Tag: GTNF 2022

  • Christopher Russell

    Christopher Russell

    Flavors other than tobacco will not be allowed on the U.S. market. In order for that to happen, a manufacturer would need to show the U.S. Food and Drug Administration that flavors other than tobacco are appropriate for the protection of public health (APPH), and that may be more complicated than once thought. This was the opinion of Christopher Russell, director at Russell Burnett Research and Consultancy.

    Presenting at the GTNF 2022 in Washington, D.C., Russell described the regulatory rationale and features of several types of research studies that can be conducted to compare the efficacy of flavored electronic nicotine-delivery system (ENDS) products versus tobacco-flavored ENDS products for facilitating switching and reducing cigarette consumption among adult smokers.

    For a premarket tobacco product application, the FDA requires a range of valid scientific data and other research information to determine whether permitting the marketing of the new tobacco product qualifies as APPH. However, Russell explains, the Food, Drugs and Cosmetics (FD&C) Act, which guides the FDA’s authority, doesn’t clearly define APPH.

    “Instead, to determine whether a new tobacco product meets the APPH standard, Section 910 of the FD&C Act requires FDA to, among other things, weigh the risks and benefits of the new tobacco product to the population as a whole, including users and nonusers of tobacco products, and taking into account both the likelihood that existing tobacco users will stop using such products if the new product is marketed and the likelihood that individuals who do not currently use tobacco products will start to use tobacco products if the new product is marketed,” Russell said.

    To consider the marketing of a new tobacco product to be APPH, the FDA states that a PMTA must contain sufficient valid scientific information that demonstrates that the new tobacco product significantly reduces harm or the risk of tobacco-related diseases to individual tobacco users. Additionally, allowing adults access to ENDS and other noncombustible tobacco products cannot come at the expense of addicting a new generation of children and teenagers to nicotine.

    “Though the FDA has sought to strike a balance in recent years between reducing youth appeal and access to ENDS on one hand while maintaining opportunities for addicted adult smokers to access ENDS on the other hand, the FDA’s current position expressed most recently in the issuance of marketing denial orders (MDOs) for flavored ENDS products is that the evidence available to FDA is clear in showing that the appeal and the likelihood of use of flavored ENDS by youth harms the public health to a level that is not outweighed by the health benefits of adult smokers switching to ENDS products,” said Russell. “In fact, flavored ENDS do not confer any incremental benefits over and above tobacco-flavored ENDS.”

    The FDA has indicated that it may require a randomized controlled trial (RCT) and or a longitudinal cohort study (LCS) that demonstrates the benefit of an applicant’s flavored products help adult smokers more than they entice youth to start vaping. The FDA said it would also consider data that showed the same results through other research routes.

    An RCT uses control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments, according to Russell. An LCS is a research study that follows large groups of people over a long time. The groups are alike in many ways but differ by a certain characteristic (for example, vapers who use flavors other than tobacco, those who vape tobacco and those who smoke combustible cigarettes).

    “I think FDA is—without being explicit—they are strongly communicating that an RCT or a longitudinal cohort study would provide the strongest evidence of an added benefit of a flavored ENDS product and that any application for a flavored ENDS product that does not contain one of those two studies or both of those studies will leave FDA in a position where they cannot possibly be confident that the potential benefits of the flavored ENDS would outweigh or overcome the risks to youth or would exceed the benefits of a comparable tobacco-flavored product,” said Russell. “I cannot see any circumstance in which flavored ENDS products will receive marketing authorization without having provided FDA with reliable and robust evidence from at least one of these two study designs. RCT is the gold standard in interventional research, and longitudinal cohort studies [are] the gold standard in observational research.”

  • The Evolution of Sustainability

    The Evolution of Sustainability

    Photo: Crhis Ferenzi Photography

    Panel Discussion: The Evolution of Sustainability

    The “pace of change is accelerating” for environmental, social and governance (ESG) issues, which requires companies to invest in policies and actions that encourage responsible behavior. “ESG is a driver of choice,” a GTNF speaker said.

    Due to the nature of its business, tobacco companies can make the greatest ESG gains by reducing the health impact of their products. Moving to a smoke-free future is the single best thing the industry can do in order to maintain its license to operate and create long-term sustainability. “We think that’s right for our consumers,” said a representative of a leading tobacco firm. “We believe it’s right for our employees. We believe it’s right for society broadly.”

