The U.S. Food and Drug Administration is planning to make recommendations on how to regulate the use of the popular cannabis compound cannabidiol (CBD) in food and supplements, the Wall Street Journal reported, citing agency officials.
After weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress, according to the report.
In an interview, Janet Woodcock, the FDA’s deputy commissioner and leader of the agency’s cannabis regulation efforts, expressed concern about the safety of CBD and whether current regulatory pathways for food and dietary supplements are suitable for this substance.
However, the agency is interested in determining whether it is safe to consume CBD on a daily basis for extended periods of time or during pregnancy.
Woodcock mentioned concerns about potential effects on fertility in the future, but, at the same time, her comment signaled that the agency is working to establish regulatory frameworks for the legal sale of appropriate cannabis and cannabis-derived products.
CBD is a chemical compound found in cannabis plants. It is one of the main ingredients in cannabis, but unlike THC, it does not cause a high or have psychoactive effects.
The 2018 Farm Bill legalized hemp cultivation in the U.S., which led to significant growth in the market for CBD products. These products, sold as dietary supplements, are believed to have health benefits. As a result, many businesses in the cannabis industry are now selling CBD products across the country.
Over the last few years, the FDA posted several warning letters to companies for illegally selling products containing CBD. The companies are accused of selling products containing CBD that the FDA states some people may confuse for traditional foods or beverages that do not contain CBD or were making medical claims about their CBD products.
In 2021, The FDA told Charlotte’s Web Holdings, one of the world’s largest CBD companies, that its cannabidiol product cannot be sold as a dietary supplement, signaling that CBD reform may have to wait for congressional action.
Interested parties can now register for the Jan. 12 U.S. Food and Drug Administration seminar covering the ban of menthol flavors in tobacco products. “The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars” is the first FDA tobacco-related seminar of the year.
The presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process the FDA utilized for review of the highly influential scientific assessments for these proposed rules.
Bridget Ambrose, director of the Division of Population Health Science in the Office of Science at the FDA’s Center for Tobacco Products, will be the speaker. Ambrose has over 20 years of experience in tobacco control and regulatory science, with specialized experience in longitudinal analyses of tobacco use.
With Republicans in control of the U.S. House, some experts expect the vape industry to thrive.
By Timothy S. Donahue
The next two years should be better than the past two years. That was the overall outlook from vapor industry experts speaking during the Vapor Technology Association’s (VTA) 2022 Post-Election Round-Up webinar in late November. Tony Abboud, executive director of the VTA, told attendees that his organization has been working diligently with two Washington, D.C.-based firms, West Front Strategies, a lobbying group, and FORA Partners, a public affairs agency, to promote the interests of the vaping industry as Republicans take over the U.S. House of Representatives in 2023. “We have a very specific agenda, some of which we’ve discussed (as an overview of what) we are pursuing,” he said. “We’ve done an enormous amount of groundwork.”
Shimmy Stein
Shimmy Stein, a partner with West Front Strategies, said the change in leadership at the House could have a positive impact on the vaping industry until at least the next election cycle. “Anytime you can take over the gavels, take over the control of the messaging, take over control of the chairmanships and the legislation, that is an important piece of governing,” he explained. “And so, while it was not to the extent or to the size which Republicans were hoping for in terms of the majority in the House of Representatives, it’s still pretty significant and will change the manner in which Washington will function.”
Over the next two years, the vaping industry should feel “a little more comfortable, a little more secure” going into a divided Congress (the U.S. Senate leadership did not change), according to Craig Kalkut, a partner with West Front Strategies. However, the vaping industry has always faced threats from both Democrats and Republicans due to their concerns over teen vaping. “We still need to work with both parties. We still could face issues and threats of overregulation and poorly conceived legislation. But the bottom line is that we will have a more comfortable environment with Republicans controlling one house of Congress,” said Kalkut.
