The retailers selling illegal flavored disposable vapes are under scrutiny. The U.S. Food and Drug Administration issued complaints for civil money penalties (CMPs) against 22 retailers for the illegal sale of Elf Bar/EB Design.
The FDA previously warned each retailer in the form of a warning letter to stop selling unauthorized tobacco products, according to the agency. During follow-up inspections, the FDA observed the retailers had not corrected the violations, which resulted in the civil money penalty actions.
“The FDA has been abundantly clear that we are committed to using the full scope of our authorities, as appropriate, to hold those who break the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “These retailers were duly warned of what could happen if they failed to correct their violations. They chose inaction and will now face the consequences.”
The complaints seek the maximum civil money penalty of $19,192 for a single violation from each retailer. While the FDA has issued civil money penalty complaints to retailers for selling unauthorized tobacco products in the past, this is the first time the agency is seeking CMPs for the maximum amount against retailers for selling illegal flavored disposable vapes.
The retailers 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. Those that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.
Courtesy: US FDA
In addition to the CMP complaints, today the FDA announced an additional 168 warning letters to brick-and-mortar retailers for illegally selling Elf Bar/EB Design products. These warning letters were the result of a coordinated nationwide retailer inspection effort conducted throughout the month of August, according to the agency.
Warning letter recipients have 15 working days to respond with the steps they have taken to correct the violation and ensure compliance with the law. Failure to promptly correct the violations can result in additional FDA actions such as injunction, seizure or civil money penalties.
“We continue to monitor closely all those in the supply chain, including retailers, for compliance with federal law,” said Ann Simoneau, director of the Office of Compliance and Enforcement in the CTP. “This includes follow-up inspections and surveillance of those who have received a warning letter, and taking additional action, as appropriate, to enforce the law.”
Vaping product sales in Oklahoma are set to get more complicated. On Oct. 1, the state will publish a list of vaping products allowed for sale within its borders.
Oklahoma’s new rules prohibit sales of products that have not received a marketing granted order (MGO) by the U.S. Food and Drug Administartion or are still under review in the regulatory agency’s premarket tobacco product application (PMTA) process.
Vaping product manufacturers were required to submit documentation by July 1 to the Oklahoma Alcoholic Beverage Laws Enforcement (ABLE) Commission that attested under penalty of perjury that the products listed were available for sale before Aug. 1, 2016 (the effective date of the FDA’s Deeming Rule), and that a PMTA had been submitted for each product on or before the agency’s Sept. 9, 2020 PMTA submission deadline.
The bill creating the Oklahoma law passed the state legislature in 2021, but vaping advocates were able last year to get implementation postponed until 2023. Attempts this year to repeal the law or delay it again until 2024 were unsuccessful.
The law will make vape shop owners criminals if they are found to be selling bottled e-liquid or disposable vaping products not named on Oklahoma’s list. Giving false information about the authorization status of any product submitted to the list is also a crime.
Manufacturers are required to notify the state of Oklahoma within 30 days of a change to the product’s authorization status with the FDA.
On Sept. 14, 2023, the U.S. Food and Drug Administration issued warning letters to 15 online retailers and three manufacturers and/or distributors for selling or distributing unauthorized e-cigarette products. Additionally, in one case, the retailer illegally sold a product to an underage purchaser. The warning letters cite a range of popular and youth-appealing e-cigarette products, including disposable products, marketed under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech.
According to the FDA, the youth-appealing e-cigarette products of focus were identified through rapid surveillance and a data-driven approach to investigations. Retail sales data, emerging internal data from surveys of youth, as well as other data sources helped the agency to identify the rising popularity of these youth-appealing products, which were subsequently prioritized for investigation across the supply chain, from manufacturers to distributors to retailers.
“Given the rapidly evolving nature of the e-cigarette landscape, it’s essential that we have nimble surveillance tools that can best keep pace to protect public health,” said Brian King, director of the FDA’s Center for Tobacco Products. “They’re a critical component of our comprehensive surveillance toolbox, so that we can proactively identify and swiftly stave off emerging threats, particularly those affecting our nation’s youth.”
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) has launched new resources to help applicants navigate the agency’s premarket tobacco product application (PMTA) process.
Specifically, CTP is offering a new webpage with more in-depth information on how to complete the three required PMTA forms to submit and amend pending applications.
Over the last few years, CTP has received more than 26 million PMTAs and made determinations on 99% of those applications.
