Vapor Technology Association
Sign In Sign In Sign Out Sign Out
  • About
    • About VTA
    • Priorities
    • Governance
    • Industry Marketing Standards
    • FAQ
  • Vaping Impact
  • Membership
  • News

Vapor Technology Association Vapor Technology Association

Join Today Dashboard
  • About
    • About VTA
    • Priorities
    • Governance
    • Industry Marketing Standards
    • FAQ
  • Vaping Impact
  • Membership
  • News

PMTA Deadline Arrives: Industry Steps Up

September 9, 2020 by Black Development Leave a Comment

PMTA DEADLINE ARRIVES:
VAPOR INDUSTRY RESPONDS

This is a BIG DAY for the vapor technology industry. The day that so many said could not come has arrived. And, just like with every other deadline imposed by the FDA, the vapor industry has stepped up to the task.

Once thought impossible, already reports are coming in of many manufacturers filing their Pre-Market Tobacco Applications (PMTAs) covering what is sure to be thousands of products. Congratulations to all those companies who dug in, did the hard work, gathered the science and submitted their PMTAs by the deadline. Yes, companies had to make some tough decisions along the way, but that was always expected as we headed into the final phase of the Deeming Regulation.

Last week, the FDA confirmed it will take each applicant’s individual circumstances into account during the review process. To be sure, FDA already has been quickly replying to early applicants and issuing initial acceptance letters accepting applications for a variety of products.

While this may feel like a finish line, it is really only the beginning of an ongoing process with FDA as CTP reviews each application submitted and engages with further questions of the applicants.

VTA will continue our existing dialogue with FDA to strongly advocate for our members participating in the process.  To that end, the process rolls out as follows:

Phase 1:  Administrative Review.  FDA initially reviews the application to make sure that basic requirements are in the application, it is in English, it includes required contact information and that it contains product identifying information. If these basic elements are included, a company should receive a letter from FDA accepting their application for further action. If not, FDA will send a “refuse to accept” letter.

Phase 2:Filing.  FDA engages in a preliminary scientific review to make sure that everything required by the statute is included, such as health risk data, HPHC studies, descriptions of components, ingredients, additives, and principles of operation, description of facility controls, manufacturing, etc.  If FDA finds these elements, a company will receive a letter accepting the application for filing.  If not, FDA will send a “refuse to file” letter.

Phase 3:  Substantive Review:  This is FDA’s full-blown evaluation of all the science and data presented in each application.  FDA will take recommendations from TPSAC and will engage with the applicant with questions.  This process could take up to 12 months and during this time FDA may send the applicant a deficiency letter, giving them 90 days to provide missing or deficient information.  If FDA has made a scientific decision to issue a marketing order, FDA will send an environmental information request letter before it can issue a final marketing order. Otherwise, FDA will send a “no marketing order” letter.

Phase 4:  Post Marketing Reporting.  As part of its approval process, FDA may require that the sale and distribution of your product is restricted (i.e., to protect kids).  Or FDA may require the applicant to establish and maintain certain records and make certain reports available to FDA.  Post market reports will vary based on submission and may include a requirement that the applicant engages in serious or unexpected adverse experience reporting or any manufacturing deviations.

VTA’s full, in-depth analysis summarizing the important developments for those impacted by the PMTA deadline, particularly as it relates to FDA’s enforcement now that the PMTA deadline has been reached, can be found here.

Filed Under: Events, News

Educate – Collaborate Advocate

September 16, 2019 by Black Development Leave a Comment

VTA’s Fourth Annual Conference Registration closing soon! Sign up now! Join us on Capitol Hill! 

Check PDF

Filed Under: Events, In The Media, News, Press Releases

VTA Asks Health Officials to Speak Responsibly

August 29, 2019 by Black Development Leave a Comment

In light of the seriousness of reports regarding lung disease in youth, the Vapor Technology Association (VTA) strongly urges public officials to thoroughly investigate the circumstances which might have led to each reported hospitalization before making statements to the public as to whether certain products are implicated in these incidents. To date, several public health agencies have failed to provide clear information and, instead, are unnecessarily frightening consumers by failing to distinguish between e-cigarettes and non-nicotine vaporizers.

Recent reports increasingly indicate that these adverse events are linked to illicit substances such as THC and cannabis, not e-cigarettes. For example, the New Mexico Department of Health has clearly determined that products containing THC are likely responsible for the cases highlighted in New Mexico. Despite this, virtually every other public health official continues with their generalized and repeated references to “e-cigarettes.” Such inaccurate warnings will result in either (1) people continuing to use the risky products actually causing the harm about which they have not been specifically warned; or (2) many smokers using e-cigarettes becoming ‘scared’ by these reports and moving back to deadly combustible cigarettes. 

VTA condemns in the strongest possible terms the sale or use of black-market products and does not endorse the manipulation or adulteration of vapor products to consume THC, THC oil, marijuana, or synthetic products like K2. E-cigarettes and other nicotine-containing vapor products are designed for the consumption of nicotine to provide adult smokers an alternative to cigarettes; they are not intended to be used to consume illicit substances.

E-cigarettes and nicotine-containing vapor products are used by millions of adults as an alternative to combustible cigarettes, and most vapor products on the market are of high-quality. Nonetheless, no person should:

  • misuse or alter a vapor device designed for vaping nicotine-containing products by attempting to vape anything other than an e-liquid designed to be used with that device;
  • use any products other than those purchased from a reputable establishment; and
  • use a vapor product offered to them by someone else without knowing precisely what they are consuming.

FDA has imposed regulatory requirements on nicotine-containing vapor products for more than three years, since August 8, 2016, including strict labeling and packaging restrictions that require vapor companies to, among other requirements, disclose all of the ingredients in the products sold.

In stark contrast, none of the products designed for THC, cannabis and any other non-nicotine substances are regulated by the FDA.

Importantly, major medical groups and governments have conclusively determined that vapor products are 95% safer than combustible cigarettes, and studies have shown that they are nearly twice as effective at helping adults quit smoking than traditional methods. 

Filed Under: Events, Government Updates, News

VTA Marketing Standards for the Industry

January 13, 2018 by Black Development Leave a Comment

We have aggressively pushed industry and policy makers to adopt marketing standards to eliminate potential appeal to youth.

Check PDF

Filed Under: Events, In The Media, News

Follow Us

  • YouTube
  • Facebook

Copyright © 2023 Vapor Technology Association.
All Rights Reserved.

Privacy Policy |
Terms Of Use

Created by Black

Association

  • About VTA
  • Priorities
  • Governance
  • FAQ
  • News

Resources

  • Reports
  • Action Center
  • Economic Impact
  • Additional Resources

Action

  • Become A Member
  • Subscribe to VTA Insider
  • Vaping Impact
  • Contact

Let’s Connect

Loading