FDA seizes Juul’s youth mar­ket­ing doc­u­ments

The Washington Times Weekly - - National - BY LAURA KELLY

The Food and Drug Ad­min­is­tra­tion raided Juul Labs and seized more than a thou­sand doc­u­ments on the e-cig­a­rette maker’s mar­ket­ing and sales strat­egy and in­for­ma­tion on its prod­uct de­sign, as part of the agency’s ef­forts to curb youth smok­ing and va­p­ing.

The sur­prise in­spec­tion, at Juul’s head­quar­ters in San Fran­cisco and an­nounced last week, fol­lowed an April an­nounce­ment by the FDA re­quest­ing the com­pany pro­vide doc­u­ments on its prod­uct’s ap­peal to young peo­ple. Sim­i­lar re­quests were made to four other e-cig­a­rette com­pa­nies in May.

A Juul e-cig­a­rette most closely re­sem­bles a sleek thumb drive and comes with in­ter­chang­ing pods filled with a salt-based nico­tine liq­uid in a va­ri­ety of fla­vors such as mint, cu­cum­ber and creme brulee.

E-cig­a­rette use among teenagers is in­creas­ing, even as cig­a­rette smok­ing has de­creased. About 11.7 per­cent of high school stu­dents and 3.3 per­cent of mid­dle school stu­dents used e-cig­a­rettes in 2017. In 2016, an es­ti­mated 7.6 per­cent of high school­ers were cig­a­rette smok­ers.

An FDA spokesman said the in­spec­tion was to de­ter­mine if Juul is com­ply­ing with all ap­pli­ca­ble agency laws and reg­u­la­tions.

“We see an op­por­tu­nity for e-cigs to help adult smok­ers quit cig­a­rettes and re­duce their health risks, but we’ve said all along it can’t come at the ex­pense of hook­ing kids on th­ese prod­ucts,” tweeted FDA Com­mis­sioner Scott Got­tlieb. “We’re tak­ing ac­tions to ad­dress youth ap­peal and ac­cess to e-cigs.”

Juul CEO Kevin Burns said in a state­ment that com­pany of­fi­cials had a “con­struc­tive and trans­par­ent di­a­logue” with the FDA dur­ing the in­spec­tion and that the com­pany has re­leased since April about 50,000 doc­u­ments re­lated to sales, mar­ket­ing and ef­forts to keep its prod­uct out of the hands of young peo­ple.

“We want to be part of the so­lu­tion in pre­vent­ing un­der­age use, and we be­lieve it will take in­dus­try and reg­u­la­tors work­ing to­gether to re­strict youth ac­cess,” Mr. Burns said.

Last month, the FDA an­nounced it in­sti­tuted fines and sent more than 1,300 warn­ing let­ters to re­tail­ers who il­le­gally sold five e-cig­a­rette prod­ucts to un­der­age buy­ers in brick-and-mor­tar stores and via web­sites. The tar­geted prod­ucts were: Juul, Vuse, MarkTen XL, Blu and Logic.

The FDA also sent let­ters to the five com­pa­nies on Sept. 12, re­quest­ing they sub­mit within 60 days plans on how they will pre­vent young peo­ple from us­ing e-cig­a­rettes.

Juul Labs main­tains that it con­ducts rou­tine checks on its re­tail­ers to test if they are iden­ti­fy­ing the age of pur­chasers and have an age-ver­i­fi­ca­tion sys­tem on their web­sites for on­line pur­chases. The com­pany also made $30 mil­lion avail­able to “in­de­pen­dent re­search, youth and par­ent ed­u­ca­tion and com­mu­nity en­gage­ment” on e-cig­a­rettes.

Juul is iden­ti­fied as one of the lead­ing con­trib­u­tors the in­crease in e-cig­a­rette use among young peo­ple, who re­fer to the use of the prod­uct as a dis­tinc­tive form of va­p­ing called “Ju­ul­ing.”

The FDA also is weigh­ing the op­tion to ban fla­vors in e-cig­a­rettes, iden­ti­fied as one of the main rea­sons for youth ini­ti­at­ing e-cig­a­rette use.

A sur­vey by the Cen­ters for Dis­ease Con­trol and Preven­tion found that 31 per­cent of mid­dle and high school stu­dents use e-cig­a­rettes be­cause they come in fla­vors such as candy, fruit and choco­late.

Juul e-cig­a­rettes, which were first mar­keted as PAX from 2015 to 2017, have ex­ploded in pop­u­lar­ity over the past three years, ex­ceed­ing more than $650 mil­lion in an­nual sales, ac­cord­ing to re­searchers from Ge­or­gia State Univer­sity’s School of Pub­lic Health.

The re­searchers, who pub­lished their re­sults in the jour­nal To­bacco Con­trol in May, found that Juul’s sales growth was dom­i­nated by a “va­ri­ety of in­no­va­tive, en­gag­ing and wide-reach­ing cam­paigns on Twit­ter, In­sta­gram and YouTube, con­ducted by Juul and its af­fil­i­ated mar­keters” at a rel­a­tively low cost to the com­pany.

Juul spent about $2.1 mil­lion on tra­di­tional ad­ver­tis­ing, com­pared to the sec­ond most pop­u­lar e-cig­a­rette maker Vuse, which spent an es­ti­mated $16 mil­lion.

The high nico­tine con­tent of Juul prod­ucts is par­tic­u­larly wor­ry­ing to health of­fi­cials, and the health risks from aerosols pro­duced by va­p­ing de­vices are not yet fully un­der­stood.

“There are no re­deem­ing ben­e­fits of e-cig­a­rettes for young peo­ple,” said Dr. Corinne Graf­fun­der, di­rec­tor of CDC’s Of­fice on Smok­ing and Health, in a state­ment. “The use of cer­tain USB-shaped e-cig­a­rettes is es­pe­cially dan­ger­ous among youth be­cause th­ese prod­ucts con­tain ex­tremely high lev­els of nico­tine, which can harm the de­vel­op­ing ado­les­cent brain.”

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