FDA gives vaping companies a clearer path for marketing their products

The US Food and Drug Administration issued its final guidance for e-cigarette makers...

Posted: Jun 11, 2019 2:18 PM

The US Food and Drug Administration issued its final guidance for e-cigarette makers to submit premarket tobacco product applications, giving these companies a clearer path to seek official authorization to market their products, the agency announced Tuesday.

In doing so, companies must show that their products "would be appropriate for the protection of the public health," the agency says.

The announcement comes about a month after a federal judge ordered the agency to speed up its review of thousands of vaping products now on the market. That decision, part of an ongoing lawsuit filed by multiple health groups, said that the agency has acted illegally by allowing e-cigarettes to remain on the market until 2022 before requiring companies to apply for FDA authorization.

"There are no authorized e-cigarettes currently on the market," Acting FDA Commissioner Dr. Ned Sharpless said in a statement Tuesday, adding that the agency's oversight of such products "is critical to our public health mission and, especially, to protecting kids from the dangers of nicotine and tobacco-related disease and death."

"The final guidance issued today provides companies seeking to market e-cigarette and [electronic nicotine delivery system] products with recommendations to consider as they prepare a premarket tobacco product application to help the FDA evaluate the public health benefits and harms of a product," Sharpless said.

The FDA said it must consider how vaping products may change people's behaviors, including the prospect of nonsmokers picking up the e-cig habit, as well as how often e-cig users tend to quit. The guidance also outlines the agency's plans to examine the ingredients and additives in vaping products, how they are packaged and labeled, and how these devices are designed and made. This could address known risks of exploding batteries and accidental nicotine poisoning among children, the agency said.

Dr. Robert Jackler, founder of the Stanford Research into the Impact of Tobacco Advertising, previously told CNN that many e-liquids with high nicotine concentrations represent "a huge poisoning risk," with some bottles lacking childproof caps and containing enough nicotine to kill an entire preschool class. With the rise in e-cig popularity has come a rise in calls to poison control centers, he added.

New York Coronavirus Cases

County data is updated nightly.

Cases: 628375

Reported Deaths: 34477
CountyCasesDeaths
Queens884967353
Kings873877498
Bronx627705028
Suffolk592732045
Nassau592382248
Westchester491021512
New York442183223
Erie23933785
Richmond222091126
Rockland21258692
Orange16555517
Monroe14338313
Onondaga10248222
Dutchess7021186
Albany5555148
Broome5201140
Oneida4655150
Niagara3599107
Ulster323898
Chemung295535
Putnam268264
Schenectady235357
Sullivan215648
Saratoga215120
Steuben171487
Rensselaer166651
Chautauqua151616
Oswego14366
Ontario125037
Tioga109549
Wayne108312
Cattaraugus105826
Tompkins10430
Columbia100556
Allegany98352
Cortland9792
Genesee9329
Madison89818
Cayuga8228
St. Lawrence7849
Greene67518
Livingston6719
Herkimer64512
Chenango62310
Orleans60457
Otsego5968
Warren57135
Wyoming5175
Jefferson5003
Fulton48428
Montgomery46616
Clinton4485
Washington44014
Lewis3459
Delaware3429
Schuyler2963
Essex27814
Seneca2765
Franklin2597
Yates2527
Schoharie1902
Hamilton421
Out of NY0120
Unassigned027
Utica
Clear
27° wxIcon
Hi: 43° Lo: 30°
Feels Like: 27°
Oneonta
Scattered Clouds
27° wxIcon
Hi: 41° Lo: 29°
Feels Like: 27°
Herkimer
Clear
27° wxIcon
Hi: 41° Lo: 31°
Feels Like: 27°
Thendara
Clear
27° wxIcon
Hi: 37° Lo: 30°
Feels Like: 27°
WKTV Radar
WKTV Temperatures
WKTV Severe Weather
Click here to learn more about A Healthier Mohawk Valley
Stuff the Bus Locations
Saluting Those Who Are Proud 2 Serve