Based on this experience and communications with applicants, CTP has developed the new online resources, which includes easy-to-access tips to help applicants submit in the future.
“These new online resources are part of CTP’s ongoing efforts to enhance the center’s efficiency, effectiveness, and transparency in response to recommendations from an independent external evaluation led by the Reagan-Udall Foundation,” a release states.
Pastel Cartel, the manufacturer of Esco Bars vaping devices, has submitted a legal complaint to the U.S. Federal District Court in the Western District of Texas.
The dispute is in regards to a U.S. Food and Drug Administration decision to reject over one hundred documents that Pastel Cartel had included in their premarket tobacco product applications (PMTAs), according to court records.
In the lawsuit, Pastel Cartel accuses the FDA of acting negligently and carelessly by issuing refusing to accept (RTA) letters for the company’s PMTAs on technical grounds.
The company is seeking:
A preliminary injunction staying the RTA orders until the case is decided;
A judgment finding the RTAs violate the Administrative Procedure Act (APA) and the U.S. Constitution (the Due Process Clause of the Fifth Amendment);
A final judgment setting aside the RTA orders and remanding the company’s PMTAs back to the FDA for further review.
Earlier this year, Shenzen Innokin Technology Co. Ltd., the producer of Esco Bars products, and Breeze Smoke, LLC who import and distribute Breeze products also received warning letters for manufacturing, distributing, and/or importing unauthorized tobacco products in the United States, according to the FDA.
The attorneys general for 33 states sent a letter to request the U.S. Food and Drug Administration do more to protect young people from e-cigarettes.
Michigan Attorney General Dana Nessel announced she signed a bi-partisan letter calling on the FDA to limit the e-cigarette flavors that draw kids in and protect them from marketing, according to media reports.
She also suggested that the FDA should require a limit on nicotine levels in e-cigarette cartridges and disposables, according to a press release.
“Nicotine use by our young people has reached epidemic levels,” Nessel said in the release. “We need impactful tobacco regulations that protect our youth from the dangers of e-cigarettes and marketing tactics that target them with products flavored to taste like fruit and candy.
“We must act to regulate young people’s exposure to these products and take robust enforcement actions against manufacturers, distributors and retailers who ignore the law.”
The letter is becoming a yearly occurrence. Last year, a bipartisan coalition of 31 attorneys general are calling on the FDA to reject marketing authorization for all non-tobacco nicotine products, which are currently being sold without regulation of their contents, manufacturing, health effects, required warning labels or marketing claims.
In the 2022 letter, the coalition argues that vaping products don’t meet the FDA’s public health standard, and the regulatory agency should not gamble on the unknown effects of the products, despite the FDA having authorized 23 vaping products.
The other attorneys general signing onto the 2023 letter are from the states of Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Illinois, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Northern Mariana Islands, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Dakota, Tennessee, Utah, Vermont, Washington, and Wisconsin.
The U.S. Food and Drug Administration has posted a new webinar to help online retailers respond to warning letters from regulatory agency’s Center for Tobacco Products (CTP).
The webinar provides an overview of warning letters and outlines the process for responding to a warning letter, such as corrective action taken by the firm to address any violations and its plan for maintaining compliance, according to an FDA release.
In the webinar, you will learn about:
FDA’s internet and publication surveillance of tobacco products
Examples of violations cited in warning letters sent to online tobacco product retailers
Actions to take after receiving a warning letter
Regulators in the United States began cracking down on online retailers selling vaping products that are attractive to youth. The Food and Drug Administration last week issued warning letters to 16 (the agency reported 15, but lists 16) online retailers for selling and/or distributing unauthorized e-cigarette products packaged to look like cartoon characters, school supplies, toys, and drinks.
The U.S. Court of Appeals for the D.C. Circuit yesterday found that the Food & Drug Administration failed to conduct the proper analyses before rejecting some vaping product applications.
This is the second circuit court of appeals to accuse the FDA of a “surprise switcheroo” when reviewing vaping product applications.
Fontem, the company behind the Blu and myBlu vaping brands, argued that the FDA had not conducted the proper analysis prior to rejecting their applications. The D.C. Circuit Court agreed with Fontem in regards to their unflavored products, ruling that the FDA had “neglected to conduct the overall public health review specified by law.”
Judge Rao’s opinion for the court (joined by Judge Walker and Senior Judge Ginsburg), stated that with respect to Fontem’s unflavored products, the FDA also denied Fontem’s applications on the public health ground.
