Of­fi­cials wor­ried about va­p­ing among U.S. youth FDA ready to speed up its review of e-cig­a­rettes

The Washington Times Weekly - - National - BY SHEN WU TAN

The Food and Drug Ad­min­is­tra­tion said it is ready to speed up the review of e-cig­a­rettes and tobacco-re­lated prod­ucts to tackle the youth va­p­ing epi­demic.

Its state­ment fol­lows a Mary­land dis­trict court judge’s de­ci­sion to have e-cig­a­rette and tobacco-prod­uct man­u­fac­tur­ers sub­mit ap­pli­ca­tions to the agency within 10 months that would al­low prod­ucts to en­ter or stay on the mar­ket, a re­sponse to a law­suit brought against the FDA for de­lay­ing prod­uct reviews.

“This court de­ci­sion comes at a time when I, like many oth­ers, are tremen­dously con­cerned about the ris­ing use of e-cig­a­rettes among our nation’s youth and es­pe­cially the po­ten­tial for them to be­come tra­di­tional cig­a­rette smok­ers,” FDA act­ing com­mis­sioner Ned Sharp­less said in a state­ment. “We cannot al­low the next gen­er­a­tion of young peo­ple to be­come ad­dicted to nico­tine be­cause of e-cig­a­rettes.”

He added U.S. Dis­trict Judge Paul Grimm’s de­ci­sion sets a “rapid pace” for the agency to re­ceive and review ap­pli­ca­tions to de­ter­mine pub­lic health ben­e­fits and harms of a prod­uct.

The FDA had post­poned the dead­line for ap­pli­ca­tion submission­s for e-cig­a­rettes un­til Au­gust 2022.

It also would have let the prod­ucts re­main on the mar­ket in­def­i­nitely dur­ing the review process, which had no dead­line, prompt­ing op­po­si­tion from health groups who cite a surge in e-cig­a­rette use among youth.

E-cig­a­rette man­u­fac­tur­ers have un­til May 12 to sub­mit their ap­pli­ca­tions to the FDA, which then gets a year to review ap­pli­ca­tions. The agency can re­move prod­ucts from man­u­fac­tur­ers who do not sub­mit their ap­pli­ca­tions on time and any re­jected ap­pli­ca­tions also.

Last year, 3.6 mil­lion mid­dle and high school stu­dents na­tion­wide had used eci­garettes, up from 1.5 mil­lion from the pre­vi­ous year, ac­cord­ing to the FDA.

The rise in e-cig­a­rette use can be at­trib­uted to man­u­fac­tur­ers that in­tro­duced sweet-fla­vored, nico­tine-loaded prod­ucts like Juul with­out any review of their pub­lic health im­pact or appeal to chil­dren, ac­cord­ing to a state­ment by the Cam­paign for Tobacco-Free Kids, Amer­i­can Academy of Pe­di­atrics and other groups that filed the law­suit against the FDA.

“The court’s de­ci­sion can help re­verse the youth e-cig­a­rette epi­demic if the FDA uses the review process to elim­i­nate prod­ucts that appeal to kids, es­pe­cially the fla­vored prod­ucts like Juul that have caused this epi­demic. The key is for the FDA to en­force the law and take these prod­ucts off the mar­ket,” said Vince Will­more, a spokesman for the Cam­paign for To­bac­coFree Kids.

Although the or­ga­ni­za­tion and other ad­vo­cacy groups had asked the judge for an even shorter ap­pli­ca­tion dead­line of 120 days, they called the new 10-month dead­line “a dra­matic im­prove­ment” from the one set by the FDA.

Gre­gory Conley, pres­i­dent of the Amer­i­can Va­p­ing As­so­ci­a­tion, said the court should ex­pect the va­p­ing and e-cig­a­rette in­dus­try to appeal the rul­ing.

He said Judge Grimm was play­ing reg­u­la­tor in court, adding the rul­ing is a move to­ward the count­down of the ex­tinc­tion of the vast ma­jor­ity of smal­land medium-sized man­u­fac­tur­ers in the in­dus­try who cannot af­ford to sub­mit review ap­pli­ca­tions.

“We think that the ini­tial de­ci­sion and the time­line set out by the judge are both il­le­gal and wrong on the law,” said Mr. Conley, com­ment­ing on how it’s a sur­prise the Trump ad­min­is­tra­tion would let a judge tell the gov­ern­ment how to run its reg­u­la­tory agency.

“Un­less you are a va­por com­pany whose sci­ence is sub­si­dized by ei­ther cig­a­rette sales or Wall Street in­vest­ment, you do not stand much of a chance at all of even be­ing able to suc­cess­fully file an ap­pli­ca­tion, let alone get one ap­proved,” he added.

The agency also said it will fi­nal­ize a pro­posed com­pli­ance pol­icy that lim­its youth ac­cess to fla­vored tobacco prod­ucts and fla­vored e-cig­a­rettes, and launch its first e-cig­a­rette pre­ven­tion TV ads this month.

It ac­knowl­edged that cer­tain e-cig­a­rette prod­ucts “hold some prom­ise” to help ad­dicted adult smok­ers tran­si­tion from tra­di­tional tobacco prod­ucts such as cig­a­rettes to pos­si­bly less harm­ful forms of nico­tine. But the FDA said these prod­ucts still pose a health risk and should stay out of the hands of chil­dren.

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