A U.S. federal judge on Feb. 23 ordered Shenzhen Weiboli Technology to stop marketing its Elfbar e-cigarettes in the U.S., finding that VPR Brands, which makes and sells Elf brand vapes, is likely to succeed on its claims that the Elfbar vapes infringe its trademark, reports Law360.
According to U.S. District Judge Aileen M. Cannon, VPR has shown there is a likelihood of confusion and the company stands to suffer harm if its Chinese competitor is allowed to keep selling the Elfbar vapes.
In November, VPR asked for an injunction blocking Shenzhen Weiboli from continuing to use the Elfbar mark, arguing the alleged infringement is costing VPR about $100 million because of the effect on future sales.
VPR claims Shenzhen Weiboli is not only infringing VPR’s Elf trademark but also its patent for its e-cigarette device.
While there is no direct evidence that Shenzhen Weiboli deliberately intended to adopt the Elf mark to take advantage of the existing trademark, Judge Cannon wrote that the company was well aware of the Elf mark and that there was potential for confusion, as the U.S. Patent and Trademark Office denied the registration of an Elfbar trademark specifically for those reasons.
VPR welcomed the judge’s decision. “VPR is pleased that the court found Elf is a strong trademark and granted the injunction,” said Joel B. Rothman of Sriplaw, which represented VPR in the case. “The injunction will allow VPR to move quickly against infringers and counterfeiters in the marketplace.”
An attorney for Shenzhen Weiboli said the company intends to appeal the order.
Peter Zhang and Luna Wang, co-founders of So Soul vaping products
Global vaping manufacturer So Soul launched three new disposable products during the Total Products Expo (TPE) 2023 in Las Vegas, held from February 22 to 24 at the Las Vegas Convention Center.
China-based So Soul debuted its NOLA Bar, Y6000 and SLIMZ disposable vaping products, company founder and CEO Luna Wang told Vapor Voice during the show.
The SLIMZ is billed as “the world’s thinnest 5000-puff pod” and holds 11mL of 5% nicotine salt e-liquid, a mesh coil, and a 550mAh rechargeable battery. The SLIMZ offers 10 flavor profiles.
The new Y6000 is So Soul’s latest 6000-puff vaping device. The Y6000 holds 14mL of 5% nicotine salt e-liquid and a mesh coil that is powered by a 650mAh rechargeable battery. The Y6000 also offers 10 flavor profiles.
So Soul’s NOLA Bar is a 10,000-puff disposable device that offers 5% nicotine salt in 10 flavor profiles. The NOLA Bar holds 22mL of e-liquid with a 650mAh rechargeable battery.
In mid-2021, Luna Wang joined forces with another experienced vapor industry entrepreneur, Peter Zhang. Both also had previous experience working with Fortune 500 companies. Together, they started the So Soul brand in Shenzhen, China, the global capital of e-cigarette manufacturing, said Wang.
So Soul began because its creators believed something was missing in the market. Aside from a device’s appearance, aroma and flavor were two areas that Wang and Zhang felt were lacking in the Chinese vaping industry. The company founded its own research and development laboratory, staffed by the world’s top experts in the field, to develop products that could meet Wang’s high standards.
The company devotes 60 percent of its profits to R&D in an effort to always be improving. It wants its products to stand out for their “combination of style, substance and soul,” explains Wang. “We are dedicated to providing our customers with products that are not only stylish and cutting-edge but also made with the highest quality ingredients and backed by extensive research and development.”
Vaporesso, one of the largest open-system vaping hardware manufacturers in the world, launched its new 80W Pod Mod, the Luxe XR Max during this year’s Total Product Expo (TPE) 2023 in Las Vegas, held from February 22 to 24 at the Las Vegas Convention Center.
The China-based subsidiary of Smoore International, the largest vaping company in the world, said that the XR Max is the latest member of Luxe X family and is fully compatible with other LUXE X products.
The Luxe products combine the core features SSS leak-resistant technology, and COREX, an innovative heating and flavor-boosting technique developed by Vaporesso, and is powered by the company’s signature Axon Chip,
The Luxe XR MAX offers an easier-than-ever user interface to help vapers get the best possible performance out of their vaping devices. The chip also equips Vaporesso’s products with a smart use mode.
