The Pitiful State of THR in the U.S. : Shouldn’t the Nation Be Getting It Right This Time Round?

The U.S. Food and Drug Administration (FDA), has long been heralded as America’s guardian of public health. However, as Lindsey Stroud recently wrote on the Washington Times, the agency has a track record marred by inconsistency. On one hand, it enabled the opioid epidemic; on the other, it now erects nearly insurmountable hurdles for tobacco harm reduction products—despite their life-saving potential.

Consider the opioid crisis, which has claimed hundreds of thousands of lives. It began in earnest in the mid-1990s when the FDA approved OxyContin with little evidence of long-term safety or low addiction risk. Purdue Pharma aggressively marketed the drug as safe for chronic pain, even though early warnings were ignored. Despite mounting deaths, the FDA delayed any meaningful response. By the time Purdue pleaded guilty to misbranding in 2007, the crisis had already cascaded downstream—heroin, fentanyl, polysubstance abuse. Billions flowed in fines, yet the FDA’s role in permitting the disaster went unquestioned.

The FDA’s reluctance to embrace harm reduction

Fast forward to the present day, and the agency ironically behaves with near-total caution toward safer nicotine alternatives. Since gaining authority over e-cigarettes in 2016, the FDA has approved only a handful of products—almost exclusively from major tobacco firms—and has blocked or pulled countless others used by adult smokers. Meanwhile, the agency continues to laser-focus on youth vaping—even during periods of historically low prevalence—and issued broad warnings during the 2019 vaping-related lung injury outbreak driven by illicit THC products, not legal nicotine vapes.

This disparity is staggering: regulators once gave millions of Americans lethal opioids with minimal scrutiny and are now erecting regulatory walls around products that could help people escape smoking dependence. Rather than learning from past missteps and embracing harm reduction, the FDA risks repeating them in reverse—denying smokers safer alternatives and entrenching the cigarette industry’s power.

The stakes go beyond abstract policy. Harm reduction practitioners themselves are not only generally not taken seriously, but in some cases also persecuted. In Tennessee, harm reduction researcher Dr. Paige Lemen was arrested in June while transporting a 0.7-gram drug sample for testing—standard practice in her work with 901 Harm Reduction. Authorities charged her with intent to distribute, despite the sample’s scientific purpose and her medical necessity. Her arrest shook the community: outreach operations have faltered, trust eroded, and clients now fear seeking help. The case underscores the fragile legal footing of harm reduction—even when public health is at stake.

Why America can’t afford another regulatory failure

Yet the evidence supporting safer alternatives keeps mounting. Instead of pursuing symbolic bans, policymakers could lean into evidence-backed strategies showing real-world results. Randomized controlled trials from Italy’s CEASEFIRE study—which tracked smokers not planning to quit—found that after 12 weeks, 39.1% of participants using heated tobacco products and 30.8% using e-cigarettes achieved successful quit rates. Meta-analyses of clinical trials reveal that smokers using nicotine-containing e-cigarettes had about a 1.7-fold higher chance of quitting than those using nicotine-free alternatives or nicotine replacement therapy.

A broad systematic review of 44 studies—including RCTs and cohort trials—involving electronic cigarettes, snus, and NRT confirmed that these products can meaningfully reduce cigarette consumption and support cessation, with fewer adverse events than traditional smoking. Taken together, the evidence suggests a smarter path forward: support proven alternatives, protect access to safer options, and focus on achieving real reductions in smoking—not just making symbolic policy gestures.

Meanwhile, a recent longitudinal NIH analysis of the PATH Study found that smokers with substance use disorders who quit smoking, had 42% greater odds of achieving sustained remission from their other addictions. These findings have enormous implications. Tobacco is not just another addiction—it compounds other substance dependencies. Helping someone quit smoking isn’t an optional add-on to addiction treatment—it may be crucial to their overall recovery.

Taken together, this paints a troubling pattern: the FDA once let a devastating addiction flood the nation, delayed needed reform, and excused industry overreach. Now, with harm-reduction tools in hand—vaping, nicotine pouches, vapes—it acts with inverse rigidity. Smokers seeking a safer path find their options limited; innovators find their products boxed out; public health suffers.

Unlearning the wrong lessons