Tag: FDA

Shaky Foundations

Credit: Mark van Dam
CTP Director Brian King’s stated ambition to build on the “strong foundation” laid by his predecessors inspires less confidence than he likely intended to communicate.
By George Gay
It is usually seen to be a good thing that something has solid foundations, but this is not necessarily so if an architectural carbuncle has been built on those foundations. In this case, those foundations simply make it more difficult to pull the whole edifice down once it has been generally admitted that what has been created is not in the public interest and has to go.
In what was billed in September by the U.S. Food and Drug Administration as an interview with Brian King, the new director of the FDA’s Center for Tobacco Products (CTP), King was quoted as saying he intended to build upon the “strong foundation of my predecessors.” This is a strange turn of phrase and could perhaps have been better presented as the “strong foundation built by my predecessors,” but never mind.
Brian King / Credit: FDA
That aside and given that one has to be diplomatic on the occasion of such an interview, I still wonder what he meant by this statement. As above, a strong foundation is usually seen as a positive, but it is hard to see much that is positive in the legacy on which King has been left to build. I see the foundation he has inherited as anything but strong—as comprising lumps of immovable ideology mixed unevenly with political interference and legal interventions.
And such a foundation is the very opposite of what King later claims to be the CTP’s driving force—science. Once science melds into such a solid, stultifying foundation, it’s time to call it a day. It’s time to pull the whole edifice down and start again. All that will arise from that foundation will be a dreadful carbuncle.
King goes on to say that the CTP aims to achieve its longstanding vision of making tobacco-related disease and death a part of America’s past not America’s future. Bold, if hackneyed words, but visions, in my experience, are things usually experienced by people of faith rather than those of science and often by those in need of help.
And this seems to chime with the foundation on which King is apparently going to build—a foundation that has seen the CTP, time and again, undermine e-cigarettes, the one product that has the potential, in the hands of lightly regulated U.S. entrepreneurs, to encourage a significant proportion of smokers to quit their habit while providing them with a satisfactory substitute.
I don’t want to criticize King or the CTP unreasonably, but words have meanings, and if you set out to release the text of such an interview, those words should be chosen with care. King goes on to say that the CTP comprises “a dedicated team of more than 1,000 staff who work day in and day out to tirelessly achieve this mission.” Readers will notice here how the “vision” seems to have become a “mission” underpinning the seemingly faith-based nature of the undertaking.
Credit: Waldemarus
But there are other aspects of this wording that I take issue with. I’m sure that a lot of those who work at the CTP are good at what they do and keen to achieve the CTP’s aims, but, as in any other group of 1,000 or more people, there will be variation in their skill levels and attitudes. It doesn’t do, I think, to make this sort of sweeping statement about the employees of an organization that some people, perhaps many people, have found wanting. This is the sort of statement made by politicians not scientists. Nor does it help to use the sort of language that has these people working day in and day out tirelessly to achieve this mission. It seems to attempt to posit these 1,000 or more people as somehow superior to the rest of the U.S.’ workers, who presumably are seen to spend some of their days goofing off work.
Some of the claims made by King seem not to stand up to scrutiny. Certainly, I would have remained [quit] rather than say, as he did, “Over the past 13 years, CTP has made significant strides in … reviewing new tobacco products before they can be legally marketed.” My observation is that if strides have been made in this respect, they have been made through treacle, with the inevitable mess that such high stepping involves.
But I think that the worst aspect of the interview is what it fails to say rather than what it says. It contains no humility, no admission that some aspects of the CTP’s work have not gone as well as one might have hoped—might have expected given the organization’s hardworking team.
The interview is couched in corporate speak and reflects the political zeitgeist that has it that admitting mistakes demonstrates weakness whereas, in reality, such admissions show strength and can comprise the first steps in avoiding mistakes in the future and moving on to a better place.
King tells us that he is a scientist by training and that he’s been working in tobacco control science for the better part of the past two decades. My question is what is tobacco control science? Tobacco control is a rather hazy term, which, I take it, is supposed to refer to the reduction of tobacco use.
And I cannot help thinking that tobacco use reduction is not about science but about devising regulations and the enforcement of those regulations. Medical science might inform why you need to try to reduce tobacco use, but it has little to say about how you should control it.
Credit: Photoma
In part, such confusion occurs because the words “science” and “scientist” are used to cover such a wide range of activities and people. It is very much like engineering and engineers in this respect, as is summed up in the old story of two acquaintances meeting in the street:
Nancy: Nice dog. Is it yours?
John: Yes, I got him last week.
Nancy: Really? You know, I never saw you as a dog person.
John: You’re right in a way; I’m not a dog person. But I thought he would be useful, his being an engineer and all?
Nancy: Did you say he was an engineer?
John: Yes, that’s right.
Nancy: An engineer? How do you figure that?
John: Well, every time the doorbell rings, he makes a bolt for the door.
Surely, it must have been the CTP’s dog that answered the door to the deeming of vaping products as tobacco products; it couldn’t have been a scientist. And yet King makes out that “[s]cience is central to the important work we do.”
But my suspicions about this claim are roused when he talks, as he does in the interview, of “sound science,” as if he believes there is such a thing as unsound science. But my ideas align with his when he talks of the “best available science,” because here he seems to be validating the idea that all scientific findings are always open to challenge in the future.
But he loses the plot, to my way of thinking, when he talks of one of the themes of his tenure at the CTP: communication. “Clear, transparent and timely communication is also important to me, including proactively messaging on the great progress our center continues to make on key priorities,” he says. This “proactively messaging” is political-type grandstanding from atop the corporate-type vagueness of the undefined “great progress” and “key priorities.”
There was a certain irony in King talking of clear, transparent and timely communication because, below the interview as I received it in an email, were links to six stories under the heading “In case you missed it: Recent CTP news,” one story of which was headed “CTP Updates ‘Grandfathered Tobacco Product’ Term to ‘Pre-Existing Tobacco Product.’”
Apparently, this change had been made because it was discovered that the grandfathered term “when used to describe someone or something exempt from a new law or regulation—has its roots in 19th century racist voting laws.” To me, this then is a progressive move.
Of course, it seems as if it has taken a while to bring it in, which is in opposition to King’s aim for timely communications, but hey, let’s be generous, King was certainly not head of the CTP when the term “grandfathered” was first used by that body in reference to tobacco products.
Still, my question is, given a substitute term was deemed necessary and given that clear communication is the aim, why wasn’t a better term than preexisting used? The problem with preexisting, as with grandfathered, is that, standing alone, it is meaningless or almost confusing.
Preexisting only makes sense in reference to a date or an event, so “preexisting tobacco product” might be seen by some—awkward customers, admittedly—as referring to something that predated the introduction of tobacco products.
It has to be admitted that this problem is difficult to sort out now. For whatever reason, the grandfathered date as it was then known was set by the CTP as Feb. 15, 2007. So, the only way to make sense of things as they stand would be to make the term “Preexisting Feb. 15, 2007, Tobacco Product.”
This would be understandable without reference to anything else, but it is a little clumsy. To make things simpler, I would be inclined to pretend that the grandfathered date had been Jan. 1, 2007. That way the term could be “Preexisting 2007 Tobacco Product.” What could be more clear or timely? I’m not sure what transparent communication involves.
But perhaps it refers to the graphic tobacco package health warnings that the FDA has been trying to bring in for some considerable time. Certainly, it’s not hard to see right through the proposed warnings.
Credit: Grandbrothers
Also accompanying the interview was a link to the story “Postponed: Cigarette health warnings effective date now Oct. 6, 2023.” The story explained how, on Aug. 10, a U.S. court, hearing a case brought against the FDA by R.J. Reynolds Tobacco Co., had ordered a further postponement of 90 days in the effective date of the “Required Warnings for Cigarette Packages and Advertisements” final rule. Despite the postponement, the FDA urged those affected by the requirement to append warnings to tobacco packaging to submit their plans for doing so as soon as possible but no later than Dec. 7, 2022.
I don’t know on what grounds Reynolds made its challenge. What interests me here is King’s claim about communications necessarily being clear, transparent and timely and how this fits with the proposed tobacco package warnings.
If it had been me, I would have aimed for the CTP’s communications to be truthful and effective, which would have ruled out most of the communications provided by the warnings, I believe. I find the wording of the warnings quite odd. I’m not a medical person, but I find it confusing that the word “can” seems to be sprinkled about without rhyme or reason. So, you have “Smoking can cause heart disease and strokes by clogging arteries,” but “Smoking causes cataracts, which can lead to blindness.”
The only meaning I can take from these particular warnings is that some smokers develop heart disease and strokes while all smokers wind up with cataracts, and some of those go blind. Is this true, I wonder? Certainly, it is not true that never having smoked protects you from ever developing cataracts.
To make this warning truthful and therefore, to my mind, effective, it is necessary to state what proportion of smokers develop cataracts and what proportion of the general population develop them—also, what proportion of smokers with cataracts become blind because of this condition and what proportion of the general public go blind because of this condition.
As these warnings stand, they are not clear, timely or truthful. In fact, by being sparing with the information they provide, they appear designed to mislead. Smokers aren’t stupid; they can see through this sort of transparent message.
I believe that King’s introductory interview was poorly conceived and executed. The people involved in tobacco and nicotine, at whatever level, deserved better.

