Representatives of 22nd Century Group will ring the Nasdaq Closing Bell on Aug. 26, 2022, celebrating the launch of VLN reduced-nicotine cigarettes.
In December 2021, the U.S. Food and Drug Administration gave 22nd Century Group permission to market VLN cigarettes as modified-risk tobacco products, making them the first combusted cigarettes to be authorized as such and the second tobacco products overall to receive “exposure modification” orders.
Since that time, the company has launched VLN cigarettes in various pilot markets, including in the Chicago area.
According to 22nd Century Group, the Chicago pilot has exceeded expectations, leading the company to accelerate and expand its launch plans to the state of Colorado.
“Our VLN pilot program in Chicago has confirmed the market’s interest in VLN as adult smokers look for new tools to help them smoke less, an important step to improving overall public health,” said John J. Miller, president of 22nd Century’s tobacco business, in a statement.
“Based on the better-than-expected results of our pilot, we are accelerating our launch plans and commencing sales in the state of Colorado through multiple partners committed to helping us offer adult smokers a real choice, a product that can help them smoke less.”
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has updated the term “grandfathered tobacco product” to “pre-existing tobacco product” to describe these products more appropriately.
Additionally, the term “grandfathered,” when used to describe someone or something exempt from a new law or regulation has its roots in 19th century racist voting laws, according to the FDA.
Like the grandfathered products before it, a pre-existing tobacco product is any tobacco product (including those products in test markets) that was commercially marketed in the United States as of Feb. 15, 2007.
As was the case with submitting a grandfathered determination request, submitting a request to determine the pre-existing status of a tobacco product is voluntary and not required under the Federal Food, Drug and Cosmetic Act.
According to the CTP, the terminology update requires no additional action by companies with pending grandfathered determination request.
A new U.S. study, published in Environmental Science and Technology, warns against the risk of “thirdhand” smoke, which forms when particles from a cigarette seep into materials like hair, clothes and furniture.
Researchers at the Berkeley Lab in California carried out a series of experiments on humans and mice.
In one study, three volunteers who did not smoke were asked to wear the clothes of a heavy cigarette user for three hours.
Tests showed they had up to 86 times higher levels of the toxic compounds NNK and NNN in their urine after the experiment.
In another study, researchers exposed the same carcinogens to human lung tissue and showed they can cause DNA damage, which is one of the triggers of cancer.
“These findings illustrate the potential health impacts of thirdhand smoke, which contains not only TSNAs but hundreds of other chemicals, some of which are also known carcinogens,” said author Neal Benowitz, a medic at the University of California, San Francisco.
“Next steps for this research will explore in more detail the mechanisms of adverse health effects associated with tobacco and cannabis residues, effective remediation strategies and translation of scientific findings to tobacco control practice.”
The U.S. Food and Drug Administration Today issued a final guidance on guidance perception and intention studies.
The guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).
TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.
These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.
The final guidance addresses several scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:
Developing study aims and hypotheses
Designing quantitative and qualitative studies
Selecting and adapting measures of study constructs
Determining study outcomes
Selecting and justifying study samples
Analyzing study results
The guidance document is intended to provide clarity to applicants regarding existing requirements under the law, according to FDA.
“FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited,” the release states.
Tobacco farmers in Pakistan on Monday urged the government to withdraw PKR380 ($1.76) per kilogram advance tax on the tobacco leaf, otherwise they would stage a protest in Islamabad.
Addressing a press conference at Islamabad National Press Club, president of the Mehnatkash Labour Federation, Ibrar Ullah, said that price of tobacco per kilogram in the open market was PKR256 per kilogram while the advance tax on it was PKR380 per kilogram, according to The News.
He said the advance tax on the tobacco leaf was hurting the sale of the crop in the market and this would render over 15,000 labourers and 20,000 families of the farmers jobless.
The president of the Kissan Board, Rizwan Ullah, also rejected the imposition of the advance tax on the crop, saying the government was destroying the value of the crop through such tactics instead of providing them relief.
He said that all farmers from Khyber-Pakhtunkhwa province would stage a sit-in in Islamabad if the advance tax on the crop was not withdrawn.
Liaqat Yousafzai of the Kashtkar Coordination Council KP termed the imposition of the advance tax on the tobacco crop as “public enmity.”
He said that rates of tobacco were increasing around the world, while they were decreasing in Pakistan.
Recently, U.S. Food and Drug Administration Commissioner Robert Califf announced an external evaluation of both the Human Foods Program and the Center for Tobacco Products (CTP). The FDA press release observed that “… even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. To that end, the review will push toward ‘organizational excellence.’”
