By Markus Lindblad, Head of External Affairs at Haypp Group, parent company of Nicokick.com and Northerner.com
At every turn, a new opinion emerges, demonizing brands for developing flavored products, to, as they say: market to those underage—often based on the notion of a “hidden agenda.” Let’s be clear: these products are created exclusively for adult consumers.
This year, the World Health Organization (WHO) is using World No Tobacco Day 2025 to push the go-to ‘anti flavor’ agenda on nicotine products. Huge surprise to no one. The claim is that they’re part of an industry ploy to attract children. The slogan—Bright Product. Dark Intentions. Unmasking the Appeal—is both misleading and dangerous. And the question we ask ourselves: to what end?
What those who are committed to this rhetoric seem to forget is that regulatory bodies have implemented strict guidelines to ensure the opposite of this mythical ‘hidden agenda’. As compliant and responsible brands, we walk a tight rope every day. Transparency is built into every layer of the industry—from marketing communications in earned, paid, and owned channels to prominent warning labels and full ingredient disclosure. The real unknown is the unchecked rise of illicit products flooding the market. Much like alcohol, flavors are not a tool for targeting youth. The logical step forward is to adopt consistent age verification measures—at both the federal and state levels—to prevent underage access.
WHO’s Campaign Ignores Science and Reality
WHO, like many other one-sided anti-tobacco organizations, paints all flavored nicotine products with the same broad brush, ignoring clear distinctions with those developed as alternatives to help adults move away from smoking. The truth is, flavored alternatives have proven to be a strong contributor to the harm reduction movement, helping millions of smokers transition away from deadly combustible tobacco.
Earlier this year, the U.S. Food and Drug Administration (FDA) authorized certain nicotine products to be marketable as a risk-reduced alternative, as part of its harm-reduction strategy, finally listening to and acknowledging the science we’ve known for years. Yet the flavor-ban fight continues, contradicting this approach.
The Real Problem: Access, Not Flavors
It begs repeating: Flavors weren’t made for kids—they were made for adults seeking an alternative to smoking. We have seen the news cycle recently, offering reports on the marginal increase in underage usage, a problem we can all agree on. But to be clear, kids don’t get access because of peach or watermelon flavor names—they get access because standardized age-verification policies present with other categories and industries are absent, so the next best thing is to ban.
How it should be:
Stronger and standardized age verification measures for all nicotine sales.
Ban proxy sales to minors.
Strict penalties for non-compliant retailers.
Bans Hurt Public Health—and Help Illicit Markets
Flavor bans don’t stop youth—they just drive demand underground. Meanwhile, they strip adults of their right to choose alternatives and damage legitimate businesses.
Restricting the appeal of reduced-risk products won’t stop young people from experimenting—it will just make quitting harder for adults and push both into more dangerous behaviors.
WHO Has It Wrong. States Must Lead.
WHO’s 2025 campaign is focused on the wrong enemy and the rhetoric continues to erode years of research and drive fear. Instead of condemning flavors, they should be calling for smarter and tighter regulations that keep products out of underage hands—not banning tools that help adults quit smoking.
Public health isn’t advanced by moral panic. It’s advanced by policy that works.
The recent marketing authorization by the U.S. Food and Drug Administration (FDA) of 20 Zyn nicotine pouch products is a good step forward in building a more robust market for smoke-free nicotine and tobacco products. This critical decision, coupled with the Trump administration, U.S. Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. and expected FDA Commissioner Marty Makary’s stated priority to “Make America Healthy Again,” foretells an emerging regulatory landscape in the U.S. that presents a meaningful opportunity to expand access to smoke-free products that can help adults who smoke make the switch away from cigarettes.
This paradigm shift has been a long time coming, and I am thrilled to see it happening in real time. Now, it is time for the FDA to step up its education efforts—with both consumers as well as the medical community—to raise awareness of these products and how, although not risk free, they are a better choice than continuing to smoke or using other traditional tobacco products.
