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.
Opinion & analysis, Vaping, Fda, Cigarettes, Big tobacco, Regulation, Free market, Public health