As part of the new design, the Luxe XR MAX adopts the classic clear, futuristic shape of the Luxe X series, and offers users a heightened vaping. Its SSS leak-resistant design, coupled with the brand’s COREX heating technology effectively increases the flavor and the lifespan of GTX coil.
The new model also has a longer battery life, making it an ideal fit for direct-to-lung (DTL) users, according to Vaporesso.
Activists are confident that Thailand will legalize vaping after the likely general elections in May. Vaping is currently prohibited in the kingdom, but discussions are ongoing to end the ban, according to ENDS Cigarette Smoke Thailand (ECST).
“This work has been several years in the making. It hasn’t stopped. In fact, draft vaping legislation awaits Thailand’s parliament to debate and ratify,” said ECST Director Asa Saligupta.
Saligupta notes that while anti-vaping campaigners appear to have the ear of the public health minister, most politicians and the public remain supportive of lifting the country’s vaping ban.
“I remain fully confident that safer nicotine products will be regulated in Thailand. Regulation will give consumers better protection, encourage more smokers to quit deadly cigarettes, and ensure we have much better control over youth vaping with a strict purchase age,” he said.
ECST says smoking kills about 50,000 Thai people every year.
“If we want to substantially reduce smoking-related illnesses and premature deaths, we must lift Thailand’s harsh ban and penalties on vape products,” said Saligupta.
According to ECST, nearly 70 countries have adopted regulatory frameworks on safer nicotine products, leading to dramatic declines in their overall smoking rates.
Some manufacturers of e-liquids could soon be paying nearly $20,000 per violation for selling vaping products without approval. Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization.
This marks the first time the regulatory agency has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket tobacco product application (PMTA) process.
The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s PMTA requirements and that failure to correct these violations could lead to enforcement action, such as a CMP, according to a press release.
Despite the agency’s warning, the companies continue to make and sell their unauthorized e-liquids to consumers.
“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”
As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:
BAM Group LLC doing business as VapEscape
Great American Vapes LLC doing business as Great American Vapes
The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
13 Vapor Co. LLC doing business as 13 Vapor
Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases.
The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”
Manufacturers that continue to violate the law risk subsequent enforcement, according to the FDA. In addition to CMPs, the agency also has the authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.
Flavor bans are creating black markets that cost U.S. states a massive amount of money in lost taxes, according to the latest research.
Just go to any online consumer-to-consumer website and flavored vaping and other tobacco products are for sale in states with flavored tobacco bans. A quick search for menthol on sites such as Craigslist and OfferUp in California or Massachusetts, where flavored products are banned, will yield results for every flavor of vaping product from apple to vanilla for sale. You can also find nearly every brand of menthol cigarettes for purchase on the online black market.
New York, New Jersey and Rhode Island also have barred the sale of flavored vaping products. Massachusetts and California banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods. Since California’s flavored tobacco ban went into effect on Dec. 21, one week after the U.S. Supreme Court blocked R.J. Reynolds Tobacco Co.’s contention that the new state law conflicted with federal law, the state’s black market for flavored tobacco products has grown exponentially.
Stat News reported that in January it visited 24 California vape shops throughout Oxnard, Ventura, Pasadena, El Monte, Carson and West Hollywood—all of which have had bans on flavored vapes on the books for at least a year and most for two or more years. Seventeen of the shops, or 70 percent, were selling the products anyway. In Oxnard, where the news group visited five shops, none of the stores sold flavored vapes.
States in the proximity of states that have enacted flavor bans have some of the highest tobacco smuggling rates in the country. A report by the nonpartisan Tax Foundation found that New York has the highest inbound smuggling activity, with an estimated 53.5 percent of cigarettes consumed in the state deriving from smuggled sources in 2020. New York is followed by California (44.8 percent).
New Hampshire has the highest level of net outbound smuggling at 52.4 percent of consumption. This is likely due to the state’s relatively low tax rates and proximity to states with strict tobacco regulations and high taxes. The report said the move by other Northeast states to raise cigarette taxes and ban certain tobacco products have made cigarette smuggling a lucrative criminal initiative.
“People respond to incentives,” said Adam Hoffer, the Tax Foundation’s director of excise tax policy. “As tax rates increase or products are banned from sale, consumers and producers search for ways around these penalties and restrictions.”