In clearing the FDA’s extensive premarket tobacco product application (PMTA) process, which includes years of scientific review, ZYN became the first and only FDA-authorized nicotine pouch in the U.S. In the FDA’s announcement, the Director of the Office of Science at the FDA’s Center for Tobacco Products (CTP), Matthew Farrelly, Ph.D., noted that these “products offer greater benefits to population health than they do risks,” and the data shows that ZYN nicotine pouches “meet that bar by benefitting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
While this should be good news for the 45 million American nicotine consumers, there is still more work for the FDA to do to clearly illustrate the potential benefits of nicotine pouches and other smoke-free products to consumers and medical experts alike. However, that will require clearing up a long history of misinformation.
According to the FDA, it is not nicotine but a toxic mix of chemicals contained in tobacco and tobacco smoke that drives the serious health threats facing tobacco users. Despite the science proving that smoke-free products represent a better option compared to smoking, various groups, such as the American Lung Association (ALA), continue to spread misinformation about the potential benefits of Zyn nicotine pouches for smokers and other tobacco users, directly contradicting the FDA and scientific evidence.
Even America’s medical community seems flummoxed by what should be a clear distinction between nicotine consumption and the serious side effects tied to cigarette smoking. According to one study, 60 percent of nurses mistakenly believe that nicotine causes cancer. Another one found that more than 80 percent of physicians “strongly agreed” that nicotine “directly contributes to the development of cardiovascular disease (83.2 percent), chronic obstructive pulmonary disease (COPD) (80.9 percent), and cancer (80.5 percent).”
Of course, none of this is true, underscoring the dire need for the FDA and CTP to prioritize educating the public and medical community with accurate information about the vital role smoke-free products could play in helping Americans who smoke to reduce their exposure to harm.
CTP Director Brian King, Ph.D., M.P.H., recently acknowledged as much, saying that “misperceptions among physicians and other healthcare professionals” may result in advising patients in a manner that is “not consistent with existing scientific evidence.” Moreover, he continued, these “misperceptions are associated with lower odds of completely transitioning from cigarettes” to a noncombustible product.
While misinformation abounds, there is still some hope. Even passionate anti-smoking groups, such as the Truth Initiative, have—to some degree—begun to acknowledge the benefits of nicotine pouches, noting that the FDA’s authorization of ZYN nicotine pouch products “addresses an ongoing need to provide adults who smoke with access to less harmful alternatives to combustible cigarettes.”
The FDA and CTP may be well aware of the misperceptions behind smoke-free products. Still, neither has taken meaningful action to counter the spread of misinformation with proper, accurate education for healthcare providers and adults who smoke. That must change, and it must change soon.
The FDA has a responsibility to not only help provide adults who smoke with more smoke-free options, but also to ensure the medical community and public at large understand the benefits and risk these products provide—both in terms of personal and public health. Recent events have made me hopeful that, together, we can build a healthier country, but the FDA and CTP must lead the way there.
Tom Price, M.D., was the 23rd Secretary of the U.S. Department of Health and Human Services and is a former member of Congress (GA06), and an advisor to PMI U.S. Corporate Services Inc.
Dr. Bina Modi, chairwoman of Modi Enterprises-KK Modi Group and chair and managing director of Godfrey Phillips India Ltd. and Indofil Industries Ltd., is a trailblazing international business executive and the first woman to lead a tobacco company in India. Dr. Modi was named to the World Economic Forum’s (WEF) Women of the Decade in Business and Leadership in 2018, and the WEF awarded her the prestigious Achiever’s Award in 2019. Named by famed business author Prem Ahluwalia as one of India’s Most Powerful Women, Dr. Modi has been further awarded and recognized as a continental business leader by numerous organizations, including the Indo-American Chambers, AsiaOne—which showcased Dr. Modi as on of Asia’s Greatest Leaders—and the Women’s Economic Forum.
