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Smoke-free surge stalled by feds clinging to old habits



The U.S. nicotine market is undergoing a historic shift — one that should be celebrated as a major public health breakthrough. A new Goldman Sachs report forecasts that smoke-free nicotine products will surpass cigarettes in consumption by 2025 and come close to matching them in revenue and profit by 2035.

This shift isn’t the result of government policy. It’s happening because consumers are making better choices. Yet federal regulators appear determined to stand in the way.

Nicotine may be addictive, but it isn’t what causes cancer, heart disease, or emphysema. The culprit is combustion.

The data couldn’t be clearer. Millions of smokers are abandoning cigarettes for reduced-risk products like vaping devices, nicotine pouches, and heated tobacco. Cigarette sales are plummeting — from 12.9 billion packs in 2016 to a projected 2.7 billion by 2035.

This trend should give public health agencies a reason to cheer. Instead, the Food and Drug Administration is dragging its feet, imposing policies that make it harder — not easier — for adult smokers to switch to safer alternatives. The FDA’s obstruction risks slowing one of the most promising developments in decades for reducing smoking-related deaths.

Free market for the win

Despite the flood of misinformation, the market is succeeding where decades of public health campaigns have failed: It’s making cigarettes obsolete. Given the choice, consumers are ditching smoke for safer alternatives that deliver nicotine without combustion’s deadly byproducts. This isn’t just progress — it’s a landmark victory for harm reduction.

The free market deserves credit for this shift. While government anti-smoking efforts have leaned heavily on punitive tactics — higher taxes, grotesque warning labels, and outright bans — real declines in smoking have come where reduced-risk nicotine products are legal and accessible. In the United States, this transformation is unfolding not because of regulators, but in spite of them.

At the heart of the problem lies the FDA’s Pre-Market Tobacco Application process. Supposedly designed to vet new nicotine products, the PMTA system has become a bureaucratic bottleneck. It’s opaque, glacial, and unreasonably strict. The result? A legal market riddled with uncertainty — and an illegal one thriving in its place.

Today, more than 60% of e-vapor sales come from illicit, unregulated products. That’s not because consumers prefer them. It’s because the FDA has made it nearly impossible for legitimate companies to get reduced-risk products approved and onto shelves. The agency has created a regulatory vacuum — and the black market has filled it.

Federal foot-dragging

The dysfunction doesn’t stop with vaping. Heated tobacco products and nicotine pouches — both widely recognized abroad as effective harm reduction tools — face the same bureaucratic purgatory. Meanwhile, traditional cigarettes remain widely available and profitable. If public health were truly the FDA’s goal, it would fast-track reduced-risk alternatives, not prop up the very products causing the most harm.

But the FDA’s foot-dragging has real consequences. More Americans will stay hooked on cigarettes longer than they otherwise would. The data is in: Alternative nicotine products help people quit smoking. Blocking legal access to them doesn’t protect public health — it prolongs addiction and guarantees more smoking-related deaths. By stalling the shift to safer products, the FDA is effectively locking millions into a habit that kills roughly half its users.

Regulatory inertia also risks stifling competition in the industry. Cigarettes still generate 66% of industry revenue and 70% of profits. The companies leading the charge toward a smoke-free future — those that don’t sell cigarettes — face the stiffest regulatory headwinds. In effect, the government is shielding the cigarette market rather than accelerating its collapse.

A better way exists. Federal regulators could champion this shift instead of obstructing it. The FDA should fast-track approvals for products with significantly lower health risks than cigarettes. Doing so would give consumers legal access to safer options while shrinking the black market.

The public also deserves the truth. Nicotine may be addictive, but it isn’t what causes cancer, heart disease, or emphysema. The culprit is combustion. And the longer that confusion persists, the more smokers the FDA leaves behind.

Outcomes or optics?

Federal regulators should stop protecting the tobacco industry and start supporting companies that are moving the U.S. away from combustible cigarettes. That means giving independent vape makers and harm-reduction innovators a fighting chance, instead of letting Big Tobacco tighten its grip through regulatory capture.