November 3, 2022
Unbearable Truth

Credit: Polifoto
‘Bear bites man’ is a news story, of course, but ‘man bites bear’ is sure to make page one.
By George Gay
Look out! There’s a brown, big bear in that tree!
No, don’t concern yourself, there’s no bear; I was just making a point. No English speaker would utter that warning. What they would say is: Look out! There’s a big, brown bear in that tree!
If you string adjectives together in English, they follow a certain order in which, for instance, size—big—comes before color—brown—and, for that matter, age—old—comes before shape—fat—and both age and shape come between size and color. I don’t know what the order is off the top of my head, so I had to look it up to describe the examples above, but I, like others, use the correct order instinctively almost all the time.
The question is, does the order really matter? Well, from a practical point of view, perhaps.
After all, you wouldn’t want Joe, the person being warned, to get into a semantic argument about whether it was right to say the bear was brown and big or big and brown because, in the meantime, the bear might have come down from the tree and the arguments would turn to whether the animal in question could be described as an angry, big, brown bear, a big, angry brown bear or any of the other adjectival combinations available—and, finally, whether it was creating a big, bloody mess of Joe, or a bloody big mess.
On the other hand, languages evolve, and if it weren’t the case that the human race was going to be wiped out within the next 100 years by the effects of environmental breakdown, it’s not hard to imagine that, many years into the future, the creature in the tree might have become known by English speakers as a brown, big bear or, in a really progressive society, referred to according to a description chosen by bears or their democratically elected representatives.
Already, there is a tendency to flexibility—I would say laxity—over word order, especially when it comes to story headings. Take this one from insidesource.com: “Public health’s misinformation against vaping is eroding its credibility.”
The way that I read this heading is by assuming that “its” refers to vaping because “its” is closer to vaping than it is to the other referential candidate, “public health,” so that what I assume is being said is that the credibility of vaping—as a means of quitting smoking—is being undermined by the misinformation put out under the name of public health.
Credit: Desdemona72
There is truth in this because such misinformation does get through to some smokers. But, when you read the story, it turns out that what is being said is that public health is undermining its own credibility by putting out misinformation about vaping.
Again, the question arises as to whether this confusion matters. I would say yes because I, and perhaps others, would be likely to skip over a story that was about vaping being undermined by public health misinformation because that happens all the time.
I would be much more likely, however, to read a story about the credibility of public health being undermined because such stories are rarer. “Bear bites man” is a story, of course, but “man bites bear” makes page one.
Finally, the point is that the heading could be fixed easily as “Public Health’s credibility eroded by its issuing misinformation on vaping.”
Credibility aside, I shouldn’t think that public health would have been overjoyed to see the following headline from eatthis.com: “Vaping versus smoking marijuana: Which is better for your body?” I cannot help thinking that public health would have found this heading unnecessarily provocative.
Given that both activities carry a level of risk, the question that public health would probably have preferred is “Vaping versus smoking marijuana: Which is worse for your body?” And this is not withstanding that these activities are seen by many people as having some positive outcomes.
This is an interesting heading, however. When I first read it, I thought the physical effects of vaping nicotine were being compared with those of smoking marijuana. It took me a while to work out that it was vaping marijuana and smoking marijuana that were being faced off.
My initial interpretation of the heading might have been perverse, but I think what was written could have been made clearer as “Which is better for your body, vaping marijuana or smoking it?”
While I usually ignore stories whose headings pose questions because I feel that I am going to be asked to do the story’s heavy lifting, this particular heading is intriguing. In fact, I would have read the whole story had I been a little cleverer and been able to activate the link from the synopsis that I saw.
One thing that intrigues me is why the headline writer didn’t pose the more general question: “Vaping versus smoking marijuana: Which is better for you?” And why, if she felt she wanted to be more specific, did she go for the body? Why not the mind? “Which is better for your mind?”
Credit: andriano_cz
Perhaps some would even have preferred the focus to have been on the soul. I don’t think there is a clue in the “eat this” name because in both cases we’re talking about inhalation. I guess I’ll never know.
The next heading I would like to look at is from thedrum.com and is perfectly clear as I read it: “Chinese vaping brand accused of flouting advertising rules designed to protect children.” It is clear, but it is misleading in an important way. Compare this heading: “Cudgel accused of breaking man’s skull in vicious daytime attack.”
Most people would laugh at such a heading, saying that you cannot accuse a cudgel of doing anything; the accusation must be aimed at the person wielding the cudgel. But by the same token, those people would probably not think twice about an accusation being leveled at a vaping brand, an equally ridiculous idea in my view. In fact, it is possibly more ridiculous.
It is conceivable that a cudgel could be made to stand in the dock and eventually be sent to prison as nonhuman animals have been in the past. But a brand does not have a bodily form.
