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The FDA is Objectively Failing

August 29, 2024 by Black Development

With over 16 million Americans suffering from smoking related disease, and nearly 500,000 Americans dying annually, the FDA’s Center for Tobacco Products has chosen to use its enormous regulatory power to deprive Americans of access, if not outright ban, all non-combustible alternatives to cigarettes in the U.S. despite leading tobacco control researchers demonstrating they are the most effective tool available to help people quit smoking.

“It is now time for the medical community to acknowledge this progress and add e-cigarettes to the smoking cessation toolkit… U.S. public health agencies and professional medical societies should reconsider their cautious positions on e-cigarettes for smoking cessation. The evidence has brought e-cigarettes to the tipping point. The burden of tobacco-related disease is too big for potential solutions such as e-cigarettes to be ignored.”

Dr. Nancy Rigotti, Harvard Medical School

Only a few years ago –  regulators, scientists and harm reduction advocates arrived at a policy consensus that would balance the relative risks posed by various tobacco products. That consensus was driven by shared goals – to reduce the number of Americans who smoke cigarettes and move them down the “continuum of risk” away from combustible tobacco and toward less risky alternatives especially vaping and other non-combustible nicotine products. The most recent government data that tracks progress in this regard is unfortunately telling us that FDA policies are risking the lives of many Americans – especially older Americans who are most at risk from continuing this deadly habit.

In August of 2021, the 15 past presidents of the staunchly anti-tobacco Society for Research on Nicotine and Tobacco published a groundbreaking essay in the American Journal of Public Health. In it, they encouraged a more balanced consideration of vaping and other alternative nicotine products within public health and in the media and policy circles. While acknowledging that vaping is not free from risks, they demonstrated that it is substantially less harmful than cigarette smoking. Furthermore, they highlighted emerging evidence showing that vaping can increase smoking cessation and is likely more effective than FDA-approved nicotine replacement products like gum and patches. 

Two years later, the FDA echoed some of those same observations and recommendations. In an August 2023 commentary published in the online journal Addiction and authored by Brian King, the current head of FDA’s Center for Tobacco Products (CTP), King highlighted that many adults were misinformed about the relative risks of various tobacco products and that misunderstanding was a barrier to moving smokers down the continuum of risk toward safer, non-combustible tobacco products. And yet, the CTP during his tenure  has  authorized a mere handful of non-combustible nicotine products. Instead, CTP has authorized thousands of new combustible tobacco products. As a result, millions of Americans continue to smoke and die from tobacco related disease.

American Smoking Deaths Under the Califf/King FDA

Since February 17, 2022

830,000,000

For an agency that spends a great deal of time talking about saving lives, by every empirical measure, they are objectively failing:

  • During the period that Brian King and FDA Chief Robert Califf have been in charge of tobacco policy for the country, FDA has authorized more than 1,500 new cigarettes and more than 11,000 combustible tobacco products
  • According to the 2023 National Youth Tobacco Survey (NYTS), past 30-day cigarette use among 12th graders, INCREASED from 5.7% to 7.5%
  • The independent Reagan-Udall Foundation criticized the FDA for putting politics over science and ignoring emerging evidence that confirms that flavor bans and other prohibitions on non-combustible nicotine products actually increase cigarettes sales
  • FDA’s own tobacco enforcement statistics confirm that smoking remains a problem and that youth smoking violations are higher than youth vaping

Scientists are now starting to sound the alarm and are warning that we have reached a tipping point where FDA’s broad opposition to flavored non-combustible tobacco products over the last four years will create enormous public health consequences in the future for many Americans. 

Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School and a member of the National Academies of Science Engineering and Medicine, has sounded the alarm after publishing a editorial stating that we have reached “the tipping point” where policymakers can no longer willfully ignore evidence and use their regulatory authority to undermine e-cigarettes. 

“It is now time for the medical community to acknowledge this progress and add e-cigarettes to the smoking cessation toolkit… U.S. public health agencies and professional medical societies should reconsider their cautious positions on e-cigarettes for smoking cessation. The evidence has brought e-cigarettes to the tipping point. The burden of tobacco-related disease is too big for potential solutions such as e-cigarettes to be ignored.”

FDA now finds itself in the awkward position of being a health agency that is facilitating the sale of cigarettes thereby undermining its own mission to reduce the incidence of smoking related disease and death. FDA’s policies are keeping more effective (and safer) alternatives to cigarettes away from consumers and are in turn propping up the sales and profits of big tobacco companies. Without a course correction that truthfully portrays the risks and benefits of various nicotine products, millions of Americans will needlessly suffer from illness and death.

Filed Under: Government Updates, News

VTA Insider June 2024: VTA Testifying before congress, Update on the state of States

June 26, 2024 by Black Development

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

The VTA Insider will keep you informed of critical issues impacting the vaping 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 with you our own analysis of what we as an industry need to do to grow and prosper.

Lets Dive In.


VTA testifies before Congress

On Wednesday, June 12, 2024, VTA’s Executive Director Tony Abboud had the unique opportunity to testify before the Senate Judiciary Committee in Washington, D.C. to address the myriad problems with FDA’s regulatory approach to e-cigarettes. Abboud’s testimony provided the Committee with critical scientific data shared tobacco-control scientists’ calls for a dramatic change in U.S. regulators’ approach to e-cigarettes. 

