Taiwanese authorities are conducting more than 2,000 vaping-related investigations per month following amendments to the Tobacco Hazards Prevention Act that banned e-cigarettes and tightened heated-tobacco product restrictions, reports The Taipei Times.
Fines totaling TWD280,000 ($9,117) have been imposed in 18 cases, the Health Promotion Administration (HPA) said.
HPA data showed that about 67 percent of the 2,173 cases were for allegedly selling e-cigarettes, 477 were for advertising e-cigarettes, 40 were for displaying e-cigarettes, and 42 were for e-cigarettes or HTP use.
“What is worth noticing is that among the 42 cases of alleged illegal use, 41 involved people aged under 20,” HPA Tobacco Control Division head Chen Miao-hsin said.
The amendments were implemented last month and also increased the age to buy cigarettes to 20, increased the size of required health warnings on cigarette cartons and expanded nonsmoking zones in public spaces.
Since the vaping ban was enacted in Taiwan on March 22, 15 out of 44 vape shops in Kaohsiung City have closed, according to the city’s Department of Health.
Among the city’s 44 stores, 10 have completely shut down their businesses while 15 have closed their doors, according to media reports. The rest of the stores have switched to selling other products, as the store owners said that the fines are too high to risk, according to Taiwan News.
In addition to intensive inspections of physical stores, the health department is monitoring online sales and social media advertisements. So far, one violator who made e-cigarette advertisements will be interviewed and fined.
The head of the FDA’s Center for Tobacco Products sent mixed messages during a recent public event.
By VV staff
When the American Vapor Manufacturers (AVM) Association announced it had secured a Q&A session with the Brian King, the industry was taken by surprise. It was the first time King, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), would speak with vaping industry advocates publicly and answer questions from the audience. Surprisingly, King was quite candid. He did shy away from certain questions, however, and some of his responses were questionable.
Brian King
Youth e-cigarette use was first declared a national epidemic in December 2018 by then U.S. Surgeon General Jerome Adams. King said the “FDA has not used that terminology” (epidemic) in its “most recent estimates” of youth use. However, during a hearing of the House Oversight Subcommittee on Economic and Consumer Policy in 2021, then acting FDA Commissioner Janet Woodcock was asked if Juul Labs was “the e-cigarette company most responsible for creating this epidemic.”
She answered that it does “appear” to be the case. The title of the FDA’s own press release was “An Epidemic Continues: Youth Vaping in America.” A 2018 FDA focus group study conducted by the agency reported that “‘epidemic’ ads [had a] perceived effectiveness score of 4.17 out 5.0.” King defended the agency’s youth-oriented anti-vaping ads, which he said were “rigorously evaluated” before and after they aired and were effective at reaching teenagers. King ignored that the ads continue to use the FDA’s approved youth vaping “epidemic” terminology.
“So, I believe you’re thinking about the CDC [U.S. Centers for Disease Control and Prevention]. And FDA has not used that terminology to view the most recent estimates of youth use. I will say that I’m an epidemiologist by training, so I’m fully cognizant of the definition of an epidemic, which is unprecedented increases over what you’d expect at baseline,” said King. “That said, I think, no, that science has shown a decline in the number of youth users. And that’s a good thing. Over the past couple of years, we have seen [a] decline since the peak in 2019. It’s still too high.
“Since I’ve started, I have not [used the term]. I’m not aware of any of my staff. But as far as I’m aware, we have not used the term. It’s ultimately up to respected individuals. There’s certainly disagreements among epidemiologists. Like there is in any discipline, you’re going to find people disagree.”
It should be noted that King’s disdain for vaping is well-documented. King is credited with creating the term “e-cigarette or vaping product use-associated lung injury,” or EVALI. The term was used by the CDC for the lung injuries caused by the 2019 spread of illicit THC cartridges tainted with vitamin E acetate during King’s tenure at the CDC. The name suggested that nicotine vaping products (e-cigarettes) were responsible for at least 70 deaths attributed to black market THC products. No nicotine vaping device has ever been associated with an EVALI death or any death; however, King and the CDC have never tried to correct the misinformation.
The event was moderated by AVM Vice President Allison Boughner and its director of legislative and external affairs, Gregory Conley. When the moderators asked King if the FDA had ever identified a single nicotine vaping product, not an illicit THC cartridge (referencing EVALI deaths), that could be more hazardous than combustible smoking, King dodged the question.