The question is, as always, does any of this matter? I would say yes. Leveling the accusation at the brand lets off the hook those who allegedly caused the rules to be flouted.
What is likely to happen if the allegations are substantiated is that the company that owns the brand name will be fined, a fine that will possibly be recouped through increasing the price customers pay for the product. The person or people who allegedly caused the laws to be flouted will be unaffected and therefore free to repeat the offense either at the same company or at a new one.
I have written previously about the dangers of anthropomorphism, which crops up in such phrases as “vaping brand accused” and, of course, “the market panicked.” But having said that, I have to admit that it is almost impossible to avoid such anthropomorphism at times as observant readers and pedants will have noticed from a couple of stories above where “public health” is said to be up to all sorts of things that, in fact, only people working in public health can do.
The problem is that trying to insert phrases such as “people working in public health” every time becomes clumsy and, frankly, unnecessary. And, of course, there are instances where this sort of thing simply doesn’t matter. I recently saw an advertisement for “meditation for businesses.” But beware when it is said that a business was found to have been involved in money laundering.
Perhaps one problem with headings is that they are thrown together at the last moment and can thus carelessly undermine what might be an article that is worth reading. I noticed this heading in thejournal.ie: “Opinion: E-cigarettes are not part of the solution to a tobacco-free Ireland.”
This seems blindingly obvious to me. The solution to a tobacco-free Ireland must surely be the introduction of tobacco in the same way that the solution to an alcohol-free Ireland would be the introduction of alcohol.
The problem here, I think, is the word “solution,” which has been allowed to slosh about all over the place in recent years, and here is clearly adrift. I guess the heading should have read something like: “Opinion: E-cigarettes will not help solve Ireland’s tobacco smoking problem.”
I must admit that, initially, I was drawn to the following heading on nst.com.my because GEG are my initials: “Two million will die if GEG bill not passed.” Nevertheless, what I really like about this heading is that, without even knowing what GEG stands for, you know that the heading is correct, and, what’s more, you know even that its negation is correct.
So, the headline writer could have written: “Two million will die if GEG bill passed.” This is because people have finite lives. The 2 million people in question will die. That’s a certainty. What I suppose the headline writer must be getting at is that 2 million people will die prematurely if the bill is not passed. But, to my way of thinking, “dying prematurely” is one of those odd concepts that seems nevertheless to be universally accepted. Surely, it’s just a case of when your number’s up, it’s up.
If you quit smoking and, on your first smoke-free day, you don’t stop at the tobacconist, you might get hit and killed by a driver jumping the lights at the intersection, something you would have avoided by stopping at the store. But, to my mind, you wouldn’t have died prematurely even then.
In any case, from the synopsis of the story, it seems as though the emphasis wasn’t on “saving lives;” it was about saving money. Tax revenues from sales of cigarettes weren’t covering the costs of treating smoking-related diseases. A cynical person might be forgiven for reaching the conclusion that the smokers were seen not to be dying “prematurely enough.”
Credit: Alswart
And you can look at this another way. By giving up smoking and living a little longer, those 2 million people will have a greater negative impact on the environment than if they had died earlier and therefore might be responsible for the earlier deaths of others. Life and death are not simple matters.
Now, I would like to draw attention to a heading at colinmendelsohn.com.au: “New Campaign Outlines the Real Truth About Vaping.”
Colin Mendelsohn is one of those brave souls who has for a long time been trying to inject some rational thinking into the debate in Australia about the use of vaping as a means of helping smokers quit their habit—a debate that has been seriously marred by misinformation. I mean, look at the heading. What does it say about us when Mendelsohn feels it necessary to include the word “real” before the word “truth”?
OK, this heading from The Herald is way beyond the usual range of stories for a vape-focused magazine, but I just cannot resist it: “Zimbabwe: Tobacco farmers earn $7 million in three days.” At one and the same time, this heading, reporting on April 5 on the first three days of leaf tobacco sales for the 2021–2022 season, is true but manages to grossly understate the work of tobacco growers and imply, incorrectly, that these growers were enjoying some sort of bonanza.
The first thing to note is that these growers are not people playing the financial markets; they don’t earn that sort of money in three days. The second thing to note is that, in fact, they worked a lot longer than three days just to earn a modest amount of money. And I mean modest.
Tobacco growers work long days, mostly out in the open, during a long, worry-filled season that can be upset by a whole range of often uncontrollable factors, including plant diseases, unhelpful weather and unscrupulous middle operators. And what do they get at the end of it?
Well, according to The Star newspaper, reporting more or less at the end of the sales season, growers received an average of about $3.05 per kilogram for their tobacco, a figure that was up 9.3 percent on the $2.79 per kilogram they received the previous season.
This sounds like a good payday, except that the $3.05 per kilogram of this year was up only 3.7 percent on what they earned in 1996—$2.94 per kilogram. You’re reading that correctly, 1996—more than a quarter of a century ago. The 2022 average price was actually lower than it was in 2008, 2012, 2013 and 2014.