Craig Kalkut
Reconciliation, a way for Congress to enact legislation on taxes, spending and the debt limit with only a majority vote, is no longer a threat to the vapor industry, according to Kalkut. He said that’s just not something that can happen in a divided Congress. “What that means, ultimately, is that anything that passes will need to have bipartisan support,” said Kalkut. “And because of that, [legislation] will likely be more limited, more moderate, and hopefully, if there’s any legislation passed in our area, that will be something that allows us to thrive, which addresses the concerns that linger over teen vaping but does not overregulate and drive people away from vaping.”
Kalkut also confirmed that gridlock is a concern in a divided Congress; however, gridlock could also provide incentives for both parties to compromise. “They’re both seen as in charge, so they both sometimes want to get something done. And that will bring people to the table and often over issues that are not central to either party’s ideology,” he said. “It’s hard to come to a compromise on taxes, or it’s hard to come to a compromise on healthcare … but something like vaping, perhaps there will be opportunity for common sense provisions to prevail in an area where Democrats and Republicans can come together.”
Max Hamel
Max Hamel, founding partner of FORA, said when Congress is split, the White House typically relies heavily on its executive privilege. There is no known administration agenda on vaping, so a vaping-related rule is unlikely. With Republicans in control of the House, they also head committees. The House oversight committee and its subcommittees could present opportunity for the vaping industry, according to Hamel.
“We do have new personalities on both the majority and the minority side, so they’ll probably have some growing pains,” he said. “The big question is, how does this new authority, especially in the House, get wielded[?] … whether it’s one seat or 40 seats, the authority with the majority is the same, and it is substantial from [an] investigation and oversight standpoint; [that’s] probably not necessarily true from a legislative standpoint … the oversight subcommittee, we do have the opportunity to surface some things, but it’s really an opportunity for us now to not be on defense and [to] put forth an agenda and some messaging that really focuses on the things that are advantageous to us.”
Additionally, with Juul losing its stranglehold on the vaping market, Hamel said the vaping landscape is changing. Juul became the focus to save youth from vaping, and today, Juul isn’t the focus. The market is made up of a more diverse group of companies with different technologies dedicated to harm reduction. Hamel said this is the message that should be projected. “I think our priority will be focusing on the messages that really emphasize the harm reduction aspects,” he said.
Kalkut then added that the vaping industry has an opportunity now to change the conversation, particularly with Democrats but also Republican critics and skeptics of vaping through the ever-expanding body of science that shows the relative safety and incredible potential for harm reduction that next-generation tobacco products have. “That has become more and more clear as time has gone on over the last couple of years,” he said. “I think once we show that, once we demonstrate our commitment as an association in the industry to addressing teen vaping, we have a real chance of changing the narrative.”
Ashley Davis
Ashley Davis, a founding partner at West Front Strategies, told attendees that, looking back on industry challenges, there has been success. However, her concerns going into the last Congress (2020–2022) were that she didn’t really know in what direction or how forcefully Biden would lean on the vapor industry. She says the industry “dodged a bullet.” The industry could have suffered more than it did those first two years in a Biden administration. She also said the issue of youth use will remain at the forefront of any discussion concerning electronic nicotine-delivery system products.
“We do have to still deal with the youth issue. And I think we all realize that any negative press that comes up is around the youth issue … Everyone loves a microphone. It’s a member of Congress. If there’s an issue to discuss, that’s what they’re going to discuss,” explained Davis. “[We are] trying to make sure that any bad legislation is not passed—it’s much more unlikely in this Congress than it was before.”
Taking a question from the audience, Abboud closed the session speculating on the impact of the Reagan-Udall Foundation’s external review of the U.S. Food and Drug Administration’s Center for Tobacco Products, the results of which are expected in mid-December.
Abboud said that numerous comments from staffers of the FDA for the Reagan-Udall assessment suggest the regulatory agency is in a state of disarray and is being influenced by outside forces not scientific research. He said he hopes the foundation will advise the FDA that premarket tobacco product application (PMTA) decisions should be free from any external pressures, especially political pressure.
“[The review should recommend to the FDA that PMTA] decisions must be made based upon the science that is submitted as well as making sure that the agency does, in fact, review all of the science that has been submitted as part of any applications as well as [reviewing] all of the applications that have [been] submitted,” said Abboud. “Because that was another big failing of the current process where applications have been rejected [without a full 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.