What we’re saying: Abboud’s testimony touched on three key points:

  1. FDA’s many failures and the hypocrisy of the leading health regulator authorizing 821 new cigarettes and ZERO less harmful vaping or pouch products in the last two years.
  2. The facts regarding the dramatically ameliorated youth vaping rates in the U.S. coupled with an urgent message to Congress to take up the long overdue marketing and access restrictions that VTA has been advocating for since 2018 to actually protect youth. 
  3. A renewed our call for the FDA to reverse course, authorize a wide variety of flavored e-cigarettes, make harm reduction its north star to encourage Americans who smoke to try e-cigarettes, and to enforce the Tobacco Control Act in a manner that will give tens of millions of Americans a regulated choice of less harmful flavored nicotine options and a fighting chance to get off deadly cigarettes.

Go deeper: You can catch the full hearing testimony here and read a transcript of Mr. Abboud’s opening testimony here.


UPDATED: State of the states

State of the States: Most state legislative sessions have adjourned till the fall, but there are still a few PMTA registry bills working their way through:

  • In North Carolina, PMTA registry language was snuck into H900 without any hearing or public input on the matter by big lobbyists activists. If you live / work in North Carolina, please use and share our call to action to help stop this pernicious and desperate tobacco ploy today. Your representatives need to hear from you. 
  • In Louisiana, HB 621 updating the state’s PMTA registry bill passed both houses of the state legislature and was signed by Gov. Jeff Landry. 
  • In Rhode Island. Gov. Dan McKee signed the state budget bill H 7225, converting the health department’s flavor ban to a state law. 
  • In Iowa, Gov. Kim Reynolds signed HF 2677 into law, beginning the process of creating a PMTA registry in Iowa later this fall. 

What’s next: Our fight against these bills is not over. 

  • We expect a few more states to address PMTA registration bills this year and we expect new and renewed attempts to create or expand PMTA registries next year. 
  • VTA is hard at work educating on the public health and small business damage these bills would create.

Vaping and Chevron deference

This week or next, the United States Supreme Court will release its remaining opinions of the term. The Court typically waits until final week to release to “big” decisions and there is none bigger than Loper Bright v. Raimando, the case that challenges the long standing doctrine known as Chevron deference. 

Why it matters: Chevron deference provides federal agencies with the ability to interpret and implement ambiguous statutes, so long as these interpretations are “reasonable.” For years, the doctrine has been used to uphold federal agency actions even when they seem to exceed statutory authority. 

For the vaping industry that has meant:

  • FDA’s arbitrary and capricious vaping policies have been protected by Chevron deference.
  • The vaping industry has been forced to bow to the political whims of an agency that does not want to approve less harmful non-combustible nicotine products.

What’s Next: Some legal analysts have opined that the Supreme Court could overturn or severely restrict Chevron deference and others have opined that the Court could narrowly restrict its ruling to the facts of the case. 

  • If the Court does the former, we see an avenue to force the FDA to fix their infamous “fatal flaw” approach that was designed to quickly deny marketing authorization for as many non-tobacco flavored ENDS as possible and start relying on science instead of politics in the PMTA process.

Flavored vapes for thee, but not for me

Last week, in a first, the FDA authorized menthol flavored vaping devices and finally acknowledged the enormous body of science proving flavored e-cigarettes help Americans quit smoking – not to mention FDA’s first authorization for a flavored disposable product at the highest nicotine concentration available on the market. 

  • The catch is that, to date, the only vaping products authorized are those manufactured by Big Tobacco companies. 
  • The second catch is that the week prior, FDA denied several other applications from small vaping maufacturers and wants to keep their products off the market. 

Why it matters: While the news is a tiny step in the right direction, it also reveals a more troubling pattern:

  •  FDA is acting only in self-interest to quell political pressure rather than acting in the interest of the American people.
  • Approving some but denying other substantially similar products is going to bring renewed scrutiny on how FDA is arbitrarily applying its it’s public health standard which, to date, it has refused to clearly articulate. 

The bottom line: The only vapes authorized today are all owned by the biggest cigarette companies in the world, demonstrating Brian King and the FDA’s hypocritical allegiance to those companies whose deadly cigarettes and other combustible products the FDA continues to flood the market with at a record pace (more below).

E-cigarettes are the most effective smoking cessation tool on the market and are at least 95% safer than combustible cigarettes. It is far past time for this FDA to approve a wide variety of flavored e- cigarettes and stop authorizing dangerous cigarettes.


FDA’s tawdry Big Tobacco record

Last year, VTA did a deep dive into FDA’s tobacco product approvals. The numbers were shocking then, and things have only gotten worse as our updated May 2024 report FDA is on Fire proves.

Why it matters: Until last week, FDA has refused to authorize a single premarket tobacco application for less harmful electronic nicotine delivery systems. And they have refused to authorize a single less harmful modern oral nicotine product.

What we found: In stark contrast to the more than 16,800 combustible products that FDA has authorized from 2009 to December 2023, the FDA has seen fit to authorize a paltry 45 next generation tobacco products. By category, FDA’s 45 authorizations include:

  • 2 new combustible cigarettes (low nicotine, but still combustible)
  • 4 oral tobacco mints and chews
  • 8 smokeless tobacco products (snus)
  • 8 heat-not-burn products (the IQOS device and assorted Marlboro HeatSticks)
  • 23* e-cigarettes (out of more than 20M applications filed).

