VTA’s Executive Director Tony Abboud sat down with Regulator Watch to do a quick review of the Reagan-Udall Report on FDA Tobacco Products Program the day that it came out. Watch the full video below.
VTA Insider May 2023: LBGTQ & Nicotine Products
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
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
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
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
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 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 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.
FDA is Creating a Tobacco Crisis for the LGBTQ Community
FDA Must Prioritize Lowering Outsized Cancer Rates Caused by Cigarette Smoking
Evidence clearly demonstrates that vaping helps adult smokers quit, yet many communities are being misinformed about the relative risks of e-cigarettes.
A policy of “harm reduction equity” that prioritizes eliminating cancer and other diseases caused by cigarette use should be the highest public health priority of the FDA. Yet FDA’s words and actions have led many to believe erroneously that vaping is as harmful as, or more harmful than smoking. FDA’s backward approach to harm reduction means that it is currently easier to get a new cigarette product approved than an e-cigarette alternative.
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. Nearly 1300 Americans die from a smoking related illness every day – almost 475,000 people annually. That is COVID scale event – every two years!
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.
LGBTQ smokers need to receive accurate information from FDA about the relative risks of vaping and smoking – it is a matter of life and death.
LGBTQ communities experience health disparities because social stigma and discriminatory treatment often cause stress and anxiety. Common coping mechanisms include smoking tobacco, drugs and alcohol. Because of higher smoking rates, LGBTQ communities carry the burden of a much higher risk of cancer and other diseases:
- Smoking rates among LGB individuals in the US are higher than that of the heterosexual population (11.4% ) with 15.5% of LGBTQ adults smoking cigarettes. (CDC)
- In transgender communities , there are reports that 62% of adults smoke cigarettes. (Journal of Addiction Medicine)
- African Americans are more likely to die of smoking related illnesses than non-Hispanic Whites – causing around 45,000 deaths per year. (CDC).
- Smoking related deaths are on track to surpass HIV/AIDS as a cause of death among gay men. (NIH)
The FDA and the Center for Tobacco Policy (CTP) is charged, ultimately, 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 currently easier to get a new cigarette product approved than an e-cigarette alternative. And the fact that the FDA is on pace to eliminate more than 99% of vaping products from the market means that the only choice left remaining will be deadly cigarettes.
The Risk of Various Nicotine Products is Not the Same
According to the American Cancer Society, cigarette smoking is the leading cause of cancer mortality in the United States – responsible for as much as 98% of all tobacco-related deaths. This is a generational health crisis that is preventable. Unfortunately it is also a problem that disparately impacts historically marginalized communities.
Regulators Must Tell the Truth
In a recent landmark essay in the American Journal of Public Health, 15 past presidents of the staunchly anti-tobacco Society for Research on Nicotine and Tobacco articulated the state of the science which demands an honest discussion about our public policy toward tobacco e-cigarettes. U.S.
policymakers are ignoring these scientific leaders’ warnings and missing the opportunity to reshape U.S. e-cigarette policy before more lives are lost.
According to these scientists, the need to pay attention to adult smokers is particularly important from a harm reduction equity perspective.
“African Americans suffer disproportionately from smoking-related deaths, a disparity that, a new clinical trial shows, vaping could reduce. Today’s smokers come disproportionately from lower education and income groups, the LGBTQ (lesbian, gay, bisexual, transgender, and queer or questioning) community, and populations suffering from mental health conditions
and from other drug addictions.”
Vaping is the Most Effective Tool to Deliver Harm Reduction Equity
While vaping is not risk free, we know that it is the most effective of all the nicotine alternatives. Since 2010, when e-cigarettes became widely available in the US, we have seen adults who smoke drop by a remarkable 62 percent. Other countries are far ahead of the U.S. in this regard.
Since 2015, the United Kingdom’s Health Agency Public Health England and the Royal College of Physicians each conducted a full review of all e-cigarette research and concluded that vapor products are at least 95% safer than combustible cigarettes. Now, Britain’s National Health Service promotes e-cigarettes as a means to quit smoking and even permits the sale of flavored vapor products inside hospitals.