“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 Tobacco Reporter that 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.
Logic must now decide if it will resubmit its applications or submit new applications to address the deficiencies for the products that are subject to the MDOs. However, these acts could prove futile since 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.
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.
New 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 U.S. Food and Drug Administration in conjunction with the Centers for Disease Control and Prevention.
“The FDA remains deeply concerned about e-cigarette use among our nation’s youth. It’s clear that we still have a serious public health problem that threatens the years of progress we have made combatting youth tobacco product use,” said FDA Commissioner Robert M. Califf. “We cannot and will not let our guard down on this issue. The FDA remains steadfast in its commitment to using the full range of our authorities to address youth e-cigarette use head-on.”
The study shows that about one in 10 middle school (3.3 percent) and high school (14.1 percent) students reported current e-cigarette use; current use is defined as use within the past 30 days. About 85 percent of surveyed students reported using flavored e-cigarettes while 27.6 percent reported daily use. Respondents most commonly used disposables, with Puff Bar being most common (14.5 percent) followed by Vuse (12.5 percent) and Hyde (5.5 percent). Puff Bar and Vuse were pre-specified options on the survey, but Hyde was written in by students as their preferred brand.
Since methodology changes occurred, including in survey administration and data collection procedures due to the Covid-19 pandemic, comparisons between the 2022 NYTS and previous years is limited.
Following the release of this data, the FDA has issued a warning letter to Puff Bar for receiving and delivering e-cigarettes in the U.S. without a marketing authorization order. The FDA has requested a response within 15 working days of receiving the letter, detailing how the company intends to address the FDA’s concerns, including the dates on which they discontinued the sale and/or distribution of these tobacco products and plans for maintaining compliance with the Federal Food, Drug and Cosmetic Act. Failure to address the violations puts the manufacturer at risk of regulatory action, such as a civil money penalty, product seizure and/or injunction.
The Puff products subject to this warning letter are nontobacco nicotine products.
After reviewing premarket tobacco product applications for 32 Hyde e-cigarettes, the FDA issued marketing denial orders (MDOs) for these applications submitted by Magellan Technology Inc. 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.
“Congress gave the FDA authority to hold manufacturers and retailers who violate the law accountable,” said Brian King, director of the FDA’s Center for Tobacco Products. “FDA is actively working to identify violations and to swiftly seek corrective actions, particularly for products popular among youth. We will use all compliance and enforcement tools available to us, as appropriate, to protect our nation’s youth.”
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.
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.”
The U.S. Court of Appeals for the Eleventh Circuit has ruled that the U.S. Food and Drug Administration’s marketing denial orders (MDOs) for Kaival Brands’ Bidi Vapor products are arbitrary and capricious.
“The Administration refused to consider the marketing and sales access restrictions plans based on both its need for efficiency and its experience that the marketing and sales access restrictions do not sufficiently reduce youth use of electronic nicotine products,” Chief Judge William Pryor wrote. “Because ‘agency action is lawful only if it rests on a consideration of the relevant factors,’ and the Administration failed to consider the marketing and sales access restrictions plans, the marketing denial orders were arbitrary and capricious.”
In the court’s 2-1 split decision, additionally, the majority stated:
The court recognizes relevant distinctions between closed/cartridge systems (that are easy to conceal and use) and the open tank liquids sold in vape shops;
FDA’s refusal to review marketing plans was error and not harmless (disagreeing with Fifth and DC Circuits).
In the 70-page opinion, Bidi Vapor, Diamond Vapor, Johnny Copper, Vapor Unlimited, Union Street Brands and Pop Vapor, the petitioners in the case, had all appeals granted, denial orders vacated and remanded.
In her dissent, Judge Robin Stacie Rosenbaum wrote, “Spoiler alert: This opinion contains spoilers on how the U.S. Food and Drug Administration will resolve petitioner vaping product companies’ premarket tobacco product applications on remand from this appeal.”