*Since facts do matter, it is important to note that the often-cited list of “23” authorized e-cigarettes, only includes about 8 unique e-cigarette devices (some of which are no longer available on the market). The remainder of the list of 23 “e-cigarettes” are either replacement pods, accessories, or other products not traditionally identified as e-cigarettes.

 You can read VTA’s Report – FDA is on Fire here. 

Post script: With the new menthol authorizations, the net available vape devices on the U.S. market now hovers around 10.


The FDA enforcement trap

The latest: At last month’s Food and Drug Law Institute’s Tobacco & Nicotine Policy Conference in Washington, D.C., VTA Executive Director Tony Abboud presented thoughts on FDA’s broken enforcement policies and what that means for the future of tobacco product regulation. 

Go Deeper: Tony’s presentation highlighted some of the major problems that that FDA has created with its misguided policies in pretending that it can enforce prohibition:

  1. FDA policies have created a de facto ban on ENDS products resulting in ZERO product approvals during the current commissioner’s tenure;
  2. FDA’s enforcement of ENDS devices is not viable or efficient and is helping to create illicit markets;
  3. FDA’s enforcement policies are misplaced given that there are three times the number of youth violations for combustible tobacco products vs. vaping products;
  4. FDA’s flavor ban enforcement is driving smokers back to cigarettes

You can view a copy of Tony’s presentation here.


Worth Your Time

  • VTA Executive Director Tony Abboud joins Fox News to discuss FDA’s failures and need for flavored e-cigarettes
  • VTA Executive Director Tony Abboud quoted in Washington Post story 
  • Vape bans could lead to smoking comeback among children
  • Phillip Morris suspends Zyn online sales nationwide after DC subpoena

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.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Filed Under: Insider, News

VTA Statement: Response to the FDA’s Ultimate Authorization of Menthol E-Cigarettes

June 24, 2024 by Black Development

WASHINGTON – June 24, 2024 – The following statement is attributable to Tony Abboud, executive
director of the Vapor Technology Association (VTA):

“VTA applauds the Food and Drug Administration’s (FDA) decision to finally follow the massive body of science proving that flavored e-cigarettes help Americans quit smoking. However, we remain deeply concerned that their actions are too little, too late for the more than 2 million Americans who died from smoking while the FDA stood idly by.

“The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern – the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people. The only vapes authorized today are all owned by the biggest cigarette companies. Today’s authorizations once again demonstrate Brian King and the FDA’s hypocriticalallegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.

“E-cigarettes are the most effective smoking cessation tool on the market and are at least 95% safer than combustible cigarettes. It is far past time for this FDA to approve a wide variety of flavored e- cigarettes to make up for all the cigarettes it has recently rushed to market and to give Americans desperately trying to quit smoking a fighting chance.

“VTA is once again calling for the FDA to stop selectively ignoring science on flavored e-cigarettes and create streamlined regulations and requirements that will allow independent companies of all sizes – not just Big Tobacco conglomerates – to get less harmful nicotine alternatives on the market as it is required to do under the law.”

Download Statement

Filed Under: Press Releases

VTA’s Executive Director Testifies Before Congress

June 12, 2024 by Black Development

VTA’s Executive Director testified before the Senate Judiciary Committee in a hearing focused on FDA’s tobacco market regulatory failures. Watch the full video here.

In his testimony, Tony highlighted how FDA’s failed approach causing real harm to millions of Americans.

“The FDA has not done its job as a regulator. And now it wants more funding to enforce the very actions which federal courts have declared as illegal while the FDA is asking for Supreme Court review. To be clear, the FDA has repeatedly stated that every single vaping product on the market is illegal regardless of whether the company has a pending application. That means FDA is enforcing prohibition. You can give it all the enforcement power in the world, but prohibition cannot be enforced.

Instead of pursuing enforcement action based on failed regulatory policy, the FDA must reverse course, make harm reduction its north star and authorize a wide variety of less harmful nicotine products. Filling the market with such flavored products which American adult consumers are clearly demanding is the only way curb illicit demand and give Americans what they need, want, and what the law intended them to have.”

Read a transcript of the testimony here.

Filed Under: News

VTA Report: FDA’s Tawdry Record With Cigarette Approvals

May 7, 2024 by Black Development

FDA has authorized more than 1,500 new cigarettes and more than 11,000 combustible tobacco products over the last five years.

Last year, VTA did a deep dive into FDA’s tobacco product approvals. The numbers were shocking then and things have only gotten worse.

FDA’s current leaders, Commissioner Robert Califf and Center for Tobacco Products Director Brian King, have refused to authorize a single premarket tobacco application for less harmful electronic nicotine delivery systems (ENDS) out of millions of products for which PMTAs were submitted. And they have refused to authorize a single less harmful modern oral nicotine product.

At the same time, under their combined leadership, Califf and King have authorized nearly 2,000 combustible tobacco products, of which 821 were new cigarettes with 662 new cigarettes being authorized in 2023 alone!

