“Policy regarding e-cigarettes in the U.S. has focused on measures intended to reduce youth vaping, including imposing taxes on e-cigarettes and restricting flavors,” said Kenneth Warner, who wrote the paper with his University of Michigan colleagues Cliff Douglas and Karalyn Kiessling, along with Alex Liber of Georgetown University.
“Unfortunately, some of the measures may be backfiring. For example, if not matched by at least comparable increases in cigarette taxes, e-cigarette taxes that reduce youth vaping may also increase kids’ smoking. As well, some of these youth-oriented taxes appear to be reducing adult smokers’ use of e-cigarettes, increasing their smoking and reducing smoking cessation. We need to find policies that simultaneously address the widely shared dual goals of preventing youth vaping and increasing adult smoking cessation.”
The authors advocate for the U.S. Food and Drug Administration to reduce nicotine levels in combustibles, adding that it would have the best outcome if “accompanied by regulations ensuring the availability of alternative products, such as e-cigarettes.”
They also advocate for “states and the federal government [levying] large excise taxes on cigarettes and other combustible tobacco products and a more modest excise tax on e-cigarettes.”
The authors insist that only vape and tobacco shops should be allowed to sell nicotine products, that flavors should be banned in combustible tobacco products and that “all e-cigarette flavors other than tobacco and menthol and possibly a relatively small selection of other flavors with clearly adult-oriented marketing” should be banned.
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.
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.
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.”
The U.S. Food and Drug Administration on Aug. 18 issued a warning letter to VPR Brands (doing business as Krave Nic) for marketing illegal flavored nicotine gummies—the first warning letter for this type of product.
According to the FDA, these types of gummies are of particular public concern because of their resemblance to kid-friendly food or candy products and the potential to cause severe nicotine toxicity or even death among young children.
VPR Brands markets gummies that have 1 mg of nicotine each and are available in three flavors – Blueraz, Cherry Bomb and Pineapple. The packaging claims that the products contain tobacco-free nicotine. This firm has not submitted a premarket tobacco product application to the FDA, and does not have a marketing authorization order to manufacture, sell or distribute these products in the U.S.
“Nicotine gummies are a public health crisis just waiting to happen among our nation’s youth, particularly as we head into a new school year,” said FDA Commissioner Robert M. Califf in a statement. “We want parents to be aware of these products and the potential for health consequences for children of all ages—including toxicity to young children and appeal of these addictive products to our youth. The FDA will not stand by as illegal products infiltrate the marketplace.”
In establishing whether a nicotine product is appropriate for the protection of public health, the U.S. Food and Drug Administration held its Center for Tobacco Products (CTP) reviewers to a lower standard than the companies submitting premarket tobacco product applications, according to Alex Norcia writing in Filter.
Citing documents obtained through the Freedom of Information Act, Filter describes procedures such as batching and bracketing, which allowed the CTP to apply conclusions to categories of products rather than evaluating them separately. “Despite imposing extremely onerous bureaucratic requirements on applicants, the agency was happy to find ways to cut through its own paperwork,” writes Norcia.
“It’s clear that FDA allows itself efficient shortcuts that it has denied to applicants,” Clive Bates, director of The Counterfactual, told Filter.
“The problem has always been that FDA’s extraordinarily burdensome process was obviously tremendously wasteful for applicants, but of course it was always going to be unmanageable for the assessors in FDA. Without this sort of shortcut, the PMTA process would have become a human resources nightmare. So FDA has allowed itself the kind of efficiencies it should have offered to the applicants—batching and bracketing thousands of near-identical products.”
The Reagan-Udall Foundation has picked Clinton-era U.S. Food and Drug Administration commissioner Jane Henney to spearhead its 60-day review of operations in the agency’s food safety and tobacco divisions, according to Politico.
Henney, the first woman to lead the agency, has not formally been announced yet.
The FDA Commissioner Robert Califf made the move in an attempt to push past several controversies that have dominated his second stint running the agency, including his issuing of a marketing denial order (MDO) to e-cigarette maker Juul Labs and later having to rescind that order.
One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).
“A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”
Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.
Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.
“Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.
Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.
“The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”
All bark, no bite
After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement.
King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.
Many retailers simply ignore the FDA warnings. One owner told Tobacco Reporter that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged the agency’s public perception.
While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.
It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.
At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.
Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.
“Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”
Malaysia’s proposed Control of Tobacco Product and Smoking Act breaches basic human rights, according to the nation’s leading tobacco industry group. Tabled for its first reading on July 27, the bill bans individuals born in 2007 or later from smoking, buying or possessing tobacco and related products. Offenders face stiff penalties, including imprisonment.
The Confederation of Malaysian Tobacco Manufacturers (CMTM) says adult Malaysians are protected under Section 6 of the Consumer Protection Act 1999, which allows them to make their own choices without worry of prejudice or repercussions.
“Moreover, these laws give the authorities too much power as it allows them to check your personal details, raid your home, inspect your telephone or luggage and access your personal details,” the group said in a statement dated July 31 and cited by the Malay Mail.
“Then you will have to give them your password, face arrest, be subject to body checks and see your home entered without permission for inspection.
“In the end, instead of creating a smoke-free generation, we are creating a generation of criminals who are being punished for buying a product others can buy.”
The CMTM also argued that prohibition will boost the illegal tobacco trade, which currently supplies 60 percent of the market estimated at MYR5 billion ($1.12 billion). The group said individuals will have to hide their habit and be stigmatized as criminals.
Meanwhile, the Special Parliamentary Select Committee on Health, Science and Innovation has urged the government to ease the punishment for teenagers caught smoking cigarettes, according to the New Straits Times.
Instead of threatening jail time, the law should penalize juvenile offenders in practical and positive ways, through community service or mandatory counseling sessions for example, the committee argued.
“We are also concerned over aspects of enforcement power in the bill itself, especially involving juveniles and even children,” said committee chairman Kelvin Yii.
“The power to inspect, possibly conduct body checks and punish a child for possession must be heavily controlled to prevent abuse. This is why the guidelines for enforcement must be very clear and specific on this to ensure the vulnerable, especially the poor, are not victimized by the law.”
A bill seeking to lower the purchase age for e-cigarettes and heated-tobacco products has lapsed into law in the Philippines, reports ABS-CBN, citing a tweet sent by Presidential Press Secretary Trixie Cruz-Angeles.
The measure moves the regulation of vapes to the Department of Trade and Industry from the Food and Drug Administration. It also lowers the age of sale from 21 to 18.
The proposal was reportedly submitted to the Presidential Palace on June 24, days before then President Rodrigo Duterte stepped down from office.
A bill will lapse into law if the chief executive fails to act on it 30 days after receipt from Congress, according to the Official Gazette.
The vape regulation bill was approved by both the Senate and the House of Representatives of the 18th Congress in January but remained on the Speaker’s table until the final days of the Duterte administration. As a consequence of its delayed transmission to the presidential office, the bill was inherited by President Ferdinand “Bongbong” Marcos Jr.
In addition to lowering the purchase age for e-cigarettes and heated-tobacco products, the bill removes a two-flavor limit on the products’ flavors or juices, allows sponsorships beyond industry associations and trade events and allows tobacco companies to conduct corporate social responsibility-related activities.
Anti-vape advocates vowed to contest the new legislation in court.