“I would say that at present, we evaluate the merits of evidence that has been submitted to this agency. In terms of applications and science on their products, at present, we have authorized 23 e-cigarette products or devices that we have found and that benefits outweigh the risks,” he explained. “And we’ll continue to do that. The onus is on the applicants to submit that information. And we’re fully open to evaluating that information and then making an informed scientific decision.”
Being more direct, moderators asked King if vaping products are far less hazardous than smoking cigarettes and if that is something consumers should know. “I would agree with the statement that if an adult smoker were to transition completely from a cigarette to an e-cigarette, that would be a benefit to their health, yes,” King responded. Moderators then questioned whether it was ethical to mislead the public, letting people believe that vaping isn’t safer than smoking cigarettes.
“Although we know that in general, e-cigarettes have lower risks than a conventional cigarette, there’s a broad class, and there’s a lot of different factors that can influence the extent of risk. And so it’s not just a simple statement that every single e-cigarette is going to be lower risk,” King said. “There are different factors that we have to consider, particularly when it comes to risks to vulnerable populations like kids.”
Fighting misinformation
Credit: Vadim Pastuh
King acknowledged that vaping has been effective at helping smokers quit smoking. He added that the FDA and CTP don’t want people using combustible cigarettes. Combustible products introduce 7,000 chemicals and 70 carcinogens into users. However, the misinformation surrounding vaping products is massive. King acknowledged that he is “fully cognizant” of the misperceptions.
“I am wholly open to enhanced efforts by the Center for Tobacco Products to message not only on the continuum of risk but also misperceptions related to nicotine,” he said. “But again, the devil is going to be in the details there in terms of making sure that we have scientifically defensible messages and that we’re delivering it to the target population, which is adult smokers, and not inadvertently delivering it to the unintended populations where there’s consequences, including youth.”
The FDA’s fight against misinformation is confusing at best. For the last several years, former CTP Director Mitch Zeller and several CTP employees have repeatedly stated in public that correcting misperceptions surrounding vaping and nicotine are part of the CTP’s agenda. King seemed to imply that little had been done so far in accomplishing that goal. He said that little had been done, and that was due to competing priorities at the CTP.
“When you have a finite number of resources and people, you have to prioritize what you do to have the greatest impact. And so, I will say that for my part, coming into this position, there’s four key tenants that I am adhering to, and that’s strong science, stakeholder relations, communications and health equity,” King said. “And so, obviously, the stakeholder relations and communications are pivotal to this. In terms of my prioritization, I think it’s important that we engage with people, hear them out, but also use science to inform our communication strategies moving forward. It’s not that we haven’t done this work before but it’s just where prioritization is moving forward. And I can tell you that we’re working on it.”
Concerning misperceptions and the FDA’s message in the public arena, moderators questioned King on the FDA’s advertising. FDA ads have portrayed vapers as being possessed by demons or shapeshifting metal dragons, and vaping will cause huge parasites to crawl through your skin. None of these things have ever been reported as being true. King said that the agency does a “rigorous evaluation” both before and after the implementation of any of its campaigns, and all of the FDA’s youth-centric campaigns have very targeted strategies to reach that target population.
“We cognitively test them and do science in the beginning, and then we evaluate them on the back end. And that science has shown demonstrably that there is a beneficial impact. That said, I think that we’ve got opportunity for better public engagement on our campaigns,” he said, which didn’t really provide a clear answer to the question. “That is a critical component of our work. We don’t function in silos, and we want the opportunity to engage, but we’ve got to give people that opportunity. And if they’ve got data, if they’ve got evidence to demonstrate that a certain message or a certain target audience is going to be problematic in terms of the campaign, we welcome it.”
Illicitly speaking
Bans on consumer goods haven’t worked well historically. Prohibition of alcohol and marijuana led to massive black markets for those products. U.S. states that have enacted tobacco flavor bans, such as Massachusetts, have seen a huge increase in black markets. King said this depends on how an illicit source is defined. He added that any vaping or other tobacco product on the market that does not have FDA authorization is considered illegal, and anyone selling those products is operating in the black market.