Source: FDA Searchable Tobacco Products Database, last accessed May 1, 2024

The FDA Commissioner actually testified last month that “the best thing to do is to stop using tobacco products altogether. The second best would be to switch to a vape.” Quite difficult to do when the agency he runs is singularly focused on pumping more and more new combustible tobacco products into the market while doing everything it can to rip vapes out of the hands of Americans trying to quit smoking.

So, what should we make of an agency which has become prolific in publicizing all of its anti-vaping actions while it is quietly accelerating deadly cigarettes into the market with rubber-stamp approvals?

Our new report – FDA Is On Fire – reveals FDA’s historical and current tawdry relationship with cigarettes and other combustible products and reveals that it has either lost sight of, or has completely abandoned, its primary mission of eliminating smoking.

Download Full Report

Also Read: FDA Approves Combustible Tobacco at a Dangerous Rate

Filed Under: News, Reports

VTA’s Executive Director Addresses the ramifications of the FDA Commissioner’s testimony

April 22, 2024 by Black Development

VTA’s Executive Director Tony Abboud sat down with Regulator Watch to address the aftermath of the FDA Commissioner, Robert Califf’s testimony in front of the U.S. House Committee on Oversight and Reform . Watch the full video below.

Filed Under: News, Video

VTA Insider April 2024: Update on the state of the States, FDA in the Hot Seat

April 18, 2024 by Black Development

VTA Insider keeps you informed of critical issues impacting the vaping 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 with you our own analysis of what we as an industry need to do to grow and prosper.

Lets Dive In.


UPDATED: State of the States

State of the States: With some state legislatures having adjourned, small business killing PMTA registry and flavor ban bills that were not stopped or amended during the regular legislative session, have reached their respective governor’s desks for signature with a mix reaction from Governors. 

  • In Virginia, Governor Youngkin substantially amended Virginia’s PMTA registry bill although he did not veto. Instead, he exercised caution by including a delayed enactment clause (meaning the most troubling provisions will not take effect until December 31, 2025) and materially changed enforcement provisions. You can read our full statement here. 
  • In Vermont, Governor Phil Scott vetoed a flavor ban bill outright and, in his veto message, delivered a refreshing perspective which highlighted the hypocrisy behind these bills when flavored cannabis and alcohol abound. 
  • In Kentucky, Governor Andy Beshear signed into law the PMTA bill, becoming only the sixth state in the country with some form of PMTA registry now on the books this year. 

What’s next: Legislation is still pending in 20 other states and VTA is hard at work educating on the public health and small business damage these bills would create. Check out VTA’s Action Center for bills needing your voice.


FDA in the hot seat

The big picture: Last week, FDA Commissioner Robert Califf was grilled before the House Oversight Committee. The issue of vaping and harm reduction came up a number of times during the three-plus hour hearing but if you were expecting any indication that FDA would come off of their unscientific approach to tobacco product regulation – you will be disappointed. 

Why it matters: Despite being forced to admit that it would be better (less harmful) for smokers to vape instead, we didn’t get any closer to a transparent explantation of where vaping fits into FDA’s smoking eradication mission. Instead, we got:

  • An incorrect explanation of how FDA is applying their “Appropriate for the Protection of Public Health (APPH) standard;
  • No explanation of how FDA will address the Reagan Udall Foundation’s critiques of the Agency allowing politics to trump science in the PMTA process;
  • No acknowledgement of FDA’s role in spreading dangerous misinformation about the risks of smoking vs. vaping.

Harm Reduction Lip Service: Remarkably, Califf raised harm reduction as the regulatory framework to be used for recreational cannabis use. But, Califf dismissively referred to “tobacco harm reduction” as an “industry term.” Clearly inconsistent on the issue, Califf paid lip service by saying “we’re all in favor of harm reduction,” but then testified that what’s found in vape “residue” is “horrifying” only to say that “it’s much less toxic in terms of all the things that cause cancer and heart disease” (i.e., cigarettes). 

By the numbers: Despite questions by Members of why CTP is authorizing 900 new cigarettes and only a handful of vape products – a finding revealed in this VTA Report – Califf incorrectly stated the public health standard as protecting against the hypothetical risk of young people getting addicted to “nicotine” and then moving to combustible products. Not only is this not the public health standard, Califf once again demonstrated FDA and CTP’s callous indifference to adult smokers.

None of this stopped FDA from stating that if CTP just had another $100 million in user fees from e-cigarette manufacturers in their budget request, they would do a better job. 

You can catch the full testimony here.


Vaping and the Supreme Court

It looking more likely that a major vaping case is likely to go before the Supreme Court in the near future. 

After the 5th Circuit Court of Appeals took apart the FDA’s bad faith denial of Triton’s PMTA, and both vacated and remanded the denials back to the agency with instructions that CTP actually review the applications, FDA has filed a filed a petition to the U.S. Supreme Court to hear the case. 

Rewind: You can read VTA’s statement on the 5th Circuit decision here. 

Why it matters: While the Supreme Court only accepts a very small percentage of the petitions filed, that the FDA as the lead regulatory agency over tobacco products has filed the petition increases the likelihood that this case will be heard. 

