Lawmakers in Hawaii last week passed a “tax parity” law that applies the tax rate for traditional tobacco products to vaping products. If signed into law by Governor Josh Green, vaping products would be subject to a 70 percent wholesale tax—one of the highest rates in the country.
The bill, SB975 SD2 HD3, defines vaping products as “tobacco products,” and was negotiated in a marathon conference session between the State House and Senate just before the deadline for this year’s legislative session. The legislative session adjourns on May 4.
It isn’t certain the exact date the bill will be sent to Green, or if he intends to sign it into law. If signed, the tax will take effect Jan. 1, 2024. Currently, Hawaii has no tax on vaping products.
Right now, e-cigarettes only have the general excise tax (GET) of between 4.1 percent and 4.7 percent attached to them. Combustible cigarettes sold in Hawaii carry other taxes.
Last year, having survived a rollercoaster legislative session that saw the bill near death on multiple occasions, Hawaii’s ban on flavored e-cigarettes was signed by its governor.
The Australian government today announced that it will ban the importation of all nonprescription vaping products – including those that do not contain nicotine. The new legislation is being billed as containing the most significant tobacco and vaping control measures in the country in a decade.
The announcement today clarifies last week’s announcement of a crackdown on illegal vaping. This time the government said it would now include a total ban on nonprescription vaping products.
To tackle youth vaping, minimum quality standards for vapes will be introduced including restricting flavors, colors and other ingredients. Vape products will require pharmaceutical-like packaging, and the allowed nicotine concentrations and volumes will be reduced.
All single-use, disposable vapes will be banned, according to The Guardian.
Speaking on ABC’s Q&A on Monday night, Australia’s health minister, Mark Butler, said that the tobacco industry was trying to create a “new generation of nicotine addicts” through vaping and that he was “determined to stamp out this public health menace.”
The move follows an inquiry into vaping reforms led by the drugs regulator, the Therapeutic Goods Administration (TGA), with submissions from health professional bodies, public health associations, individual health professionals and university researchers that overwhelmingly support tightening border controls.
Many public health experts and bodies submitted to the inquiry that border controls should also be placed on non-nicotine vaping products to prevent mislabelling and exploitation of import loopholes. It follows manufacturers falsely labeling products containing nicotine as “nicotine-free” to get around import restrictions, leaving children easily able to buy vapes, often unknowingly inhaling nicotine and becoming addicted.
The government will also work with states and territories to end vape sales in convenience stores and other retailers. Prescriptions for nicotine vaping products for smokers trying to quit tobacco will be made easier to obtain, with stronger standards around the vaping products that can be bought in pharmacies so people can be assured of the content of the products.
Butler said he will expand on the reforms in a speech to the National Press Club on Tuesday, where he is expected to say vaping has become “the biggest loophole in Australian history” and announce that the following Tuesday’s federal budget will include AUS$234 million in funding for tobacco and vaping reforms, the biggest since plain packaging of tobacco products was introduced.
The Philippine National Police (PNP) yesterday announced that it would arrest students caught vaping and smoking in public places.
In an interview aired over dzBB, PNP Public Information Office chief Col. Redrico Maranan said the police would be enforcing the laws and ordinances by local government units against vaping and smoking, according to PhilStar Global.
“Yes, we will (also apprehend students vaping and smoking.) Our local ordinances will be enforced by the police, as ordered by our chief PNP (Gen. Benjamin Acorda Jr.),” Maranan said, according to media reports.
He explained that the ordinances would be a big help in ensuring discipline among the people.
“These local ordinances will ensure that discipline and the obedience of the people will return. So, that is part of the things that will be enforced by the police in communities,” he said.
He also underscored the Oplan Bisita Eskwela of the PNP, which requires police officers to go to communities and patrol schools.
“The police should go to schools and connect with principals, teachers and students,” Maranan said.
“There are crimes in schools, whether connected to fraternities and rumbles. Our police should be there in schools and coordinate with our school officials,” he added.
The trial of the San Francisco Unified School District’s lawsuit against Marlboro maker Altria continues this week. At the end of the first week, jurors heard testimony that use of vape pens by students had declined before more than doubling from 2017 to 2019.