“In terms of our enforcement and compliance strategy, we’re committed to taking action to address those that are violating it. And that can take a broad spectrum of action, whether it’ll be warning letters all the way up to civil money penalties as well as injunctions,” he said. “But we have an obligation to enforce the law. And that’s what we will do. That is what Congress has told us to do. And so we’re committed to continuing to do that. But in addition, we’re also working to make sure we get efficiencies and ramp up our efforts around reviewing applications.”
When questioned whether he had concerns about the black market continuing to grow, King said the CTP is committed to continuing to review premarket tobacco product applications as quickly as possible to guarantee a clear pathway to a marketing order. He’s also equally committed to making sure that the regulatory agency enforces the law. He says he’s committed to continue to implement the law.
“This is what Congress has told us to do. We have specific authorities that we are responsible for, and in my job as the director [of the CTP], I have to make sure that we exercise those authorities, and toward that end, I don’t think we’re perfect,” said King. “I think we’ve got opportunity for improvement. I think that there’s always [an] opportunity for improvement. We acknowledge that. I think we can do some things better, and from our part, I’m happy to continue to move us into the next chapter of the center to make sure that we’re engaging people in a meaningful way.”
On the enforcement front, King was asked why only small businesses bore the brunt of FDA action. King said that the CTP does not have a policy against small business and that its enforcement compliance actions have been taken against small and large businesses. However, one participant explained, many small businesses don’t have the finances to hire lawyers to petition the courts to fight the FDA. They also question whether the FDA would ever approve open-system products, which are mostly sold by independent vape shops.
“We’re committed to enforcing the law. I will say that some of the recent actions in terms of the civil money penalties and also the injunctions were a result of companies that did not obey the law after repeated warnings. And there are many small businesses that are obeying the law and have submitted their applications and have gone through the process,” said King. And so it’s certainly possible. I will say that for our part, we’re committed to continuing to explore opportunities where we can better provide information to applicants to make sure that the process is as flexible and straightforward as possible.”
A bad taste
During the open question session, one participant questioned whether the FDA would ever approve a flavor other than tobacco. The business owner wanted to know if the FDA intended to have an outright ban on flavored products or any open system with potential for flavored e-juice options. King said the CTP does not have an outright ban on flavored products, but the onus is on the applicants to submit the evidence to demonstrate that the benefits among adult smokers outweigh the risks to youth.
“So, there is no de facto policy within this center that would prevent the authorization of a flavored e-cigarette. But I will say that with continued high rates of youth use, the onus is high to make sure … to demonstrate that benefit to adult smokers,” King said. “But it’s not impossible. We’ve seen the authorization of several products already, all tobacco flavored, but we are certainly open to applications on flavored products.
“And if the science demonstrated that there was a net benefit compared to the risk, we would authorize it. And so that’s my take-home here [that] there’s no blanket policy against flavored, but we’ve got to follow the science, and at present, we have not got sufficiently strong evidence that demonstrates that the flavors are needed for the adult smoker to quit.”
King was also asked about memos submitted to the U.S. Court of Appeals for the 3rd Circuit but an attorney for Logic Technology showed that King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists. King said that that was an “erroneous description” of what occurred. It was not an overrule.
“In this case, there was [an] initial assessment of that science, and then there was further scientific discussion. And I am a scientist by training. I have been for many, many years. And we sat down and discussed the merits of the available science that was presented,” explained King. “And after the discussion of that science and those merits, the determination was made that the applicant did not meet the standard.”
A recent report published in the journal Addiction examined e-cigarette use in England among young adults between 2007 and 2018. That study concluded that 18-year-olds to 24-year-olds who use e-cigarettes did not use vaping as a gateway to smoke combustible cigarettes. King was asked about the study and whether he believed a “gateway effect” existed despite evidence that one did not. King responded that there’s still a strong body of evidence that suggests that the gateway does exist, but it’s dependent on a variety of different factors.
“[It’s] certainly not conclusive evidence, but there’s moderate evidence to demonstrate that [a gateway exists]. But you also have to look at the net impact of the science. And so I’ve said publicly many times that you do have some gateway effects. We’ve seen that through the past study and others, but that doesn’t mean that every single kid who’s using an e-cigarette is going to go on to smoke,” King explained. “There’s a variety of factors that impact that. So I caution folks against definitive statements like that, that every person is going to transition who uses the product. It’s certainly happening. But when you look at the net effect, we’ve definitely seen a decline in overall e-cigarette use.”