And in April of 2023, the UK government announced its landmark program in which “One million smokers will be encouraged to swap cigarettes for vapes under a pioneering new ‘swap to stop’ scheme designed to improve the health of the nation and cut smoking rates.” The UK government is handing out free vaping starter kits to smokers to achieve its smoke free by 2030 goal..
Even in the U.S., the National Academies of Sciences Engineering and Medicine conducted its
own review of all the research and concluded in 2018:
- “There is conclusive evidence that completely substituting e-cigarettes for combustible tobacco cigarettes reduces users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes.”
- “There is substantial evidence that completely switching from regular use of combustible tobacco cigarettes to e-cigarettes results in reduced short-term adverse health outcomes in
- several organ systems.”
- “The evidence about harm reduction suggests that across a range of studies and outcomes, e-cigarettes pose less risk to an individual than combustible tobacco cigarettes.”
So, while the FDA repeatedly talks about health equity, FDA’s refusal to acknowledge and apply the obvious principles of harm reduction to vaping dramatically highlights the inequity of its approach to harm reduction. Ultimately, the FDA will fail in its mission to end smoking and will particularly fail those in the LGBTQ communities who are disproportionately affected by smoking death and disease.
The Bottom Line
Less than 4% of underage youth indicate that they use vaping products “frequently.” FDA’s singular focus on decreasing this number by removing vaping products from the market is leaving millions of adult smokers with no alternatives to cigarettes. Vaping can be a benefit to public health and there is ample evidence supporting the potential of vaping to reduce smoking’s toll – particularly among the communities that remain addicted to cigarettes at higher rates. 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.
Given the unequal burden the LGBTQ community bears for cancer and other health risks directly associated with smoking, limiting adult choice for a lower risk product only serves to expand the harm reduction equity gap. Quitting smoking is hard. Only 10% of adults who try to quit will ultimately succeed. FDA needs to expand the understanding of less risky alternatives to smoking for the communities most at risk.
FDA Approves Combustible Tobacco at a Dangerous Rate
While the FDA rejects thousands of less harmful vaping product applications, it approves the sale of more than 1,200 combustible tobacco products.
The FDA has spent the “vast majority” of its resources denigrating e-cigarettes and denying 99% of all applications from hundreds of companies seeking to market the very products, which Center for Tobacco Products Director King admitted have “markedly less risk than a combustible cigarette product.” This begs the question of what FDA has been doing with its remaining resources to address combustible tobacco products which FDA Commissioner Califf has said are the “most dangerous”?
To find out, the Vapor Technology Association conducted an analysis of FDA data and the answer is, frankly, disturbing. Based on a review of all marketing authorizations for cigarettes and vaping products made by the FDA over the last five years, we have learned that FDA has authorized combustible tobacco products at a dangerously high rate.
In the last five years, while the FDA has approved only a handful of e-cigarettes in tobacco flavor only, it has at the same time accelerated the introduction of 1,213 new combustible tobacco products into the U.S. market. Of these 1,213 new combustible tobacco products, the FDA has approved for sale 892 new cigarette products amounting to a whopping 74% of all the new combustible tobacco products FDA has allowed to be marketed.
FDA Approvals of Combustible Tobacco Products: January 2018 – December 2022
To make matters worse, the FDA allowed every one of these combustible products to be expedited to the market with only 90-days’ notice and without any demonstration that these new combustible tobacco products are appropriate for the protection of public health – because, of course, such products could never meet that same standard applied only to the new and innovative less harmful products. Moreover, all of the new combustible products approved were not subject to any robust scientific review and more than half of the new cigarettes authorized by the FDA were exempted from providing any scientific evidence at all.
The FDA Commissioner said this month that getting rid of combustible tobacco products “is written into the mission of the FDA.” That’s an odd statement given the FDA is approving combustible tobacco products over less harmful vaping products at a rate of 45:1. Not sure how that advances the FDA’s mission. Perhaps the FDA can explain it, because we cannot.
Also Read: How FDA’s Anti-Vaping Policies Affect Minorities in America
How FDA’s Anti-Vaping Policies Affect Minorities in America
In the last half-century, America has made significant strides in reducing cigarette smoking rates. However, despite these improvements, 34 million Americans are still addicted to cigarettes, leading to 480,000 smoking-related deaths each year. It’s worth shedding light on the demographics of these “forgotten smokers” and how the FDA’s anti-vaping policies are directly harming low-income and racial minority populations.