Only a little more than 7 percent of students throughout the district had reported using vape pens in 2017, former district health administrator Erica Lingell testified Friday. By 2019, she said, that figure had more than doubled to 16 percent.
Lingell said students were using Juul and the district was scrambling to build support systems and give guidance to teachers and staff about them, according to Courthouse News.
“We didn’t have anything for this new substance that the kids were using,” Lingell said in answer to questioning by the school district’s attorney Dena Sharp. “We didn’t have lessons. We didn’t have enough research except for what experts were telling us.”
The school district was building systems to combat Juul from scratch, the attorney claimed. Even after the San Francisco Board of Supervisors banned the sale of e-cigarettes in the city — the corporate home of Juul Labs — in 2019, youth use continued.
For school district officials, it was a scramble to pull together the resources needed to combat Juul’s growth among students. “It was like flying the plane while we were building it,” said Lingrell.
For other substance use issues in the district, there were materials lesson plans, and support groups in place to help teachers tackle the problem. Students leaving class to smoke would interfere with teaching time for the rest of the kids, she said. “Teachers have an incredibly hard and busy schedule already. One kid being gone affects everybody.”
Much of the school district’s argument in its case against Altria involves the distraction which occurred when vaping became “endemic,” interfering not only with teachers’ abilities to control their classrooms but nearly all levels of student life.
The bellwether trial forces Altria to publicly defend itself solo for the first time as it faces thousands more cases that were brought against the company and Juul. In December, Juul Labs agreed to pay more than $1.2 billion to settle more than 5,000 suits blaming the company for a youth vaping epidemic across the U.S.
Juul and Altria defended the first trial that started in March over a case brought by Minnesota over deceptive marketing of e-cigarettes. The companies last month settled the state’s case, though details are yet to be disclosed.
In April, Juul agreed to pay $462 million to six states and the District of Columbia to resolve lawsuits and investigations into the marketing of addictive vaping products to children.
The major complaint against the proposed U.S. rules for vape manufacturing is that they took too long.
By Maria Verven
The U.S. Food and Drug Administration published a new set of proposed requirements for tobacco and vape product manufacturers in March 2023 with the goal of ensuring product consistency and ostensibly protecting public health. But vape industry experts say the new rules should have come out years ago. And for most vape manufacturers, it’s simply too late.
The FDA held a public hearing on April 12, and stakeholders can still comment on the proposed rule until sometime this fall before the regulatory agency issues the final guidance. In the meantime, Vapor Voice spoke with several industry experts to gather their perspectives.
Minimizing the risks
The proposed requirements apply to all manufacturers of nicotine vaping products and tobacco products designed for consumer use, whether complete and sealed in packaging or simply their parts or components. Applied to the manufacture, design, packing and storage of these products, the rules are designed, among other things, to ensure product consistency and prevent contamination with foreign substances.
“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” said Brian King, director of the FDA’s Center for Tobacco Products. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”
Key aspects of the proposal affecting vape manufacturers cover product design and development controls, manufacturing specifications, potential contamination and the traceability of components, ingredients and materials. Any inconsistencies between e-liquid product labeling and the actual nicotine concentrations are also addressed in the proposed rule.
Finally, the rule includes what corrective actions the FDA will take for products that fail to meet these specifications, such as issuing a recall for incorrectly produced products that have already been distributed.
What took so long?
The FDA’s proposed rule was at least 10 years in the making. Sometime in 2012, a group of 13 tobacco manufacturers submitted to the FDA a list of recommendations for good manufacturing practices—a system for ensuring that products are consistently produced and controlled. The following year, the FDA created a public docket to obtain input on the recommended regulations for good manufacturing practices that had been submitted by the tobacco companies.
And in 2017, an expanded group of manufacturers submitted proposals following the FDA’s 2016 Deeming Rule, which brought vaping manufacturers and products under the FDA’s jurisdiction, according to Patricia Kovacevic, general counsel for Cryomass Technologies Inc. A nicotine/cannabis regulatory consultant, Kovacevic has over 20 years’ experience in legal and regulatory affairs.