In the end, King said that the one thing people should realize is that he’s the type of person who speaks plainly and honestly. He doesn’t have the stereotypical characteristics of a civil servant. “If there’s anything that folks know about me, it’s I aim to be the most nonbureaucratic bureaucrat that you’ve ever met, and that involves just straight-shooting. And so, if we can do better, I want to know about it, and we can definitely enhance the communication on that front,” explains King. “So, I would say more to come, but the science is going to drive it. And we’re at the initial stages in informing what effective messages are most critical to reach the target audience without unintended consequences.”
In the last few weeks, numerous sources have suggested vaping could be a risk factor for either contracting or increasing the severity of COVID-19. These reports are almost entirely based on the speculation from anti-vaping advocates, who rarely receive significant pushback, writes Guy Bentley, director of Consumer Freedom for the Reason Foundation.
Appearing on NBC’s Today Show on March 23, U.S. Surgeon General Jerome Adams postulated, without evidence, that vaping could be the reason young people may be at higher risk from COVID-19 than previously thought. “There are theories that it could be because we know we have a higher proportion of people in the United States and also in Italy who vape,” said Adams.
But [on April 16] the U.S. Food and Drug Administration (FDA) told Bloomberg News, “E-cigarette use can expose the lungs to toxic chemicals, but whether those exposures increase the risk of COVID-19 is not known.”
While seemingly anodyne, the statement differs significantly from those of Nora Volkow, director of the National Institute on Drug Abuse (NIDA). Volkow, recently wrote in the Annals of Internal Medicine that vapers could be at high risk for coronavirus.
Similarly, last week, Massachusetts Attorney General Maura Healey went so far to issue an advisory warning that vaping could worsen the spread of COVID-19. And last month, New York City Mayor Bill de Blasio claimed, “If you are a smoker or a vaper that does make you more vulnerable.”
Following an apparently unclear email exchange with an FDA official, Bloomberg News published a story with the headline: “Vaping Could Compound Health Risks Tied to Virus, FDA Says,” that prompted Iowa Attorney General Tom Miller and 12 public health experts to write to the FDA to complain. The signatories warned the FDA that if its communications are “arbitrary and ill-conceived, spreading fear and confusion with little scientific basis and unpredictable consequences, then it would be better if the FDA and its media spokespeople did not comment further at this time.”
Thankfully, the FDA finally appears to be taking this advice seriously. There is currently no evidence from anywhere in the world showing vapers to be at higher risk for COVID-19, Bentley writes in his editorial.
The Science Media Research Center recently released statements from public health experts to help reporters understand what we do know about smoking, vaping, and COVID-19. “There is no evidence that vaping increases the risk of infection or progression to severe conditions of COVID-19,” said Dr. Caitlin Notley. She added that since switching from smoking to vaping improves cardiovascular and respiratory conditions, smokers who switch “might be expected to have a better prognosis if infected by COVID-19.”
Similar to last year’s outbreak of lung illnesses that were initially wrongly associated with conventional e-cigarettes, but later found to be the result of adulterated black market marijuana products, much of the communication around vaping and COVID-19 is targeted at young people in an effort to get them to stop vaping.
The Campaign for Tobacco Free-Kids (CTFK) and Parents Against Vaping Electronic Cigarettes (PAVE) has consistently promoted stories linking vaping and the coronavirus. On April 15, for example, they even promoted a campaign to tell the White House that vape shops are not essential businesses.
“There is growing concern among public health experts that e-cigarettes can put users at greater risk for serious complications from COVID-19, these products are addicting our kids, and they have not been proven to help smokers quit,” says CTFK.
The statement is disingenuous. E-cigarettes have been proven beyond any reasonable doubt to be far safer than combustible cigarettes and consistently shown to help smokers quit. Italy, Spain, France, and Switzerland are keeping their vape shops open because they recognize the public health benefit of ensuring access to safer alternatives to cigarettes.
It’s time for anti-vaping groups to stick to the facts and stop spreading fear and misinformation about a product that is saving millions of lives both in the U.S. and across the globe. Stopping kids from vaping is undoubtedly a noble goal, but it’s not an excuse for misleading the public in ways that could prevent smokers from switching to a dramatically safer product.