Smoke ‘Em If You Got ‘Em
Smoking Affects the Marginalized Most
Many educated and affluent individuals mistakenly believe that the problem of smoking has been largely resolved. This is because they rarely encounter smoking in their social circles or workplaces. However, this perception ignores the reality faced by tens of millions of Americans who continue to struggle with smoking addiction.
Today’s smokers are increasingly those with lower education, lower income, and belonging to historically marginalized groups. Racial minorities, the LGBTQ communities, and populations with mental health conditions or other drug addictions suffer disproportionately from smoking-related illnesses. The FDA’s current policies overlook this reality, making it more likely that many adults will remain addicted to cigarettes.
The Struggle to Quit Smoking
Quitting smoking is a monumental challenge. Only 10% of smokers who attempt to quit succeed in any given year. Surprisingly, the age of smoking initiation is also on the rise. Data from the National Survey on Drug Use and Health shows that among daily smokers, the proportion who began smoking during young adulthood increased from about 39% in 2002 to nearly 56% in 2018 – an alarming statistic that is indicative of the FDA failing in its harm reduction mission.
ENDS Is An Effective Choice
The FDA’s smoking cessation mission has not been accomplished, and the Agency must balance the public health benefits of adults using ENDS to quit smoking combustible tobacco products against the potential public health harms from youth who use ENDS products. To help young adults quit smoking, vaping is the most effective of all the non-combustible nicotine alternatives. The 62% drop in adult smokers since 2010 is a testament to that.
If the FDA were truly a data driven agency with science at the “cornerstone” of their decision making – we would see an agency working overtime to move adult smokers off of cigarettes and toward healthier alternatives. Instead, we see the FDA keeps approving cigarettes at an alarming rate.
Also Read: FDA is Creating a Tobacco Crisis for the LGBTQ Community
FDA’s Formal Position on Enforcement Discretion Revealed
VTA presses CTP on clarifying enforcement discretion policy
The “million dollar” question: CTP has historically allowed all tobacco products with pending pre-market tobacco applications (PMTAs) to remain on the market, subject to FDA’s enforcement discretion, but in the past few months has been making confusing statements particularly with respect to non-tobacco nicotine (NTN) products, also known as synthetic nicotine products. Following up on VTA correspondence from early November 2022, we asked Director King directly during our January 10, 2023 meeting: “Has CTP had changed its well-established enforcement discretion policy for non-tobacco nicotine products only?”
What we said: It’s extremely important that we get clarity on this question so all market participants understand CTP’s position and so that companies are not able to misrepresent CTP’s position for their own benefit.
- For years, CTP has used enforcement discretion to allow all tobacco products with pending PMTAs to remain on the market and that policy should be consistently applied to tobacco-derived and non-tobacco derived nicotine products alike.
- CTP has exercised enforcement discretion for years. CTP has asked courts not to limit its enforcement discretion. CTP has explained its actions or inactions based on enforcement discretion.
- Some companies have been attempting to confuse retailers and dissuade them from carrying synthetic nicotine products by claiming that CTP uses enforcement discretion only for tobacco-derived nicotine products and not for synthetic nicotine products.
- Nothing in the new law limited CTP’s enforcement discretion – in fact, CTP has been exercising that discretion – and CTP would never unilaterally limit its own discretion.
What FDA said: During the January 10 meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion. Director King promised a formal letter soon from CTP in response to VTA’s questions to clarify CTP’s position.
King to VTA: FDA has no enforcement discretion policy for TDN or NTN products!
VTA received a letter from Director King on February 2, 2023 outlining CTP’s formal position on enforcement discretion regarding tobacco-derived nicotine (TDN) and non-tobacco/synthetic nicotine (NTN) products.
About Face: The formal response letter promised from Director King stated, among other things, that:
- TDN products are not being treated differently than NTN products.
- CTP has not been using enforcement discretion for tobacco-derived nicotine products or synthetic nicotine products.
- All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold unless and until their PMTAs have been authorized.