Dr. Modi agreed to sit down with Tobacco Reporter; the following conversation is lightly edited for clarity and fit.
Let’s begin with the current landscape of the global cigarette industry. What lies ahead for combustibles in an age of transformation? Could you start by providing us with an overview of the current global tobacco market and the position of traditional cigarettes within it?
The global tobacco market remains a substantial economic sector, demonstrating consistent growth. Despite the narrative around declining cigarette consumption, the global cigarette market remains robust at around usd1.1 trillion in 2024 and is projected to reach usd1.38 trillion by 2033, exhibiting a steady growth rate of 1.9% over the next decade. This trajectory clearly indicates that combustible cigarettes continue to be the backbone of the tobacco industry, with substantial consumer loyalty and market penetration that newer products have yet to achieve. The tobacco products market encompasses various categories, including cigarettes, cigars, and other smoking and smokeless products, with combustible tobacco being a fundamental product type. Geographically, Asia-Pacific emerged as the largest region in the tobacco products market in 2024, followed by North America. Notably, countries like China and India stand out as some of the largest consumers of cigarettes on a global scale. This regional concentration highlights the importance of understanding diverse consumption patterns across the world. In essence, traditional cigarettes continue to represent a substantial portion of a large and expanding global tobacco market, with Asia-Pacific playing a particularly dominant role in consumption.
That’s interesting. How do you see the impact of heated-tobacco products and vape on traditional combustibles? Many industry observers suggest these alternatives might eventually replace cigarettes.
In India, the Prohibition of Electronic Cigarettes Act, 2019 was passed by the Indian Parliament and came into effect in September 2019. It bans the production, manufacture, import, export, transport, sale, distribution, storage, and advertisement of e-cigarettes. It covers, e-cigarettes (also called vapes, vaping devices, or ENDS (electronic nicotine-delivery systems)) and heat-not-burn products (devices that heat tobacco without burning it).
While data from Europe and North America shows that innovative alternatives are growing up to 20% to 25% faster in market uptake, our focus has been on reinventing the cigarette experience. By refining blend quality, diversifying flavor profiles, and optimizing packaging design, we have ensured that our traditional brands maintain a consumer preference share well above 70% in many regions. This balanced approach—leveraging established distribution channels alongside controlled innovation—cements the future of combustibles even as the market transforms.
Regional differences seem to play a significant role in tobacco consumption patterns. Could you elaborate on how these regional variations might affect the future of combustibles?
Absolutely. Asia-Pacific, excluding Australia, continues to be the powerhouse of the global commercial cigarette market. Countries like China, India, Indonesia, and Japan remain among the largest consumers of cigarettes globally. Cultural factors, social acceptance, and longstanding traditions associated with smoking in these regions create a stable consumer base. In North America, while there’s greater adoption of alternatives, the cigarette market remains substantial. Different regions are at different stages of the tobacco consumption evolution, which actually ensures the longevity of combustibles on a global scale. For instance, in emerging markets across Asia and Africa, we’re seeing continued growth in traditional cigarette consumption as disposable incomes rise.
With growing health consciousness among consumers worldwide, how are cigarette companies innovating to maintain their market positions?
Innovation is indeed key to our continued success. Low delivery products currently hold the largest market share globally, indicating consumer preference for products perceived to be less harmful. At Godfrey Phillips, we’ve invested significantly in product refinement—optimizing tobacco blends, enhancing filtration technology, and improving the overall smoking experience while adhering to regulatory requirements.
We’re also seeing innovation in packaging, marketing strategies adapted to local regulations, and diversification of distribution channels. While tobacco shops remain dominant globally, accounting for approximately 38% of sales, we’re witnessing rapid growth in online retail channels in regions where it’s permitted. This omnichannel approach helps maintain consumer engagement with combustible products.
What would you say to industry stakeholders who are concerned about shifting investments away from combustibles toward alternative products?
