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!

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.

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Also Read: FDA Approves Combustible Tobacco at a Dangerous Rate

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.

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.

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Also Read: How FDA’s Anti-Vaping Policies Affect Minorities in America

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.

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.

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 PMTA Recommendations

1. FDA must implement safeguards at the Center for Tobacco Products (CTP) to ensure that the scientific review process is insulated from external pressures and that CTP scientists are allowed to unapologetically follow the science.
2. Immediately rescind the July 9, 2021 and August 17, 2021 process memos which resulted in the en masse denial of flavored ENDS products, restore the holistic review process and the primacy of the appropriateness for the protection of public health balancing test.
3. Build the off-ramp from smoking by accelerating the authorization of ENDS products and using the full scope of CTP’s post-marketing order authority to monitor and control for youth concerns.
4. Clearly articulate CTP’s use of enforcement discretion to work companies through the PMTA process, particularly for non-tobacco nicotine (i.e., synthetic nicotine) applications.
5. Communicate with companies to seek additional information or corrections and avoid rejections based on administrative or technical failings and the needless litigation that follows.
6. Establish defined testing methods for END products which create transparency and certainty.
7. Eliminate redundant and unnecessary testing to streamline the PMTA process.
8. Develop and publish a PMTA proposed regulation with a finite checklist of required information that is required for PMTA review.
9. Equally fund research for identifying how ENDS products can be solutions for smoking, rather than simply identifying problems with ENDS products and youth.

VTA Regulations and Guidance Recommendations

1. CTP should implement a Comprehensive Plan on tobacco and nicotine that includes a clear acknowledgment of the FDA’s commitment to:
   1. the continuum of risk related to tobacco products and a recognition that ENDS and modern oral nicotine products sit at the lower end of the risk continuum,
   2. promoting innovation of those products at the lower end of the risk continuum, particularly ENDS and modern oral nicotine products,
   3. promoting innovation in nicotine, particularly synthetic nicotine,
   4. a pure scientific review process,
   5. funding science to evaluate the benefits of ENDS and modern oral nicotine products,
   6. working with companies to facilitate the application review process,
   7. aggressively educating adult smokers on the benefits of trying ENDS products if they are otherwise unwilling or unable to quit smoking using other methods,
   8. using its enforcement discretion to allow products under review to remain on the market pending authorization reviews, and
   9. a streamlined process which will ensure prompt review of product applications.
2. CTP should engage industry and other stakeholders in the guidance and regulation processes by:
   1. Converting its listening sessions to engagement sessions so that CTP personnel are encouraged to communicate, ask questions and engage with stakeholders during meetings;
   2. Reinstituting its public stakeholder workshops which bring together all stakeholders to provide input on key regulatory policies and strategies; and
   3. Establishing an additional technical advisory committee dedicated to newly deemed alternative nicotine products to have a more focused strategy for less harmful nicotine products
3. CTP should issue proposed regulation or guidance on product standards that:
   1. Explicitly allows widely accepted statistical design methods of research, aggregate testing, and extrapolation for ENDS product stability testing, and
   2. Permits manufacturers to market safety and/or quality enhancements with 60-Day notice to FDA.  

VTA Enforcement Recommendations

1. CTP must use its full authority to ramp up interdiction of illicit products at the ports.
2. CTP needs to streamline and reprioritize its enforcement efforts, rather than focusing so much on generally ineffective retail level enforcement.
3. CTP should publish list of NTN products currently under PMTA review to facilitate industry and FDA enforcement efforts.
4. CTP should restructure its enforcement efforts, through a guidance document, to achieve the following altered enforcement priorities:
   1. Stopping the flow all disposables into the U.S. market for which no PMTA has been filed by interdicting products at the ports;
   2. Enforcing against other ENDS products for which no PMTA has been filed, first prioritizing tobacco-derived products which make up the bulk of the market and then NTN products (since the latter are only a fraction of the market);
   3. Enforcing against counterfeit and illicit products which grossly violate marketing standards, trademark laws, or otherwise have marketing campaigns directed at youth; and
   4. Enforcing against products for which CTP has issued marketing denial orders (MDOs) after a full scientific review consistent with requirements of the Tobacco Control Act, except of course, those subject to an FDA administrative stay or a court-ordered stay of enforcement.

VTA Public Education & Communication Recommendations

1. CTP must loudly and repeatedly correct the public record that nicotine does not cause cancer and that ENDS products, in the words of CTP Director King “have markedly less risk than a combustible cigarette”;
2. CTP must commit equal resources to conducting an aggressive public education campaign, targeted to the adult consuming public, on the dangers of smoking and the lower risks of ENDS and modern oral nicotine products, explaining the continuum of risk, and encouraging adult smokers who have been unable or unwilling to quit to try e-cigarettes; and
3. CTP must end the misleading youth education campaigns that are designed to scare youth (and adults) with false statements regarding the risks of e-cigarettes.