FDA’s double standard: Approves deadly opioids while banning safer smoking alternatives

The Food and Drug Administration likes to present itself as the nation’s gatekeeper against dangerous products, but history tells a different story: one in which the agency’s decisions have helped fuel the deadliest drug crisis in American history while stifling far safer alternatives to cigarettes.

The FDA-approved opioid epidemic has killed hundreds of thousands of Americans since 2000. Yet the agency applies an entirely different standard to tobacco harm reduction by cracking down on products that could save lives while protecting the market share of the very companies it claims to restrain.

The dangers of smoking have been well-known since the 1964 Surgeon General’s report, and decades of policy, such as advertising bans and minimum-age laws, have aimed to drive down rates. In 2009, Congress gave the FDA sweeping authority over tobacco through the Family Smoking Prevention and Tobacco Control Act, forcing most new nicotine products into an onerous application process requiring them to prove they are “appropriate for the protection of public health.”

However, as the FDA moved aggressively against tobacco, another crisis of the agency’s own making quietly grew. In 1996, the FDA approved Purdue Pharma’s OxyContin, a high-dose, long-acting opioid. Purdue then launched a massive marketing campaign claiming minimal addiction risk. These claims were rooted in a five-sentence 1980 letter to the editor in the New England Journal of Medicine, not rigorous science. By 2001, the Drug Enforcement Administration was reporting sharp increases in overdoses and emergency visits from oxycodone, yet the FDA and Congress responded with little urgency.

Congressional hearings in 2001 and 2002 featured DEA officials, medical experts and local law enforcement sounding the alarm. Still, Purdue executives insisted the drug was safe “when used as directed” and denied early knowledge of the scale of abuse. Even when rural physicians such as Dr. Art Van Zee warned that the crisis would spread nationwide, some lawmakers dismissed it as “one of those Appalachian things.”

No sweeping reforms followed. The FDA required a black box warning but allowed Purdue’s aggressive marketing to continue. It sent its sole warning letter to Purdue in 2003, chastising the company for overstating OxyContin’s safety in a JAMA ad. It wasn’t until 2007, after the crisis had morphed into a national epidemic, that the Justice Department prosecuted Purdue for misbranding. The company and three executives pleaded guilty and paid $600 million in fines but kept the drug on the market.

The damage was irreversible. As prescriptions tightened, addiction pushed many users to heroin (wave two of the opioid crisis), then illicit fentanyl (wave three) and now a deadly polysubstance epidemic (wave four). In 2020, Purdue pleaded guilty again, this time to conspiracy to defraud the U.S. and to violate anti-kickback laws, resulting in more than $7 billion in corporate penalties and a $225 million Sackler family settlement. Still, no executive went to prison, and the FDA’s role in approving, labeling and overseeing these products has largely escaped public scrutiny.

Contrast that with tobacco harm reduction. Since 2018, Congress has held at least seven hearings on electronic cigarettes, often fixated on youth use, even when youth vaping rates were at record lows. In 2019, during the vaping-related lung injury outbreak caused by illicit THC cartridges, the Centers for Disease Control and Prevention and the FDA issued blanket warnings against all vaping, despite knowing legal nicotine vapes were not the cause. Meanwhile, more than 260 Americans die from drug overdoses daily without weekly CDC briefings or coordinated public health panic. All in all, only 68 deaths were attributed to illicit vape products during the crisis.

The FDA doesn’t approve tobacco products, yet since asserting authority over e-cigarettes in 2016, it has authorized only 39 products, the majority owned by Big Tobacco, while millions of products used by adult smokers have been effectively banned. In opioids, the FDA left the market flooded with addictive, lethal pills for decades. In 2014, it even approved Zohydro, a new high-dose, time-released opioid with no abuse-deterrent formulation. This despite its advisory panel recommending against the drug and 28 governors calling for the decision to be reversed. In tobacco harm reduction, the agency has strangled innovation and handed the field to the largest cigarette companies.

The lesson from the opioid crisis is clear: The FDA failed to protect the public when it mattered most, siding with industry over health. Today, that mistake is repeated in reverse. The agency protects the industry by blocking products that could help millions of smokers quit. Big Pharma executives gave America the opioid epidemic. Smokers and innovators created tobacco harm reduction. The FDA now seems determined to deliver that to Big Business too.

Originally published in the Washington Times. Nothing in this analysis is intended to influence the passage of legislation, and it does not necessarily represent the views of Tobacco Harm Reduction 101.