In this context, our own view at Godfrey Phillips India is that combustibles will continue to be a core business. We certainly recognize the rise of new products. Philip Morris and other multinationals have invested heavily in HnB (heat-not-burn) and vaping—for example, PMI launched IQOS in Japan and Europe, but these products are not yet available in India due to regulations. For now, we see them as complementary categories for future consideration, not immediate threats. We are partnering with PMI to distribute Marlboro in India, and if the regulatory landscape ever changes, we would be open to responsibly participating in reduced-risk products. Meanwhile, our immediate focus is on enhancing the appeal of our cigarette portfolio through innovation and quality. For example, our flagship Four Square brand has introduced new variants (like the clove-infused Four Square Crush), and Stellar, our slim cigarette line, continues to gain consumers as India’s first modern slim cigarette. These innovations keep us competitive even as the market evolves.
Globally, we’re seeing more women breaking glass ceilings across industries. Before we discuss the tobacco industry specifically, what are your observations about women in leadership globally?
Women’s leadership has evolved significantly across sectors. Today, approximately 24% of C-suite positions globally are held by women, up from just 17% a decade ago. Women-led companies have demonstrated superior financial performance, with studies showing 25% higher profitability in companies with gender-diverse leadership. In industries ranging from technology to finance, healthcare to consumer goods, women are not just participating but leading transformative changes. Leaders like Emma Walmsley at GSK, Jane Fraser at Citigroup, and Mary Barra at General Motors are redefining leadership paradigms in traditionally male-dominated industries.
What’s particularly encouraging is that beyond individual success stories, we’re seeing systemic changes in how organizations approach diversity, with more structured pathways for women to advance to leadership positions.
That’s a great overview. Now, focusing specifically on the tobacco industry, which has traditionally been male dominated, what progress do you see for women leaders?
The tobacco industry has indeed been traditionally male dominated, but we’re witnessing meaningful change. Currently, women represent approximately 15% of executive leadership positions in major global tobacco companies, up from less than 5% two decades ago. Several remarkable women have paved the way. Susan Cameron’s leadership as CEO of Reynolds American transformed that company before its acquisition by BAT. Alison Cooper served as CEO of Imperial Brands for nine years, steering the company through significant market challenges. In Japan, Eddy Pirard has increased female executive representation at JTI substantially.
At Philip Morris International, Jacek Olczak has committed to achieving at least 40% female representation in management by 2025. These are not just token appointments—women are increasingly driving critical business decisions, innovation initiatives, and organizational transformations across the industry.
As one of the few women leading a major cigarette company, could you share your personal journey? What challenges did you face in rising to your current position?
My journey hasn’t been without its challenges. I began my entrepreneurial career by founding Bina Fashions, which expanded globally, followed by establishing the Ego Specialty Restaurant Chain, Dessange Salon, and Beacon Travels. These diverse entrepreneurial experiences gave me a unique perspective on building and scaling businesses across sectors. When I assumed the role of CMD (chairperson and managing director) of Godfrey Phillips in November 2019, I faced the triple challenge of being a woman in a male-dominated industry, managing a complex transition of leadership, and, soon after, navigating a global pandemic.
Throughout my career, I’ve encountered skepticism about my understanding of the tobacco business, faced unconscious bias in industry forums, and had to work twice as hard to establish credibility. However, these challenges strengthened my resolve and sharpened my business acumen.
I’ve always believed that competence speaks louder than gender. My approach has been to lead with knowledge, decisiveness, and a collaborative style that brings out the best in our teams. Being a woman leader in this industry has actually been an advantage in many ways—it’s allowed me to bring fresh perspectives and inclusive leadership practices that have contributed to our company’s success.
Under your leadership, Godfrey Phillips has shown remarkable performance. Could you share some specific achievements and how they reflect your leadership approach?
