E-cig­a­rette users urged to quit amid deadly illness rise

Juul mar­ket­ing ques­tioned

The Washington Times Daily - - FRONT PAGE - BY SHEN WU TAN

Alarm over the po­ten­tially harm­ful ef­fects of e-cig­a­rettes grew Tues­day as Kansas re­ported its first vaping-re­lated death and Alabama and Delaware re­ported a to­tal of eight new cases of vaping-re­lated respirator­y ill­nesses.

The num­ber is tick­ing up as the Food and Drug Ad­min­is­tra­tion ac­cuses Juul, a lead­ing e-cig­a­rette maker, of il­le­gally mar­ket­ing its mer­chan­dise as “unau­tho­rized mod­i­fied risk to­bacco prod­ucts.” The FDA also is re­quest­ing in­for­ma­tion about the com­pany’s mar­ket­ing prac­tices, par­tic­u­larly those tar­get­ing stu­dents, tribes, health in­sur­ers and em­ploy­ers.

A Juul Labs spokesman told The Wash­ing­ton Times on Tues­day that the com­pany is re­view­ing the FDA’s warn­ing

let­ters and will fully co­op­er­ate. The Fed­eral Trade Com­mis­sion also is re­port­edly in­ves­ti­gat­ing the e-cig­a­rette maker’s mar­ket­ing prac­tices.

Mean­while, pub­lic health of­fi­cials across the coun­try are urg­ing peo­ple to stop vaping, and Michi­gan has be­come the first state to ban the sale of fla­vored e-cig­a­rette prod­ucts.

Kansas health of­fi­cials on Tues­day con­firmed the state’s first death linked to a vaping-re­lated lung illness. Sim­i­lar deaths have been re­ported in Min­nesota, In­di­ana, Ore­gon, Illi­nois and Los An­ge­les.

In ad­di­tion, Delaware re­ported three new cases and Alabama five. They joined the in­creas­ing num­ber of states with in­stances of se­vere lung in­juries linked to e-cig­a­rettes, with more than 450 sus­pected cases na­tion­wide.

Amid the rapid in­crease in va­p­in­gre­lated lung in­juries, health of­fi­cials are in­ves­ti­gat­ing what is caus­ing the ill­nesses. New York health of­fi­cials are turn­ing their at­ten­tion to vi­ta­min E ac­etate, a com­mon ad­di­tive for skin creams and di­etary sup­ple­ments that has been found in cannabis-containing prod­ucts.

Fed­eral health agen­cies say they have not pin­pointed a cause and are look­ing into a va­ri­ety of sub­stances in­clud­ing nico­tine, cannabi­noids such as THC, opi­oids, pes­ti­cides and poi­sons.

More state of­fi­cials are tak­ing ac­tion against fla­vored e-cig­a­rettes. New York Gov. An­drew Cuomo said Mon­day that he was ad­vanc­ing leg­is­la­tion to ban fla­vored e-cig­a­rettes, fol­low­ing Michi­gan’s move last week.

“Com­mon sense says if you do not know what you are smok­ing, don’t smoke it, and right now we don’t know what you are smok­ing in a lot of th­ese vaping sub­stances,” said Mr. Cuomo, a Demo­crat.

Mr. Cuomo said he has or­dered the state health depart­ment to is­sue emer­gency reg­u­la­tions man­dat­ing that vape and to­bacco shops post warn­ing signs to ad­dress the in­creas­ing num­ber of respirator­y ill­nesses and the e-cig­a­rette youth epi­demic.

Vince Will­more, a spokesman for the Cam­paign for To­bacco-Free Kids, said Juul helped hook youths on e-cig­a­rettes by com­bin­ing high-tech de­signs and sweet fla­vors such as mint and mango with a nico­tine-salt for­mu­la­tion or salt­based nico­tine e-liq­uids.

Last year, 3.6 mil­lion mid­dle and high school stu­dents across the coun­try used e-cig­a­rettes, up 1.5 mil­lion from the pre­vi­ous year, the FDA re­ported.

Tony Ab­boud, ex­ec­u­tive di­rec­tor of the Vapor Tech­nol­ogy As­so­ci­a­tion, has said science demon­strates that fla­vors are not the rea­son youths il­le­gally use vaping prod­ucts but shows that fla­vors play a “crit­i­cal role” in help­ing adult smok­ers quit tra­di­tional cig­a­rettes.