Last year, JAMA Internal Medicine published a study about the impact of banning flavored tobacco products in Massachusetts. The study found that the sale of flavored tobacco decreased following the ban. However, when comparing sales in Massachusetts with sales across 27 other states, the authors found that sales had decreased more in Massachusetts than in the control states.
“Such a result would indicate that the flavor ban has been a success. Unfortunately, the study left out a very important piece of information: cross-border trade,” Ulrik Boesen, also with the Tax Foundation, stated at the time. “The end result of the ban, in fact, is that Massachusetts is stuck with the societal costs associated with consumption while the revenue from taxing flavored tobacco products is being raised in neighboring states.”
A 2022 report from the Massachusetts Multi-Agency Illegal Tobacco Taskforce found that in 2021, state police and the Department of Revenue seized more than 5,000 packs of cigarettes and more than 100,000 vapor products. It also details multiple investigations and prosecutions, including ones leading to sentences of six months to a year. Some of these were for smuggling that predate the flavor ban, but others clearly involve it.
For example, the report notes an ongoing investigation into a February 2022 seizure of more than 5,000 flavored e-cigarettes as well as a motor vehicle stop that netted “a large quantity of untaxed flavored ENDS [electronic nicotine-delivery system] products, cigars, smokeless tobacco and cigarettes” representing $21,000 in unpaid taxes. “As it happens, looking at the New England region as a whole confirms that the flavor ban did not work as intended. Sales moved around rather than disappeared, and the ban evidently did not impact consumption,” stated Boesen. “Total sales for the region decreased by slightly more than 1 percent comparing the 12 months preceding the ban to the 12 months following the ban—largely comparable to the national sales trends.”
Imperial Brands has launched the first all-new upgrade of its Pulze heated tobacco device, as it continues to innovate to create more compelling, potentially reduced harm products.
Pulze 2.0 offers new levels of convenience with a compact all-in-one design and 25 or more sessions from a single charge.
Paired with Imperial’s iD sticks now available in 10 different flavors, Pulze offers an attractive, potentially less risky alternative to consumers seeking to switch away from combustible cigarettes, according to Imperial.
“Our consumer-centric approach to innovation is accelerating the pace of development across all categories,” said Andy Dasgupta, Imperial Brands’ chief consumer officer, in a statement. “Pulze 2.0 is another important milestone on Imperial’s journey to build a healthier future and offers consumers alternative ways to enjoy moments of relaxation and pleasure.”
Heated tobacco devices such as Pulze release nicotine and tobacco aromas without burning and producing smoke. This means that aerosols produced by Pulze contain substantially lower levels of harmful chemicals than those found in cigarette smoke, research shows.
Pulze 2.0 is being launched initially in four markets—Italy, Poland, the Czech Republic and Greece—and will be rolled out more widely across Imperial’s heated tobacco footprint in Europe during the remainder of 2023.
Heated tobacco forms part of Imperial’s multi-category approach to building a strong, focused next generation products business. The company has also recently unveiled major product innovations in vape, with the new Blu 2.0 and Blu bar devices, and modern oral with nine new varieties of its fast-growing Zone X brand.
The launch of Pulze 2.0 comes as Imperial CEO Stefan Bomhard and CFO Lukas Paravicini today present on the progress of the business’ transformation at the Consumer Analyst Group of New York conference in Boca Raton, Florida, USA.
The presentation by Bomhard and Paravicini starts at 4 pm EST. Participants can register here.
Australia’s National Health and Medical Research Council’s (NHMRC) statement on e-cigarettes fails to meet the scientific standard expected of a leading national scientific body, according to 11 addiction scientists, reports Medical Express.
Published in June 2022, the NHMRC statement aims to provide “public health advice on the safety and impacts of electronic cigarettes (e-cigarettes) based on review of the current evidence.”
This critique of the NHMRC statement, published in Addiction, argues that the statement inaccurately summarizes the current evidence on e-cigarettes. The authors contend that the NHMRC exaggerates the risks of vaping and fails to compare them with smoking; incorrectly claims that adolescent vaping causes subsequent smoking; and ignores evidence of the benefits of vaping in helping smokers quit.
The NHMRC statement also ignores evidence that vaping is likely already having a positive effect on public health and misapplies the precautionary principle, which requires policymakers to compare the risks of introducing a product with the risks of delaying its introduction.