“Tobacco product manufacturing practices (TPMPs) are not unexpected or new to the industry,” Kovacevic said. “Most reputable manufacturers already have a quality management system in place and design their manufacturing facilities to comply with the general principles of current good manufacturing practices (CGMPs).
“The 2023 proposed rule on TPMPs is consistent with the manner in which the FDA regulates the practices, design and construction of personal hygiene products,” she said. As early as 1969, the FDA established CGMPs for foods as well as dietary supplements, infant formula and the like, added Kovacevic.
This is a positive step in the right direction, both for the industry and the FDA, agreed Azim Chowdhury, a partner with Keller and Heckman LLP. Chowdhury advises domestic and international corporations on regulatory compliance with the FDA, focusing on vapor, nicotine, tobacco product and cannabis/CBD regulation.
“This proposed rule is long overdue,” Chowdhury said. “This proposed rule should have come out years ago following the industry-proposed TPMPs that were submitted back in 2012. The vapor industry in particular has been in dire need of this type of regulation, which can only benefit public health.”
In essence, the principles are not substantially different from other FDA-regulated industries, Kovacevic said, adding that some manufacturers also comply with ISO quality standards, the world’s best-known quality management standards for companies of all types and sizes.
“It’s important to understand that TPMPs do not impose a certain product or manufacturing facility design or even dynamic of reporting,” Kovacevic said. “TPMPs are not prescriptive. They allow great latitude to manufacturers; thus, they should not be a great burden to be implemented.”
As with all CGMPs, the common components are documenting procedures for business operations and outcomes, ensuring that personnel are appropriately trained, work procedures are followed and a document trail is created. This allows manufacturers to design the day-to-day practices for maintaining their equipment and facilities to maximize product quality, cleanliness, consistency and employee safety.
TPMPs and PMTAs
While the general reaction to the FDA’s proposed rule is positive, frustrations remain that the FDA has already banned most vaping manufacturers through the premarket tobacco product application (PMTA) process. Large manufacturers (with 350-plus employees) will be subject to the TPMP rule as soon as it is finalized, according to Chowdhury. Smaller companies have four years after the effective date to meet the requirements.
“However, the question is will the small vape industry even be around in four years?” Chowdhury said. “The way things are going with the PMTA process and FDA enforcement, it seems that only the larger players will survive to see the implementation of this rule.”
“As it became evident from the vast number of PMTAs that were denied or refused to file, small manufacturers and even some of the large ones did not meet FDA’s expectations regarding premarket review of vaping products and are consequently out of business for now,” Kovacevic said.
“The vaping industry has tried in vain for more than a decade to work with the FDA on sensible manufacturing standards only to be ignored while the agency recklessly vilified nicotine vaping,” said Gregory Conley, president of the American Vaping Association. “While the FDA’s proposed requirements are a step in the right direction, the larger issue of the PMTA process disproportionately affecting smaller manufacturers and limiting market diversity must be addressed.”
“The FDA needs to strike a balance between ensuring public health and maintaining a diverse and competitive market,” he said. “Without PMTA reform, there won’t be many companies left to be impacted by this proposed rule. It’s highly likely that vaping product manufacturers that received marketing orders under the PMTA pathway already have rather robust quality systems. So, complying with TPMPs will not represent a meaningful burden to them.
“These regulations do not appear to differ a great deal from what would already be contemplated in a PMTA. But if the FDA’s Center for Tobacco Products does not reform itself, the real-world impact of this rule will be small, as companies with PMTAs will have no issue meeting just about any standard the FDA issues,” he said, adding that he wouldn’t recommend any manufacturer put themselves on the FDA’s radar at this junction.
Kovacevic agreed. “Compliance with TPMPs, when effective, should not require a massive effort for responsible manufacturers, who by now should have a robust quality management system,” she said.
Monica Schick, CEO and regulatory consultant with North Guide Solutions, predicted that the new rules could impact the industry financially. Smaller companies that are holding onto their market share with the rise of illicit products might need to increase their price points to add quality processes and/or testing requirements, according to Schick.