Go deeper: While CTP has always acknowledged that FDA was using its enforcement discretion, that has changed. Here is how CTP recasts its historical and current position:
“Accordingly, your letter’s assertion that FDA is “us[ing] its enforcement discretion to allow…products to remain on the market” while they undergo review is not correct. On the contrary, as the guidance reiterates, all illegally marketed TDN e-cigarette products are subject to FDA enforcement. The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement.”
“FDA cannot affirmatively allow or permit the unlawful marketing of tobacco products, including TDN and NTN e-cigarette products; as the above statements reflect, all illegally marketed products are subject to FDA enforcement, such a seizure, civil money penalty, or injunction. Moreover, FDA has not adopted a broad policy of enforcement discretion with respect to TDN or NTN e-cigarette products that lack the required premarket authorization.”
Why Now?
- Sure, VTA has been pressing CTP on clarifying the question of enforcement discretion for months.
- But, it is worth noting that CTP’s letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued another yet another press release and sent a letter to HHS Secretary Xavier Becerra blasting CTP for its, yes, “exercise [of] enforcement discretion,” and demanding “This enforcement discretion should have ended years ago. It must end today.”
- According to CTP’s letter, they have never been using and are not using enforcement discretion for any nicotine-containing product.
Takeaway. As far as the FDA is concerned, every nicotine product that is on the market without having already received a PMTA authorization (even if that PMTA is still being reviewed by FDA) cannot be marketed. And, there is no enforcement discretion preference for tobacco-derived nicotine products as compared with non-tobacco/synthetic nicotine products. They are all in the same boat from FDA’s perspective.
VTA Responds to the Final Reagan-Udall Foundation Report
Leading Vape Trade Association Raises Concerns Over Continued Political Interference at the Center for Tobacco Policy
WASHINGTON, FEBRUARY 24, 2023 – Following the FDA’s response to the
Reagan-Udall Foundation’s critical report, Vapor Technology Association Executive Director Tony Abboud released the following statement:
“The FDA’s response to the Reagan-Udall Report highlights deep, structural problems with the CTP leadership and its operations. The agency’s response does not give any confidence that the biggest problem – the ongoing interference in the scientific process by political officials will ultimately be addressed – particularly since CTP continued this practice after the Reagan-Udall Foundation report was issued.”
“Tellingly, CTP has acknowledged that it operates with no long-term strategic plan yet at the same time turns around and asks for more money both in the form taxpayer funded appropriations as well as $100M in ‘user fees’. Under no circumstances should Congress consider appropriating even more money to an agency bureaucracy that operates with a such a concerning lack of transparency and without a long-term strategic plan in place.”
“To be clear, the request for user fee funding would require passage of a new federal excise tax that ultimately will be passed on to consumers in violation of President Biden’s pledge of no new taxes. According to the FDA, every single manufacturer is selling illegal products (because FDA has only authorized a handful of e-cigarettes). Yet, FDA has no concern about government imposing and collecting new taxes on illegal products to fund their bureaucracy.”
“Unfortunately, CTP currently operates with a de facto policy that denies market approval to any non-tobacco flavored vaping products. This goes against the preponderance of the scientific evidence, including CTP’s own internal documentation, that concluded flavored vaping products are effective tools to help adult smokers quit. Since 2010, when e-cigarettes became widely available in the US, we have seen adults who smoke drop by a remarkable 62 percent. Flavored e-cigarettes should be a key part of the Administration’s cancer moonshot. Unfortunately, CTP seems determined to drive smokers to the riskiest of all nicotine devices – combustible cigarettes – and, while the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine containing product.”
ABOUT VTA
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The Problem With The FDA’s Retail Tobacco Enforcement
The FDA Center for Tobacco Products (CTP) is being criticized for its enforcement efforts and with good reason. A new report of the Vapor Technology Association’s analysis of FDA’s enforcement data has revealed some striking findings that the FDA chooses not to synthesize for the public.
Since 2018, the FDA has spent presumably millions of dollars conducting more than 325,000 retail inspections resulting in a high compliance rate of 86% of inspections with “no violations” for the sale of tobacco products. Furthermore, 96% of FDA retail inspections used minors and the overwhelming majority of those inspections resulted in 85% with in “no violations”, again a high compliance rate.