“Many leading international scientists in the field hold more supportive views than the NHMRC on the potential of e-cigarettes as a strategy to improve public health,” said Colin Mendelsohn, lead author of the Addiction article. “In particular, invoking the precautionary principle to prevent the use of much less harmful smoke-free products is unjustified in the face of the massive public health burden of smoking.”
Excise taxes on vapor and OTPs can present considerable administrative burdens on businesses.
By Bryan Haynes, Christina Sava and Robert Claiborne
Excise taxes on vapor products and tobacco products other than cigarettes, also referred to as “other tobacco products” (OTPs), present considerable administrative burdens on businesses dealing in these products. All 50 states impose excise taxes on most traditional OTPs, and have for a long time, but operators in the vapor category have been subject to rapidly shifting regulatory conditions as states update their OTP laws and other laws to account for vapor products.
Many of these laws are framed on traditional distribution models, and businesses’ innovations in routing taxable products to market can raise unique compliance questions. Recent legal changes have also raised new issues over the permissibility of state taxation of products coming in from another state. Where excise taxes are imposed on a product, the sale of such products requires licensure at various points in the supply chain, accurate bookkeeping, regular reporting, and tax remittance practices.
Typically, distributors and wholesalers of these highly regulated products may be the subject of audits by state revenue departments, and manufacturers and retailers may similarly be subject to audit depending on the auditing state. In our experience, it is a rare audit that does not result in an alleged deficiency. Some deficiency determinations are minor and easily paid while others can add up to hundreds of thousands—and even millions—of dollars due, plus interest and penalties. In such cases, it is imperative to engage the assistance of experienced counsel who can assist you in addressing the assessment.
A final deficiency determination can be crippling to a business. The audit process itself can be time-consuming and disruptive to normal operations, and any ensuing disputes will be even more so. It’s never a bad time to either establish an audit-readiness plan or clean up existing operating procedures to make sure a future audit and possible dispute go as smoothly as possible. We have drawn on our experience representing clients in such disputes to compile this list of best practices for avoiding or contesting OTP and vapor tax assessments.
Best Practices for Avoiding a Dispute
Understand your state’s licensure requirements. This tip should go without saying, but it is worth repeating given the rapid evolution of vapor products laws and innovations in businesses’ routing of taxable vapor or OTP products to market. If you do any business in traditional forms of tobacco, and begin selling vapor products, it would be prudent to confirm whether your state requires additional licenses, taxes or reporting for these products.
Know your regulator. For any highly regulated business, it’s important to be familiar with your primary regulatory agency and its agents and maintain a good relationship with them. Any time you are communicating with your regulator is a chance to make a good impression, so remain courteous and professional in your dealings with them, whether via email, by phone or in person. If there are occasions where you disagree with the regulator, you can do so respectfully and without being disagreeable.
Keep and organize accurate books and records. This tip is important for all business owners but especially for businesses that deal in excise-taxed products. Being able to produce accurate documentation of your activities can make all the difference in a dispute as well as prevent disputes. State laws typically establish the minimum record-keeping requirements. A good record-keeping system will include:
copies of invoices and receipts;
copies of bills of lading and other shipping documentation;
copies of all communications with state regulators; and
copies of documentation for any tax payments, tax reports and tax returns.
Make your records readily accessible as you will be asked to produce them during an audit. You will also want to promptly transmit records to your attorneys if you involve them in any phase of the matter. Verify whether your state requires you to maintain physical copies on-site or whether you can organize your records digitally.
Understand the applicable laws. This one is, again, obvious for all businesses but crucial for those dealing in highly regulated products. Keep track of the tax rate applicable to all of your product classes. If there is a question about whether your products qualify as taxable tobacco or vapor products, you should seek clarification and probably involve your attorney. Some laws, for instance, tax liquid nicotine but not certain other forms of nicotine while other laws tax products, such as vape products, that do not contain nicotine at all. Make sure you are signed up for alerts from your regulatory agency. If you don’t understand a change in law or policy, follow up with the regulator or experienced counsel for clarification. If you are going to seek a formal advisory opinion or even informal guidance from a state department of revenue, you will likely want to involve your attorney to ensure that you inform the department of all material facts and legal grounds that may distinguish your product or activities from coverage under the state’s excise tax laws.