November 1, 2022
Resolving the Past
Credit: Standap
The spoils of Juul Labs’ settlement over its marketing practices is not divided equally among the suing states.
VV staff report
On Sept. 6, e-cigarette maker Juul Labs agreed to pay $438.5 million to 33 U.S. states and Puerto Rico in a settlement following a two-year investigation into the company’s marketing and sales practices. On Sept. 23, at least one state had opted out of the settlement, and other states are considering the same action.
The Maine Attorney General’s Office said the state would be backing out of its $11 million agreement with the e-cigarette manufacturer after objecting to certain conditions from the company. As part of the agreement, Juul wanted states to waive the rights of school districts to pursue their own lawsuits. Maine wasn’t willing to agree to that.
“We are disappointed in the outcome of these negotiations, but ultimately, we were unwilling to waive the rights of other entities who are also trying to hold Juul accountable for its deception,” Attorney General Aaron Frey said in a statement to The Maine Monitor.
For the remaining states, the multimillion-dollar settlement will be paid out over a period of six years to 10 years. Both the financial and injunctive terms exceed any prior agreement Juul Labs has reached with states to date.
“We recently submitted an administrative appeal, based on science and evidence, to [the U.S. Food and Drug Administration], demonstrating that its marketing denial order (MDO) of our products was substantively and procedurally flawed and should be rescinded,” Juul Labs wrote in a statement. “We believe that once the FDA does a complete review of all of the science and evidence presented, as required by law and without political interference, we should receive marketing authorization. As we go through the FDA’s administrative appeals process, we continue to offer our products to adult smokers throughout the U.S.”
The multistate investigation found that Juul became the U.S. e-cigarette market’s leader by “willfully engaging in an advertising campaign that appealed to youth, even though its e-cigarettes are both illegal for youngsters to purchase and are unhealthy for youth to use, according to Connecticut Attorney General William Tong. The investigation found that Juul relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts and free samples.
According to the investigation report, Juul’s misguided marketing began in 2015 and 2016 when the company bought ad space on websites targeted at youth, like nick.com, nickjr.com, cartoonnetwork.com and others. “It marketed a technology-focused, sleek design that could be easily concealed and sold its product in flavors known to be attractive to underage users,” New Hampshire Attorney General John Formella said in a press release. “Juul also manipulated the chemical composition of its product to make the vapor less harsh on the throats of the young and inexperienced users. To preserve its young customer base, Juul relied on age verification techniques that it knew were ineffective.”
Credit: Standap
The investigation further found that Juul’s original packaging was misleading in that it did not clearly disclose that it contained nicotine and implied that it contained a lower concentration of nicotine than it did. Consumers were also misled to believe that consuming one Juul pod was the equivalent of smoking one pack of combustible cigarettes. The company also misrepresented that its product was a smoking cessation device without FDA approval to make such claims.
“This settlement with 34 [now 33] states and territories is a significant part of our ongoing commitment to resolve issues from the past,” Juul Labs said. “The terms of the agreement are aligned with our current business practices, which we started to implement after our company-wide reset in the fall of 2019.” Altria invested $12.8 billion for a 35 percent stake in Juul in late 2018 and began guiding the company’s new direction in 2019.
Connecticut led the investigation and negotiations into Juul Labs’ marketing practices along with Texas and Oregon. The other states and territories involved in the settlement include Alabama, Arkansas, Connecticut, Delaware, Georgia, Hawaii, Idaho, Indiana, Kansas, Kentucky, Maryland, Maine, Mississippi, Montana, North Dakota, Nebraska, New Hampshire, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia, Vermont, Wisconsin and Wyoming. Colorado and New Mexico weren’t part of the settlement but have their own suits pending.
The plaintiff states will not be splitting the settlement equally. Connecticut will receive a minimum of $16.2 million through the settlement, for example, while Texas will receive $42.8 million. Oregon will receive at least $18.8 million. Tong stated that the settlement total amounts to about 25 percent of Juul’s U.S. sales of $1.9 billion last year. He stated it was an “agreement in principle,” meaning the states will be finalizing the settlement documents over the next several weeks, so the dollar amounts may not be exact. While not expressly stated, it is believed the amount of Juul products sold in a state determined the settlement amounts.
The money will go to programs, across the states and territory, that aim to reduce tobacco use, especially among young people. The amounts paid begin to increase the longer the company takes to make the payments.
The remainder of the funds after the investigative leaders’ cuts is estimated to be distributed as follows:

Alabama: $15.5 million

Arkansas: $13.6 million

Delaware: $7.8 million to $8.5 million

Georgia: $19 million

Hawaii: $6.8 million

Idaho: $8.3 million

Indiana: Unknown

Kansas: $9.8 million

Kentucky: $14 million

Maryland: $13 million

Maine: Opted out

Mississippi: Unknown

Montana: $6.1 million

North Dakota: $6 million

Nebraska: Unknown

New Hampshire: $8.5 million

New Jersey: Unknown

Nevada: $14.4 million

Ohio: Unknown

Oklahoma: $8.9 million

Puerto Rico: Unknown

Rhode Island: Unknown

South Carolina: Unknown

South Dakota: $6 million

Tennessee: $13 million

Utah: $8.6 million

Virginia: $16.1 million

Vermont: $8 million

Wisconsin: $14.4 million

Wyoming: Unknown
Juul previously settled lawsuits in Arizona, Louisiana, North Carolina and Washington. Many states, including Hawaii, also have claims against Altria Group (the parent company of Philip Morris USA and Juul’s largest shareholder) that are not affected by the settlement and remain active. Additionally, the company faces lawsuits filed by New York and California that are still pending, and an estimated 3,600 lawsuits by individuals, school districts and local governments have been consolidated in an action that is still wending its way through a California court.
In addition to the financial terms, the settlement also forces Juul Labs to comply with a series of strict injunctive terms severely limiting the company’s marketing and sales practices. Most of the limits imposed by settlement won’t immediately affect Juul, which halted use of parties, giveaways and other promotions after coming under scrutiny several years ago. The company currently makes up about one-third of the U.S. retail vaping market, down from 75 percent several years ago. As part of the settlement, the embattled manufacturer has agreed to refrain from:

