FDA ex­am­in­ing whether many e-cig­a­rette items are sold il­le­gally

The Washington Post - - FREE FOR ALL - BY LAU­RIE MCGIN­LEY

The Food and Drug Ad­min­is­tra­tion, in its lat­est ef­fort to curb youth va­p­ing, is in­ves­ti­gat­ing whether dozens of e-cig­a­rette prod­ucts are be­ing sold il­le­gally, the agency an­nounced Fri­day.

The FDA said it has asked 21 man­u­fac­tur­ers and im­porters to pro­vide in­for­ma­tion about whether more than 40 prod­ucts were on the mar­ket be­fore Aug. 8, 2016. Prod­ucts in­tro­duced or changed af­ter that date must re­ceive FDA clear­ance be­fore go­ing on sale.

If the FDA de­ter­mines that the prod­ucts are be­ing sold il­le­gally, the com­pa­nies could face fines, seizures or a court or­der to take them off the mar­ket. Fri­day’s move is the agency’s first largescale ac­tion to en­force the re­quire­ment that prod­ucts in­tro­duced af­ter the Au­gust 2016 date get ad­vance agency clear­ance, of­fi­cials said.

Last month, FDA Com­mis­sioner Scott Got­tlieb said youth use of e-cig­a­rettes has be­come an “epi­demic,” and he ratch­eted up en­force­ment ac­tions against re­tail­ers. He also di­rected lead­ing man­u­fac­tur­ers of e-cig­a­rettes to come up with de­tailed plans for re­duc­ing un­der­age use and warned that the agency would con­sider a pos­si­ble ban on fla­vored e-cig­a­rette prod­ucts or a pro­hi­bi­tion on on­line sales of e-cig­a­rettes.

Pub­lic health groups have re­peat­edly urged the agency to take ac­tion against what they say are new prod­ucts that have not re­ceived FDA clear­ance. In a let­ter to Got­tlieb in Au­gust, six health and to­bacco-con­trol or­ga­ni­za­tions said that “man­u­fac­tur­ers of e-cig­a­rette prod­ucts have in­tro­duced new prod­ucts at an alarm­ing pace in to­tal de­fi­ance of law, with no ap­par­ent con­cern for FDA en­force­ment.”

The let­ter, whose sign­ers in­cluded the Amer­i­can Academy of Pe­di­atrics and the Cam­paign for To­bacco-Free Kids, added that many new prod­ucts ap­peared to be try­ing to cap­i­tal­ize on the suc­cess of Juul Labs, whose e-cig­a­rettes have boomed in pop­u­lar­ity among young peo­ple.

Among the prod­ucts un­der scru­tiny by the FDA ac­tion are Vuse Alto, man­u­fac­tured by R. J. Reynolds Va­por; my­blu Starter Kit by Fon­tem U.S.; and Rubi by Kandypens. The agency said that Juul did not re­ceive a re­quest for in­for­ma­tion be­cause the FDA re­cently con­ducted an unan­nounced in­spec­tion of the com­pany’s cor­po­rate head­quar­ters to learn more about its mar­ket­ing prac­tices.

A spokesman for Reynolds said that the com­pany no­ti­fied the FDA in May “that we would be mak­ing VUSE Alto na­tion­ally avail­able and that it was a repack­aged and re­branded ver­sion of a va­por prod­uct that was law­fully mar­keted in the U.S. as of Au­gust 8, 2016.”

The agency said that there may be sit­u­a­tions in which an e-cig­a­rette prod­uct did not ap­pear to be on the mar­ket as of Aug. 8, 2016, but ac­tu­ally was com­mer­cially avail­able and in com­pli­ance with the law. For ex­am­ple, a prod­uct might have been avail­able but not pub­licly an­nounced or ad­ver­tised or might have had a dif­fer­ent name.

In cases where prod­ucts are be­ing sold il­le­gally, how­ever, “we will take swift ac­tion when com­pa­nies are skirt­ing the law,” Got­tlieb said in a state­ment. More at wash­ing­ton­post.com/ news/ to-your-health

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