News | Page 7 | Vapor Technology Association

Gov. DeSantis Veto’s Flavor Ban SB 810!

September 9, 2020 by Black Development Leave a Comment

VAPOR TECHNOLOGY ASSOCIATION APPLAUDS GOVERNOR DESANTIS FOR DECISION TO VETO ADULT FLAVOR BAN BILL

Governor DeSantis is the First Governor to Veto A Flavor Ban

Washington, D.C. – September 9, 2020 – The Vapor Technology Association (VTA) applauds Florida Governor Ron DeSantis (R) for his decision to veto SB 810, a flavor ban. SB 810 was passed by the legislature in March of this year under the mistaken belief that it would raise the age to purchase vapor products to 21. But, due to federal legislation passed in December 2019, the legal age to purchase vapor products was already 21 in Florida making that portion of the bill “superfluous” in the Governor’s words.

“Governor DeSantis has shown true leadership and understanding in his decision to veto SB 810,” said Tony Abboud, Executive Director of the Vapor Technology Association. “On behalf of all the vapor companies, large and small, and the more than one million vapers in the state of Florida, VTA thanks Governor DeSantis for his bold decision to protect Florida’s public health and economy, which comes at a time of great uncertainty for many. This is the positive reinforcement the industry and the people of Florida need.”

The Vapor Technology Association worked closely with the Florida Smoke Free Association, a VTA member association, to educate legislators throughout the legislative session and had moved a meaningful regulatory bill that would have provided real solutions to the core issue of youth access and/or appeal. However, that effort was tossed in favor of an unnecessary and last minute flavor ban, disguised as a bill that would merely raise the age to 21.

Immediately after the bill’s passage in March, VTA went to work on a multi-media veto campaign strategy that involved:

the VapersSayVeto call to action site,
the industry’s only television advertisement directed at the Governor,
a social media drumbeat, and
professional economic analysis from VTA economist John Dunham & Associates

The statewide campaign educating the Governor and his advisors on the negative public health and economic impacts of SB 810 was deployed in cooperation with the Florida Smoke Free Association, which also delivered sophisticated and passionate messages of their own to the Governor.

Moreover, VTA’s economists prepared a report and were deployed to explain that, if enacted, this bill would have removed $605.6 million from Florida’s economy, cost $41.3 million in state and local tax revenue, and put more than 4,500 Floridians out of work. In addition, VTA’s economist testified before the Florida Office of Economic Development Review Committee and was asked to provide additional data for consideration leading to the commission announcing that SB 810 would have serious adverse tax implications for Florida’s economy.

Governor DeSantis took the time to learn about the industry’s impact in the state and understand the legislation’s negative consequences, as seen in his veto transmission letter to Florida’s Secretary of State Laurel Lee. He also recognized that this bill would not achieve its goal of reducing youth vaping. We are pleased that the Governor’s thoughtful veto message clearly reflected the same core issues that we presented in VTA’s request for a veto.

VTA has led national efforts to address underage use of e-cigarettes. Our comprehensive plan announced last year, ensures controlled distribution of all tobacco products, including e-cigarettes, and to impose real limits on access and appeal of all tobacco products to youth. Flavor bans like SB 810 are not effective, rather they eliminate adult alternatives to dangerous cigarettes for adult smokers and devastate small businesses. VTA commends Governor DeSantis for listening to his constituents and understanding the real public health policy implications at stake, specifically, that flavor bans will lead to an unregulated black market and will drive adults back to smoking dangerous cigarettes.

About the Vapor Technology Association

The Vapor Technology Association is the U.S. non-profit industry trade association whose 1000+ members are dedicated to innovating and selling high quality vapor products that provide adult consumers with a better alternative to traditional combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, flavorings, and components, as well as the largest wholesalers, distributors, importers, and e-commerce retailers, in addition to hundreds of hard-working American brick-and-mortar retail store owners throughout the United States. Follow us on Twitter.

PMTA Deadline Reached: Now, What’s Next?

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.