Youth marketing

Funding education programs

Depicting persons under age 35 in any marketing

Use of cartoons

Paid product placement

Sale of brand-name merchandise

Sale of flavors not approved by the FDA

Allowing access to websites without age verification on the landing page

Representations about nicotine not approved by the FDA

Misleading representations about nicotine content

Sponsorships/naming rights

Advertising in outlets unless 85 percent of the audience is adult

Advertising on billboards

Advertising on public transportation

Advertising on social media (other than testimonials by individuals over the age of 35, with no health claims)

Use of paid influencers

Direct-to-consumer ads unless age verified

Free samples
The agreement also includes sales and distribution restrictions, including where the product may be displayed/accessed in stores, online sales limits, retail sales limits, age verification on all sales and a retail compliance check protocol. Juul came under its most intense scrutiny earlier this summer when the U.S. Food and Drug Administration attempted to ban all Juul e-cigarettes from the market. A federal appeals court blocked the government’s ban, and then the FDA placed Juul’s MDO under administrative review.
In late September, the vapor manufacturer filed a lawsuit against the FDA over the agency’s refusal to disclose documents supporting its MDO. In a complaint filed with a federal court in Washington, D.C., Juul Labs accused the FDA of invoking the “widely abused” deliberative process privilege to improperly withhold scientific materials that are “central” to understanding the basis for the June 23 issuance of the MDO, according to Reuters.
The company claims that the materials would show whether the FDA conducted a legally required balancing of the public health benefits and risks of its products, including claims that Juul e-cigarettes help smokers quit combustible cigarettes and whether the agency’s reasoning was scientifically sound. “The public deserves a complete picture of the scientific facts behind one of the agency’s most controversial and closely scrutinized decisions in recent years,” Juul Labs stated.
An FDA spokeswoman declined to comment, saying the agency does not discuss pending litigation.
November 1, 2022
Anonymous Staff Comments say FDA Dysfunctional

Credit: Andrii Yalanskyi
Numerous comments from purported staffers of the U.S. Food and Drug Administration for the Reagan Udall assessment of the performance of the FDA’s Center for Tobacco Products (CTP) claim the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of premarket tobacco product applications (PMTAs) in the CTP Office of Science (OS) lack the autonomy to exercise “best scientific practices” in their reviews of PMTAs.
“Scientific disagreement is frowned upon, if not entirely suppressed, and punished through various backhanded methods (e.g., lack of assignments, projects, and other opportunities that are needed for career development/promotion),” the comment states. “In some divisions (e.g., Division of Nonclinical Science [DNCS]), leadership pushes a ‘gotta get em’ mentality onto staff, which is unsupportive of a reviewer’s fundamental duty to provide an unbiased review using the best available science.”
In July, the FDA commissioned an independent review of the regulatory agency’s food and tobacco programs following months of criticism over its handling of the baby formula shortage and e-cigarette reviews. FDA Commissioner Robert Califf chose the non-profit Reagan-Udall Foundation, a non-governmental research group created by Congress to support the FDA’s work.
The comments are anonymous and open to the public. Many of the comments paint a picture of an agency that is inept and making decisions persuaded by political agendas and not based on the science surrounding next generation nicotine products. One reported FDA staffer claimed that there’s a toxic culture permeating the OS that begins with the FDA’s leadership teams.
“The so-called leaders do not solicit feedbacks from the actual reviewers, instead, listening to few of the loudest ducks, who are not the experts in any of the specific disciplines,” the commenter wrote. “Favoritism/nepotisms, unconscious bias, racism/sexism, permeating the whole office/Division, the minority and women consistently being ignored for their suggestions/feedbacks, although they are the ones who did most amount of work.”
Another comment claims that arbitrary and politically driven timelines set externally (by a judge for example) are driving reviews as opposed to allowing for a thorough scientific review. “When errors are found the CTP reviewers are blamed when in fact the lack of adequate time to complete the reviews are at fault. Staff are burned out and constantly told to do more in less time and blamed for not meeting insane deadlines,” the comment states. “In cases where reviews are finished and scientific decisions are made they are also overruled by political agendas and pushed to change decisions.”
Another comment states that the Tobacco Control Act (TCA) favors combustible tobacco products by allowing new combustible products to take easier pathways to market, such as being considered pre-existing tobacco products or through the standard equivalency (SE) pathway.
“CTP has explicitly stated that the science supports the notion of a continuum of risk, i.e. that combustible products are the deadliest and noncombustible products appear to be nominally safer. Nevertheless, CTP has elected to conduct a product by product premarket review of new tobacco products,” the comment states. “So any innovative product, such as an e-cigarette, would most likely have to undergo a more robust and burdensome pathway to market, e.g. PMTA.”
It not all doom and gloom, however, as some claim that agency staffers are just overworked. One commenter stated that CTP is constantly working under impossible deadlines with long review queues that none of the other centers overseen by the FDA are required to endure.
“The volume of applications it sees and products it regulates are astronomical in comparison, but we are not being given any protection, support, or leeway to handle this burden,” the comment states. “Instead, it seems as if CTP and OS are blamed for having large queues or not making deadlines, without anyone taking a look to see just how much work is being done to ensure that things are done as soon as humanly possible. Treating this Center as the rest of the Centers in terms of queues and timelines is unhelpful and encourages burnout.”
Another commenter wrote that the FDA doesn’t have the ability to give all PMTAs a “fair and equal” review, a claim that has been denied by the agency in court cases surrounding its issuing of marketing denial orders. “There are so many layers to make sure the science makes sense, its being communicated in a way that makes sense. But it doesn’t have the people or breathing room to apply that system to every single application equally,” the comment states. “We are definitely all being overworked and stretched too thin with unreasonable deadlines, lack of protection from those outside of CTP, and a staffing shortage.”
October 28, 2022
FDA Denies First Menthol-Flavor PMTAs After Review