“While the FDA identified multiple ‘deficiencies,’ it failed to analyze the tradeoffs necessary to make a public health finding. Nor did the agency explain how the specific deficiencies relate to its overall conclusion that Fontem failed to demonstrate its unflavored products were appropriate for the protection of public health,” the opinion states. “The agency’s denial therefore failed to comport with the requirements of the Tobacco Control Act.”
In denying Fontem’s unflavored products, the FDA relies solely on the public health ground. The FDA could have promulgated regulations imposing consistent requirements on the composition and manufacturing of tobacco products, according to the order.
“Had the agency done so, Fontem’s failure to meet those standards would be an independent and sufficient ground for denying the applications, regardless of the overall public health consequences of Fontem’s products,” the order states. “But the agency has not exercised its regulatory authority. Because the FDA has chosen to proceed application by application under the public health ground, it must undertake the holistic inquiry required by the statute.”
Instead of making an overall assessment that Fontem had not shown its products were beneficial to the public, the agency identified five highly technical deficiencies, according to the order. But nothing in the denial order explains how the deficiencies relate to the overall public health consequences of Fontem’s unflavored products.
The FDA’s failure to correctly apply the public health inquiry to Fontem’s unflavored products led it to make another serious error, according to the order. In its initial deficiency letter, the FDA requested certain information from Fontem, thereby indicating such information would be sufficient for the agency to approve Fontem’s products.
“Cf. 21 U.S.C. § 387j(c)(3) (providing an application denial “be accompanied by a statement informing the applicant of the measures required to remove such application from deniable form”),” the order states. “But in several instances, the FDA changed its tune in the denial order, reproaching Fontem for failing to provide information the agency had never explicitly sought.
“Shifting the regulatory goalposts without explanation is arbitrary and capricious. By indicating in its deficiency letter that Fontem could resolve issues with its applications by providing specific information, the FDA represented such information would be sufficient to secure approval.”
FDA is extending the proposed rule’s comment period by an additional 30 days to allow people additional time to submit comments. Comments on the proposed rule will now be accepted through Oct. 6, 2023.
The proposed TPMP rule would place new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of their products.
These proposed requirements would help protect public health by, among other things, minimizing or preventing contamination and limiting additional risks by ensuring product consistency.
When it comes to advertising, vaping and alcohol have separate standards of regulation.
By George Gay
Here are a couple of newspaper quotes worth comparing:
“Marked with a label showing a cartoonish red beast [my emphasis] in shorts and high socks wielding some glasses, Chin Chin has become the wine of now, the Casillero del Diablo of Gen Z, relatively affordable, instantly recognizable, and it looks good on Instagram.”
“One of the recommendations was closing the loophole on free samples, but others included considering banning the online sale of vapes, banning cartoon characters [my emphasis] or images appealing to young people from vaping products ….”
The first quote is from a piece in the U.K. edition of The Guardian newspaper of May 8, “Chin Chin! The party drink putting fizz into summer”;the second is from a piece in The Guardian of May 31, “New laws for vaping mooted to deter sale [sic] to children.” The May 8 story was promotional; the May 31 story was denunciatory.
Yes, hypocrisy is alive and well. Apparently, according to The Guardian, cartoon characters on vaping products, never known to have killed anybody in the U.K. as far as I am aware, are beyond the pale, but a cartoon character on alcohol, the biggest risk factor for death, ill health and disability among people 15–49 years of age in the U.K., is just tickety-boo.
The Guardian has seemed lately to take every opportunity to issue dire warnings about unproven risks related to vaping, a habit that is helping many people to quit smoking, while it treats alcohol as a product worth promoting and drunkenness as just a bit of fun. On May 4, it ran a story under the headline “Solved: Why bubbles in champagne follow a straight line, unlike people who drink it.”
While I would admit there is something comical about a person staggering down the pavement under the influence of alcohol, seeing him step into the path of an oncoming vehicle is less so. And according to a National Institutes of Health study, “The most numerous group of road accident fatalities among pedestrians are men, with a particular emphasis on men under the influence of alcohol.”
It seems to me that The Guardian, a newspaper I have read daily for 40 years and that I generally admire, is lending its voice to the forces of those trying to ban vaping and generally undermine tobacco harm reduction in the U.K., something I find puzzling since the paper takes what I would describe as a generally liberal attitude to the use of recreational drugs.