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database
The utility of CTP’s local enforcement efforts, aimed at youth sales and potential violations at retail stores, needs to be re-examined to determine whether they are worth the expenditure.
FDA Ignoring Combustible Tobacco Product Sales to Youth
The FDA has been rightly criticized by leading tobacco-control scientists for focusing its narrative, policies and efforts on youth vaping and e-cigarette products, but the data shows that warning letters for youth sales violations involving nicotine vaping products only account for 3.8% of all retail inspections conducted since 2018. In comparison, warning letters for youth sales violations for combustible products were twice as high. In 2022 alone, the rate of combustible violations was two and a half times that of nicotine vaping products.
Source: FDA Compliance Check Inspections of Tobacco Product Retailers database
Moreover, FDA data reveals that penalties beyond warning letters for flagrant violations are imposed far more often for violations of combustible products than for vaping products.
The FDA’s continued refusal to publicly acknowledge that youth sales of combustible products are more than two times that of less harmful e-cigarette products raises serious questions about its purpose and intent.
FDA Ignoring the Fact that Vape Shops and Other Adult-Only Stores Have Best Compliance Rates
Our vaping association’s data has determined that FDA policies have, by design or effect, dramatically reduced the number of independent vape shops around the country since 2018 by 27%. This has occurred despite the fact that the FDA has known these stores have the best compliance rate.
However, VTA’s analysis of FDA data reveals that since 2018 adult-only retailers, such as vape shops, have been best at preventing unlawful sales to youth. While almost 78% of youth violations occurred at non-adult only stores, such as gas stations and convenience stores, only 21% of violations occurred in adult-only vape shops (5%) and tobacco shops (16%).
FDA Ignoring the Fact that Tobacco/Menthol E-Cigarettes Far Exceed Other Flavored Vape Sales Violations
FDA rarely makes any statement regarding vaping products without also warning about sales of flavored vaping products to youth. However, FDA’s data reveals that since 2018 youth sales violations of tobacco and menthol flavored vapes exceeded 55%, while sales violations involving other flavors lagged behind at 39%.
The FDA Center for Tobacco Products not only needs to question the resources it is spending to enforce against small businesses, but it needs to be truthful and transparent when it publicly characterizes the issues of youth vaping and retail sales.
VTA Insider Jan 2023 – Smoking vs Vaping, Vaping Info and Regulations.
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.
1 big thing: VTA meets with King…again
The big picture: Kicking off the New Year, on January 10, 2023, VTA leadership and select board members met with CTP Director Brian King and other leadership at the Center for Tobacco Products (CTP) to discuss top agenda items for the year. This was the second meeting that VTA has had with King in the last four months.
Top takeaway: Director King acknowledged the fact that youth e-cigarette use continues to decline but was ambiguous on the reshaping of CTP policy regarding adults, noting they are considering how to address the Reagan-Udall recommendations and looking to engage more with stakeholders.
Remember, Reagan-Udall told CTP to: “resolve how to weigh the public health benefits of adults who use ENDS that will quit smoking combustible tobacco products against the potential public health harms to youth who use e-cigarettes.”
The rest of the agenda: VTA focused on the most pressing issues impacting our members and the industry including:
- Implementing Reagan-Udall Recommendations
- Enforcement Discretion for Non-Tobacco Nicotine
- Need for an Objective APPH Test
- Industry Stakeholder Engagement
VTA presses CTP on clarifying enforcement discretion policy
The “million dollar” question: CTP has historically allowed all tobacco products with pending PMTAs to remain on the market, subject to FDA’s enforcement discretion, but in the past few months has been making confusing statements particularly with respect to non-tobacco nicotine products. Following up on VTA correspondence from early November 2022, we asked Director King: “Has CTP had changed its well-established enforcement discretion policy for non-tobacco nicotine products only?”
What we said: It’s extremely important that we get clarity on this question so all market participants understand CTP’s position and so that companies are not able to misrepresent CTP’s position for their own benefit.
- For years, CTP has used enforcement discretion to allow all tobacco products with pending PMTAs to remain on the market and that policy should be consistently applied to tobacco and non-tobacco nicotine products alike.