The U.S. Food and Drug Administration has issued marketing denial orders (MDOs) for several menthol-flavored vaping products marketed by Logic Technology Development. The products include the Logic Pro Menthol e-Liquid Package and Logic Power Menthol e-Liquid Package. It’s the first time the FDA has issued MDOs for menthol products after receiving a scientific review.
The move seems inline with the regulatory agency’s goal to ban menthol flavors from tobacco products. The FDA also isn’t expected to approve any flavored vaping product other than tobacco. In June, the National Institutes of Health and the FDA gave the University of Louisville a $3.6 million grant to study the effects of flavorings like mango and bubblegum used in vaping products. The study is still being conducted.
“Ensuring new tobacco products undergo premarket evaluation is a critical part of the FDA’s work to reduce tobacco-related disease and death,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP), in a release. “We remain committed to evaluating new tobacco products based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, told Vapor Voice the latest move by the FDA to ban menthol vaping flavors is reminiscent of the agency’s “fatal flaw” review of PMTAs that resulted in millions of denials. The term “fatal flaw” was used by the FDA for PMTA submissions that didn’t have specific studies. The term has been at the center of nearly all lawsuits filed against the FDA for its handling of the PMTA process.
“The dysfunction at the FDA knows no bounds. For the last year-plus, the FDA has sat back deferred decision making on menthol vaping products,” Conley said. “Lest anyone believe that FDA was hard at work coming up with ways to achieve balance, today they revealed that their big plan for menthol vaping products is to follow the exact same ‘fatal flaw’ review process that has led to dozens of lawsuits being filed against the agency.”
The agency stated that after reviewing the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health (APPH), the applicable standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.”
The FDA stated that the evidence provided within Logic’s denied PMTAs did not demonstrate that menthol-flavored e-cigarettes are more effective in promoting “complete switching or significant cigarette use reduction” relative to tobacco-flavored e-cigarettes.
The announcement is concerning, especially since CTP is undergoing an external review in which many industry stakeholders have called for a comprehensive plan for PMTA reviews, according to Tony Abboud, executive director of the Vapor Technology Association. He says that the FDA’s action raises at least four major concerns.
“First, the announced rationale makes no mention of the net public health benefit prong, begging the question of whether FDA addressed that required element of the APPH test? Second, how is the public health benefitted by FDA’s approval of 123 new menthol cigarette/cigar products, given its inability to authorize a single less-harmful menthol vaping product?” Abboud asks. “Third, how can the Agency continue to rely on general (i.e., non-Logic specific) menthol youth data to impose a heightened Logic-specific cessation standard, especially given the dramatically reduced [National Youth Tobacco Survey] NYTS youth use rates and no apparent tie to Logic products?
“Fourth, is the Agency undermining its proposed menthol cigarette rule, given that FDA’s science shows that half of the predicted quitters under the proposed standard must switch to menthol vapes, none of which have been authorized?”
Logic must now decide if it will resubmit applications or submit new applications to address the deficiencies for the products that are subject to these MDOs. However, the FDA states that for non-tobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, “existing evidence demonstrates a known and substantial risk” with regard to youth appeal, uptake and use.
“The FDA conducts a rigorous, scientific review of submitted premarket tobacco product applications, evaluating the data for each product to determine if it meets the public health standard,” said King. “In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth.”
A recently accepted manuscript of an article set for publication in Nicotine & Tobacco Research found that flavored vaping and other tobacco sales restrictions in California did not affect youth e-cigarette use.
The MDO letter that Logic received today is not limited to the two products named above, according to the agency. In general, the FDA publicly names only products that the applicant is marketing to avoid potential disclosure of confidential commercial information.
Any products subject to an MDO may not be offered for sale or distributed in the United States, or the FDA may take enforcement action. These products cannot be legally introduced into interstate commerce in the U.S. without risking FDA enforcement. In March, the FDA authorized several tobacco-flavored e-cigarette products from the company under the Logic Vapeleaf, Logic Power and Logic Pro brands, including devices.
In addition to ensuring that Logic complies with this order, the FDA intends to ensure compliance by distributors and retailers. Specifically, the FDA notes that all new tobacco products on the market without the “statutorily required premarket authorization” are marketed unlawfully and their distribution or sale is subject to enforcement action.
Recently, the U.S. Department of Justice filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers on behalf of the FDA. The cases represent the first time the FDA has initiated injunction proceedings to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.
Retailers should contact Logic with any questions about products in their inventory.
October 26, 2022
FDA Fails to First Inform Hyde of MDOs Before Public