She then stated “never mind. There’s nothing to spoil here. Anyone who knows all the relevant facts necessarily already knows how this one ends.”
She stated that the while the majority faulted the FDA for not considering the companies’ proposed restrictions on youth use, the FDA’s framework for evaluating PMTAs leaves “no room for doubt that the FDA will deny—in fact, under the Family Smoking Prevention and Tobacco Control Act, must deny—the applications on remand. To paraphrase the Borg, then, remand is futile.”
The U.S. Food and Drug Administration Today issued a final guidance on guidance perception and intention studies.
The guidance, “Tobacco Products: Principles for Designing and Conducting Tobacco Product Perception and Intention Studies,” is intended to help applicants design and conduct tobacco product perception and intention (TPPI) studies that may be submitted as part of a modified risk tobacco product (MRTP) application, a premarket tobacco product application (PMTA), or a substantial equivalence report (SE Report).
TPPI studies can be used to assess, among other things, individuals’ perceptions of tobacco products, understanding of tobacco product information (e.g., labeling, modified risk information), and intentions to use tobacco products, according to the FDA.
These studies provide critical information during the review of product applications and this guidance provides recommendations on how to perform these studies.
The final guidance addresses several scientific issues for applicants to consider when designing and conducting TPPI studies to support tobacco product applications:
Developing study aims and hypotheses
Designing quantitative and qualitative studies
Selecting and adapting measures of study constructs
Determining study outcomes
Selecting and justifying study samples
Analyzing study results
The guidance document is intended to provide clarity to applicants regarding existing requirements under the law, according to FDA.
“FDA guidance documents, including this guidance, should be viewed as recommendations for consideration, unless specific regulatory or statutory requirements are cited,” the release states.
Recently, U.S. Food and Drug Administration Commissioner Robert Califf announced an external evaluation of both the Human Foods Program and the Center for Tobacco Products (CTP). The FDA press release observed that “… even greater challenges lie ahead as we determine how the agency will navigate complex policy issues and determine enforcement activities for an increasing number of novel products that could potentially have significant consequences for public health. To that end, the review will push toward ‘organizational excellence.’”
Califf is right—the CTP clearly requires assistance. The purpose of this article is to review how the CTP arrived in this untenable situation and to suggest areas of focus for the review of the CTP processes.
How Did We Get Here?
There is little doubt that the CTP is in an unenviable position. No matter which way the agency turns, it is impossible to please everyone. The anti-tobacco/vaping groups will never be satisfied until all tobacco products are gone—so realistic harm reduction propositions from the center will always be met with opposition. And when the CTP tries to develop policies with a focus on efficiency, many in the industry claim that they are “prohibitionist” and that they have no regard for harm reduction and/or the human and economic consequences of their decision-making.
Recently, several court opinions and CTP actions have significantly contributed to the challenging environment for the CTP:
West Virginia v. EPA. While not directly related to the CTP, the West Virginia v. EPA Supreme Court decision has reopened the question as to whether discretion of regulatory agencies may become more limited in the future. The court seems poised to chip away at longstanding doctrines (or apply them more forcefully) to limit agency power and place policymaking back with the legislature.
Cigar Association of American v. FDA. More recently, in the Cigar Association of America v. FDA case, Judge Amit Mehta of the U.S. District Court for the District of Columbia examined whether the FDA’s decision not to exempt premium cigars from the Deeming Rule was arbitrary and capricious. The court ultimately found that the FDA ignored evidence in the rulemaking record—and ruled against the agency.
Juul v. FDA. Days later, the CTP found toxicological issues with Juul’s popular vapor products and issued marketing denial orders (MDOs) for those products. Not surprisingly, Juul immediately requested and received an emergency stay of the MDOs from the D.C. Circuit. Without missing a beat, the CTP promptly “… administratively stayed the marketing denial order. The agency [determined] that there are scientific issues unique to the Juul application that warrant additional review.” Several commentators questioned the CTP’s rationale for its decision to re-review Juul’s applications, and some have gone so far as to suggest that this quick reversal indicates a less than appropriate review of Juul’s data or worse—a lack of confidence in the CTP’s decision-making. Either way, the entire chain of events draws into question the CTP’s review process.
