Throughout his first year as director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), the agency has maintained a steadfast commitment to its core principles of sound science, strategic partnerships, health equity and transparency, CTP Director Brian King said in a recent interview.
King underscored the enduring importance of these principles. He emphasized that the center’s recent decisions and enforcement efforts have been grounded in comprehensive scientific analysis. This approach, he noted, ensures that product marketing and regulatory actions are well-informed and evidence-based.
Furthermore, the director highlighted the importance of teamwork, a skill honed through his background as a scientist. Scientific thinking, rooted in objective evidence evaluation, plays a pivotal role in CTP’s work. This scientific approach is instrumental in addressing the complexities of tobacco product regulation effectively, according to King, who also emphasized the importance of effective communication in conveying scientific findings and messages.
A significant focus of CTP’s work is promoting health equity in tobacco product regulation. King discussed efforts to address disparities in tobacco use, especially among youth and young adults. Notably, the CTP is working on product standards that would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars. King views these standards as a major step toward reducing the appeal of these products, particularly among communities disproportionately affected, such as people of color, low-income populations and LGBTQ+ individuals.
To further advance health equity, the CTP has undertaken initiatives like the “Next Legends” campaign to educate American Indian and Alaska Native youth about the harms of e-cigarettes and providing Spanish-language adult cessation education resources.
During his tenure, the center welcomed Charlene Le Fauve as its first senior advisor for health equity, a crucial role in integrating health equity into the center’s programmatic plans and priorities, according to King.
Looking ahead to the next three to five years, the director stressed the importance of having a clear vision. The CTP is in the process of creating a new strategic plan with the involvement of internal staff and external stakeholders to ensure the center’s continued growth and adaptation in a dynamic regulatory landscape. The plan, to be released by December 2023, will provide a roadmap for CTP’s future, aligning its actions with changing times and the goal of reducing tobacco-related diseases and deaths in the United States.
In an article published in Addiction magazine, Brian King, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP), explores the chances and considerations for informing adults who smoke cigarettes about the relative dangers of tobacco products, including e-cigarettes. He collaborated with Benjamin Toll, director of the Medical University of South Carolina Tobacco Treatment Program and co-director of the Lung Cancer Screening Program.
The commentary highlights the findings of a recent survey about misperceptions of tobacco product harms, including cigarettes and e-cigarettes. The survey found that only about 20 percent of adults who smoke cigarettes believed e-cigarettes contain fewer harmful chemicals than cigarettes. While there are no safe tobacco products, the available scientific evidence indicates that tobacco products exist on a continuum of risk, with cigarettes being the most harmful.
The commentary notes that opportunities exist to educate adults who smoke about the relative risks of tobacco products, including e-cigarettes. However, these efforts should be accompanied by efforts to prevent youth tobacco product use; encourage first-line use of FDA-approved cessation therapies; and for adults who both smoke and use e-cigarettes, reinforce the importance of completely transitioning to e-cigarettes.
The commentary further emphasizes that any education efforts on the relative risks of tobacco products must be evidence-based. In particular, it is important to assess the benefits among the intended population (i.e., adults who smoke) and risks among unintended populations (e.g., youth). Currently, FDA is in the early stages of a research effort to assess messaging about the continuum of risk of tobacco products among adults who smoke.
Last week, the FDA announced a virtual listening session opportunity to verbally provide open public comment on the development of the new strategic plan, including proposed strategic goals. After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan, including proposed goal areas.
Registration is open for the virtual listening session on the development of the CTP’s five-year strategic plan, which will take place on Aug. 22 beginning at 10 a.m. EDT.
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.”
A new webpage was published by the U.S. Food and Drug Administration of all the tobacco products-related citizen petitions received by the agency’s Center for Tobacco Products (CTP).
A citizen petition is a way for the FDA to give individuals, regulated industry representatives, or consumer groups to petition the agency to issue, amend, revoke a regulation, or take other administrative action. The requirements for a citizen petition are set out in the Code of Federal Regulations.
As part of CTP’s stated commitment to increase transparency, the webpage was developed to provide the public with more easily accessible and user-friendly information about tobacco product-related citizen petitions submitted to FDA and the center’s responses.
This webpage was one of the immediate actions toward transparency outlined by CTP Director Brian King in CTP’s Response to the Reagan-Udall Foundation’s report.
The Head of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) said in a perspective released today that the Center recently received the findings from the Reagan-Udall Foundation’s independent evaluation of its program and is in the process of closely reviewing the feedback. In February, the Center will provide an update on its planned actions in response to the evaluation.
When the Reagan-Udall Foundation submitted its recommendations to Robert Califf, commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the PMTA process.
CTP Director Brian King also announced the Center has accepted for review more than 8,600 marketing applications for synthetic products. In a recently released perspective, King said the center received more than 1 million premarket tobacco product applications (PMTAs) from 200 companies by May 14, 2022.