Indeed, as I have indicated, it promotes alcohol. The Chin Chin story, cartoon character and all, took up about three-quarters of a right-hand page. The paper runs adverts for alcohol, and each week, it devotes a page of its half-page-format Feast magazine to the promotion of alcohol. On June 17, it included in its Saturday edition a 36-page supplement on Food and Drink, which probably should have read “Drink and Food,” partly because most of the front page was taken up with a picture of “this season’s hottest cocktail.”
Ironically, in a different section of the same paper, a book reviewer described how Drug Science, an organization set up by neuropsychopharmacologist professor David Nutt, had, in the past, published a table showing the relative risks of different drugs in which alcohol was rated by far the most dangerous.
It’s not that The Guardian doesn’t think about the ethics of what it does. In its June 16 edition, it announced a global ban on gambling advertising, arguing it was “unethical to take money from services that can lead to ‘addiction and financial ruin.’” The announcement, in my opinion, was nuanced and demonstrated that the paper’s position was not judgmental toward those who wanted to bet occasionally.
But vaping is not given a similarly fair hearing. The significant volume of negative vaping stories the paper carries and the way the stories are presented indicates to me a lack of objectivity over this issue. Here is one example taken from a story on June 6, “Disposable vapes should be banned to protect children, U.K. pediatricians say.” In this piece, the paper references Action on Smoking and Health (ASH) just once: “Action on Smoking and Health data also shows that experimental use of e-cigarettes among 11-to-17-year-olds is up 50 percent on [that of] last year.”
Credit: Beam Suntory
This quote is taken from the 2023 ASH-commissioned YouGov survey published online in May, “Experimental child vaping up significantly since 2022 but not current vaping.”1 It is based on the second bullet point of four that open the document, but the significant thing is that the story makes no reference to the first bullet point: “No significant change between 2022 and 2023 in the proportion of 11[-year-olds to] 17-year-olds currently vaping or smoking.”
There is no reference either to the statement made further down in the document: “However, fears that vaping is leading a whole generation to be addicted to nicotine are not justified by the evidence to date.”
What is happening here? I suspect that for some reason, The Guardian has picked up on the moral panic centered on “children” and “kids” that was whipped up in the U.S. and that proved successful in throwing doubt on whether it was appropriate to use vaping as a tool to quit smoking and decided to run with it.
I say this because what is striking is that there seems to be little interest at The Guardian in respect of the issue of tobacco smoking among young people, an activity that should be much higher up the agenda of concern. Why is this? Could it be that, as in the U.S., the vaping-and-children issue has risen to the top because it is the “children” of the financially better off who are vaping?
Let me be clear. I do not have a shred of evidence to support this speculation, but I think it is worth asking questions along these lines. Could it be that the offspring of financially impoverished people who tend not to have a public voice are still smoking tobacco while those of financially more secure parents who tend to be pushier have moved on to vaping?
If I am correct, nobody needs to be surprised because such a divide would be in line with what has become the natural order in the U.K., where the large and growing number of young people from disadvantaged backgrounds are to be found at the back of the queues when it comes to food, basic hygiene products, good health outcomes, clothing, education, recreational opportunities, employment prospects … well, you name it.
But, circling back to the question of alcohol, I don’t want to be unfair because The Guardian does occasionally run a negative piece on drinking. On May 24, for instance, it carried this story: “Government’s failures on alcohol have led to health crisis, say MPs.” Below are the first two paragraphs of that story, which was by Andrew Gregory, health editor:
“The government’s failure to tackle alcohol harm in England has caused a public health crisis affecting millions of people, according to a damning report by the public accounts committee published today,” the story stated.
“Problem drinking is fueling violent crime and costing the NHS [National Health Service] and wider society [GBP]25 billion a year, with deaths almost doubling in two decades, the report says. Ministers are accused of slashing funding for support services by hundreds of millions of pounds while breaking promises of action and ditching policies aimed at resolving the crisis.”
Two questions arise, I think. Why, when it is clearly aware of this stuff, does The Guardian promote alcohol and drinking and, indirectly, violent crime? And can The Guardian be surprised with what has been happening when the U.K. Parliament operates out of subsidized bars with attached debating chambers?
Another reason why I believe The Guardian’s coverage amounts to a campaign against vaping is that its stories drag in a lot of issues in support of its take on underage vaping that, while important, need to be addressed separately. The stories embrace such issues as illicit products, illegal sales and the environment, but no attempt is made to get to the root of these issues.