I’m proud to share that since I took over as chairperson and managing director in late 2019, we’ve achieved consistent growth despite unprecedented global challenges. In fiscal year 2024, Godfrey Phillips recorded a gross revenue of over inr53 billion (usd620.4 million), marking a significant increase compared to the previous fiscal year.
This growth hasn’t come by chance but through strategic initiatives. We’ve optimized our product portfolio, particularly strengthening our position in the premium segment with brands like Marlboro, which we manufacture and distribute in India. We’ve improved operational efficiencies across our manufacturing facilities, resulting in a 13% increase in production output in FY24 over FY20, while maintaining stringent quality standards.
Our market share in India has grown by approximately 4.4 percentage points over the last four years, outpacing industry growth. We’ve also expanded our international footprint, with exports increasing by 125% over the past four years.
Beyond financial metrics, I’m equally proud of our organizational transformation. We’ve worked on increasing our female representation across all levels of the organization, implemented comprehensive sustainability initiatives that have resulted in increased use of renewable energy by over 30% year-over-year in FY24, and significantly enhanced our CSR programs, which now impact over 250,000 lives annually.
Your achievements are indeed impressive. Looking at the broader industry, what advice would you give to young women aspiring to leadership in the tobacco sector?
My advice would be multifaceted. First, develop deep industry knowledge—understand not just your specific role but the entire value chain from agriculture to consumer insights. The tobacco industry is complex, highly regulated, and constantly evolving—technical expertise is non-negotiable.
Second, build resilience. This industry faces unique challenges and public scrutiny. The ability to maintain focus, make difficult decisions, and lead with conviction during challenging times is essential.
Third, embrace innovation. The industry is transforming, and those who can lead change rather than merely respond to it will define its future. At Godfrey Phillips, we’ve created innovation incubators that have yielded several breakthrough initiatives, including our digital trade engagement platform that connects with over 650,000 retailers.
Fourth, cultivate authentic leadership. Your unique perspective as a woman is valuable—don’t try to lead like someone else. I’ve found that authentic leadership builds stronger teams and more sustainable results.
Finally, find allies and mentors, both women and men, who support your growth. I’ve been fortunate to have mentors who believed in my capabilities, including my late husband, Mr. K.K. Modi, whose vision for Modi Enterprises continues to inspire me.
The future is bright for women in this industry, and I’m committed to ensuring that Godfrey Phillips remains at the forefront of gender-inclusive leadership.
Thank you, Dr. Modi, for these profound insights. Your journey and leadership at Godfrey Phillips are truly inspiring, and your balanced perspective on both the future of combustibles and women’s leadership in the industry has been enlightening for all of us.
Thank you for this opportunity. I firmly believe that both our industry and the cause of women’s leadership have bright futures ahead. At Godfrey Phillips, we remain committed to excellence in our products, sustainability in our practices, and inclusivity in our leadership as we navigate the transformations ahead.
The recent leadership changes and staffing reductions at the FDA’s Center for Tobacco Products (CTP) have created a moment of uncertainty, but also opportunity, for the tobacco and nicotine industry. With shifting priorities and new leadership on the horizon, some manufacturers see a chance to reset the regulatory conversation. While some companies are using this moment to tighten up operations and reinforce compliance in order to have a better chance at a favorable premarket tobacco product application (PMTA) outcome, others are taking a gamble, scaling back on quality systems and asking themselves, “Do we really have to keep doing all of this?”
The question often centers around the expectations outlined in 21 CFR Part 1114 and the commitments companies made in their PMTAs. In a push to save costs, some manufacturers are reportedly reducing quality oversight, cutting corners in documentation, and stepping away from key controls they originally described in their PMTAs. The rationale? If enforcement is slowing down, maybe the FDA won’t notice or maybe it won’t matter.
That’s a risky assumption.