Finally, the CTP is still under pressure to complete decisions on premarket tobacco product applications (PMTAs) for those companies addressed in the Maryland court decision which, according to the CTP, will not be completed until next summer. Further compounding the CTP’s problems, the center continues “processing” approximately 1,000,000 synthetic nicotine PMTAs past the congressional deadline for marketing decisions on July 13, 2022. How the center will respond to this pressure is anyone’s guess. So far, it seems like the CTP continues to move at its own pace, following the Maryland court’s order to the best of its abilities.
These external and internal factors point to one conclusion that cannot be ignored—the CTP appears to be struggling and needs something to change. With the above in mind, the following are a few areas ripe for external (and internal) review at the CTP.
Credit: Fizkes
Operational Changes
Operationally, the CTP seems to have the resources (personnel and budget) to successfully regulate tobacco products. That said, certain policy choices and administrative actions (both self-inflicted and externally inflicted) appear to hamper the center’s ability to effectively manage the space. Importantly, effective regulation is hamstrung by the complexity of the U.S. tobacco regulatory scheme, a lack of clear standards for product testing and approval and a too opaque product application process.
The most challenging operational issues come from the existing regulatory scheme, which is too complex for tobacco products. The Tobacco Control Act dictates the parameters/guardrails, but the CTP has latitude in how the process is implemented. The comprehensive PMTA guidance and robust final rule demand a scientific depth that goes too far. The question is: Is all of the delineated scientific data really necessary to determine that a product is appropriate for the protection of public health (APPH)?
If comparing to combustible cigarettes, it would seem that most electronic nicotine-delivery product APPH determinations could be made based on chemistry alone. Piling on bench toxicology, human factors, pharmacokinetic and behavioral studies, it’s no wonder the review process takes so long.
Standards are not clear. Without clear standards, the CTP and industry both are left constantly employing guesswork and conjecture to facilitate decision-making. While understandably there is no simple formula for APPH, clear expectations would be beneficial and efficient. By way of example, which device characteristics really need testing? What is the depth of stability testing necessary? What constitutes a sufficient PK [pharmacokinetic] study? While the initial meeting with the Office of Science is often useful to help answer questions like these, better defining product-specific standards and setting minimums would go a long way to streamlining the approval process.
Transparency is lacking. While one can review the Technical Project Lead Reviews and some of the review standards memos that the CTP places on its website, few PMTA applicants have any idea what’s going on with their applications at any given time. Other than the initial pre-PMTA meeting and the sole deficiency letter, there is little that applicants know about the status (both administratively and substantively) of their applications. While more transparency about the status of applications would be welcome, more back and forth on issues in applications would benefit everyone—particularly the CTP. In the case of Juul, reports indicate that Juul provided thousands of pages of data related to the toxicological issue that the CTP raised in the MDOs. If the now outdated additional information requests were utilized by the CTP, Juul would have pointed out this data, and at least one issue could have been resolved well short of a trip to the courthouse.
Credit: Oleg
Policy Changes
It goes without saying that U.S. government policy can be fickle to say the least. Setting and maintaining long-term policy is difficult—especially in light of changing administrations every few years. Despite this, overriding policy tenants as they relate to harm reduction can, and should, form the cornerstone of tobacco regulatory policy. If harm reduction is the priority, then regulators need to prioritize pathways for reduced-harm products to enter the market, incentivize innovation and focus on providing offramps to combustible cigarette smokers seeking to quit smoking.
Harm reduction policy. During the tenure of former Commissioner Gottlieb at the FDA, many in the industry thought harm reduction would prevail and that all would recognize vapor products’ place at the opposite end of the continuum of risk from combustible cigarettes. Unfortunately, the significant uptick in youth experimentation with a few types of vapor products prodded the CTP into a tough position. Public health groups, dissatisfied with the CTP’s pace, forced the center into a corner via litigation.