“My concern is are we bringing out the cart when we are sending the horse to slaughter? With illicit products still being marketed and sold and open systems getting continuously MDOed [marketing denial orders from the FDA], what will be left to hitch this cart to?” she asked. “I would like to see this as FDA’s attempt to work with the industry and possibly see some increase in the number of legal products on the market.”
What about foreign manufacturing?
The FDA’s new regulations will also apply to Shenzhen and other foreign-based e-cigarette manufacturers, although just how they will exercise enforcement is in question as the FDA currently doesn’t conduct regular foreign tobacco product manufacturing site inspections.
“Unlike domestic manufacturers, this rule does not require foreign manufacturers to register their establishments, submit a product list or be subject to regular biennial inspections,” Chowdhury said. “However, FDA’s unified agenda of upcoming rulemakings indicates the agency may soon propose another rule that extends the Tobacco Control Act’s registration and product listing requirement to foreign establishments,” he said.
The TPMP rule also highlights the FDA’s existing authority under Section 801(a) of the Federal Food, Drug and Cosmetic Act to refuse the importation of tobacco products that are manufactured, processed or packed under unsanitary conditions, are adulterated or misbranded and/or are forbidden or restricted in sale in the country where they were produced or exported, Chowdhury explained.
Chowdhury said he doesn’t believe the FDA has ever exercised its authority under this provision to deny entry of imported vapor products, such as open-system devices or nontobacco-flavored vapes that are prohibited from domestic sale in China, as this would require the agency to evaluate imported tobacco products not only with respect to the FDA’s own rules but also on the importing country’s applicable laws and regulations. That could prove to be highly inefficient and impractical.
“Furthermore, provisions concerning unsanitary conditions and adulteration/misbranding suggests that the FDA’s overall intent may be to control the quality of tobacco products rather than the specific legal status of tobacco products in their country of manufacture,” he said. “That said, members of Congress, public health groups and even Big Tobacco have been pressuring FDA to find a way to prevent illegal and counterfeit disposable vapor products from continuing to enter the country.
“The TPMP rule could be highlighting that FDA already has the ability to accomplish this.”
Final ruling could take years
A final rule could take at least a year or more. First, the FDA needs to address all the comments from industry stakeholders. And even after that, it’s likely the final rule will be similar if not outright identical to the proposed rule, predicted Kovacevic.
Chowdhury expects that thousands of comments will be submitted over the next six months, which the FDA will need to review carefully before finalizing the rule. “All in all, this rule will likely take at least one [year] to two years to become final. While it won’t directly impact pending PMTAs, companies should be reviewing this rule carefully and bolstering their existing practices to ensure compliance,” he said. “We now know what FDA expects.”
“It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market,” Conley said. “Our recommendations for the FDA include reconsidering the PMTA process, as its current review standards will shutter most legally operating manufacturers.
“We also want the FDA to focus on how to support smaller manufacturers that are committed to producing high-quality, compliant products. The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”
The original “Vaping Vamp,” Maria Verven owns Verve Communications Inc., a public relations and marketing firm specializing in the vapor industry.
The Vapor Technology Association continues its mission to promote sensible regulation.
By Timothy S. Donahue
In many countries, such as the U.K., vaping is synonymous with harm reduction. These governments recognize the harm reduction benefits of vaping versus smoking combustible cigarettes. They actively engage their citizens in “swap to stop” efforts backed by sound policy and known science.
In the U.S., however, the Food and Drug Administration is actively pursuing policies that protect, if not elevate, combustible tobacco products’ status in the marketplace and limit consumer access to alternatives that are safer than cigarettes, according to Tony Abboud, the executive director of the Vapor Technology Association (VTA). Abboud and the VTA have been instrumental in advocating for rational science-based regulations for vaping products that will enable a diverse and robust industry to thrive in the U.S.
Vapor Voice sat down with Abboud to discuss the current state of vaping and the future of the VTA. He said that one needs only look at the fact that the FDA is authorizing combustible tobacco products over less harmful vaping products at a rate of 45:1. This is a huge problem for an evolving and innovative industry but with graver public health consequences.
Vapor Voice: What is the current state of the vaping industry in the U.S. in your opinion?