Califf is right—the CTP clearly requires assistance. The purpose of this article is to review how the CTP arrived in this untenable situation and to suggest areas of focus for the review of the CTP processes.
How Did We Get Here?
There is little doubt that the CTP is in an unenviable position. No matter which way the agency turns, it is impossible to please everyone. The anti-tobacco/vaping groups will never be satisfied until all tobacco products are gone—so realistic harm reduction propositions from the center will always be met with opposition. And when the CTP tries to develop policies with a focus on efficiency, many in the industry claim that they are “prohibitionist” and that they have no regard for harm reduction and/or the human and economic consequences of their decision-making.
Recently, several court opinions and CTP actions have significantly contributed to the challenging environment for the CTP:
West Virginia v. EPA. While not directly related to the CTP, the West Virginia v. EPA Supreme Court decision has reopened the question as to whether discretion of regulatory agencies may become more limited in the future. The court seems poised to chip away at longstanding doctrines (or apply them more forcefully) to limit agency power and place policymaking back with the legislature.
Cigar Association of American v. FDA. More recently, in the Cigar Association of America v. FDA case, Judge Amit Mehta of the U.S. District Court for the District of Columbia examined whether the FDA’s decision not to exempt premium cigars from the Deeming Rule was arbitrary and capricious. The court ultimately found that the FDA ignored evidence in the rulemaking record—and ruled against the agency.
Juul v. FDA. Days later, the CTP found toxicological issues with Juul’s popular vapor products and issued marketing denial orders (MDOs) for those products. Not surprisingly, Juul immediately requested and received an emergency stay of the MDOs from the D.C. Circuit. Without missing a beat, the CTP promptly “… administratively stayed the marketing denial order. The agency [determined] that there are scientific issues unique to the Juul application that warrant additional review.” Several commentators questioned the CTP’s rationale for its decision to re-review Juul’s applications, and some have gone so far as to suggest that this quick reversal indicates a less than appropriate review of Juul’s data or worse—a lack of confidence in the CTP’s decision-making. Either way, the entire chain of events draws into question the CTP’s review process.
Finally, the CTP is still under pressure to complete decisions on premarket tobacco product applications (PMTAs) for those companies addressed in the Maryland court decision which, according to the CTP, will not be completed until next summer. Further compounding the CTP’s problems, the center continues “processing” approximately 1,000,000 synthetic nicotine PMTAs past the congressional deadline for marketing decisions on July 13, 2022. How the center will respond to this pressure is anyone’s guess. So far, it seems like the CTP continues to move at its own pace, following the Maryland court’s order to the best of its abilities.
These external and internal factors point to one conclusion that cannot be ignored—the CTP appears to be struggling and needs something to change. With the above in mind, the following are a few areas ripe for external (and internal) review at the CTP.
Credit: Fizkes
Operational Changes
Operationally, the CTP seems to have the resources (personnel and budget) to successfully regulate tobacco products. That said, certain policy choices and administrative actions (both self-inflicted and externally inflicted) appear to hamper the center’s ability to effectively manage the space. Importantly, effective regulation is hamstrung by the complexity of the U.S. tobacco regulatory scheme, a lack of clear standards for product testing and approval and a too opaque product application process.
The most challenging operational issues come from the existing regulatory scheme, which is too complex for tobacco products. The Tobacco Control Act dictates the parameters/guardrails, but the CTP has latitude in how the process is implemented. The comprehensive PMTA guidance and robust final rule demand a scientific depth that goes too far. The question is: Is all of the delineated scientific data really necessary to determine that a product is appropriate for the protection of public health (APPH)?
If comparing to combustible cigarettes, it would seem that most electronic nicotine-delivery product APPH determinations could be made based on chemistry alone. Piling on bench toxicology, human factors, pharmacokinetic and behavioral studies, it’s no wonder the review process takes so long.
Standards are not clear. Without clear standards, the CTP and industry both are left constantly employing guesswork and conjecture to facilitate decision-making. While understandably there is no simple formula for APPH, clear expectations would be beneficial and efficient. By way of example, which device characteristics really need testing? What is the depth of stability testing necessary? What constitutes a sufficient PK [pharmacokinetic] study? While the initial meeting with the Office of Science is often useful to help answer questions like these, better defining product-specific standards and setting minimums would go a long way to streamlining the approval process.
