VTA Insider June 2023: Fentanyl Threat & FDA Over Regulations
Published on July 12, 2023
VTA Insider keeps 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.
Beware of the Fentanyl False Flag
What’s New: Recently, VTA’s Executive Director Tony Abboud presented a stark warning to the industry at the Next Generation Nicotine Delivery Conference in Miami, Florida. The newest and greatest threat to the availability of less harmful nicotine vaping products in the U.S. is an ongoing orchestrated public affairs campaign to the unsubstantiated claims that illicit Chinese supplied vaping products are being laced with products such as fentanyl.
Why it matters: This will have ramifications for the entire industry and the millions of consumers because it jeopardizes all vaping products.
The facts: If, as asserted, millions of “illegal flavored disposables” are being imported into the U.S. with fentanyl, where’s the outbreak? The made up fentanyl narrative has all the markings of EVALI:
- Hospitalizations and illnesses involving young people using THC vapes.
- Products clearly adulterated by unscrupulous drug dealers.
- Headlines are hyped and conflate all vaping products.
- Direct calls for eliminating flavored nicotine vaping.
- Regulators and legislators are feeding the misleading narrative.
What it means: The fentanyl narrative threatens all nicotine vaping because nearly every vaping product is manufactured in China. If we allow this fiction to take root – it will scare consumers away from vaping and back to smoking and create an opening for FDA to deny all PMTAs.
The damage will NOT be limited to disposables. The campaign is as anti-flavor as it is anti-disposable.The geopolitical narrative is so hyped it will taint all vape devices since they ALL are made in China.
Bottom line: the vaping industry will not get three strikes. The industry must coalesce around a response on the level of the actions we took to stop the ill-conceived flavor ban response to the EVALI crisis. A copy of VTA’s presentation is available here.
FDA’s Poisonous Pantomime
The big picture: At the end of June, the FDA staged yet another “retail blitz” to manufacture a vaping crisis that does not exist. If this sounds vaguely familiar it’s because it’s the same playbook that FDA has used time and again.
- What’s different this time: FDA paired their blitz announcement with two CDC reports that traffic in dangerous misinformation and blatantly misrepresent the real trends in youth vaping.
- The first study FDA presents includes aggregated retail data (not youth usage) that show vapes sales are up and by implication – youth usage. This is not the case. CDC’s own National Youth Tobacco Survey has shown the dramatic reduction in youth e-cigarette use. As smokers use ENDS products to quit cigarettes – we should expect to see replacement trends at the retail level.
- The second study FDA presents attempts to portray an increase in calls to poison control centers related to vaping as sign that a crisis as at our doorstep. To do that, FDA presents this data out of context.
- Go deeper: If we told you that there were 6,074 cases for children under the age of five related to vaping you might be concerned. But what if you also knew that:
- There were 96,000 cases involving cosmetics
- There were 94,000 cases involving household cleaners
- There were 72,000 cases involving prescription drugs
- There were 6,180 cases involving THC (cannabis)
The bottom line: 34 million adults are addicted to cigarettes – the only product which when used as intended will kill you. By selectively targeting vaping under the false pretense of a youth cris, FDA is working overtime to eliminate effective harm reduction options for adults and ensuring the only option for many will be to continue smoking.
VTA Files SCOTUS Brief Supporting Avail Vapor’s 4th Circuit Appeal
The big picture: On June 14, 2023, the Vapor Technology Association (VTA) filed an amicus curiae brief with the Supreme Court of the United States in the case Avail Vapor, LLC, et al. v. US Food & Drug Administration. VTA’s petition seeks Supreme Court review of the Marketing Denial Orders issued to petitioners in connection with their open-system flavored vaping products.
Go deeper: World’s leading tobacco and nicotine researchers have undermined the scientific underpinnings of the FDA’s decision-making rationale. Review by the Court is important not to re-examine the science (which courts will not do), but to evaluate the propriety of the highly questionable process.
By the numbers: The independent vapor industry comprises more than 10,000 companies across the U.S. The industry is responsible for generating more than 130,000 jobs. FDA’s removal of all flavored vaping products from the market would lead to the shutdown of close to 10,000 businesses, causing the loss of 99,158 full-time equivalent jobs.
Why it matters: One week after the Fourth Circuit’s decision upholding the MDOs, an Independent Tobacco Expert Panel released its report on FDA’s Center for Tobacco Products which revealed serious regulatory failings of the agency, including those specifically raised by Petitioners in the Supreme Court Petition.
Worth your time
- A recent study in the American Journal of Medicine finds that among individuals attempting to quit smoking, nicotine e-cigarettes are more efficacious than conventional nicotine replacement or behavioral smoking cessation therapies, and may prove beneficial in reducing smoking-related health risks.
- Reason Magazine recently published a piece highlighting that since the Food and Drug Administration began regulating ENDS as “tobacco products,” public understanding of the relative risks of various tobacco products has declined.
Stay tuned in with us for lots of new developments and make sure your friends and colleagues are signed up to receive our news and information.
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