Tony Abboud, director of the Vapor Technology Association. To learn more about the Vapor Technology Association
Abboud: Today, the U.S. industry remains in unnecessary regulatory chaos due to the FDA’s lack of vision in executing its statutory obligations, loss of focus on its harm reduction mission and reactionary decisions made to ameliorate political pressure of special interest groups untethered from science.
[The] FDA’s obstinate inability or refusal to speak truthfully about the importance of less harmful nicotine alternatives, such as vaping and modern oral nicotine products, is imperiling its clearly articulated mission to end smoking. Specifically, [the] FDA’s actions to date have only driven up the public’s irrational fear of nicotine vaping, a fear that can only cement consumers’ bond with cigarettes.
[The] FDA’s unscientific and dramatic policy shifts (cloaked as case-by-case decision-making) have plunged the agency and the industry into costly and unnecessary litigation that will take years to resolve, and, thus, it will be years before a rational regulated marketplace will exist. The net result is that, rather than creating a clear and achievable pathway for innovative companies to introduce new technologies that are 2 [times] to 3 times more effective at helping people quit smoking than the few products, FDA’s actions will continue to drive a wedge between people who smoke cigarettes that kill and the myriad options that will give them dramatic relief.
It is essential that companies in the industry galvanize behind thoughtful efforts to reset the narrative, demand accountability and make common sense changes. It is equally essential that [the] FDA resets its narrative, unapologetically follows the science and uses its power not to rob Americans looking for alternatives to cigarettes but empower them with myriad attractive options that will entice them to switch.
Now that the Covid shutdown and Zoom calls have ended, what has changed for the VTA?
Organizationally, one of the biggest impacts of Covid was the recognition that we had to focus our efforts on the biggest challenges that needed to be addressed rather than taking on every fight. That refocusing has enabled us to architect a thoughtful and impactful strategy to engage with policymakers and decision-makers on the issues most critical to our industry and to public health.
From a practical perspective, the biggest change in the reopening of this country has been the reopening of congressional offices, which only fully occurred this year. That change has made it possible for our team to sit down across the table this year and have meaningful and essential conversations with congressional offices and to bring voices into the fold that have not been heard before. We are on pace this year to far outstrip our prior levels of congressional engagement with a clear and persuasive policy message not only based on science but also supported by leading tobacco control scientists.
What are the VTA’s goals for 2023?
There are 34 million Americans who still smoke. Every two years, a million of them will die from smoking-related diseases. This is an unconscionable and ongoing public health crisis. We can save tens of thousands of lives by not hiding the fact that vaping is far less risky than smoking.
In this year, our priorities are a set of common sense new marketing standards and smart science-based access restrictions for flavored vape products to ensure such flavored products remain available for adult smokers while less accessible to youth. At the same time, we will continue our constructive engagement with [the] FDA to provide insight on the key policy issues and specific regulatory strategies that are necessary to achieve a rationally regulated marketplace.
What will it take to accomplish these goals?
Despite the FDA’s parroting of its mantra that it “follows the science,” the examples of where it has failed to do so have become too numerous to ignore. And despite the FDA’s proclaimed concerns about misinformation, the examples of which it has engaged in are simply too extreme to believe that the agency can easily correct the course it has embarked upon to denigrate, dismiss and deny alternative nicotine products. Hence, public pressure, congressional oversight and accountability in the courts all are necessary to ensure that FDA adheres to the science, follows the law and corrects the record.
In addition, notwithstanding the dramatic decline in youth vaping (now at pre-“epidemic” levels) that has taken place even with the broad availability of flavored products, the industry must continue to demonstrate its commitment to reducing youth access and appeal by supporting long overdue and common sense marketing restrictions that will further reduce underage use. Additionally, just like with 21-plus legislation, for which the industry advocated, new 21-plus policies can further limit youth access to flavored vaping products.
Given the chaos in the marketplace created by [the] FDA’s past and present actions, and its apparent policy to bar every nontobacco-flavored vape product from the marketplace, congressional action can help calm the chaos by adopting leading tobacco control scientists’ recommendations that flavored vape products be sold in adult-only stores, making them less accessible to youth while preserving the availability of adults. All of our goals and strategies are based on both data and science as we continue to amplify the voice and role of science in the decision-making process.