Transparency is lacking. While one can review the Technical Project Lead Reviews and some of the review standards memos that the CTP places on its website, few PMTA applicants have any idea what’s going on with their applications at any given time. Other than the initial pre-PMTA meeting and the sole deficiency letter, there is little that applicants know about the status (both administratively and substantively) of their applications. While more transparency about the status of applications would be welcome, more back and forth on issues in applications would benefit everyone—particularly the CTP. In the case of Juul, reports indicate that Juul provided thousands of pages of data related to the toxicological issue that the CTP raised in the MDOs. If the now outdated additional information requests were utilized by the CTP, Juul would have pointed out this data, and at least one issue could have been resolved well short of a trip to the courthouse.
Credit: Oleg
Policy Changes
It goes without saying that U.S. government policy can be fickle to say the least. Setting and maintaining long-term policy is difficult—especially in light of changing administrations every few years. Despite this, overriding policy tenants as they relate to harm reduction can, and should, form the cornerstone of tobacco regulatory policy. If harm reduction is the priority, then regulators need to prioritize pathways for reduced-harm products to enter the market, incentivize innovation and focus on providing offramps to combustible cigarette smokers seeking to quit smoking.
Harm reduction policy. During the tenure of former Commissioner Gottlieb at the FDA, many in the industry thought harm reduction would prevail and that all would recognize vapor products’ place at the opposite end of the continuum of risk from combustible cigarettes. Unfortunately, the significant uptick in youth experimentation with a few types of vapor products prodded the CTP into a tough position. Public health groups, dissatisfied with the CTP’s pace, forced the center into a corner via litigation.
Assuming the goal of the Tobacco Control Act remains to reduce smoking-related morbidity and mortality, harm reduction strategies are central to achieving that goal. Importantly, harm reduction strategies should be palatable to all stakeholders. While the CTP has several initiatives moving forward, is there a plan for initiatives dedicated to moving smokers to safer alternatives? Efforts to move smokers to less risky alternatives do nothing when those less risky alternatives cannot succeed via the PMTA pathway. Current tobacco policy is remarkably dissimilar from the variety of strategies employed for other unsafe behaviors where harm reduction is embraced as the primary alternative. In areas such as drug use and sexually transmitted diseases, our society generally accepts reduced-harm efforts, but for tobacco, collectively we are still searching for that sweet spot.
Given all the challenges that the CTP faces, working on harm reduction policies hand-in-glove with nongovernmental groups and industry probably does not seem like the best use of time. When the center was first formed, frequent scientific meetings were held on various issues (such as harmful and potentially harmful constituents). These have fallen off in recent years, likely in part due to Covid and also due to the onerous demands on the center. Prioritizing genuine and open conversations between the CTP, industry and tobacco control groups is critical to developing strong harm reduction policies. Holding scientific meetings (either through the CTP or the Tobacco Products Scientific Advisory Committee) on harm reduction plans and policies would add transparency and bring all ideas to the table.
The FDA should not let the perfect be the enemy of the good when considering reduced-harm products. At present, PMTA reviews appear to be searching for the perfect. Reviews seem to focus on the smallest details that might pose a risk while ignoring a more generalized comparison to combustible products with 70 known carcinogens (and a track record of 480,000 deaths per year). APPH does not mean no risk—it means less risk than the deadliest consumer product ever invented, the combustible cigarette. Reconsidering how APPH is adjudged would be an excellent first step in combatting morbidity and mortality attributable to smoking.
Investing in harm reduction must be incentivized. If one wants to develop a new product, the timeline is a hard stop. A year of product development, up to three years of PMTA testing (including two years of stability and time to plan, conduct and write up the studies) plus one year to three years of the CTP review before the possibility of a marketing order sounds like a pretty poor investment. The PMTA process must change to bring less risky products more rapidly to market.
Society must not forget about smokers. Youth tobacco issues are important, but the 1,300 smokers dying each day are important too. A balanced harm reduction policy—controlling youth access and exposure while moving combustible cigarette smokers to quitting tobacco altogether or moving to a less risky product is necessary.
Moving Forward
Hopefully the external review will be a fruitful exercise—one that provides robust alternatives for the CTP to consider. The review, if rightly focused, will address foundational issues that will, in the end, lead tobacco regulation to a reasonable, reduced-harm world where smokers are given hope for a future.
Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
Rich Hill is the compliance director and associate general counsel of E-Alternative Solutions.
Milo Vapes Global (MVG) has announced its plan for its Fall 2022 product launch. The range of flavored nicotine vaping products will be released under two brands, Milo Vapour and Sahara Mist, which will be distributed exclusively in the Middle East market.