    Innovation creates value. Sustainability creates value. And those two things are not in conflict, according to one speaker. They are instead reinforcing ideas. Companies cannot innovate alone. They need to innovate alongside their consumer base. The speakers agreed that everyone needs to be involved in innovation with a shared goal of sustainability.

    “We believe [one way] we can create positive change is to address the harm of our products. And so that gets more to our vision, which is moving beyond smoking,” a speaker noted, adding that some of the challenges in ESG are knowing what expectations are, especially from consumers and shareholders. “You take the time to understand what they expect, you identify where are the areas of your business where you can align those expectations into your business practices and then measure and communicate the progress that you’re making.”

    ESG used to exist on an island. Today, it’s a core part of how leadership drives the long-term success of a business. The speakers noted that changes brought about through ESG initiatives will determine the long-term success of companies. A company must address its “most pressing issues” that stakeholders care about.

    “We talk about transforming people’s lives so that together we can grow better. It’s frankly something that all our employees around the world can really get behind. But it’s not just the talk; it’s the walk, right?” a speaker asked. “It’s measuring what you have and setting real targets of what we want to achieve and reporting on those in a very public way. I think this industry is way too shy about talking about some of the positive achievements that it’s had and it’s made and continues to make around the globe.”

    The best practice is to intertwine sustainability and business strategies—where the board and the executive team are acting as the coaches of the company’s sustainability goals. “It is about being standardized, being transparent, basing your numbers on actual science and facts, and being [able to implement these policies throughout] the full value chain,” one speaker explained. “One of the key takeaways is that perhaps ESG/sustainability efforts at some point were seen as optional. But the reality is that this is not the case now. It is no longer optional. And I think we’re all committed to trying to do the right thing.”

    ESG can be driven by governmental regulation too. Those regulations can become game changers for companies, according to several speakers. For example, the European Union has launched the “European Standards for Sustainability Report.” The report essentially outlines what companies have done over the past 20 years to move toward a more sustainable future. The report also shows that ESG isn’t easy. It also offers a potential blueprint for companies struggling for innovative sustainability ideas.

    “[The meaning of] ultimate sustainability is really sort of combatting climate change and decreasing emissions, saving water … minimizing pollution and waste, looking at diversity and quantity, having zero corruption, looking at almost everything from tax clarity to human rights and supply chains,” one speaker said. “It’s a lot of work and you don’t want to invest in that work if you’re not going to get the value to actually build a more successful, sustainable company.”

    In the end, sustainability, ESG and tobacco harm reduction go hand in hand. One speaker explained it as a three-legged stool. When you think about the products themselves, you have to have products that are satisfactory to the adult tobacco consumer. It’s a product that’s going to be commercially successful. Consumers will enjoy it, and they will transition to authorized smoke-free products.

    “We also know that there are consumers who want to entirely quit using tobacco products, and so we think supporting adult tobacco consumers who have made the decision to quit [and are] able to do so successfully is also an important element of harm reduction.”

    “And then we absolutely have to make sure that underage use is not an issue,” one speaker explained. “We’ve heard the conversation about innovative reduced-risk products cannot be an offramp for the adult tobacco consumer and an on-ramp for youth, and so there has to continue to be a lot of attention to those three pillars of the stool to make sure that underage use [is limited], especially as we start thinking about new-to-market products.”

  • Jonathan Adler

    Jonathan Adler

    Photo: Chris Ferenzi

    There are numerous challenges to achieving the goal of tobacco harm reduction. Addressing these challenges might require thinking differently about how to approach the regulatory process and perhaps the extent to which the regulatory process needs to be changed, according to Jonathan Adler, the inaugural Johan Verheij Memorial Professor of Law and the founding director of the Coleman P. Burke Center for Environmental Law at the Case Western Reserve University School of Law, where he teaches courses in environmental, administrative and constitutional law.