Regulation should make cigarettes less appealing — not safer alternatives harder to get. Risk-proportionate rules would prioritize public health by nudging smokers toward lower-risk products, not driving them into the black market or back to Marlboro.

Goldman Sachs’ latest data shows the market is doing what public health campaigns never could: making smoking obsolete. If regulators got out of the way — or better yet, helped — the fall of Big Tobacco could come even faster.

Cigarettes are dying. The FDA can either help bury them or keep dragging out their final act. The question is whether public health officials care more about optics or outcomes. The market has already chosen. It’s time for the government to catch up.

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Supreme Court must end the FDA’s vaping power-grab



For the tens of millions of Americans eager to quit smoking cigarettes, the Supreme Court may represent their best hope. On December 2, the court heard oral arguments in the landmark case Wages and White Lion (Triton) v. FDA. The justices considered whether the Food and Drug Administration overstepped its authority by banning the sale of certain e-cigarette products.

The stakes are monumental. As the Taxpayers Protection Alliance argued in an amicus brief supporting the respondents, rejecting agency overreach, vague legislation, and unchecked bureaucracy could save millions of lives.

Expanding the market could provide smokers with more effective alternatives to deadly tobacco products.

The foundation of the American experiment is often taken for granted. Without basic safeguards like the separation of powers, unchecked authority could concentrate in the hands of a few, free from accountability. This is why Congress — not regulatory agencies — must fulfill its legislative responsibilities.

Unfortunately, Congress passed the buck on vaping policy. Lawmakers essentially tasked FDA bureaucrats with making critical decisions, offering only vague direction. The Tobacco Control Act of 2009 requires the FDA to assess e-cigarette products based on whether marketing them is “appropriate for the protection of public health.”

The phrase “public health” is often used in political ads, op-eds, and classrooms, but it is an extremely flimsy legal standard for product approvals. The term encompasses an almost infinite range of variables, making it nearly impossible to weigh them all accurately. For instance, e-cigarettes are clearly safer than traditional cigarettes and effective at helping adult smokers quit. However, regulators must decide how to balance this reality against the potential risks of youth access. Congress provided no clear guidance to the FDA on this issue, leaving regulators to operate in a state of uncertainty.

This “judge, jury, and executioner” approach was evident when the FDA denied Triton’s marketing applications for vaping products. In its decision, the agency prioritized the “risk of youth uptake” without adequately considering the health benefits of increasing the availability of vaping products. A broader market with more competitors is less likely to face supply shortages than a narrow, bottlenecked market. By ignoring these factors, the FDA risks stifling innovation and reducing access to safer alternatives for adult smokers.

Unfortunately, the current regulatory environment has stifled the development of a broad and vibrant e-cigarette market. The FDA has granted marketing authorizations to only three companies, covering a total of eight “families” of e-cigarettes and compatible refill cartridges. Expanding the market could provide smokers with more effective alternatives to deadly tobacco products. However, the FDA has failed to consider how a larger, more diverse market could bolster “public health.”

Open-system products, like those offered by Triton, present additional advantages the FDA has ignored. University of California toxicologist Gideon St. Helen notes the significant differences between closed-system e-cigarettes, which allow minimal user modification, and open systems. Open systems enable users to adjust settings like power and temperature, modify components, and use refillable tanks with customizable e-liquids. Former smokers often prefer open-system products, while youth vapers generally favor closed systems.

According to the CDC’s National Youth Tobacco Survey, only 5.9% of U.S. middle and high school students who reported using e-cigarettes in 2023 used a tank or mod (open-system) device. By contrast, 60.7% reported using disposable, closed-system products. These findings underscore the untapped potential of open systems to help adult smokers quit while posing a lower risk of youth appeal.