A proposal by the government of Quebec to ban nontobacco-flavored nicotine vaping products will have negative consequences for public health if enacted, according to the Canadian Vaping Association (CVA).
In addition to the flavor restrictions, the recently released draft legislation proposes a volume limit of 2 mL on prefilled devices and a limit of 30 mL on refill containers. Additionally, the regulations would restrict nicotine concentrations to 20 mg/mL and prohibit the use of any form, appearance or function that may be attractive to minors, both of which have already been regulated by the federal government.
If the draft rules are implemented, Quebec, with its population of 8.5 million, will become the largest Canadian province to prohibit flavors, according to media reports. Quebec is the country’s second-most populous province. According to the Alliance of Vape Shops in Quebec, there are over 400 independent vape shops in the province, employing over 2,200 people and generating more than $300 million in economic activity. The trade group predicts the shops will all close.
Quebec’s decision to ban flavors is a major win for tobacco companies, out-of-province vendors and contraband sellers.
In 2021, federal health agency Health Canada proposed a flavor ban that was scheduled to take effect in early 2022, but that plan seems to have been abandoned or postponed indefinitely without explanation. Health Canada’s updated vaping products regulations page makes no mention of the flavor restrictions.
The CVA says Quebec proposed its rules despite warnings by the industry about their negative impacts. Vaping is proven to be significantly less harmful than smoking, according to the CVA, which says there is substantial evidence from jurisdictions that have already implemented flavor bans that the public health outcome is negative, as many vapers will return to smoking and fewer smokers will switch to vaping.
“Quebec’s decision to ban flavors is a major win for tobacco companies, out-of-province vendors and contraband sellers,” said Darryl Tempest, government relations counsel to the CVA board, in a statement. “What Quebec has done is shift demand to tobacco owned products, retailers outside of Quebec and criminals. Quebec’s small businesses and domestic industry will be irreparably harmed in favor of multinational corporations,” said Tempest.
Vaping products that contain flavors or aromas other than tobacco could soon be banned in Quebec under new rules proposed by the government Wednesday.
The Quebec government hopes the change to the provincial regulations will make vaping products less attractive to minors.
“We’re not eliminating vaping, but we’re eliminating flavors,” Health Minister Christian Dubé told Radio-Canada in an interview. “There will only be the taste of nicotine and all other flavors will be prohibited.”
The minister responsible for sports, Isabelle Charest, said the changes are about keeping “extremely harmful” products out of the reach of minors, according to CBC.
“They start to vape because they find it fun or attractive to have a vape pen that tastes like strawberries,” she said, adding that sweet-flavored products make up 90 percent of what minors vape, with only the remaining 10 percent choosing tobacco-flavored products.
The draft regulations also include proposals to limit the maximum nicotine concentration in vaping products to 20 milligrams per milliliter, restrict vape tank and capsule capacity to two milliliters, and limit the maximum volume refill capacity of liquid cartridges to 30 milliliters.
Vaping products will be prohibited from resembling toys, food or taking other forms that might be attractive to minors.
The ministry also acknowledges the new rules will likely mean job losses and a drop in sales for companies primarily selling vaping products.
As part of the new regulations, there will be a 45-day public consultation period.
“Their correction grade, the inmate they’ve gotta barcode on it they will scan it the inmate has to give this particular unit back to get another one if it’s altered in any way they won’t get another one,” said Sheriff Mike Griffis, according to CBS7.
All of the revenue will go towards the jail, at no expense to taxpayers, Ector County Judge Dustin Fawcett says it will offset costs to keep the inmates locked up.
“The supplies it takes to pay for the inmates, their beds, their pillows, all those types of things taxpayers are on foot for so we are certainly going to look to relieve all taxpayer items to the best of our ability,” said Fawcett.
Griffis says their buying the e-cigarettes at $3.85 a piece selling them for around $14. They’ll start with 1,000 and see how it goes…
“I hope we sell a bunch of them and make a lot of money. The vendor said y’all may make $1 million a year selling these,” said Griffis.
One e-cigarette is equivalent to one pack of cigarettes.