“Influenced by history and culture, we carefully selected and drafted new and innovative tobacco products that are tailored to the consumers’ tastes and cravings,” says Mike Khalil, president, and founder of MVG. “The company is committed to its mission of delivering solutions to the smoking epidemic by delivering new tobacco products that aim to better smokers’ quality of life.”
The e-cigarettes market is estimated to grow at a rate of 9.7 percent annually and is estimated to reach $485 million by 2025, up from $267.9 million in 2018. MVG aims to contribute to the growth of the e-cigarette market through innovations and brand recognition in conjunction with our harm reduction initiative, according to a press release.
“Governments could play an essential role in changing the population’s behavior toward smoking. The government must regulate and oversee the vape industry in each country, and the health departments should safeguard the vape industry and protect consumers in each country by ensuring the safety and integrity of e-cigarettes,” said Khalil. “Furthermore, healthcare providers should advise smoking patients to transition to less harmful alternatives such as e-cigarettes through healthcare strategies and disease prevention programs.”
While offering various benefits, heated-tobacco products (HTPs) require lots of dedication from tobacco retailers to be successful, according to an article in the U.K. publication Better Retailing.
Although vaping has rapidly taken off since its introduction in the U.K. two decades ago, HTP is a younger technology that has taken some time to build momentum. Philip Morris Limited (PML) entered the market in 2016 with IQOS, and Japan Tobacco International debuted its Ploom device in the U.K. in 2020.
In 2021, HTPs represented 18.6 percent of the total reduced-risk product market in the U.K., up 86 percent compared to 2020, suggesting considerable gains for retailers who can invest the time, energy and research that this category demands.
The retailers interviewed by Better Retailing reported hit-or-miss success with heat-not-burn products, with one shop owner keeping IQOS Heets in store for a single customer and another bringing in more than £1,000 ($1,183) per week with the product.
JTI advises retailers to maintain good stock levels and to have devices available for in-store demonstrations and for using platforms, such as JTI’s trade website jtiadvance.co.uk, to generate repeat sales.
Kate O’Dowd, head of commercial planning for U.K. and Ireland at PML, urges retailers to not limit themselves by a “stock-and-sell” mentality. “Build connections with customers to understand their preferences so you can offer a smoke-free alternative that meets their needs,” she says.
Researchers worked with general practitioners and the National Health Service (NHS) to set up a pilot vape shop voucher scheme to help patients who had tried and failed to quit smoking in the past.
An evaluation of the scheme, funded by Norfolk County Council, showed it was a big success as 42 percent of the entrenched smokers who were referred to it and redeemed their vape voucher quit smoking within a month.
“Research shows that vaping is an effective way of quitting smoking compared to nicotine-replacement therapies like patches and gum,” said lead researcher and addiction expert Caitlin Notley of the UEA’s Norwich Medical School.
“This innovative approach saw the NHS local stop-smoking service, vape retailers and researchers working together, recognizing that other forms of smoking cessation support do not work for everyone.
“This scheme enabled 42 percent of entrenched smokers who redeemed a voucher to have successfully quit smoking at four weeks. This is especially important because it helped those who have tried and failed to quit smoking many times to move away from tobacco.”
Following its initial success, the scheme has been rolled out across Norfolk.
Vaping activists have praised the Philippines for enacting progressive e-cigarette legislation.
On July 25, legislation took effect that lowers the purchase age for e-cigarettes and heated-tobacco products, removes a two-flavor limit on e-liquids and allows vaping sponsorships beyond industry associations and trade events.
“Enacting some of the most progressive vaping legislation in Asia-Pacific now makes the Philippines an international leader in effective tobacco harm reduction,” said Nancy Loucas, executive coordinator of the Coalition of Asia Pacific Tobacco Harm Reduction Advocates (CAPHRA). “It’s a massive wake-up call for other countries to also enable smokers to switch to safer nicotine products.”
Peter Dator, president of Vapers PH, says the new law protects minors, helps to eradicate black markets, ensures safety standards and gives adult smokers access to viable cigarette alternatives.
“By adopting a successful THR strategy, we now join about 70 countries worldwide which are all seeing smoking rates fall,” said Dator. “This is truly a landmark piece of legislation which I hope other countries now follow. Embracing vaping is the only way to eradicate smoking.”
Dator also praised Philippine lawmakers for resisting foreign attempts to influence the country’s health policies.
“It’s well established that the Philippines has been a target of American billionaires and their so-called philanthropic foundations fueling anti-vaping sentiment,” he said. “Our leaders have now stood up to the bullies with a legacy that will endure for generations.”