E-cig­a­rettes en­tered the Chi­nese mar­ket­place in 2003 and were patented in­ter­na­tion­ally in 2007, ac­cord­ing to the Amer­i­can Heart As­so­ci­a­tion.

The U.S. be­gan im­port­ing the prod­ucts in 2008, said Erika Sward, na­tional vice pres­i­dent for ad­vo­cacy for the Amer­i­can Lung As­so­ci­a­tion.

The first vaping prod­uct to en­ter the U.S. mar­ket was a Ruyan e-cig­a­rette im­ported by Mark Weiss, founder of eci­garette com­pany NJOY.

The prod­uct re­ceived lit­tle at­ten­tion un­til the FDA tried to ban its im­por­ta­tion in 2009, said Gre­gory Con­ley, pres­i­dent of the Amer­i­can Vaping As­so­ci­a­tion.

That year, the FDA de­nied the im­port of elec­tronic cig­a­rettes into the U.S. from a cou­ple of man­u­fac­tur­ers be­cause the prod­ucts were not ap­proved as drug de­liv­ery de­vices in­tended to help treat with­drawal symp­toms of nico­tine addiction, ac­cord­ing to the Pub­lic Health Law Cen­ter.

The man­u­fac­tur­ers, Smok­ing Ev­ery­where and NJOY, filed a fed­eral law­suit stat­ing that e-cig­a­rettes are not in­tended to treat with­drawal symp­toms of nico­tine addiction but for smok­ing en­joy­ment sim­i­lar to tra­di­tional cig­a­rettes. The two com­pa­nies sought an in­junc­tion to stop the FDA from block­ing im­ports of the prod­ucts un­til a court ruled on the case.

The court granted a mo­tion for a pre­lim­i­nary in­junc­tion in 2010 and found that e-cig­a­rettes are in­tended to en­cour­age rather than pre­vent or mit­i­gate nico­tine use. Un­der the court rul­ing, e-cig­a­rettes could be reg­u­lated as to­bacco prod­ucts and not as drug de­liv­ery de­vices un­less they are mar­keted with a ther­a­peu­tic pur­pose such as ces­sa­tion.

E-cig­a­rettes have been un­der the To­bacco Con­trol Act since Au­gust 2016, the FDA said.

No au­tho­rized e-cig­a­rette prod­ucts are on the mar­ket.

The Amer­i­can Vaping As­so­ci­a­tion es­ti­mates that more than 500 man­u­fac­tur­ers or im­porters are regis­tered with the FDA but be­lieves 8,000 to 10,000 vaping or to­bacco shops fea­ture e-cig­a­rette prod­ucts.

Un­der the To­bacco Con­trol Act, eci­garette mak­ers are sup­posed to sub­mit prod­uct ap­pli­ca­tions to the FDA for ap­proval to stay on the mar­ket. How­ever, the FDA tried to de­lay the re­view process un­til 2021 and 2022, prompt­ing out­cry from ad­vo­cacy groups such as the Amer­i­can Lung As­so­ci­a­tion and the Cam­paign for To­bacco-Free Kids.

Ms. Sward of the Amer­i­can Lung As­so­ci­a­tion said in­hal­ing chem­i­cals is not safe. She said it is trou­bling that the prod­ucts have gone un­reg­u­lated for so long and that the FDA’s de­lay of the re­view process has par­tially con­trib­uted to the youth epi­demic.

E-cig­a­rette mak­ers now have to sub­mit pre­mar­ket prod­uct ap­pli­ca­tions to the FDA by May 2020, the re­sult of a fed­eral law­suit filed by ad­vo­cacy groups against the fed­eral agency last year.

The vaping in­dus­try is fight­ing back and su­ing the FDA for its “grossly ac­cel­er­ated” time­line for e-cig­a­rette mak­ers to sub­mit pre­mar­ket prod­uct ap­pli­ca­tions.

E-cig­a­rettes are bat­tery-pow­ered de­vices that have car­tridges or re­fill­able tanks containing liq­uid mix­tures that may con­tain nico­tine in com­bi­na­tion with propy­lene gly­col, vegetable glyc­erin, fla­vor­ing and other chem­i­cals such as ac­etalde­hyde, which is also found in cig­a­rette smoke.


E-cig­a­rettes have been linked to se­vere lung in­juries, some re­sult­ing in death. Pub­lic health of­fi­cials across the coun­try are in­ves­ti­gat­ing and urg­ing peo­ple to stop vaping. Michi­gan has be­come the first state to ban the sale of fla­vored e-cig­a­rette prod­ucts.

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