Fawcett says other counties have used this before, as the e-cigarettes act as a behavioral tool.
“Whenever you have inmates who cooperate who are on good terms it helps with our jailing numbers, our staff when you have good inmates you don’t see as much turnover with staff,” said Fawcett.
Griffis says the e-cigarettes are fairly indestructible, basic enough to hopefully not pose a safety threat.
Authorities in Panama have rejected a proposal to regulate vaping products. In March, the Panamanian Tobacco Harm Reduction Association together with citizens who use vaping products presented a proposal for the regulation of electronic nicotine-delivery systems (ENDS) in order to modify Law 315 of June 30, 2022, which prevents the more than 170,000 Panamanian smokers from using ENDS products.
The proposal was rejected by the Technical Secretariat of Economic Affairs, which issued an unfavorable report. According to the report, the government believes that Panama should continue with the strategy set by the WHO Framework Convention on Tobacco Control and reject the use of reduced-risk products to help smokers quit.
The report also justified its decision to reject the proposal on the grounds that they follow the legislation of countries such as Mexico and Argentina.
Michael Landl, director of the World Vapers’ Alliance, said the government of Panama continues to ignore users and science. Tobacco harm reduction should be an indispensable element in the fight against smoking.
“Science has already proven that vaping is far less harmful than smoking and is the most effective therapy for quitting tobacco,” Landl said in an email. “The thousands of Panamanian vapers are proof of this. Panama should follow the example of countries that are succeeding in defeating smoking, such as the United Kingdom or Sweden, which is about to become the first tobacco-free country in the world, instead of copying the failure of Argentina and Mexico.”
The rejected proposal also looked to guarantee users’ access to a legal market free of contraband. Currently, the black market is gaining prominence and it is estimated that smuggling reaches 80 percent of the trade of combustion cigarettes and 100 percent of the trade of smoke-free devices, according to the president of the Panama Tobacco Harm Reduction Association, Tomás Sánchez.
“Since last year’s ban, thousands of users of reduced-risk products have been forced to return to tobacco smoking or purchase their products illegally on the black market, where there are no guarantees of quality and safety,” Sánchez wrote in an email. “The ban has been a failure for public health and the Panamanian government needs to correct its position as soon as possible to allow smokers access to an alternative. Their response shows that they do not understand tobacco harm reduction and are unwilling to listen to users, who are the main victims of the ban.”
The fact sheet provides quick tips for completing Form FDA 4057a—Premarket Tobacco Product Application Amendment and General Correspondence Submission. In most circumstances, the CTP can only accept PMTA amendments for review that include Form FDA 4057a. In general, when submitting amendments for a PMTA, the FDA will review the required Form FDA 4057a first. If required content is missing from the form, the FDA may not continue reviewing the amendment.
The video provides an overview of the CTP Portal and how to use it, including how to find application submission tracking numbers online.
Recently, CTP Director Brian King outlined several new actions to enhance the center’s efficiency, effectiveness and transparency. These activities include enhanced communication on scientific issues and practices. By providing these new resources, the CTP is aiming to better support applicants navigating the PMTA process.
On April 12, 2023, the Food and Drug Administration’s Center for Tobacco Products (CTP) held an online public hearing regarding its recently released proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”
This public hearing was scheduled when the CTP issued the proposed rule on March 10.
The hearing began with introductory comments by CTP Director Brian King. In addition to welcoming the participants and audience to the hearing, King noted that the CTP has been designing this proposed rule since 2011. Following King was Matthew Brenner, CTP senior regulatory counsel.
Brenner summarized the proposed rule and highlighted the definitions of a “finished tobacco product” and a “bulk tobacco product” with regard to the rule. Emil Wang, senior advisor for manufacturing and regulatory policy at the CTP’s Office of Compliance, concluded the introductory session by detailing the timeline of the proposed rule.
The proposed rule’s 180-day public comment period is between March 10 and Sept. 6, 2023. The effective date for the regulation would be two years after the final rule is published in the Federal Register. For small manufacturers (those manufacturers with fewer than 350 employees), the effective date for the regulation would be six years after the final rule is published in the Federal Register.