The U.S. Food and Drug Administration confirmed that Magellan Technology received marketing denial orders (MDOs) on Oct. 6 for 32 products. However, Magellan CEO Jon Glauser said the FDA acknowledged in writing that it had “erred in failing to inform the company” about the MDOs and only after the Oct. 6 announcement did Magellan receive the letters from the FDA.
“Because the affected PMTAs had been pending with the agency for over two years, we can only surmise that what the FDA deemed an “inadvertent error” in failing to inform the company was caused by an apparent rush to include the MDO action with the Agency’s press release on the National Youth Tobacco Survey data, which shows youth vaping down 50% since 2019,” Glauser states in an email. “The MDOs covered only certain Hyde products containing tobacco-derived nicotine. No Hyde products containing non-tobacco nicotine are subject to an MDO.”
In response to an inquiry by Vaping360, the FDA reiterated that it had served Magellan Technology with an MDO.
“After reviewing premarket tobacco applications for 32 Hyde e-cigarettes, FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology, Inc. on Oct. 6,” the agency told Vaping360. “In addition to the MDOs issued on Oct. 6, as acknowledged by Magellan Technology, Inc. in their statement, FDA also issued a Refuse to Accept (RTA) Letter for other Hyde e-cigarette products.”
Glauser states that the FDA did issue a Refuse to Accept (RTA) letter for certain of Magellan’s Hyde
products containing non-tobacco nicotine, identifying two administrative requirements the regulatory agency claims the company’s premarket tobacco product applications (PMTAs) were lacking.
“First, with respect to two of our bundled applications, the FDA stated that a signed statement as to the accuracy of certain translated documents was missing. However, the agency misunderstood the fact that the documents themselves are dual language documents that are maintained by our Chinese manufacturer in both English and Chinese. Because the relevant FDA regulation only requires a
certification for documents that have been translated from another language into English, we believe that the cited regulation is inapplicable,” Glauser explains. “This is the only issue cited against one of our bundled applications and on October 12, 2022, we filed a petition for stay with FDA requesting that the agency immediately stay the RTA determination on this basis.”
The second Item, Glauser wrote, relates to nine other applications that the FDA claims a certification statement verifying the PMTA submissions were “true and correct” was missing from those submissions. The FDA had preciously told Magellan that the company already had submitted amendments to its applications with the certification, but the agency could not determine to which applications the amendments needed to be applied.
“To that end, the FDA noted that ‘although your submission(s) may include the required content for a PMTA,’ the absence of the form made it impossible for the FDA to review the applications. While it is unfortunate that these technical issues cropped up with respect to these applications which had to be filed under enormously short time constraints, it is not a reflection of the high quality of scientific work that Magellan has assembled and continues to generate as part of its commitment to the PMTA process, work which the FDA has not yet reviewed,” wrote Glauser. “Magellan’s counsel and consultants already are engaging with the FDA regarding these issues and are asking the Agency to reconsider its initial determination so that Magellan’s application review can progress forward. In the event that FDA refuses, Magellan intends to move promptly to seek judicial relief regarding the RTA letter.”
In response to the FDA press statement announcing the order, Magellan Technology denied having received an MDO, saying the agency had refused to accept its premarket tobacco product application (PMTA) on a technicality without reviewing the PMTA on its merits.
Magellan Technology demanded that FDA not only retract the press announcement but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.
October 14, 2022
VTA Skeptical of FDA’s Latest Youth Vaping Analysis

After the U.S. Food and Drug Administration released its latest National Youth Tobacco Survey, Vapor Technology Association (VTA) Executive Director Tony Abboud said the FDA’s reporting of the data is misleading.
“Yesterday, the FDA, in coordination with the [U.S. Centers for Disease Control and Prevention ], released new data from the 2022 National Youth Tobacco Survey (NYTS) on e-cigarette use among U.S. youth,” Abboud stated. “The FDA represents the NYTS data to show that youth vaping ‘remains high,’ yet a deeper dive into the data show only a small uptick in experimental or infrequent use while regular use remains flat or is slightly down.
Abboud notes that since 2019, according to the CDC, the number of high school students who have tried vaping (1 time in the last 30 days) has dropped by 50 percent, and the number of middle school students has plummeted by 70 percent. During that same time period, the number of high-school students who ‘frequently’ vape dropped by 37 percent and the number of middle school students dropped by 65 percent.
” FDA’s near single-minded focus on youth who experiment with vaping versus those who are frequent users ignores what clearly is a consistent trend of youth away from vaping products. Rather than focusing on removing products from the market in an attempt to impact youth vaping, the FDA should instead support common-sense regulatory reforms that would better restrict access to products instead,” Abboud stated. “Simply removing products from the market is not the answer when those products are also proven to help adult smokers quit.”
Abboud explained that it is well documented that flavored vapor products help adult smokers to switch to less harmful vaping and “study after study after study” has confirmed the data. Since 2010, when e-cigarettes became widely available in the U.S., smoking rates have declined by more than half, he stated.
“Tobacco use is down. Youth vaping is down. These are both good things and are not in dispute. Unfortunately, there are still 40 million Americans addicted to cigarettes,” Abboud stated. “Every year, 500,000 die from smoking-related diseases and yet less than three percent of our kids are using vapes on a regular basis. The FDA’s failure to acknowledge this reality ignores the role vaping plays in harm reduction and smoking cessation, and puts more lives at risk.”
October 9, 2022
FDA, Hyde Bar Disagree on MDO; Puff Bar Defiant