- Some companies have been attempting to confuse retailers and dissuade them from carrying synthetic nicotine products by claiming that CTP uses enforcement discretion only for tobacco-dervied nicotine products and not for synthetic nicotine products.
- Nothing in the new law limited CTP’s enforcement discretion – in fact, CTP has been exercising that discretion – and CTP would never unilaterally limit its own discretion.
What they’re saying: During the meeting Director King indicated that had been no policy change with respect to CTP’s use of enforcement discretion.
- 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.
King to VTA: FDA has no enforcement discretion policy for TDN or NTN products
The big picture: CTP has exercised enforcement discretion for years. CTP has asked courts not to limit its enforcement discretion. CTP has explained its actions or inactions based on enforcement discretion.
Why it matters: CTP has consistently used its enforcement discretion to allow products under PMTA review to remain on the market pending a final PMTA determination. Manufacturers, distributors and retailers have relied on CTP’s statements to continue selling less harmful vaping products. Heck, CTP has been criticized by anti-harm reduction forces for using enforcment discretion.
About Face: On February 2, 2023, VTA received the formal response letter promised by Director King in which he clarified that:
- TDN products are not being treated differently than NTN products.
- CTP has not been using enforcement discretion for tobacco-derived nicotine products or synthetic nicotine products.
- In fact, CTP does not even have a policy on enforcement discretion.
- All products, regardless of whether they include tobacco-derived nicotine or synthetic nicotine, are illegal and cannot be sold until their PMTAs have been authorized.
Go deeper: While CTP acknowledged that FDA originally said it would use enforcement discretion, that changed. Here is how Director King recasts what CTP has been doing:
“Accordingly, your letter’s assertion that FDA is “us[ing] its enforcement discretion to allow . . .products to remain on the market” while they undergo review is not correct. On the contrary, as the guidance reiterates, all illegally marketed TDN e-cigarette products are subject to FDA enforcement. The same principle applies to NTN products; specifically, all illegally marketed NTN products are subject to enforcement.”
“FDA cannot affirmatively allow or permit the unlawful marketing of tobacco products, including TDN and NTN e-cigarette products; as the above statements reflect, all illegally marketed products are subject to FDA enforcement, such a seizure, civil money penalty, or injunction. Moreover, FDA has not adopted a broad policy of enforcement discretion with respect to TDN or NTN e-cigarette products that lack the required premarket authorization.”
Why Now?
- Sure, VTA has been presssing CTP on clarifying the question of enforcement discretion for months.
- But, we can’t help noting that CTP’s 2-page letter (three months in the making) was received just one day after Sen. Richard Durbin (D-IL) and other Senators issued another press release and sent a letter to HHS Secretary Xavier Becerra blasting CTP for its, yes, “exercise [of] enforcement discretion,” and demanding “This enforcement discretion should have ended years ago. It must end today.”
- At least now we know that FDA is not using enforement discretion for any nicotine-containing product.
VTA to FDA on Reagan-Udall: Need to Pull It Together, Together
One big thing: The Reagan-Udall report raised a number of critical issues regarding CTP’s handling of tobacco regulation that demand immediate attention and immediate industry engagement. VTA learned that CTP will formally respond to the Reagan-Udall report in mid – February. With that in mind, in our January conversation with Director King, VTA highlighted the Reagan-Udall recommendations that mirrored VTA’s own recommendations:
- CTP needs a strategy: Reagan-Udall said that CTP has no strategic plan and “must create [a strategic plan] that identifies the CTP’s strategic objectives and plots an operational roadmap of the steps CTP will take over the next five years to achieve those objectives.” VTA strongly supports this recommendation and noted its agreement with Reagan-Udall that the path to resolving many of the CTP’s self inflicted problems starts with establishing the scientific and policy framework for tobacco harm reduction.
- CTP needs to establish what is APPH: Reagan-Udall made clear that CTP must “explain how FDA is interpreting the [appropriate for the protection of public health] APPH standard” and how it is weighing “the public health benefits of the percentage of adults who use ENDS that will completely quit smoking … against the potential public health harms [to] youth.” VTA noted that APPH evaluations were being subjectively decided in conflict with the science. VTA offered to work with CTP on an objective process for ensuring that APPH decisions are made without political or outside interference.