“FDA has also issued refuse-to-accept (RTA) letters for more than 925,000 products in applications submitted by May 14 that do not meet the criteria for acceptance,” King wrote. “The RTA letters state that it is illegal to sell or distribute the product in the U.S. marketplace without a premarket authorization.”
Brian King / Credit: FDA
He also stated that in 2022, CTP participated in 52 meetings with stakeholders – averaging one per week – including 25 meetings since King became director. King also stated that starting when the FDA was given the authority by Congress to regulate non-tobacco nicotine products in April 2022, the CTP has issued more than 75 warning letters to manufacturers through Jan. 20, 2023, including manufacturers of brands popular among youth, such as Puff Bar.
“We have also issued over 585 warning letters to retailers for the sale of non-tobacco nicotine products to underage purchasers as of December 2022. In October 2022, the U.S. Department of Justice (DOJ), on behalf of the FDA,” filed complaints for permanent injunctions in federal district courts against six e-cigarette manufacturers that failed to submit PMTAs and continued to sell products,” wrote King.
In a court filing last week, the FDA stated it will take until possibly December 31, 2023, before it completes the PMTA review process for some of the most popular vapes on the market.
Much like an earlier op-ed this year, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion of a recent investigation conducted by the U.S. Office of Special Counsel that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns.
The U.S. Food and Drug Administration’s Center for Tobacco Products Director Brian King will participate in an open discussion with the vaping industry in late February.
The virtual event will be moderated by American Vapor Manufacturers Association (AVM) legislative director Gregory Conley and newly-named AVM vice president Allison Boughner.
“The Future of Vaping in the US: A Conversation with FDA’s Dr. Brian King” will be held on Feb. 24 at 1:00 p.m. EST, and is open to the public. Participants must register in advance, and AVM has provided an opportunity to submit questions for King.
King has been quiet since memos recently submitted to the U.S. Court of Appeals for the Third Circuit show that he reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
In a new op-ed published in the HPHR Journal, The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Director Brian King writes about what the FDA is calling “health equity.” However, missing from the editorial is any response to either the recent Reagan-Udall Review or the findings of a recent investigation into the CTP by the U.S. Office of Special Counsel (OSC).
In the editorial, King writes that “there is no safe tobacco product; however, products do exist on a continuum of risk, with combustible products being responsible for the overwhelming burden of disease and death from tobacco use.”
He also states that “science is central to informing tobacco regulatory decision making,” noting that he is “a scientist by training” and is “particularly attuned to the vital importance of ensuring we gather and use the best scientific evidence available.”
In writing about his “vision” for the CTP, King does not address memos recently submitted to the U.S. Court of Appeals for the Third Circuit that show King reversed a recommended marketing approval of Logic Technology’s menthol vaping products, ignoring the advice of FDA scientists, according to Logic’s lawyers.
King also failed to address the conclusion a recent investigation conducted by the OSC that found the CTP had relaxed its standards of review for certain tobacco products and stifled attempts by its scientists to raise concerns. The OSC sent a letter to the U.S. President and Congress outlining the findings.
In the op-ed, King claims that the CTP “strive[s] to engage with a wide array of stakeholders, including those that work with and represent individuals and communities who are disproportionately impacted by tobacco use, to facilitate an open exchange of opinion from diverse groups.”
However, when the Reagan-Udall Foundation submitted its recommendations to Robert Califf , commissioner of the FDA, in December, the report concluded that vaping industry stakeholders observed a lack of “consistent implementation” of what the industry understood to be the policies of the CTP, particularly with respect to tobacco harm reduction and the requirements needed to navigate the premarket tobacco product application (PMTA) process.
King then goes on to state that in the 13 years since the landmark Tobacco Control Act (TCA) was signed into law, CTP has done “significant work to effectively research, regulate, and educate in a complex and rapidly changing tobacco product landscape.”
However, the Reagan-Udall report stated that the CTP needs to make “process improvements and identify and address the policy and scientific questions” that underpin its regulatory framework. The review concluded that CTP’s implementation of its PMTA program also has been affected by “changes in leadership and administrations.”
Since the implementation of the TCA, CTP has operated under seven different commissioners in three different administrations, and recently hired its third CTP director, King. In October, numerous comments from staffers of the CTP for the Reagan-Udall assessment of the performance of the FDA’s tobacco center claimed the regulatory agency is in a state of disarray and being influenced by outside forces, not scientific research.
One comment stated that reviewers of PMTAs in the CTP’s 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.”
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.
One month into his new job, Brian King is already praising his agency’s hard work. The director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) released a statement that he wanted to make it “unequivocally clear” that the agency was “working diligently” to process synthetic nicotine premarket tobacco product applications (PMTAs).