What’s at stake: Given the breadth of the 5th Circuit’s incisive en bancruling, the entire PMTA process being used by FDA to block vaping products from market authorization could be evaluated. Importantly, the petition would be heard only after SCOTUS issues its ruling on the Chevrondoctrine which could significantly impact how it evaluates the 5th Circuit’s stinging critique of regulatory malfeasance at FDA’s Center for Tobacco Products.


Worth Your Time

  • New research published in the Oxford Academic demonstrates that giving consumers smoking alternatives drives smoking cessation.
  • Jonathan Adler explores just how backwards FDA policy is concerning menthol cigarettes and menthol vapes.
  • Drug policy iconoclast Ethan Nadelman slams misguided nicotine prohibitionists.
  • Check out VTA’s most recent piece on how FDA is ignoring the real harm to our kids.

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.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Filed Under: Insider, News

FDA Spreading Misinformation About Teen Vaping Threat While Ignoring Greater Problem of Drug, Alcohol and Cigarette Use.

April 12, 2024 by Black Development

Every year the government reports teen usage across alcohol, tobacco and drug substance categories. A quick look at the data shows that things are not what they seem. We are of course worried about underage use of any adult oriented product. But what the government’s own data show is media and government regulators hype the threat from teen vaping, which is in dramatic decline, while ignoring the growing and more concerning problem of kids drinking, taking opioids and other hard drugs, consuming cannabis in all its forms and even smoking cigarettes, in some cases at increasingly higher rates.

According to the CDC’s 2023 National Youth Tobacco Survey, the youth vaping rate (i.e., used once in the last 30 days) sits at 10%.  This reflects a 60% decline in youth e-cigarette use between 2019 and 2023.  Additionally, CDC researchers found that less than four percent of youth are vaping regularly.   In fact, as demonstrated in the chart below, the youth vaping rate has plunged to levels not seen since 2013, before e-cigarettes were even regulated.

Importantly, this dramatic decline has occurred even with the dramatic increase in flavored vapes in the market, demonstrating that there is no real world connection between flavored vapes and youth use.  If anything, there is an inverse correlation.

But what about kids that are drinking, doing drugs or even smoking cigarettes? Despite what we are being told, the concerning reality is that a significantly higher percentage of teens drink and do drugs than vape. According to a report authored by Dr. Robert J. Shapiro, a former Undersecretary for President Clinton, and former advisor to Presidents Obama and Biden, vaping among adolescents emerges as one of the less alarming “risk adolescent behaviors.” Nearly six percent of high schoolers are engaging in opioid use, five percent are using ecstasy or cocaine use, 11 percent engage in binge drinking, and 16 percent in regular marijuana. 

To compare apples to apples – we compared the data from the National Youth Tobacco Survey, the Monitoring the Future Survey and other government data sources* concerning drug and alcohol use by underage users and the results are concerning. In short – a higher percent of teens now drink or do drugs monthly, than vape.

*In some cases only 2021 & 2022 data is available.

Teens are Increasingly Turning to Drugs and Alcohol

Teen Vaping

  • 2023 NYTS data indicates a 41% drop in year-over-year teen vaping
  • ~7.7% of teens report current use
  • ~2.5% of teens are daily users 
  • Teen vaping has dropped 61% since 2019

Teen Alcohol Use

  • 2021 NSDUH data indicates that 15.1% of teens are current users of alcohol
  • Levels of teen alcohol use significantly increased between 2021 and 2022, returning to pre-pandemic levels. (Monitoring the Future)
  • Teen past 30-day alcohol use is 3X higher than “current use” of nicotine vapes. 
  • Binge drinking (more than 5 drinks) is 50% higher than nicotine vaping
  • Past 30-day alcohol use for 12th graders INCREASED from 29.3% to 33.6%
  • 21% of 12th grader drinkers are current users of flavored alcohol

Teen Drug Use

  • Among 12th grade students significant increases in 12th grade took place for past 30-day use of cocaine, hallucinogens, and heroin, as well as past 12-month use of prescription opioids.
  • 31% of 12th grade students used cannabis in the past 12 months.
  • 11.5% of 12-17 year olds used cannabis in the last 12 months. 
  • Teen past-30-day use (12th grade) has been stuck at around 20% for the past 25 years despite being both illegal and more harmful

Teen Smoking

  • Teen smoking overall continues to decline – down 90% over the last decade
  • Current use among all teens of combustible tobacco is 3.4%
  • Past 30-day cigarette use for 12th graders, however, INCREASED from 5.7% to 7.5% 

Misinformation and Misplaced Priorities Have Tragic Consequences

To date, no known deaths have been attributed to nicotine vaping. The same can not be said for drinking and drugs:

  • According to the CDC, underage drinking was responsible for 4,000 deaths in 2022;
  • According to the National Institute for Drug Abuse, overdose deaths among teenagers remains elevated with approximately 1,232 deaths in 2022; 
  • According to the American Academy of Pediatrics, the risk is not just for intentional users. Pediatric cannabis exposures have increased 1375% since 2017.

Considering this data, there are a number of uncomfortable questions that deserve rational, honest answers from federal regulators and politicians: 

  1. Why is FDA promoting cannabis research to encourage descheduling marijuana when flavored marijuana vapes or, worse, cannabis gummies pose greater risks for youth than mere nicotine vapes?  
  2. Why is Senator Chuck Schumer, one of the loudest voices for legalizing cannabis in all flavor varieties including edibles, also the loudest voice for banning flavored nicotine vapes? 
  3. Why does the Biden-Harris Administration support marijuana legalization but stand by while their FDA removes all flavored vaping products from the market? 