    Speaking at the GTNF 2022, Adler said that the U.S. Food and Drug Administration’s handling of premarket tobacco product applications (PMTAs) has been arbitrary. It’s been sloppy. It hasn’t followed its own guidances. “It’s pretty clear that the FDA was not prepared for this onslaught of applications, prepared for the volume, prepared for the type of analyses it would have to conduct,” he told attendees. “And [the agency] responded to that with a mixture of cutting corners and adopting shortcuts that would enable it to make decisions, typically negative decisions, so that it could process these applications.”

    Companies aren’t happy with how the FDA has handled the PMTA process. Numerous companies have taken the agency to court, with mixed results. There are currently more than 30 court cases surrounding PMTA actions. Adler said that the FDA has responded inconsistently to these lawsuits. After denying Juul’s application, for example, the FDA decided to reconsider and review all the things it was supposed to review before issuing a marketing denial order. The agency took the same type of action with Turning Point Brands.

    In other cases, however, the FDA has been willing to let the courts decide. The challenge in this approach is that the FDA is being strategic about which cases it fights in court and which cases it retreats on. “As someone that follows a lot of administrative litigation, it certainly looks as if FDA is retreating where the cases against its actions are the strongest and allowing cases to proceed where it thinks the challenges are weak,” said Adler. “[This is] either because issues haven’t been raised or because issues haven’t been printed in the strongest way possible or perhaps because the applications were weaker to begin with.

    “As these precedents build, it will become easier and easier for FDA to defend against challenges to even the strongest arguments, so this is certainly part of the regulatory challenge …. We know—and this is all information that you’re all aware of—that the majority of people in the United States believe that ENDS [electronic nicotine-delivery systems] are as [dangerous] if not more dangerous than combustible cigarettes.”

    There are other challenges too. Adler said the United States also has trust issues on both sides of the aisle. Many of the institutions and authorities that historically have been seen as trustworthy and would provide accurate information aren’t considered to be as reputable anymore.

    “And certainly, the experience of Covid and the like has eroded that trust even more,” he said. “We need to think more broadly about how we might overcome this challenge. My own view is that we need to think more about the competitive process and how we discover how to communicate to consumers. And that word ‘discover’ is important. Because it’s not always clear what consumers want, why they want it and how you let them know that what you have might be what they want.”

    In the case of nicotine products, due to FDA regulations, companies can’t compete in trying to convince smokers that their product will satisfy the desire for nicotine, or whatever else, in a less risky way. In Section 911 of the Tobacco Control Act, there are strict restrictions on what can be said about modified-risk tobacco products, including factually true statements. Adler said that’s a problem because if companies are able to compete on characteristics like health impact, it affects not only the behavior of those companies, but it also affects consumer understanding.

    “This statute has also been interpreted, I would argue quite aggressively, by the FDA. The FDA’s position is that producers of electronic cigarettes can’t quote things that Brian King said here yesterday [the CTP director spoke at the GTNF on Sept. 28]. Can’t quote things the FDA has put in the Federal Register that are indisputably factually true. And if they say things like ‘This might help you quit smoking,’ well, then the FDA’s position is ‘forget [the modified-risk order] …. That makes you a drug device.’ And there’s a whole different approval process you have to go through for that.”

    A constitutional law professor, Adler views Section 911 as a potential First Amendment issue. The U.S. Supreme Court, he said, has stated repeatedly that courts should be especially skeptical of regulations that seek to keep people in the dark for what the government perceives to be their own good. That includes attempts to deprive consumers of accurate information about their chosen product.

    “We’re not talking about sensational claims about unproven medications or unproven treatments. We are talking about claims that the FDA itself acknowledges are true. [In a case involving the FDA and a compounding pharmacy that the agency wanted to prevent from advertising,] we rejected the notion that the government has an interest in preventing the dissemination of truthful, commercial information in order to prevent members of the public from making bad decisions with the information.

    “And the circuit, in the context of nutritional supplements, has also said that it is clear that when the government chooses a policy of suppression over disclosure, at least where there was no showing that disclosure would not suffice to cure misleadingness, government disregards are far less restrictive means. It violates the relevant standards under the First Amendment.

    “The FDA’s position is that no disclaimer, no disclosure can somehow cure the problem of telling people what the FDA itself has said about noncombustible products. It’s not clear to me—I mean that’s not only not rational, [but] it’s not clear to me why that’s constitutional.”