The FDA had the opportunity to address these critical considerations but instead clung to its narrow interpretation of “public health.” This poses a significant problem for those who value accountability and the rule of law. When unelected bureaucrats define vague terms like “public health” however they choose, they — not lawmakers or the public — control the outcomes. Life-or-death decisions about quitting smoking are now in the hands of an agency notorious for its risk-averse approach.

The Supreme Court has the power to stop this overreach and end the FDA’s unconstitutional power-grab. The justices must act to protect the millions of Americans fighting to save their lives.

RFK Jr.’s confirmation would be a blow to Big Pharma and a big win for health



The Washington, D.C., Beltway publications left no doubt about who stood to lose the most after President Trump nominated Robert F. Kennedy Jr. as secretary of health and human services.

Politico highlighted the uproar, reporting fierce opposition from Washington lobbyists to Trump’s decision to place Kennedy at the helm of the $3 trillion health agency. Kennedy’s proposals — tighter pesticide regulations, re-examining vaccine safety, banning processed foods in schools, and overhauling health and food agencies — pose significant threats to corporate profits. Caught off guard, lobbyists are now scrambling to block Kennedy’s Senate confirmation and leveraging connections to minimize risks.

RFK Jr. has consistently unveiled critical truths and fought for transparency in public health.

As a physician committed to my patients, my community, and my country, I fully support Kennedy’s nomination. His lifelong dedication to health, safety, and medical autonomy makes him the ideal candidate for this vital Cabinet position. President Trump deserves praise for this bold and courageous choice.

The United States faces an epidemic of poor health. Over 80% of adults suffer from at least one chronic illness, while obesity rates among children and adults have reached record highs. Simultaneously, drug prices and health care costs continue to soar. Substance abuse plagues society, and mental illness rates rise every year. The role of secretary of health and human services requires a leader with diverse expertise, a broad perspective, and a deep understanding of both health care and the forces shaping the system.

For decades, Kennedy has worked tirelessly for the health and welfare of America’s children. Despite relentless accusations of spreading “disinformation” and “conspiracy theories,” Kennedy is not “anti-vaccine.” Instead, he has championed transparency in vaccine efficacy and injury data, which threatens powerful profit-driven interests. Even the treatments he promoted for COVID-19, such as ivermectin and hydroxychloroquine — once dismissed as “discredited” — have quietly and surreptitiously returned to good standing.

RFK Jr. has consistently unveiled critical truths and fought for transparency in public health. He revealed that no double-blind randomized controlled trials exist for childhood vaccines on the CDC's schedule, a fact that demands scrutiny. Kennedy has also investigated disparities in disease prevalence, finding higher rates of autoimmune diseases, neurological disorders, allergies, and autism in vaccinated populations compared to unvaccinated ones, raising questions that require answers, not dismissal.

Kennedy has vowed to end the financial ties between pharmaceutical companies and medical journals, which have eroded research integrity and left physicians without trustworthy sources of unbiased data. He advocates removing harmful additives, such as trans fats, artificial coloring, and preservatives, from America’s food supply — ingredients banned in many other countries.

Kennedy is also committed to ending pharmaceutical advertising on television, a practice unique to the United States and New Zealand, which compromises media independence. His approach prioritizes the four pillars of medical ethics — autonomy, non-maleficence, beneficence, and justice — seeking to restore medical autonomy, personal sovereignty, and an end to mandates that strip individuals of choice.

I understand that Kennedy’s nomination to oversee the massive federal health apparatus is threatening to many, including those associated with the pharmaceutical industry, doctors and the health care systems that employ them, lobbyists, insurance companies, media outlets that have become accustomed to massive pharmaceutical advertising dollars, and the food industry that maximizes profits by using inexpensive but toxic ingredients. But we need qualified leadership at HHS that prioritizes science, the protection of public health, and the well-being of all Americans. The health and future of our country depend on it.

Change, especially radical change, can be difficult — especially for those who have financially and professionally benefited from the status quo. However, our health care system is desperately in need of radical change, which is why I urge the Senate to confirm Kennedy’s appointment quickly so that he can begin the much-needed work to mend our health care system and to make America healthy again.

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