Assuming the goal of the Tobacco Control Act remains to reduce smoking-related morbidity and mortality, harm reduction strategies are central to achieving that goal. Importantly, harm reduction strategies should be palatable to all stakeholders. While the CTP has several initiatives moving forward, is there a plan for initiatives dedicated to moving smokers to safer alternatives? Efforts to move smokers to less risky alternatives do nothing when those less risky alternatives cannot succeed via the PMTA pathway. Current tobacco policy is remarkably dissimilar from the variety of strategies employed for other unsafe behaviors where harm reduction is embraced as the primary alternative. In areas such as drug use and sexually transmitted diseases, our society generally accepts reduced-harm efforts, but for tobacco, collectively we are still searching for that sweet spot.
Given all the challenges that the CTP faces, working on harm reduction policies hand-in-glove with nongovernmental groups and industry probably does not seem like the best use of time. When the center was first formed, frequent scientific meetings were held on various issues (such as harmful and potentially harmful constituents). These have fallen off in recent years, likely in part due to Covid and also due to the onerous demands on the center. Prioritizing genuine and open conversations between the CTP, industry and tobacco control groups is critical to developing strong harm reduction policies. Holding scientific meetings (either through the CTP or the Tobacco Products Scientific Advisory Committee) on harm reduction plans and policies would add transparency and bring all ideas to the table.
The FDA should not let the perfect be the enemy of the good when considering reduced-harm products. At present, PMTA reviews appear to be searching for the perfect. Reviews seem to focus on the smallest details that might pose a risk while ignoring a more generalized comparison to combustible products with 70 known carcinogens (and a track record of 480,000 deaths per year). APPH does not mean no risk—it means less risk than the deadliest consumer product ever invented, the combustible cigarette. Reconsidering how APPH is adjudged would be an excellent first step in combatting morbidity and mortality attributable to smoking.
Investing in harm reduction must be incentivized. If one wants to develop a new product, the timeline is a hard stop. A year of product development, up to three years of PMTA testing (including two years of stability and time to plan, conduct and write up the studies) plus one year to three years of the CTP review before the possibility of a marketing order sounds like a pretty poor investment. The PMTA process must change to bring less risky products more rapidly to market.
Society must not forget about smokers. Youth tobacco issues are important, but the 1,300 smokers dying each day are important too. A balanced harm reduction policy—controlling youth access and exposure while moving combustible cigarette smokers to quitting tobacco altogether or moving to a less risky product is necessary.
Moving Forward
Hopefully the external review will be a fruitful exercise—one that provides robust alternatives for the CTP to consider. The review, if rightly focused, will address foundational issues that will, in the end, lead tobacco regulation to a reasonable, reduced-harm world where smokers are given hope for a future.
Chris Howard is vice president, general counsel and chief compliance officer at E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
Rich Hill is the compliance director and associate general counsel of E-Alternative Solutions.
Matt Holman, director of the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) Office of Science, is leaving the agency to join Philip Morris International effective immediately, reports The Hill, citing a memo from CTP Director Brian King. Holman has been director since 2017.
“I know that he led the Office through a critical time, including preparing for and overseeing review for the bolus of PMTA [premarket tobacco product application] applications,” King said in the memo. “I’m grateful to Matt for his contributions to the Center and unwavering commitment to you all over the years, and I wish him well in his next chapter.”
Holman’s departure comes after Mitch Zeller, the longtime CTP head, retired in April. King was appointed director earlier this month.
According to King’s memo, Holman has been on leave and has recused himself from all CTP and FDA work while exploring career opportunities outside government.
While free to pursue employment outside of the government, FDA employees are required to immediately disclose that they are exploring opportunities outside the government.
Holman leaves the CTP as the agency faces series of major tobacco-related decisions, including a potential ban on menthol cigarettes, lowering nicotine levels, and the next step in its ongoing attempt to regulate Juul and other electronic cigarettes.
A spokesperson for Philip Morris said Holman “is committed to helping existing adult smokers access scientifically substantiated smoke-free alternatives while protecting youth. We are looking forward to him joining our team as we continue to pursue a smoke free future.”
