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New FDA policy could get some flavored e-cigarette products pulled off the market

The US Food and Drug Administration released a...

Posted: Mar 13, 2019 1:35 PM
Updated: Mar 13, 2019 2:15 PM

The US Food and Drug Administration released a policy draft Wednesday aimed at preventing e-cigarette products from getting into kids' hands. The result could be that some flavored products are taken off the market.

The draft compliance policy, which is awaiting comments for 30 days and pending finalization, would take action against stores selling flavored e-cig products that are accessible to minors and against websites selling them without verifying buyers' ages and limiting the maximum quantities they sell.

'We expect that some flavored e-cigarette products will no longer be sold at all,' as well as some flavored cigars that are included in the policy, FDA Commissioner Dr. Scott Gottlieb said in a statement Wednesday.

The FDA also proposed moving up a key timeline: how long these products can stay on shelves without pre-market review. Instead of requiring e-cigarettes to undergo FDA approval before they could be sold, the agency decided in 2017 that it would allow such products that were on the market before August 2016 to stay on shelves until 2022 without pre-market review. The new deadline to submit those applications would be August 8, 2021.

Public health advocates have called for more immediate pre-market review, however. At an FDA hearing in January, Gottlieb said that requiring e-cigarettes to go down such a regulatory path could be 'game over for some of these products.' But he maintained that if the prevalence of youth vaping continued to rise, that could prompt the agency to take more extreme action.

Certain flavors are exempted from these proposed changes: tobacco, mint and menthol. Gottlieb has said that he wants to leave the door open for adults, to whom these flavors may appeal more than kids, to quit smoking cigarettes, 'but it can't come at the expense of addicting a generation of kids on nicotine,' he told CNN in November.

'E-cigarette use among kids has become so widespread, so pervasive, and so troubling, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we've made in reducing smoking rates be erased,' he said in a statement announcing the proposed policy Wednesday.

Alex Azar, secretary of the Department of Health and Human Services, said in a statement Wednesday that his agency 'and the entire Trump Administration support a comprehensive, balanced policy approach to close the on-ramp for kids to become addicted to nicotine through e-cigarettes, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.'

But some in the anti-tobacco arena say the new policy doesn't go far enough.

'A public health crisis of this magnitude demands faster and more forceful action than the steps announced by the FDA,' Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a statement Wednesday.

Pointing to data showing that roughly half of high schoolers who vape use mint and menthol flavors, Myers said the FDA ' should prohibit all flavored e-cigarettes that have not been subject to public health review by the agency, halt online sales of e-cigarettes until stronger safeguards are in place to prevent sales to kids, restrict marketing that attracts kids, and enforce rules prohibiting the sale of new products without FDA authorization.' He also advocated a ban on flavored cigars and menthol cigarettes.

'The restrictions on flavored e-cigarettes announced today by the FDA are a step forward, but they are inadequate to reverse the youth e-cigarette epidemic and fall short of prohibiting the flavors that have made e-cigarettes so popular with kids,' he said.

Wednesday's announcement mirrors regulations Gottlieb proposed in November, when the FDA revealed that vaping had increased nearly 80% among high schoolers and 50% among middle schoolers since the year before.

The agency has made a number of other moves in recent months to counter vaping among kids, including warning and fining retailers for illegally selling e-cig products to kids. The agency has also expanded its investigation into e-cigarette companies in an effort to uncover whether they are marketing products illegally and outside the agency's compliance policy.

In October, the FDA conducted a surprise inspection of the corporate headquarters of leading e-cig manufacturer Juul in San Francisco, seizing thousands of documents from the company. The FDA has not released the findings of the inspection.

In January, the agency held a public hearing to consider the role of drug therapies to get kids to quit vapes and other nicotine products, with medical organizations and vaping groups weighing in on how to address rising levels of e-cigarette use among youth.