File timely returns. Set up a system for making tax reporting easy and automatic. There are third-party providers that can assist if necessary. Filing thorough, well-prepared returns on time each month generates goodwill and can help prevent audits.
Periodically audit yourself. Set up periodic self-audits to ensure your reporting is accurate. Self-audits can help businesses mitigate issues that, if not discovered sooner, may result in large assessments. If you discover an issue, many state excise tax laws require that returns be corrected proactively. If you discover a major issue, it may be prudent to have a discussion with relevant taxing authorities but involve counsel early if you think you’ve discovered deficiencies. Some states have voluntary disclosure programs that may mitigate potential consequences from noncompliance.
If you are audited, make timely and thorough responses. If you are audited, it is critical to be responsive to auditors’ legitimate requests. Initial interactions with auditors can set the tone for the rest of the audit. Review requests for production thoroughly, note the deadlines and begin working on the responses early. Auditors appreciate well-organized productions, which are easier to provide if they are already organized and you’ve given yourself time to put together a thorough response.
Best Practices for Dealing with a Potential or Actual Dispute
Engage experienced counsel early. Consider contacting counsel the moment a request for records arrives. Counsel does not always have to respond on your behalf, but they can help you evaluate the legitimacy of requests and help you respond. You should contact counsel immediately upon receipt of a deficiency determination.
Be aware of deadlines. This one bears repeating because, in tax matters, missing a deadline can mean you have conceded to the assessment. Review the assessment carefully and note all deadlines. Review statutes, regulations and agency guidance to familiarize yourself with the appeal process, including any additional deadlines that might not have been identified in your notice.
Provide relevant information to your counsel as soon as possible and throughout the dispute. Is the disputed issue one that your business has previously discussed with the tax department? Has the tax department’s position changed at any point? Does the disputed issue concern products that had taxes paid on them in another state? Have there been any changes in the manner in which you conduct your business? What individuals or documents can address the facts in issue? These are just some of the questions your counsel may have, and there will be others depending on the nature of your dispute. It is important to make sure that you fully inform counsel of the relevant facts and documents early on and throughout the matter.
Keep perspective. Running a business is hard work, and a tax dispute will not make it easier. While you will naturally be eager for the dispute’s resolution, it is important to bear in mind that the dispute process can be lengthy. Most states route tax disputes through a maze of administrative processes before the taxpayer can have its day in court. Either party can have multiple stages for appeal. Also bear in mind that most disputes eventually settle. Keep a cool head, maintain professionalism and know that you’ll eventually be on the other side of this.
Proactive measures can help you streamline audits and mitigate the risk of tax assessments. If a dispute arises, early engagement with counsel is critical to developing and executing an effective strategy. Troutman Pepper’s tobacco team has substantial experience advising clients in vape and OTP tax matters and, when necessary, assisting them in disputing assessments. In 2022, we assisted clients in successfully disputing more than $45 million in claimed tobacco tax deficiencies.
When the taxman asserts a deficiency, you don’t have to resign yourself to “be[ing] thankful [he] don’t take it all.”[1] There is more that you can do before and after that point. Please let us know if we can help.
Bryan Haynes, Christina Sava and Robert Claiborne are attorneys for the law firm Troutman Pepper Tobacco Practice.
If you improve the way that you implement bad policies, you are still left with bad policies.
By George Gay
Yet another report has demonstrated that the quest to encourage cigarette smokers to switch to the consumption of less risky tobacco and nicotine products is being subsumed under what now seems to be seen as the loftier aim of counting how many anti-tobacco policies and strategies can dance on the head of a pin. Constantinople is under attack.
The report, Operational Evaluation of Certain Components of FDA’s Tobacco Program, was drawn up by an Independent Expert Panel convened by the Reagan-Udall Foundation at the request, in July, of U.S. Food and Drug Administration Commissioner Robert Califf.
I should point out, however, that the direction the report took was not due to some gratuitous decision on the part of those serving on the panel but was rather determined by the terms of reference they were given. According to the report, issued in December, the panel members were charged with conducting “an evaluation of the FDA Center for Tobacco Products (CTP) with the aim of addressing immediate issues and providing recommendations to position the center for greater success in the future.”
But the key to the direction the panel took was provided in the following sentence. “This report focuses on operational issues; it does not address tobacco policy.”
