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The FDA Takes Serious Notice of E-Cig Dangers: As Leav & Steinberg, LLP reported last week the concern for safety and dangers of E-Cig/Vapor use is alarming

 

In 2018 the Food and Drug Administration (FDA) expanded its 2014 “The Real Cost” campaign, which educates at-risk teens on the dangers of tobacco use, to educate teens on the dangers of E-Cigarette use.  Now the FDA is considering taking these dangerous products off the market altogether.

 

Alarmingly:

 

  • Among middle and high school students, 3.62 million were current users of e-cigarettes in 2018.[1]
  • E-cigarette use, from 2017 to 2018, increased 78 percent among high school students (11.7% to 20.8%) and 48 percent among middle school students (3.3% to 4.9%) from 2017 to 2018.[2]
  • According to a 2013-2014 survey, 81 percent of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.[3]
  • About 80 percent of teens to do not perceive a great risk of harm from daily regular use of e-cigarettes.[4]

 

The FDA has taken notice of these facts and held a hearing on e-cigarettes on January 18, 2019 at the FDA White Oak Campus in Silver Spring, Maryland.  Comments may be submitted until February 1, 2019.[5]

 

At the hearing, Scott Gottlieb, FDA Commissioner said “I’ll tell you this. If the youth use continues to rise, and we see significant increases in use in 2019, on top of the dramatic rise in 2018, the entire category will face an existential threat.”

 

Gottlieb remarked that “youth use of e-cigarettes has become an epidemic.”  He cautioned that “it could be ‘game over’ for some [of] these products until they can successfully traverse the regulatory process. I think the stakes are that high.” Gottlieb also spoke of stories that “make clear that, for many young e-cigarette users, addiction has already taken hold. Perhaps the kids didn’t realize that what they were inhaling contained nicotine, a highly addictive chemical. Perhaps they simply thought that e-cigarettes were safer than combustible cigarettes, chewing tobacco and other forms of nicotine delivery about which they’d been warned. Perhaps the ‘cool factor’ outweighed other concerns.”

 

If Gottlieb’s comments are to be taken seriously, this can mean serious trouble for the e-cigarette industry – further highlighting the dangers of this deceptive industry.

 

If you or someone you know has suffered illness or injury as the result of e-cigarette use, contact the attorneys at Leav & Steinberg, LLP to fight for your rights and hold the e-cigarette industry accountable for the needlessly harmful products they have been marketing and selling to our children for years.

 

 

[1] https://www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm456610.htm (citing Cullen KA, Ambrose BK, Gentzke AS, Apelberg BJ, Jamal A, King BA. Notes from the Field: Increase in use of electronic cigarettes and any tobacco product among middle and high school students — United States, 2011–2018. MMWR Morbid Mortal Wkly Rep. 2018;67[45]:1276–1277.)

[2] Id.

[3] https://www.fda.gov/tobaccoproducts/labeling/productsingredientscomponents/ucm456610.htm (citing Villanti AC, Johnson AL, Ambrose BK, et al. Use of flavored tobacco products among U.S. youth and adults; findings from the first wave of the PATH Study [2013-2014]).

[4] Johnston, L. D., Miech, R. A., O’Malley, P. M., Bachman, J. G., Schulenberg, J. E., & Patrick, M. E. (2018). Monitoring the Future national survey results on drug use: 1975-2017: Overview, key findings on adolescent drug use. Ann Arbor: Institute for Social Research, The University of Michigan.

[5] You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 1, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified as confidential if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2018-N-3952 for “Eliminating Youth Electronic Cigarette and Other Tobacco Product Use: The Role for Drug Therapies; Public Hearing; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 Start Printed Page 64753a.m. and 4 p.m., Monday through Friday.

Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.