“A substantial number of applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long,” King stated. “Preparing these applications for review takes several steps and submissions varied widely in their organization, size, and completeness of data, which impacts the time it takes to process the information.”
Amanda Wheeler, president of the American Vapor Manufacturers Association (AVM), Tweeted, “Read between the lines: Millions of applications submitted, ZERO approved, yet King assures us the system is working. We do know the only thing preventing vape products from saving lives is the FDA itself, rigging the system in favor of prohibition over harm reduction,” in response to King’s statement.
Despite the challenges of reviewing PMTAs, King stated that the agency was “making significant progress” in processing and reviewing the applications. The FDA has issued refuse-to-accept (RTA) letters for more than 88,000 products for applications that “do not meet the criteria” for acceptance. Applications are required to provide important information needed for processing and reviewing.
“Without the required information, applications cannot proceed past the acceptance phase of the review process,” King stated. “The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.
Of the nearly a million applications submitted by May 14, the FDA only accepted an estimated 350, with the vast majority being for e-cigarette or e-liquid products, according to the statement. Accepted applications are then evaluated in the filing stage before going under scientific review.
“The substantive review phase includes evaluation of the scientific information and data in an application, which often results in follow-up questions and conversations with companies, including in situations where elements of an application raise questions needing clarification,” stated King. “It is only after the substantive phase that a company may be granted a marketing order. If no marketing order is granted, it remains illegal to market the product. To date, no non-tobacco nicotine product has received a marketing granted order.”
All bark, no bite
After July 13, 2022, a non-tobacco nicotine product can only be legally marketed in the United States if it has received a marketing order from the FDA. This means that it is illegal for a retailer or distributor to sell or distribute a synthetic nicotine products is in violation of the law and its manufacturer, retailer, or distributor may be subject to FDA enforcement.
King stated that the agency’s compliance and enforcement work is a multi-step process that cannot “happen overnight.” it takes time to ensure that any enforcement taken is supported by the available evidence with respect to the legal standards. Typically, the FDA will first issue warning letters to promote compliance and then follow up to ensure the violations addressed in the warning letter are corrected. If firms continue to violate the law, the FDA can pursue further actions, such as civil money penalties, seizures, and injunctions.
Many retailers simply ignore the FDA warnings. One owner told Vapor Voice that they “know” the agency is overworked and understaffed and is unlikely to follow up or pursue further steps. The agency has also made some very public mistakes over the past month, including its reversal of Juul’s marketing denial order (MDO), that has damaged the agency’s public perception.
While there isn’t much data surrounding what tobacco products remain on the market that have received warning letters, however, numerous companies on the agency’s MDO list still market products in the U.S.
It isn’t only for tobacco products that the agency doesn’t enforce its warnings. A considerable proportion of drug supplement products remain available for purchase after issuance of FDA warning letters, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Researchers found that the FDA issued warning letters regarding 31 supplement products. Only one of these 31 products was recalled by the manufacturer.
At a mean of six years following the issue of warning letters, nine of the products (29 percent) remained available for purchase online, according to the authors. Four of these nine products (44 percent) listed the presence of at least one prohibited ingredient on the label: One label declared the prohibited ingredient included in the FDA warning letter and three listed other FDA-prohibited ingredients. Five of the nine products were found to contain at least one FDA-prohibited ingredient after chemical analysis: Four products contained one prohibited ingredient and one product contained three. Two products contained the ingredient for which the FDA issued the warning letter.
Despite its challenges, the FDA issued 17 new warning letters on Aug. 1 to manufacturers for marketing products without FDA approval. On July 28, the agency issued 102 warning letters to retailers for illegally selling non-tobacco nicotine products to underage purchasers.
“Our goal is clear communication and transparency, and toward that end, we intend to include information about non-tobacco nicotine products in our regular metrics reporting in the future,” stated King. “To keep stakeholders and the general public informed, we also launched a non-tobacco nicotine product webpage that includes information about how synthetic nicotine is made and our regulation of non-tobacco nicotine products.”
Matt Holman, director of the Office of Science at the Center for Tobacco Products (CTP) of the U.S. Food and Drug Administration is stepping down immediately to join Philip Morris International.
A Tweet from Katherine Ellen Foley (@katherineefoley), a journalist who covers the FDA for Politico, first announced the news and the FDA has not yet confirmed publicly.
“PMI wouldn’t comment on what role Holman will be taking over; Ben [Apelberg] and Todd Cecil (both currently in CTP) will be rotating interim directors while the search for a permanent head of OS continues,” Foley Tweeted. “Cecil taking first shift.”
In that memo, obtained by Vapor Voice, King writes that Holman “has been on leave since before my tenure began at the Center, as he has recused himself, consistent with agency policies, from all CTP/FDA work while exploring career opportunities outside of government.”
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.