In other words (my words), the panel members were given the task of addressing the symptoms afflicting the CTP, not the causes of its malaise. Their task resembled that undertaken by engineers charged with halting or slowing the collapse of the Leaning Tower of Pisa. Theirs was not to ask whether the tottering tower was fit for purpose. Theirs was to underpin the edifice.
Of course, there was a major difference between the engineers working beneath the tower and the academics working to prop up the CTP. The former had the joy of working on a beautiful, if foundationally flawed, Romanesque campanile that each year attracts countless tourists. All panel members had to work on, however, was the CTP edifice, whose superadditions rival those of a Gaudi building while lacking the charm or joie de vivre.
But I have digressed and, in doing so, skipped over something mentioned above that might have puzzled—even angered—some readers. I can assure you, however, that I detected no implied irony in the statement that the aim of the report should be, in part, to provide “recommendations to position the center for greater success [my emphasis] in the future.”
Indeed, the report says that, since its creation in 2009, the CTP has accomplished a great deal. “Between 2009 and 2022,” it says, “CTP published 16 proposed rules, 16 final rules, 35 draft guidances and 50 final Level 1 guidances.” And the report continues in that vein, listing such things as the number of applications the CTP has dealt with, the manufacturing and retail inspections it has carried out, the number of warning letters it has sent out and the amount of money it has collected from retailers in civil monetary penalties.
There are two things that strike me about this. The first is that it seems as though the tasks listed as having been carried out are merely part of the job description and therefore hardly worthy of remark.
The other point is more important, I think. There was no mention within the paragraph on CTP achievements as to how many smokers the center estimates it has encouraged to quit their habit or how many it has encouraged to move, either partially or wholly, to less risky tobacco and nicotine products.
Credit: Postmodern Studio
This is significant because the CTP’s stated mission is to protect people in the U.S. from tobacco-related disease and death, and you’re a million miles from the coalface of such an undertaking if you’re sitting in your office sending out warning letters to retailers. In fact, we seem to be talking mission impossible. “The lack of clarity about CTP’s direction, its priorities and its near-term and longer-term goals and objectives hinders CTP’s ability to effectively carry out its mission,” the report says.
Indeed, far from mission-judged achievements, the report is clear that things are not going well. “Tobacco is the leading preventable cause of death in the U.S., with cigarette smoking accounting for more than 480,000 deaths annually, according to the Centers for Disease Control and Prevention (CDC),” the report says. “Despite efforts to curb tobacco use, the smoking epidemic continues to contribute to an enormous, avoidable public health catastrophe.”
And the report then goes on to provide some statistics on smoking and vaping and their outcomes in respect of U.S. adults and young people. With the exception of the references to vaping, that same summation, including the huge death toll, could have been made before the formation of the CTP. It would seem that no progress has been made.
On the other hand, the report seems very good given the limits of the panel’s mandate, which saw it address four CTP program areas: regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. As far as I am able to judge and given the time restraints involved, the panel members seem to have consulted widely, summed up the situation well and presented a host of necessary recommendations to improve the performance of the CTP.
I would worry, however, that in trying to implement the recommendations, the CTP would simply take on more work at a time when it is said to be overworked and almost overwhelmed to the point of being regularly reactive rather than proactive. Whereas the recommendations, if implemented, would no doubt be timesaving in the long run, it is difficult to see how the CTP can put those recommendations into place in the short term without additional resources, which we are told are in short supply.
Surely, the only way out of this vicious circle is to go back to basics and trim the policies to the resources available. This would be no bad thing in any case. The level of complexity of the CTP’s proffered solution to the problem of tobacco consumption is out of all proportion to the problem, or how do we put it now? The “challenge,” or, more recently, the “solution opportunity.” Concentrating on operational aspects means that the CTP, having lost sight of its objectives, is going to redouble its efforts.
While the panel was robust but diplomatic in its presentation, the report will not have made easy reading for those at the top of the CTP. Reading between the lines, I came away with the impression that the performance of the center has been unnecessarily bureaucratic, confused on the question of the interaction between science and policy, verging on the chaotic and, in large part, ineffective. But, in fairness, I must say that this was broadly my opinion before I read the report, so I cannot claim that my reading was impartial.
In what I thought was the most important aspect of the report, the panel addressed the tricky issue of science and how it informs the CTP’s work. The report notes that some issues before the CTP were fundamental policy questions that had to be informed by science but were not, themselves, scientific issues. “Rather, they are policy issues with profound societal impacts,” the report said.