For instance, I would have thought it would have been worthwhile asking why the U.K. is seemingly awash with noncompliant vaping products. I would have thought it would have been worthwhile asking why retailers can apparently sell vaping products to underaged customers with near impunity. And I would have thought it would have been worthwhile asking whether underage people are the victims, the villains or both in respect of the environmental harms being caused by carelessly discarded vaping devices, especially “single-use” devices.
But even I found that such issues took a back seat when, on June 14, The Guardian’s coverage of vaping took an even worse turn. On that day, the “children”-and-vaping issue was relegated to a double-page spread in G2, which styles itself as the Life and Arts section of the paper. That’s a bit of a push. Most serious reviews seem to be presented in the news section of the main paper.
G2 is more about entertainment. There’s the television guide, some often light-hearted columns and a regular turnaround of pieces on how to sleep better, how to improve your sex life, how to eat more-nutritional food, how to understand your companion animal … oh yes, and, of course, there are the interviews with celebrities who have active agents and a book, film or album coming out and that always start with Joe Bloggs talking to Eoj Sgolb about … (insert three words from the list of drugs, loss, love, sex, drink, rehab …).
OK, I’m sure you know the sort of stuff. Harmless, perhaps, but G2 is not the sort of vehicle, I would have thought, for a discussion of vapes, whose primary purpose is to help shift smokers from their highly risky habit with its high cost to society in general and, especially, to the under-pressure NHS. But then, perhaps I am being unfair because The Guardian, which has otherwise undertaken some serious and important journalism, alone and in conjunction with other outlets, possibly doesn’t believe the vaping issue is serious. Certainly, in relegating it to the G2, it seems to have shown its hand; it believes the “children”-and-vaping issue is entertainment.
The first two-thirds of the opening page of the G2 splash was taken up with a close-up picture of somebody wearing a hoodie and holding a vape, a picture the art department had done its best to make look sinister. In fact, the picture tends to support the idea that we are dealing with a middle-class issue.
The hoodie is neat and clean, and underneath it (to indicate we are looking at a young person) you can see a smart shirt and what looks like a school tie, part of a uniform many financially impoverished people could not afford. The top button of the shirt is done up and the tie neatly secured. The fingers shown holding the vape are definitely not tattooed with H A T E.
In fact, in this guise, vaping has been relegated not only to entertainment but to something resembling a poorly scripted soap opera. The June 14 story was headed “Mum, I can’t go any longer —I really need a vape.” This plaintiff cry was apparently issued from the lips of 16-year-old Josh, who was taking exams, and the reaction of his mum, Hannah, was apparently to break the law and buy him a vape—only this once, she was quoted as saying, rather implausibly. There was no discussion in the story as to whether Hannah would have bought other drugs if Josh had said he needed amphetamines, cocaine or heroin.
Credit: Millstream Brewing Co.
Notwithstanding Hannah’s seeming lack of judgment, she is given a platform on which to expound her assumed expertise on addiction and relative addiction, whatever that might be. At one point, Hannah tells us Josh is “massively” addicted while later, she says he is more addicted than she thought, which presumably takes him into massively addicted-plus territory.
In fact, the June 14 soap was the second episode of the story that had started with what I would describe as a shamefully bad piece The Guardian ran in its main section on March 18—unbelievably on page 5. In the earlier piece, we were told about 14-year-old Liam, who, according to his mother, Sarah, was “completely addicted to vaping,” which raises the question of whether it is possible to be incompletely addicted. Sarah’s reaction? Apparently, to break the law and feed her son’s habit.
The soap’s two episodes are closely similar in format, with drawers full of vapes and seemingly naive, inadequate, middle-class parents blaming others for their offspring’s behavior. They admit to the apparent illegal purchase of vapes for their underage offspring, presumably their nearest and dearest, but complain about retailers, unrelated to the young people, selling them vapes.
And all the while these parents eschew any responsibility for their own actions or those of their offspring, preferring to present themselves as victims. I’m sure they would be shocked to learn that one of the main risk factors of drug-taking among young people is a lack of parental supervision while others are genes and alcohol “misuse” by parents.
But who are these victimizers? Having read columns of this stuff, I’m still not clear who these parents and The Guardian believe are to blame for the current situation as they see it. There is little attempt to get to the bottom of these issues, which seem to me to stem simply from acute and chronic government-imposed austerity measures that, predictably, have led to a failure of policing.
