­lems.

E-cig­a­rettes have been on the U.S. mar­ket for more than a decade, but the FDA didn’t gain the author­ity to reg­u­late them un­til 2016. E- cig­a­rette mak­ers have un­til next May to sub­mit their prod­ucts to the FDA for health re­views.

Most ex­perts, though, agree the aerosol from eci­garettes is less harm­ful than cig­a­rette smoke since it doesn’t con­tain most of the can­cer-caus­ing byprod­ucts of burn­ing to­bacco. Eci­garettes gen­er­ally heat liq­uid containing nico­tine. But there is vir­tu­ally no re­search on the long-term ef­fects of va­p­ing.

The re­cent out­break of lung ill­nesses mostly in­volves peo­ple who said they vaped marijuana.

In the let­ter to Juul CEO Kevin Burns, FDA reg­u­la­tors said they were “trou­bled” by a num­ber of other points raised at the con­gres­sional hear­ing. The let­ter cites tes­ti­mony that Juul’s ad­ver­tis­ing “sat­u­rated so­cial me­dia chan­nels fre­quented by un­der­age teens,” and “used in­flu­encers and dis­count coupons to at­tract new cus­tomers.”

Last year, Juul closed down its so­cial me­dia sites. And un­der pres­sure, it also vol­un­tar­ily re­moved its fruit and dessert fla­vors from re­tail stores. The FDA has pro­posed reg­u­la­tions on e-cig­a­rettes that would re­strict their sales in most stores, though they have not been fi­nal­ized.

In a tweet Mon­day, first lady Me­la­nia Trump said she was con­cerned about the “grow­ing epi­demic of e-cig­a­rette use in our chil­dren.”

FDA reg­u­la­tors also asked Juul to turn over de­tailed in­for­ma­tion about its po­tent nico­tine for­mula. In the last year, re­searchers have pub­lished sev­eral papers an­a­lyz­ing Juul’s use of “nico­tine salts,” a for­mu­la­tion which al­lows users to inhale higher lev­els of nico­tine with re­duced throat harsh­ness.

Reg­u­la­tors asked the com­pany to ex­plain why it uses nico­tine salts and how this af­fects po­ten­tial addiction.

The let­ter also crit­i­cizes the com­pany for ap­par­ently turn­ing over more doc­u­ments to con­gres­sional in­ves­ti­ga­tors than to the agency “de­spite pre­vi­ous doc­u­ment re­quests from FDA.”

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