Myers said in December that 'The FDA has concluded that the level of addiction it is seeing among youthful e-cigarette users is so disturbing and so unprecedented that it needs to at least ask whether we need a solution that goes beyond what we ever did with cigarettes.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 1130719

Reported Deaths: 17736
CountyCasesDeaths
Marion1468762242
Lake732391255
Allen68004883
Hamilton51739488
St. Joseph50459650
Elkhart40619547
Vanderburgh34963497
Tippecanoe31212276
Johnson27963467
Hendricks26585385
Porter25969387
Madison21318457
Clark20392279
Vigo19244309
LaPorte17405261
Delaware17004303
Howard16942315
Monroe16794220
Kosciusko14447167
Hancock13259186
Bartholomew13180191
Warrick12320190
Wayne12200269
Grant12181247
Floyd12096226
Morgan10552192
Boone9966124
Noble9429123
Marshall9295147
Henry9268169
Dearborn9053100
Dubois8877140
Shelby8402130
Cass8241128
Lawrence8134185
DeKalb7933109
Jackson779993
Huntington7761116
Montgomery7213123
Gibson7179118
Harrison7031100
Knox6958116
Steuben676589
Miami6675114
Whitley667260
Putnam651286
Clinton633179
Wabash6323111
Jasper622192
Jefferson5946105
Ripley565994
Adams547981
Daviess5124118
Scott498980
Wells4894106
White486069
Greene4749101
Clay468662
Decatur4659110
Fayette462597
Jennings457167
LaGrange432291
Posey412944
Randolph4010107
Washington393656
Fountain382264
Fulton368374
Spencer365147
Starke361474
Owen358577
Sullivan351155
Jay336450
Orange335272
Rush314833
Carroll301639
Franklin295244
Perry292853
Vermillion285958
Tipton253367
Parke251630
Pike251244
Blackford224944
Pulaski213759
Newton185052
Brown179750
Benton171717
Crawford170729
Martin152619
Switzerland149412
Warren137816
Union125116
Ohio92913
Unassigned0599

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1735925

Reported Deaths: 26851
CountyCasesDeaths
Franklin1807941843
Cuyahoga1705042655
Hamilton1146441544
Montgomery811601405
Summit728891210
Lucas637861027
Butler57319814
Stark544971183
Lorain42941645
Warren36238417
Mahoning36168788
Lake32818501
Clermont31601369
Trumbull27766620
Delaware27462185
Licking26929344
Medina26408353
Fairfield24875287
Greene24585373
Clark22391390
Portage21591283
Richland21339342
Wood20348248
Allen19172326
Miami17486352
Columbiana17078335
Muskingum16882207
Wayne15914307
Tuscarawas14631362
Marion13477196
Ashtabula12980237
Erie12832199
Scioto12586188
Pickaway12326155
Ross11824226
Hancock11659175
Geauga11090179
Lawrence10729172
Belmont10548234
Huron9891159
Jefferson9724228
Union966575
Sandusky9465166
Seneca9020161
Knox8893176
Washington8738159
Darke8446181
Athens842897
Ashland8130152
Auglaize8042120
Shelby7575135
Defiance7431117
Crawford7376150
Fulton7284113
Brown7225116
Logan7087111
Guernsey701786
Mercer6964100
Highland6822120
Clinton6554106
Williams655299
Madison653990
Preble6343140
Putnam6300122
Jackson586597
Champaign586187
Perry571279
Coshocton5700108
Ottawa5696102
Morrow524665
Fayette499072
Hardin4960100
Gallia475878
Van Wert470895
Pike468478
Adams4638110
Henry440380
Hocking414293
Holmes4044141
Wyandot379975
Carroll373678
Paulding327551
Meigs307961
Monroe237261
Noble221949
Morgan219439
Harrison216953
Vinton189738
Unassigned06
Fort Wayne
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Angola
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Huntington
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Decatur
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Van Wert
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After a cold start to the week, warmer air begins to filter back into the region Wednesday.
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