And then it went on to make what is a vital point about an issue that, to my way of thinking, has tripped the CTP up on its mission path. One such question that scientific analysis alone would not resolve, the report said, was how to weigh the public health benefits achieved through smokers using electronic nicotine-delivery systems (ENDS) to completely quit smoking combustible tobacco products against the public health harms that might occur if young people used ENDS and thereby acquired a lifelong addiction to nicotine or proceeded to use combustible tobacco products,
Again, in fairness, I don’t believe that all the problems that have beset the CTP since it was set up as part of the FDA following the passing in 2009 of the Tobacco Control Act can be laid solely at the door of the center. The decision to hand to the FDA responsibility for the oversight of products whose consumption was known to be risky was fraught, especially given the tendency of politicians to use tobacco as a way of burnishing their often tarnished credentials in the eyes of populations made up overwhelmingly of people who do not use tobacco products. Putting the boot into smokers is generally a vote winner.
The CTP has been confronted, too, with legal challenges, but here it must be prepared to take a large part of the blame because important aspects of what it has done have been characterized by a lack of consistency. The report is awash with stakeholder comments about a lack of clarity, transparency and communication regarding its priorities and its decision-making processes.
Application processes were said by stakeholders to be extremely cumbersome and time-consuming, with submission requirements vague, frequently changing and favoring established companies. Application reviews were said to be inefficient and unpredictable, which is unsurprising given that FDA employees described the past several years of application review programs as full of ad hoc troubleshooting and abrupt shifts in direction.
What will have particularly exercised the minds of most of the readers of this magazine are those sections that deal with tobacco harm reduction issues, though much of what was said will have been widely known. At one point, the report notes that the agency announced its intention to apply a harm reduction strategy designed to move tobacco product consumers down the continuum of risk: switching from using combustible tobacco products to noncombustible products.
“However, stakeholders observed the agency’s more recent marketing authorization decisions appear to reflect a policy shift—specifically a reluctance to authorize any … ENDS other than those that are tobacco flavored,” the report notes. “If such a policy shift occurred, the agency did not specifically announce it in a regulation or guidance, leaving stakeholders to glean it from documents posted on FDA’s website such as a Technical Project Lead (TPL) review of PMTAs [premarket tobacco product applications], MDOs [marketing denial orders] posted in abbreviated form, or from heavily redacted documents provided in response to Freedom of Information Act (FOIA) requests.”
There are two main points in the report with which I would take issue. My main gripe concerns the following sentence. “Although CTP has a critical mission to protect the public health from tobacco-related disease and death and is regulating products that have no inherent benefit and huge societal costs, it is a government regulatory program with a duty to run efficiently, fairly and transparently.”
“No inherent benefit”? Unless I am misunderstanding what is being said here, and I hope that is the case, I have to ask how such a distinguished panel can have arrived at this idea. How can the panel say that a product consumed by, we are told, more than 30 million people in the U.S., often at great financial sacrifice, has no inherent value? Is the panel saying that these people have no agency—are zombie consumers?
The other issue has to do with enforcement of the various rules laid down by the CTP, which were seen by some CTP staff and stakeholders as being cumbersome. There seemed to be a suggestion that a task force should be formed of half a dozen or so agencies, including the Bureau of Alcohol, Tobacco, Firearms and Explosives, and the Department of Homeland Security.
Wouldn’t this be somewhat heavy handed? Whenever such issues arise, surely it is incumbent upon us to take a step back and ask, is enforcement really the problem? Is it time to increase penalties as some apparently suggest, or is it time to say that perhaps the rules are the problem? And, in this case, it seems to me that the rules are the problem, or rather that the problems arise because the rules are changed without warning and are therefore difficult to follow.
Overall, given such circumstances, I cannot see how this report will help smokers, even indirectly. The problem lies in the CTP’s policies. If you improve the way that you implement bad policies, you are still left with bad policies.
Stat News
What will have particularly exercised the minds of most of the readers of this magazine are those sections that deal with tobacco harm reduction issues, though much of what was said will have been widely known. At one point, the report notes that the agency announced its intention to apply a harm reduction strategy designed to move tobacco product consumers down the continuum of risk: switching from using combustible tobacco products to noncombustible products.