The public comment session featured the following scheduled participants (in order):
James O’Reilly—professor of public health policy at the University of Cincinnati. O’Reilly called the proposed rule “comprehensive” and noted that the CTP needs to add another $100 million in additional staff to properly enforce this rule. O’Reilly also called on the CTP to coordinate with other federal agencies, such as the Environmental Protection Agency, to handle foreign chemical imports that relate to this rule.
Drew Newman—JC Newman. The premium cigar maker representative highlighted four items: flexibility is required as each tobacco product differs from one another; recordkeeping is lengthy and costly; qualifying suppliers such as tobacco leaf growers will be difficult; and batch coding for final products will prove very difficult for the premium cigar industry.
Hiuyu Shi—e-cigarette manufacturer from Shenzhen, China. Shi noted that foreign components will be very difficult to regulate and monitor. One example was the difference in water quality between nations.
Laura Searcy—National Association of Pediatric Nurse Practitioners. Searcy supports the proposed rule.
Gabby Kaife—Boutique Cigar Association. Kaife is against the proposed rule.
Jason Hodge—former smoker and current vaper. Hodge is against the proposed rule.
Joshua Habursky—deputy executive director of the Cigar Association. Habursky is against the proposed rule.
Meredith Berkman—Parents Against Vaping. Berkman supports the proposed rule.
Maham Akbar—The Truth Initiative. Akbar supports the proposed rule.
Connor Fuchs—Campaign for Tobacco-Free Kids. Fuchs supports the proposed rule and notes that the timeline is too long and should be shortened.
Mark Anton—e-cigarette/vapor product manufacturer. Anton believes that sections of the proposed rule conflict with previous statements by the CTP. Also, he believes that the burden has been shifted from the regulator to the manufacturer.
Patrick Murphy—vice president of scientific and regulatory affairs at Reynolds American Inc. (RAI). Murphy calls for further refinement and guidance to the proposed rule. He calls for more clarity in several sections and better processes that are product dependent. RAI will forward its notes in a written comment.
Michelle Paige—tobacco chemist. Paige discussed storage conditions and stability issues regarding electronic nicotine-delivery system liquids. Further product standards are needed in this area.
Sammy Hamdouche—Lucy, manufacturer of oral nicotine products. Hamdouche called the regulation onerous for small manufacturers such as his company. Further labor for his company and their suppliers could eliminate parts or potentially all of their business. Costs could be 10-fold for these processes for his company. Predetermined acceptance criteria could be one solution. The CTP has wide latitude to make this rule more flexible, but Hamdouche is not optimistic.
Ron Tully—tobacco industry consultant. Tully believes that the proposed rule should recognize manufacturers of different products and sizes. Small manufacturers could face financial disaster with this rule.
Pamela Ling—professor at the University of California at San Francisco. Ling supports the proposed rule. She also calls to strengthen the section of the rule regarding storage procedures and shelf life.
Pamela Granger—anti-tobacco activist. Granger supports the proposed rule.
The public comment session featured the following additional participants who missed their original slotted time (in order):
Jason Hodge concluded his earlier diatribe
Delores Orlando—Florida Smoke-Free Association and vape shop owner. Orlando is against portions of the proposed rule.
On May 18, 2023, the CTP’s Tobacco Product Scientific Advisory Committee will meet the discuss the proposed rule on “Requirements for Tobacco Product Manufacturing Practice.”
The U.S. Food and Drug Administration will hold a public hearing tomorrow, April 12, concerning its proposed guidelines for vaping product manufacturers. When finalizing its rules, the agency weighs the public’s perspective and the perspective of stakeholders like the vapor manufacturing companies that produce the products.
The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts. The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.
When announcing the hearing, the FDA said speaking spots were limited, and the agency could not guarantee that it would be able to accommodate all requests. The agency asked groups and organizations to select a single spokesperson to help the agency hear as many different perspectives as possible.
Registration to provide oral comments closed on March 31, 2023. The oral session will be recorded, and a transcript will be added to the docket of the proposed rule.
Bans on consumer goods haven’t worked well historically. Prohibition of alcohol and marijuana led to massive black markets for those products. U.S. states that have enacted tobacco flavor bans, such as Massachusetts, have seen a huge increase in black markets. King said this depends on how an illicit source is defined. He added that any vaping or other tobacco product on the market that does not have FDA authorization is considered illegal, and anyone selling those products is operating in the black market.
