FDA warns Juul over claims of e-cigs’ safety

The Morning Call - - BUSINESS CYCLE - 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 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.

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.

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 “Juul prod­ucts poses less risk or is less harm­ful than cig­a­rettes.”

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 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.

SETH WENIG/AP

Juul said the com­pany “will fully co­op­er­ate” with the U.S. Food and Drug Ad­min­is­tra­tion’s scru­tiny of its prac­tices.

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