A PMTA is more than a regulatory formality. It’s a company’s game plan. A commitment to how the product will be manufactured, tested, controlled, and distributed. If your application included a robust quality management system (QMS), specific product testing protocols, or detailed supplier qualification processes, you’re expected to follow through. Along with the science, those commitments were the basis on which the FDA evaluated whether your product was “appropriate for the protection of public health.”
Under Section 910 of the Federal Food, Drug, and Cosmetic Act (FDCA), the FDA has the authority to withdraw or suspend a marketing granted order (MGO) if it determines that a tobacco product is no longer “appropriate for the protection of public health,” the standard upon which PMTAs are evaluated and approved. If an inspection or oversight activity reveals that a company has significantly deviated from the manufacturing methods, testing protocols, or quality systems described in its PMTA, the FDA may conclude that the product no longer meets the criteria for market authorization. While there hasn’t yet been a public case of an MGO being rescinded solely for failure to follow internal PMTA commitments, the legal basis for such action is clear. An MGO is conditional—it depends on a company continuing to manufacture its product as promised. Deviating from that blueprint introduces real regulatory risk.
While some in the industry viewed the Fifth Circuit’s ruling in Bidi Vapor v. FDA as a signal that the tide was turning in manufacturers’ favor, the outcome in FDA v. Wages and White Lion Investments LLC made it clear: Companies are still expected to meet regulatory requirements and support their products with quality data and compliance. The courts may question FDA procedures, but they won’t eliminate the work required to maintain market authorization.
Even in a more industry-friendly political environment, the responsibility to protect public health isn’t going away. The current administration may support regulatory efficiency and streamlined processes, but not at the expense of consumer safety. Companies that ignore or scale back their quality systems risk finding themselves unprepared when FDA inspections or compliance reviews resume in full force.
Now is the time for manufacturers to take stock of their internal systems and ensure alignment with their PMTAs. This includes verifying that quality controls, personnel training, document management, complaint handling, and supplier oversight are functioning as described. A comprehensive, well-maintained QMS doesn’t just satisfy regulatory requirements; it builds trust and stability, especially in a time of change.
This transition at CTP represents a golden opportunity, but only if companies take the right approach. Cutting corners today to save money may end up costing you far more if it puts your MGO at risk. Regulatory clarity, product stability, and long-term market access depend on more than a favorable headline—they depend on daily operational integrity.
The FDA may be shifting, but its core mandate remains. This is the moment for responsible manufacturers to lead by example, double down on quality, and show that this industry can thrive without sacrificing quality or consumer trust. For those willing to roll the dice, just remember, being the first company to lose an MGO over PMTA noncompliance isn’t the kind of milestone you want your brand remembered for.
Gabriel Muñiz, an independent consultant with EAS Consulting Group, is a regulatory compliance expert with extensive experience in the tobacco industry. Muñiz’s tenure at the FDA, particularly as a director within the Office of Regulatory Affairs (ORA), involved leading compliance and enforcement activities for the agency’s tobacco program. His work in building the tobacco operations program and shaping tobacco regulatory policy was instrumental in the development of key compliance strategies and regulatory frameworks, including the proposed tobacco product manufacturing practices. After his FDA career, Muñiz further honed his skills at Juul Labs, where he played a key role in developing premarket tobacco product applications and ensuring alignment with evolving federal regulations. His deep expertise in tobacco regulation will be invaluable to EAS’ clients seeking strategic compliance advice and navigating tobacco-related regulatory challenges.
About EAS Consulting Group
EAS Consulting Group, a member of the Certified family of companies, is a global leader in regulatory solutions for industries regulated by the FDA, USDA, and other federal and state agencies. As part of Certified Group, EAS Consulting Group delivers expert regulatory solutions our customers can feel confident in—so the world can trust in what it consumes. Our network of over 200 independent consultants enables EAS to provide comprehensive consulting, training, and auditing services, ensuring proactive regulatory compliance for food, dietary supplements, pharmaceuticals, medical devices, cosmetics, tobacco, hemp, and CBD.