Credit: Jean Claude
It shouldn’t be this complicated. Magellan Technology says it didn’t receive a marketing denial order (MDO). The U.S. Food and Drug Administration says it did. It wouldn’t be the first time the regulatory agency made a mistake. The FDA seems to be making a habit of it recently.
Magellan claims that the FDA made a “glaring error” and the company did not receive an MDO for its 32 products under the Hyde brand. In an email, Jon Glauser, CEO of Magellan, stated that the FDA’s announcement is false for two reasons. First, the regulatory agency only issued the company a Refuse to Accept (RTA) letter and, second, the FDA failed to conduct a proper review of Magellan’s scientific evidence in its premarket tobacco product application (PMTA) review for its Hyde products.
“Contrary to the FDA’s statement, FDA only issued a Refuse to Accept letter for the identified Magellan products, not an MDO,” stated Glauser. “A Refuse to Accept letter is a refusal based on nothing more than a technical review of the applications’ contents which, in this case, was a missing document, i.e., a sworn certification related to the translation of certain components of the application. In other words, the Refusal to Accept was based on bureaucratic technicalities.
“This is much more than a misnomer or clerical error by the FDA since the agency elaborated that it had conducted a scientific review and reached a conclusion that the PMTAs ‘lacked sufficient evidence.’ However, no such scientific review was referred to and no scientific justification was provided in FDA’s correspondence today.”
Magellan currently has pending litigation against the regulatory agency with the Second Circuit Court of Appeals concerning an MDO issued by the FDA last year for Magellan’s pod-based Juno vaping products.
New FDA data from the 2022 National Youth Tobacco Survey (NYTS) shows that 2.5 million U.S. youth use e-cigarettes, according to the published findings in the Morbidity & Mortality Weekly Report released by the FDA in conjunction with the Centers for Disease Control and Prevention. This is a slight rise over last year’s data.
Armed with this information, the FDA also issued Puff Bar (no relation to Magellan products) a warning letter for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA also requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns.
It’s at least the second letter the FDA has sent to Puff Bar without any follow-up action. The FDA issued at least two warning letters for Puff Bar’s non-tobacco nicotine disposable products.
During a Next Generation Nicotine Conference in Miami, Patrick Beltran, CEO of Puff Bar, said his disposable products were the “end of the road” for vaping products. “This is the end of the road for vaping in my opinion. It doesn’t get any more convenient for the consumer than a disposable vape device.”
Beltran then blamed U.S. retailers and Chinese manufacturers for the youth initiation issues. “We’re pioneering the disposable industry and the disposable sector of this industry, and it’s very tough when I go to the store and I see people and I see these brands being pushed and there is no enforcement whatsoever,” he explained. “I have to go … I have to spend millions of dollars on a PMTA. Juul, [expletive] Juul, and I’m sure everyone here has heard the news what happened … It’s all [expletive],” referring to Juul’s MDO that the FDA later retracted.
During GTNF 2022, a nicotine industry conference held in Washington D.C. in September, Brian King, director of the the FDA’s Center for Tobacco Products, the division charged with regulating next-generation tobacco products, discussed the FDA’s ability to force companies to comply with its MDOs (and warning letters). So far, very few companies that have been told to remove their products from the market have complied (including Puff Bar). King said the agency has multiple enforcement options to bring both manufacturers and retailers to heel.
“We have several tools available to us, including advisory actions,” he said. “We also have regulatory enforcement actions, including voluntary recalls as well as various other requested recalls. We can also take administrative action, civil money penalties (in terms of manufacturers, that penalty cannot exceed $15,000 for any single violation or $1 million for any number of violations related to a single action),” explained King. “When it comes to judicial action, we can do seizure, injunction and also criminal prosecution. I will say that when it comes to enforcement and compliance, nothing is off the table.”
The FDA has not taken any serious action against any vaping company for violating it’s orders. Puff Bar products can still be found at retailers across the U.S., even though the company has received multiple warning letters from the FDA.
Puff Bar has not received an MDO from the regulatory agency to date.
After reviewing PMTAs for 32 Hyde e-cigarettes, however, the FDA issued MDOs for the applications submitted by Magellan (the company argues they were actually RTAs). In conducting its scientific review, the FDA determined that the applications lacked “sufficient evidence demonstrating that the products would provide a benefit to adult users that would be adequate to outweigh the risks to youth.”
No Hyde products have received marketing authorization orders from the FDA.
“To be sure, the FDA expressly wrote to Magellan that ‘The absence of these required FDA forms impedes FDA ingestion and processing of applications.’ In other words, FDA could not have conducted any scientific review because it refused to accept the application,” wrote Glauser. “Our counsel has demanded that FDA not only retract the press statement it made but also issue a corrective statement making clear that FDA did not issue an MDO to Magellan and that it has not yet conducted a scientific review of Magellan’s products.”
The FDA has a history of making mistakes in the PMTA process. It’s currently facing more than 20 lawsuits and has had to retract MDOs from numerous companies, including Juul Labs, Turning Point Brands and Kavial Brands, among others.
“Magellan Technology looks forward to addressing whatever administrative technicalities are present so that FDA can, in fact, conduct a full scientific review of its products,” wrote Glauser.
October 7, 2022
Altria Ends Non-Compete Agreement With Juul Labs

Altria Group on Friday said it had exercised the option to be released from its non-compete deal with Juul Labs. The move comes nearly four years after the tobacco giant purchased a 35 percent stake in the e-cigarette manufacturer that at the time was dominating the market.
Altria is looking to permanently terminate its non-competition obligations to Juul Labs, give up certain rights including its board designation rights and reduce its voting power, according to a 8-K filing to the Securities and Exchange Commission.
The filing states Altria has exercised its option to permanently terminate its non-competition obligations to Juul Labs, losing the right to the board designation and significantly reducing its voting power, according to Barron’s.
“This decision … increases the financial and strategic options we can pursue to secure our business and address the impact of the (U.S. Food and Drug Administration’s) now stayed [marketing denial] order,” a Juul spokesperson said.
In July, Altria slashed the value of its stake in Juul to $450 million, down from the original value of $12.8 billion, allowing itself the option to be released from the non-compete clause and invest in or engage with any other e-cigarette manufacturers.
However, it did not seek to be released from the obligations at the time, and said it saw value in its investment rights in Juul. “The decision to terminate our non-compete maximizes our flexibility to compete in the e-vapor space while maintaining our economic interest in Juul,” Altria said on Friday.
A change in its stance means Altria could go it alone or pursue other vaping products. Privately owned Njoy, which has already survived the FDA’s controversial premarket tobacco product application (PMTA) process, could be a takeover target for Altria, according to some analysts.
In July of this year, NJOY Holdings Inc hired bankers for a possible sale of the company. The news report stated that privately held NJOY was likely to be valued at up to $5 billion.
“It’s more likely that Altria will seek to buy its way back into the e-cigarette category (which represents 7 percent of U.S. nicotine sales),” Cowen analyst Vivien Azer said.
October 1, 2022
CTP’s King to AP: Nicotine Salts Show Potential
During an exclusive interview with the Associated Press, the director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), Brian King, said the FDA is well on its way in setting a foundation for substantial reductions in combustible tobacco smoking with the product standards such as a menthol ban and flavor bans for e-cigarettes and cigars.
Brian King / Credit: FDA
When asked about several surveys that have shown many adults think e-cigarettes are as dangerous as traditional cigarettes, King said he was fully aware of the misperceptions surrounding vaping products those misperceptions aren’t consistent with the known science.
“We do know that e-cigarettes — as a general class — have markedly less risk than a combustible cigarette product,” King said. “That said, I think it’s very critical that we inform any communication campaigns using science and evidence. It has to be very carefully thought out to ensure that we’re maximizing impact and avoiding unintended consequences.”
King also said he believes “there’s a lot of really important science and innovations” that have occurred in the vaping industry in recent years, adding that the most notable is nicotine salts in e-liquids.
“We know that when you smoke a tobacco product, it’s a very efficient way to deliver nicotine across the blood-brain barrier. So it’s been very difficult to rival that efficiency in another product,” said King. “But in the case of nicotine salts you have the potential to more efficiently deliver nicotine which could hold some public health promise in terms of giving smokers enough nicotine that they would transition completely.
“But you also have to consider the opposite side of the coin, which is the inherent risks of initiation among youth. So I do worry about that … there’s a lot happening and I think that it could be promise or peril. But I think it’s important that the science drives that.”
September 27, 2022