- CTP must advocate clearly for harm reduction: Reagan-Udall noted that “CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction” which undercuts CTP’s mission. CTP has acknowledged the continuum of risk but has no clear policy or strategy on harm reduction. VTA emphasized the need for a clear APPH standard and clear messaging from FDA on harm reduction.
- CTP must be transparent: VTA has consistently raised concerns regarding the opaque operations of the CTP. Reagan-Udall’s review highlights a shifting decision-making process, lack of clarity on responsibilities, and impact of extreme external pressures. Transparency in decision making is as imporatnt as transparency and engagement in the policy process. We urged CTP to create opportunities for communication outside of the rule making process and recognize that companies which are spending millions of dollars are acting in good faith and need to be engaged early.
What’s next: Based on Director King’s statements and promises, we should expect a much higher degree of stakeholder engagement, including VTA and other industry engagement, with CTP on the critical issues raised by Reagan-Udall. However, it is unclear how FDA/CTP will choose to address Reagan-Udall’s serious criticisms. It is equally unclear whether CTP will tackle the problems with enough force to change CTP’s trajectory away from propping up cigarettes and toward replacing them with less harmful vaping and modern oral products.
Progress in The Courts
The big picture: FDA CTP is embroiled in litigation throughtout the country which is testing whether FDA’s “fatal flaw” approach to PMTAs and its implementation of post-application testing prerequisites violate the law. Those cases, pending in various federal appellate courts, could end up in conflict thus paving the way for SCOTUS review.
One important case: Wages & White Lion v. FDA, is pending in the 5th Circuit. There, the petitionr originally secured the “suprise switcheroo” opinion which heavily criticized the FDA for changing the application requirements after the fact and imposed a preliminary injunction barring the FDA from enforcing its MDO against Wages & White Lion. However, in a split-decision (2-1), the final panel agreed with the FDA and denied the appeal.
5th Circuit Rehearing: Wages & White Lion asked all 9 judges of the 5th Circuit to review the case and that request was granted so the full 5th Circuit panel will now make the court’s final decision. VTA filed an amicus brief in support of the request for a rehearing en banc, provinding the court with the findings of its experts’ analysis of the severe economic ramifications of the FDA’s flavor ban.
FDA’s Illogical VUSE on Menthol
The big picture: Last month, FDA issued market denial orders for two VUSE menthol PMTAs filed by R.J. Reynolds. You can read FDA’s statement here. This after FDA denied LOGIC’s menthol vape PMTAs, filed by JTI, last year. The tobacco giant quickly obtained an injunction from a federal court to bar enforcement of the FDA’s decisions.
Why it matters: It is safe to say that we have entered the unfortunate reality where FDA is intent on treating menthol products in the same dismissive manner in which it has treated all other flavored vaping products to date. It appears that no amount of science will be sufficient for FDA leadership and that in the absence of menthol vapes, former smokers will become smokers again.
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.
VTA Insider December 2022 – FDA Tobacco Regulations
Welcome to the December edition of the VTA Insider, your industry focused briefing from the Vapor Technology Association.
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.
Reagan-Udall Issues Critical Report on FDA Tobacco
The big picture: Last July, FDA Commissioner Robert Califf called for an indpendent review of the FDA’s heavily criticized Center for Tobacco Products (CTP) by the Reagan-Udall Foundation (RUF). The RUF report, released last week, painted a troubled picture of a CTP’s culture, inconsistent and opaque rules and standards, and political interference with what should be scientific decisions.
What the experts found: RUF’s independent panel of tobacco experts found:
- CTP has no strategic plan and must create one that identifies the Center’s strategic objectives and plots an operational roadmap to achieve them.
- CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health (APPH) standard or how it is applying the APPH standard.
- CTP struggles to function as a regulator due to some of its own policy choices.
- CTP faces significant challenges in clearing policies through the career and political infrastructure.
- CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.
RUF Recommendations: Some of the most important recommendations of the independent tobacco expert panel:
- “The Panel strongly recommends that the center invests the time – now – in … thinking strategically about where it is deficient, where it needs to be in the future, and how best to get to that future.”