Why is a Bloomberg reporter editorializing that vaping devices should be used for cannabis instead of nicotine?

Flavored Vapes Are Not the Problem

The Center for Tobacco Products (CTP) under the leadership of Brian King has not approved a single vaping product since Biden took office. It has been well documented that adult smokers who wish to quit prefer flavored vapes. This fact is presented in the scientific literature including by the esteemed National Institutes of Health. 

Yet, flavored alcohol and cannabis products are pervasive. Regulators, legislators and the media who advocate for cannabis are perpetuating the use of substances where the use and abuse actually causes documented harm to developing brains. The government’s own data shows that past 30-day alcohol use is three times higher than “current use” of nicotine vapes.  Binge drinking is 50% higher.  Past 30-day pot smoking is nearly 50% higher. This is where the real problem – and the hypocrisy – lies. 

The Bottom Line

For years, regulators, lawmakers, and the media have painted teen vaping as the number one threat to our children’s health while pushing policies that increase our children’s exposure to truly dangerous substances. Teen smoking has dropped 90% over the past decade; total teen nicotine use is now at a 50-year low; teen nicotine vaping dropped 61% over the past 4 years. It’s time to start fighting the real fight.

Filed Under: News

VTA Insider March 2024: Action across the States & Health Advocates join the fight

March 24, 2024 by Black Development Leave a Comment

VTA Insider keeps you informed of critical issues impacting the vaping 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 with you our own analysis of what we as an industry need to do to grow and prosper.

Lets Dive In.


State of the States

America pulse line graphic

The Big Picture: the most pressing issue facing the vaping industry remains the dozens of PMTA registry bills that are winding their way through state legislatures in over 30 states. These bills are a blatant effort by Big Tobacco to remove safer vaping products from the market to prop up their sagging profits as Americans quit smoking in favor of safer products.

Why it Matters: The flurry of anti-vaping bills were filed on the heels of FDA’s November 2023 National Youth Tobacco Survey (NYTS). 

The 2023 NYTS survey showed plainly that there is no youth vaping crisis. It highlights:

  • A 41% drop YOY in youth vaping;
  • Only ~7.7% of teens report current use (once in the last 30 days)
  • Only ~2.5% of teens are daily users 
  • Teen vaping has dropped 61% since 2019

Given these undisputed facts, it should be increasingly difficult for elected officials and policy makers to continue to spread the lie that there is a youth vaping crisis. Unfortunately for Big Tobacco, cigarette sales are crashing so we are now facing a fight in dozens of states where legislation written by and promoted by Big Tobacco would eliminate their competition and create a monopoly for their dangerous products.

How to Fight Back: VTA is fighting back in as many states as we can but we can’t be everywhere. In the states we have lobbyists on the ground, we are running public education campaigns to explain the dangers and we are working to mobilize vape businesses that would be shuttered under these new laws. 

  • Our efforts are paying off but we need your help.

First, bills in Virginia and Florida have reached the desks of Governor Youngkin and Governor DeSantis. VTA has set up an ACTION CENTER with all the information you need to make sure the governors hear your voice.

  • In Virginia, the clock is ticking. We have less than 30 days before the General Assembly reconvenes to consider the Governor’s vetos. If you are in Virginia, please visit the VTA Action Center and urge the Governor to veto HB 1069 and SB 550.
  • In Florida, the legislative session ended on March 8th. VTA joined with the Florida Smoke Free Association urging the Governor to veto this harmful legislation.  Governor DeSantis knows that H 1007 and S 1006 are bad for public health and bad for business. The Governor has less than three weeks remaining to make his veto decisions and it is critical that he hears from you!

Health Advocates Join the Fight

Doctor looking at tablet

Strange Bedfellows Unite: When public health groups join with the vaping industry to oppose legislation, it should be a clear signal to lawmakers that these bills are bad for everybody involved. That is exactly what is happening in many of the states where we are fighting. Groups like the American Cancer Society and Clean Air For Everyone (CAFE) have registered to lobby against these bills. 

“At the end of the day, this bill will do nothing to reduce youth consumption and nor adult (use), likely,” said Threase Harms, a lobbyist for CAFE Iowa Citizens Action Network. “ … We see it as an industry bill that does nothing other than help tobacco companies increase their market share and ultimately their profits.” 

Retailers Have Problems Too: Retailers are sounding the alarm in many states that these Big Tobacco protection bills will overregulate them to the point of putting them out of business. 

What’s At Stake: Removing flavored vapes from the market will only increase cigarette sales. This is what Big Tobacco wants but it will come at a cost. For the 34 million Americans still addicted to cigarettes, without access to smoke-free alternatives, the only option for many who have tried and failed to quit will be to continue smoking. 


By The Numbers

Data in America

The negative impact of these bills goes beyond our health and wellness. Thousands of jobs are at stake and millions of dollars of economic activity supported by small businesses across the country are at risk of being eliminated. 