Is there any hope for open systems and/or flavors?
Yes. Facts are stubborn things. There is no scientific or real-world evidence that youth are attracted to or use open systems in any material numbers. At the same time, data from the National Youth Tobacco Survey year after year proves that flavors are now one of the least cited reasons that youth may experiment with vaping.
And each day, more and more peer-reviewed science is published proving the important role that flavored vaping plays in the decision to switch away from deadly combustible cigarettes, particularly when compared to the FDA’s favorite ineffective solutions. There is also hope in the fact that the industry will continue to innovate.
There will be new technologies that capture the market in the future, and we should be open to that—and so should [the] FDA. Flavors are proven to be the preference for adults who are looking to quit, and adults are more likely to succeed when flavors are available to them. Consumers’ demand for flavored nicotine products should be no more paternalistically rejected than consumers’ demand for cannabis products.
Are nontobacco nicotine products going to gain broad acceptance, especially with regulators?
Well, that is entirely up to the FDA now that Congress was convinced by certain industry players that nontobacco nicotine was somehow a problem. True, it was a problem, but primarily for certain businesses which were dependent on tobacco-derived nicotine. But the reality is that nontobacco nicotine is the cleanest and purest form of nicotine available on the market, which is perfectly replicable and traceable to the batch level.
Nontobacco nicotine is precisely the type of innovation in a constantly changing landscape that should be encouraged as the industry advances toward a combustible-free future. Regulators have a huge opportunity to use their authority to regulate nontobacco (synthetic) nicotine products and to encourage their entry into the marketplace. But, given [the] FDA’s current trend toward eliminating virtually all nicotine alternatives from the market, one can only question whether [the] FDA could seize the opportunity to provide consumers access to products that would allow them to break free from the last vestige of tobacco.
Do you see congressional action as the only cure to the current FDA regulatory process?
Congressional action can help, but the challenges are significant. There are three ways that Congress can assist. The first is through its oversight committees, which have jurisdiction to question the FDA’s prior actions that have been inconsistent with the law and inconsistent with, according to CTP’s [Center for Tobacco Products] scientists, the science on vaping.
The second is through its appropriations committees, which must question exactly how FDA is using the hundreds of millions of dollars it receives, why it uses the majority of its resources to remove e-cigarettes from the market while ushering hundreds of new cigarettes to the market and what could possibly justify its request for another $100 million in fees that ultimately will be borne by the vaping consumer (giving them yet another disincentive to switch).
The third is through committees of jurisdiction that can end the absurd discussion of “ban, ban, ban” when it comes to flavors and instead focus on real solutions to real marketing issues of which vaping opponents have complained for years but have never truly sought to address.
Congressional action is not the only cure because [the] FDA currently has placed its thumb on the scale by creating a standard for companies seeking to comply and secure marketing approval without giving them the knowledge or opportunity to do so. For that reason, [the] FDA appears content with letting the courts sort out the mess that it has created.
After all, CTP appears to take delight in declaring that every vaping product on the market is “illegal” and “cannot be lawfully marketed” except for the small handful of tobacco-flavored products [the] FDA has authorized. So, while regulators often complain about industry lawyers, it should come as no surprise that the actions of prior agency leadership, which in a very short period of time demanded a complete reversal of CTP’s priorities, plans and policies as they related to flavored vaping products, would lead to legal challenges.
In the end, any branch of our federal government can have a major impact in fixing the mess created by a disregard for science and the law. The question now is which one(s) will do so.
The Alabama Legislature passed a bill this week that bans smoking or vaping in a car with children 14 years old and younger.
House Bill 3 was created by Birmingham Representative Rolanda Hollis. She says she’s pushed for this for six years now.
The bill makes it illegal to smoke or vape inside a car with the windows up or down, whether it’s on or off. A violation of this can result in a $100 fine, according to WBRC.
“We’re going to save these kids from having bad allergies, having respiratory issues and everything that goes along with second-hand smoke,” said Hollis. “Even saving them from, as they go along in life, from getting cancer.”
