Science First: How the FDA Has the Blueprint to Safeguard Vaping 

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In a bureaucracy often criticized for its sluggish pace and overreach, Food and Drug Administration (FDA) Commissioner Marty Makary is proving what a science-first approach can achieve.

In under a year, Makary has already spearheaded more than 40 major reforms, accelerating drug approvals, updating outdated nutrition guidelines, driving down drug prices, reclaiming U.S. leadership in biotech from China, and integrating artificial intelligence (AI) to prioritize patient outcomes.

Under his leadership, the FDA is finally operating with speed and intelligence in the service of public health. Yet one critical area demands more of Makary’s bold vision: vaping and tobacco harm reduction.

The FDA has taken an encouraging first step in this direction. In September, the agency launched a pilot program to streamline requirements for nicotine pouch manufacturers. By easing unnecessary research burdens, this initiative speeds up approvals for products that deliver a net public health benefit, helping adult smokers transition away from combustible cigarettes.

It’s a pragmatic acknowledgment that excessive regulation only delays safer alternatives, benefiting no one. This move signals that the FDA recognizes harm reduction succeeds only when legitimate, vetted products can compete in the marketplace.

However, the legal vaping market remains effectively barricaded. Today, only 39 e-cigarette products have received FDA authorization—a mere 0.6 percent of the total U.S. vaping device market. This scarcity isn’t due to a lack of innovation or demand; it’s the result of a regulatory gauntlet that has stifled competition and innovation.

Into this vacuum have rushed illicit Chinese disposable vapes, which now dominate more than 85 percent of the market. These products are the direct consequence of the FDA’s limited approvals for lawful alternatives. Untested and unregulated, they are manufactured in facilities beyond FDA oversight, often exceeding legal nicotine limits, and flavored with youth-appealing candy-like profiles. Worse, many have been linked to toxic contaminants such as lead, nickel, and antimony.

By failing to apply the same evidence-based pragmatism to vaping as it has to nicotine pouches, the FDA risks sabotaging its own harm reduction objectives.

Denying approval to legitimate products is a direct detriment to public health. Adult smokers, desperate for lower-risk options, are funneled toward a shadowy black market devoid of safety standards or accountability. Enforcement actions alone—raids on stores or seizures at ports—cannot resolve a crisis that the FDA’s own policies have created. Without accessible, regulated alternatives, smokers are left with fewer paths to quit, and the illicit trade thrives.

Makary already holds the blueprint for change. In sectors such as pharmaceuticals, biotechnology, food safety, and AI, he has slashed redundant red tape while ensuring that safe, science-backed products reach Americans swiftly. Vaping deserves the same treatment. By accelerating approvals for legal, FDA-authorized e-cigarettes, the agency can displace these dangerous Chinese imports, empower adults with reliable quitting tools, and transform a public health hazard into progress.

Marty Makary has demonstrated that the FDA can be modern, responsive, and driven by evidence rather than inertia. Extending that philosophy to vaping is not just logical—it’s essential for safeguarding American lives.