- “The path to resolving many of the Center’s current challengesstarts with establishing the scientific and policy framework to make clear and timely product decisions.”
- “The plan must … explain how FDA is interpreting the APPH standard.”
- “CTP has a responsibility to clearly identify application requirements.”
- “CTP must resolve how to weigh the public health benefits of adults who use ENDS that will quit smoking combustible tobacco products against the potential public health harms to youth who use e-cigarettes.”
Why it matters: Using the addled prcess described by RUF, CTP hasrejected the overwhelming majority of applications for millions of less-harmful vaping products and has done so without being able to articulate how it is balancing the public health standard.
Keeping score: 600 – 8 – 0 – 0 – 0 – 0
- 600 = the # of combustible tobacco products, including 250 new cigarettes, authorized for sale.
- 8 = the # of less harmful tobacco-flavored e-cigarettes authorized.
- 0 = the # of less harmful menthol-flavored e-cigarettes authorized.
- 0 = the # of less harmful other-flavored e-cigarettes authorized.
- 0 = the # of less harmful open-system devices authorized.
- 0 = the # of less harmful nicotine pouch products authorized.
Our thought bubble: “The FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary,” said VTA’s Executive Director.
Read VTA’s full statement on the RUF Report, VTA’s oral testimony to RUF, the summary of VTA’s recommendations and its full written submission to RUF.
Watch VTA’s Executive Director discuss the RUF report on Regulator Watch.
Where’s the logic?
The big picture: On October 26, 2022, FDA denied Logic Technology Development, LLC’s (LOGIC) menthol-ENDS PMTA applications claiming that LOGIC failed to prove that its menthol products were appropriate for the protection of public health (APPH). But, in documents made public recently, LOGIC revealed that CTP’s Office of Science changed its standards for reviewing menthol-ENDS PMTAs aftereffectively being told to do so by the CTP Center Director’s office.
- In a memo written by the head of the Office of Science, it was disclsoed that the scientists initially decided to authorizeLOGIC’s menthol-ENDS products back “in the latter half of 2021” after taking into account all factors including potential attraction to youth.
- But, after the Center Director’s office “shared [its] views,” the Office of Science changed its approach and recommendation to deny LOGIC’s menthol PMTAs.
Why it matters: It appears that CTP is applying the same flawed youth-oriented decision making process for evaluating menthol-flavored vaping products as it did other-flavored vaping products. In other words, anypotential youth use outweighs LOGIC’s studies demonstrating little to no youth uptake and significant adult smoking cessation.
What we’re saying: CTP’s decision was made during using a process which the Reagan-Udall Foundation was highly critical of due to CTP’s lack of transparency on the balancing test and what appear to be scientific decisions getting overriden by policymakers at the agency. VTAshared copies of the internal FDA memos with the Reagan-Udall Foundation before it issued its report.
What’s next: LOGIC, having already filed suit, has its case on what appears to be a fast track so we hope to see a court decision soon.
Worth your time…
Must-see webinar on age-gating. Missed the recent webinar Protecting your Brand, Products, & Consumers: Age-Gating and Supply Chain Security? Watch this free 60-minute webinar moderated by Dr. Jessica Zdinak, with Dave DeJean and Eric Hawk. Use the passcode: =rk0V3k0
Attorney General Tom Miller and leading tobacco-control scientists published a must-read editorial in Addiction entitled United States Public Health Officials Need to Correct E-cigarette Health Misinformation
“Health misinformation is harmful as it can cause confusion and sow mistrust regarding the adoption of public health recommendations and policies. We provide examples of e-cigarette misinformation promoted by the United States public health officials, which have persisted despite new data challenging the validity of the original assertions.”
VTA Executive Director Tony Abboud speaks to Regulator Watchabout a number of regulatory updates. Abboud discusses litigation, flavored ENDS appeals, and Supreme Court flavor cases and much more.
Happy Holidays To All
We at VTA are wishing everyone a safe (warm!) and happy holidays as we look forward to a new year filled with change and prosperity!
Stay tuned in with us for lots of new developments in the coming year and make sure your friends and colleagues are signed up to receive our news and information..
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