The bill is now waiting on the governor’s signature to make it law.
The Smoke-Free Alternatives Trade Association continues to help business owners navigate regulation.
By Timothy S. Donahue
In 2012, the Smoke-Free Alternatives Trade Association (SFATA), a trade association representing small and large vaping businesses, began when the industry was still in its infancy. The trade group has been a staple in the tobacco harm reduction circle for more than a decade fighting for balanced regulations in the United States. It hasn’t been easy. The U.S. Food and Drug Administration has nearly decimated the numerous small business owners who once made up most of the vaping industry.
While the industry has had to evolve, so have the trade industry groups that support it. The SFATA began as an advocacy group for states in its early stages. As federal regulation began to come into reality in 2016, the SFATA altered course and focused on getting balanced regulations on the federal level. In 2021, however, after the FDA either denied or failed to review over 8 million premarket tobacco product applications (PMTAs), it sent the industry scrambling, explains SFATA Board President and CEO April L. Meyers.
“In the winter of that year, it also sent the states scrambling, so we had to shift our focus from federal to state so that we could save as many small businesses as we could,” she says. “There were several battlefronts and issues, most notably, flavor bans.” The organization had success at the state level. The SFATA had stopped several flavor bans. It was around this time that the organization also introduced its Responsible Industry Network (RIN) program.
The RIN program helps retailers combat the problem of youth use. It’s a program that provides a postmarket surveillance pathway through data, training, accountability and corrective measures for vapor manufacturers, distributors and retailers as well as a method for law enforcement and regulatory authorities to ensure that significantly fewer vapor products end up in the hands of youth. The RIN program serves the interest of business owners navigating the complexity of a highly regulated market while also assisting enforcement agencies.
Additionally, authorities can confiscate products that do find their way into the hands of youth and conduct enforcement actions against the parties who are responsible, whether they are manufacturers, distributors, retailers or straw buyers, such as family members or friends. An added value for the industry is that curtailing youth access will lower the biased media attacks that the vapor industry targets children, creating a more stable regulatory environment that allows businesses to grow.
April Meyers, SFATA
“If you’re a small [-sized] to mid-sized manufacturer and you received a marketing order, you’d have to either hire somebody full-time to collect the data for postmarket surveillance or spend a lot of valuable time trying to do it yourself,” said Meyers. “That’s where we came up with a program that streamlines the process. Everybody’s got the same due dates and the same forms. And then the agency is looking at the same form coming in at the same time.”
To receive a marketing order, the FDA states that it “intends to consider how an applicant will target the marketing of its new tobacco product to reach its intended consumers of legal age and to assess the potential effect on nonusers.” The FDA will also consider how the applicant intends to minimize the extent to which youth can access the product and are exposed to its marketing.
“If the PMTA does not address youth access to the product, youth exposure to the product’s labeling, advertising, marketing and promotion, and youth initiation, such as describing how it proposes to restrict the sale or distribution of its product to limit potential youth access to the product, it’s going to be impossible to get a marketing order,” said Meyers. “[The] FDA may be unable to determine that the applicant has made a showing that permitting the marketing of the new tobacco product would be appropriate for the protection of public health. RIN can help provide that data. And that data can be useful in several meaningful ways.”
The RIN program will create a rich database that will expose useful sales and marketing insights for participants, according to Meyers. She said that the data can show aggregate buying and selling behaviors of vapor products, data that can also be useful when faced with federal and state flavor bans and taxation bills.
In order to further help its members, Meyers said the SFATA recently entered a “strategic alignment” with the United States Vaping Association (USVA). She said that teamwork is an important aspect of vapor advocacy and that businesses need to support each other. The partnership creates a more unified voice and prevents wasting valuable industry resources by multiple organizations doing the same work.
“You’d have to be a dual member to realize the full benefits of advocacy. We’re also trying to make it reasonably priced where a store that’s on its feet and planning to move forward can participate,” she explains. “And we wanted to keep it even across the board because we don’t want to tell a big company that you must pay more just because you’re bigger. Nor a small company [that] you have to pay so much, and then they get costed out.”
