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VTA Insider November 2022 – FDA Tobacco Laws and Regulations

Welcome to the inaugural edition of the VTA Insider, your industry focused briefing from the Vapor Technology Association.

The VTA Insider will keep you informed of critical issues impacting the nicotine products industry both in Washington, DC and in the states. We will cover regulatory developments, legislation, news of note and other industry insights. VTA will also share our analysis of what we as an industry need to do to grow and prosper.

Let’s Dive In.

1 big thing: GOP takes the House

The big picture: Although vote counting continues in some races, Republicans have officially picked up enough seats to take majority control in the House. But, with Republican control of the House floor, committees and the policy agenda, split party rule returns to Washington D.C. While this is often a recipe for legislative gridlock – split control can help focus leaders of both parties on solving problems that they were not motivated to address before. 

Why it matters: The vast oversight and investigation authority the new House majority will have will put a number of federal agencies and programs under the microscope. GOP leaders already have articulated a large number of issues on which they plan to conduct oversight and investigations: everything from the Afghanistan withdrawal, to COVID, to possible impeachment.

What’s next: VTA’s lobbying and public affairs teams will share their insights on what happened in the recent election and what we can expect to change in Congres in 2023 during VTA’s 2022 Post-Election Round Up webinar on November 30, 2022. Register for the webinar today.

Our thought bubble: VTA has spent the past year working on a bi-partisan strategy that would take serious strides in addressing both youth and adult access to flavored vaping products and the closely divided Congress will necessitate a bi-partisan approach. Also, VTA will be working with the new Congress to ensure they it understands the problems that FDA’s Center for Tobacco Products has had historically.


FDA under the microscope?

FDA Commissioner Califf calls for an independent review

The big picture: This summer, FDA Commissioner Califf called for an independent review, by the Reagan – Udall Foundation (RUF), of FDA’s Center for Tobacco Products (CTP) and its handling of tobacco products. RUF was created by Congress “to advance the mission of the FDA…” and it is now taking a deep dive into the operations of the CTP.

Why it matters: The issues at CTP which VTA has been working to resolve for a number of years, particularly how CTP has handled e-cigarette PMTAs, are beginning to receive long overdue attention. All parties were able to submit comments to RUF and, suprisingly, some of the most troubling feedback has come from FDA staff. 

What they’re saying: Some CTP staff have been highly critical of how CTP has handled e-cigarettes and they lay bare some of the worst fears about what has been going on inside CTP. Here’s a sample of some of the more concerning comments from CTP staff:

  • “Politics are being permitted to drive the science and even limit or alter science-based decisions.”
  • “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
  • “…leadership pushes a “gotta get em” mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
  • “FDA needs to use its authority … to refuse import of all disposable tobacco ENDS products that lack pre-market authorization. This would virtually eliminate youth access to disposables and address unauthorized, unsafe, and in many cases counterfeit disposable products.”

Go deeper: VTA was invited to present comments on needed changes to RUF’s independent tobacco expert panel in October and offered a number of specific recommendations, most notably stating the need for CTP to insulate itself from politics and external pressures in reviewing PMTAs and to “unapologetically” follow the science.

What’s next: RUF will complete its review and will publish a report with recommendations in December of this year.


Defending flavored vapes

Flavored Vapes

The big picture: On Nov. 8, 2022, voters in California passed a ballot initiative (Proposition 31) upholding a 2020 law banning the sale of most flavored tobacco products. The next day, R.J. Reynolds (RJR), filed a federal lawsuit challenging California’s ban. On November 14, VTA filed an amicus brief with SCOTUS in support of a similar RJR case arguing that federal law preempts local and state flavor bans. These cases could have a big impact on local/state flavor bans across the country.

VTA argued that Supreme Court review is critical for economic and public health reasons:

By the numbers: The independent vapor industry comprises more than 10,000 companies across the U.S. VTA’s economists found that the independent vapor industry is responsible for generating more than 130,000 jobs. In new economic impact report VTA commissioned, experts found that a flavor ban would cause the loss of more than:

  • 99,000 jobs;
  • $5 billion in wages and benefits; and
  • $16 billion in lost economic output for the U.S.

What experts are saying: VTA also argued that leading tobacco-control scientists have challenged banning flavored e-cigarettes and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking. Instead of blanket bans, these tobacco-control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products.

The bottom line to SCOTUS: Permitting local and state governments to implement unscientific sales bans which directly interfere with the fundamental purpose of the TCA and which would overrule FDA’s decisions that a product is appropriate for the protection of public health, is not only unlawful, but is dangerous from a public health perspective.

What’s next: VTA will keep you updated as the litigation proceeds. 


Worth your time…

E-Cigarette News

What we’re saying

VTA’s Executive Director at the ENDS US 2022 conference speaking on “PMTA: Lessons Learned.” Watch the video below.

In an excellent piece by Marc Gunter in Filter Mag entitled Can the Tobacco Control Debate Find Common Ground?:

“Some industry leaders are willing to accept regulation. Tony Abboud, the Executive Director of the Vapor Technology Association, which represents vape shops, says his group would accept reasonable restrictions on where e-cigarettes can be sold and how they can be marketed. Abboud also said: ‘We’ll sit down with anybody.’”

Worth the read

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