For Example: To demonstrate how big of a problem this is, VTA commissioned an econometric analysis of the small business market for smoke free alternatives in Florida. 

The vapor product industry is an important part of Florida’s economy. About $1.4 billion in vapor sales lead to 7,440 jobs and almost $1.3 billion in economic activity. Of these 7,440 jobs:

  • 2,471 are held by Floridians working for the 774 independent retail vape shops;
  • 369 are held by Floridians working in 13 Florida manufacturing facilities;2
  • 691 are held by Floridians working in wholesale and other retail establishments (like convenience
    stores); and
  • Nearly 3,910 full-time-equivalent jobs in Florida depend on the manufacture, distribution, and sale
    of vapor products in the state.

What’s at Stake: According to independent economists, if Governor DeSantis signs the bills, the adverse impact on the Florida economy would be nearly $1.1 billion with $845.4 million in direct sales losses.

Go deeper: You can read the full analysis here. 


The Science is Clear

The Big Picture: For smokers that want to quit, the CDC only recommends prescription nicotine replacement and counseling, despite these approaches showing little effectiveness. 

Why it matters: For years there has been a steady stream of research providing that vaping is a safer and more effective alternative for smokers looking to quit. In early February, the New England Journal of Medicine, one of the world’s most well regarded peer-reviewed journals, put the lie to the government’s recommendations.

By the Numbers: The comprehensive study tracked 1,246 smokers who wished to quit. 

  • The control group received counseling and the government approved nicotine replacement therapy. 
  • The other group was also permitted to also try to quit using e-cigarettes. 
  • The participants who were given the option to vape were able to quit at rates that were 21% higher than the control group.

What they’re saying: In an editorial accompanying the study, Professor Nancy Rigotti, Professor of Medicine at Harvard Medical School indicated that: 

“It is now time for the medical community to acknowledge this progress and add e-cigarettes to the smoking cessation toolkit… U.S. public health agencies and professional medical societies should reconsider their cautious positions on e-cigarettes for smoking cessation. The evidence has brought e-cigarettes to the tipping point. The burden of tobacco-related disease is too big for potential solutions such as e-cigarettes to be ignored.”

It is time for scientists, not bureaucrats at FDA and CDC to lead the public health discussion.


Worth Your Time

Clock on medicine pill
  • Investors cut guidance on Big Tobacco stocks as vaping cuts into profits. This is an October 2023 story, but it tells you everything you need to know about why tobacco companies are pushing these PMTA registry bills across the country.
  • Restrictive anti-vaping policies are fueling a dangerous black market in other countries.  
  • Consumer groups are sounding the alarm against state PMTA registry bills.
  • When doctors are the source of public health misinformation.

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.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Filed Under: Insider, News

VTA Insider May 2023: LBGTQ & Nicotine Products

May 30, 2023 by Black Development Leave a Comment

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.


A heavy lift in DC

E-Cig Summit

The big picture: The E-Cig Summit and the Food and Drug Law Institute convened in Washington, D.C. There is too much to detail in this newsletter but a few key big-picture takeaways:

Science is clear: Scientists from around the world convened to discuss the continuing growing body of the science behind the importance of vaping and nicotine alternatives to smoking cigarettes. In study after study presented, the scientists presented unflinching perspectives on everything from data to policy. 

The Consensus: FDA is broken and is failing in delivering an effective harm reduction message. Vaping can be a huge benefit to public health and there is ample evidence supporting the potential of vaping to reduce smoking’s toll. Making it harder for adults to access vapor products makes it harder for them quit and ensures that they engage in the riskiest behavior, (smoking) longer.

Why it matters: Litigation is now effectively driving health policy. FDA had a plan to review the large number of PMTAs received and to streamline its reviews in a scientifically defensible matter for flavored ENDS. FDA had announced its plans, priorities and processes in June 2021. 

  • Then, all that changed with the direct interference from a former Acting Commissioner who forced the creation of the “fatal flaw” memorandum which was used to en masse deny all flavored vaping products.
  • This and other interference with scientific decisions was called out by scientists inside & outside FDA’s Center for Tobacco Products.
  • Given FDA’s actions, companies had no option but to litigate.

FDA enforcement needs to be focused on the bad actors, i.e., those companies which have completely ignored FDA’s regulations. While Director Brian King proudly spoke about the pace of PMTA denials (99% of all vaping products) he acknowledged the difficulty with enforcement. No surprise here since bans cannot be enforced. But, as was highlighted in the Reagan-Udall report, FDA has taken little action against companies that chose never to even apply through the PMTA process.


Misinformation for the masses

Data courtesy of Clive Bates from Counterfactual
Data courtesy of Clive Bates from Counterfactual

At the E-Cig summit last week, our friend Clive Bates of Counterfactual gave an excellent presentation focused on how the U.S. should be rethinking tobacco and nicotine regulation. The entire presentation is worth a read but the chart above is a perfect encapsulation of the problem. 

The public is being fed misinformation concerning the relative health risks of smoking vs. vaping and the problem is getting worse. People are now more likely to believe that vaping is as dangerous as smoking than they were ten years ago. 

FDA officials acknowledged the problem of misinformation during the Q&A segment at the E-Cig Summit and committed to developing a public affairs campaign targeted at adults. These type of campaigns take months to develop so don’t expect anything dramatic anytime soon. 