Currently, the USVA is focused on winning its lawsuit against the FDA. The USVA believes the regulatory agency didn’t consider the economic impact on small businesses that the PMTA process and subsequent denial orders would have. The USVA suit claims that the FDA acted as if vapor applicants would be able to substantially rely on public data or on 70 studies that the FDA itself was conducting at that time. However, the FDA instead wrote an impossibly burdensome PMTA rule that began putting people out of business.
The suit is hoping the courts declare the PMTA final rule in violation of the Regulatory Flexibility Act, an effort by the U.S. federal government to balance the social goals of federal regulations with the needs and capabilities of small businesses and other small entities. The USVA also hopes the judges remand the PMTA final rule to the FDA and enjoin the agency from enforcing the final rule against any members of the USVA. This would also include joint SFATA members.
The suit also criticizes the FDA for prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies were also allowed to make changes to issues with their PMTA submissions whereas smaller companies with the same issues received marketing denial orders for those issues.
Credit: Rafel
“If the courts hand down an emergency injunction for relief, it would mean that every member of the USVA, SFATA joint members and the named plaintiffs on the case go back into review. Where we found synergy between the organizations is if you go back into review, what happens? Are you better off? No. Do you have more time? Yes. Can you make more money in the extra time you’ve been given? Yes. But then what? If you don’t address the broken process, that is the PMTA, you have nothing,” said Meyers. “It affects every state, every business, every vapor product retailer.”
Meyers explained that joining the SFATA helps to safeguard that manufacturers are able to produce products and businesses are able to sell lifesaving vapor devices. The organization is currently laser-focused on the U.S. House of Representatives and is dedicated to trying to do its part to stamp out overzealous and overreaching legislation.
“We focus on the House because that’s where the oversight is of FDA, and that’s where most bills also get introduced. So that’s where we’ve put our focus and where most of our meetings will be concentrated on at the federal level for this year’s session,” she said. “The FDA’s rules are the problem. The members of the House we have spoken to understand that the process is broken. We are presenting science-based solutions and innovation to show that it can be fixed.” While legal action safeguards against the lack of guidance and transparency from the FDA, the SFATA is working with lawmakers to ensure that its “commonsense solutions for American smokers” are understood and communicated to the FDA and Congress, which oversees the agency, according to Meyers.
“The recent report from the Reagan-Udall Foundation found numerous wide-ranging problems at CTP,” she said. “Now Congress is asking the FDA to answer those same questions the Reagan-Udall report asked … SFATA is asking those questions too. What is your strategy? What is your plan? What are you going to do? There’s a lot of pressure on FDA to do something and be clear about it. [The] FDA can’t come up with that plan by themselves. They need industry insight and support. Our goal is to come up with that input. That’s why you would support SFATA. You want to be a part of that conversation and get that information. We are here to help.”
U.S. cigarette smoking dropped to another all-time low last year, with 1 in 9 adults saying they were current smokers, according to government survey data released Thursday. Meanwhile, electronic cigarette use rose, to about 1 in 17 adults.
The preliminary findings from the U.S. Centers for Disease Control and Prevention are based on survey responses from more than 27,000 adults.
Last year, the percentage of adult smokers dropped to about 11 percent, down from about 12.5 percent in 2020 and 2021. The survey findings sometimes are revised after further analysis, and CDC is expected to release final 2021 data soon.
E-cigarette use rose to nearly 6 percent last year, from about 4.5 percent the year before, according to survey data.
The Philippines government is set to remove 15,000 more noncompliant electronic cigarette sellers in online marketplaces, reports The Philippine Star.
“We have monitored almost 15,000 sellers online,” said Ruth Castelo, trade undersecretary. “We’ve advised platforms to remove almost 15,000 we observed that were noncompliant. These sellers all have cases already.”
Unregistered vapor products are subject to the Vape Law, which came into effect Dec. 28, 2022, and prohibits flavors, colorful caricatures on packaging and selling products within 100 meters of schools, among other restrictions.
“If online platforms would just strictly follow, there is no need to remove the sale of this product from them,” said Castelo. “It’s already indicated which products they can’t sell, but some still evade detection.”