Doubling Down on Youth.  In the same talk, however, CTP Director Brian King, who again acknowledged the dramatic decline in youth vaping, doubled down on youth experiementation. He said there is no acceptable level of youth vaping usage, foretelling what will continue to dictate FDA’s continued vaping product denials. 

The bottom line: Quitting smoking is hard. Only 10% of adults who try to quit will ultimately succeed. FDA needs to expand the understanding of the dramatically less risky alternatives to smoking for tens of millions of adults who are addicted. Of course vaping is not free from risk and there are trade-offs but those tradeoffs should be made explicit so that we can reduce death and disease by giving people the information to de-risk their behavior.

  • But, Director King went on to say that there was a difference between enforcement discretion and enforcement prioritization.
  • King promised promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.

Advancing harm reduction equity

fda vapor regulations
FDA Must First Practice Harm Reduction Equity to Achieve Health Equity

The big picture: CTP Director Brian King has made the concept of “health equity” as it relates to tobacco product regulation a centerpiece of his plan. King characterized FDA’s focus on health equity in the following way:

  • “We have a tremendous opportunity to prioritize health equity and create meaningful change for populations that have been disproportionately affected by tobacco use.”
  • Director King also created the first “health equity” leadership position inside CTP.

By the numbers: Smoking remains the number one health risk to adults in the United States. Approximately 34 million adults are still addicted to cigarettes – the only product which when used as intended will kill you. In the LBGTQ communities – the problem is worse. LGBTQ people out-smoke the general population by 68%. This high rate of LGBTQ smoking is a current and ongoing health crisis. In fact, according to the NIH, smoking related deaths are on track to surpass HIV/AIDS as a cause of death among gay men.

Why it matters: CTP is promoting health inequity and would be better served to focus on vaping as a tool to promote “harm reduction equity” which would have more immediate benefits and potentially immeasurable benefits for historically marginalized communities. 

The bottom line: The FDA and its Center for Tobacco Products (CTP) is charged with protecting all Americans from tobacco-related disease and death. 

  • This means the FDA must do everything to help people move off combustible tobacco and toward lower risk alternatives. FDA’s backward approach to harm reduction means that it is easier to get a new deadly cigarette product approved than an e-cigarette alternative.
  • And the fact that the FDA has declared more than 99% of vaping products “illegal” means that the only choice left remaining will be deadly cigarettes.

Harm Reduction Equity: Conversely, a focus on harm reduction equity means telling the communities that are disproportionately impacted by smoking related death and disease the truth – that vaping while not risk free is less risky than smoking. Given the unequal burden the LGBTQ community and other populations disproportionately affected by smoking (such as the African-American community, those of lower incomes, those afflicted with mental health issues) bear for cancer and other health risks associated with smoking, limiting adult choices and access to lower risk products will only serve to expand health inequities in our society.


The real story on combustibles

vape laws
The Smoking Gun

FDA has a responsibility to create a marketplace that allows the most innovative and safe products to emerge so that adults have access to them. With all the news about the product denials for flavored vaping products, you might be surprised to learn that the FDA has approved for sale more than 1,200 combustible products including nearly 900 new cigarettes!

FDA Approvals of Combustible Tobacco Products 2018 –2022

FDA Approvals of Combustible Tobacco Products
Source: Vapor Technology Association analysis of FDA Tobacco Products Marketing Orders, last accessed 3/16/23; content current as of 2/23/23.

FDA Commissioner Robert Califf recently said in a March 6, 2023 Wall Street Journal interview, “There aren’t many people who argue in favor of combustible tobacco … Well, I mean, we always start from the presumption that combustible tobacco is the most dangerous part of this. And we need to get rid of that as much as we possibly can. It’s written into the mission of the FDA.”

There aren’t many people who would argue with that. So why is the FDA under his leadership approving so many of combustible products? You can check out the full VTA analysis of FDA product approval data here. 

FDA’s continued refusal to accept known scientific truths about vaping and modern oral nicotine will only ensure that cigarettes remain dominant in the U.S. 


Worth your time

Leading Tobacco Control Experts
News and information you can use.

Leading Tobacco-Control Experts call on FDA to change – and fast.

  • some of the world’s leading tobacco-control scientists and public health experts wrote to FDA Commissioner Califf calling on him and the FDA to rethink its current posture.
  • The group focused on the hyper-critical findings of the Reagan-Udall Foundation’s review of CTP and made specific recommendations for changing the way CTP handles tobacco and vaping regulations.

Juul Whitepaper:  Juul Labs Inc. has published  “The Real-World Impact of ENDS for Adult Smokers: Tobacco Harm Reduction Through Real-World Data and Evidence.” We encourage you to read it here. 

Two main requirements of effective harm reduction: (1) that the products are much less harmful than cigarettes, and (2) that these products displace smoking at the population level. 

No doubt the whitepaper it will be panned because of the source but “risk-proportionate regulation” is related to FDA’s “continuum of risk” concept. We have to keep pushing to embed this harm reduction priority as our public health strategy.


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.

Got questions? If you have any questions about the issues we have covered, have suggestions for content, or how you can support our efforts, please feel free to contact us at press@vaportechnology.org.

Filed Under: Insider, News

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