On May 5, 2016, the vaping community was rocked by the introduction of stringent FDA e-cig regulations, a move that had been stealthily influenced by pharmaceutical giants for decades. Recognizing the potential of electronic vaping devices for both medication delivery and smoking cessation as early as the 1990s, companies like GlaxoSmithKline and Johnson & Johnson began to anticipate their impact on their nicotine replacement therapies, like gums and patches.
As vaping devices gained popularity as a quit-smoking aid, Big Pharma faced a threat to their lucrative cessation products. This market tension was palpable when Williamson Tobacco Corporation challenged the FDA’s regulatory authority over tobacco products in 1998, an action closely monitored by pharmaceutical companies.
FDA versus Brown & Williamson: A Turning Point
The pivotal legal battle reached the U.S. Supreme Court, where the FDA contended that nicotine was a drug, thus bringing cigarettes and nicotine delivery systems within their regulatory scope. The Court’s decision favored Brown and Williamson, setting the stage for the Tobacco Control Act of 2009. This act granted the FDA the power they sought, leading to the establishment of the Center for Tobacco Products, with the legislation enjoying support from groups like the American Cancer Society, which had undisclosed financial ties to Big Pharma.
Mitch Zeller’s Appointment and the Tightening of Regulations
The Obama administration, tasked with nominating a head for the new FDA division, turned to Mitch Zeller—a former consultant for GlaxoSmithKline. Zeller’s appointment was strategic, aimed at crafting bulletproof regulations that could withstand judicial scrutiny and level the playing field for pharmaceutical nicotine cessation products against the rising tide of e-cigarettes.
The Pharmaceutical Crusade Against Vaping
The vaping industry finds itself at a crossroads, embroiled in a war not only with Big Tobacco but also with the pharmaceutical industry’s giants. Despite its rapid growth, the vaping sector lacks the historical political leverage of its adversaries. With the predicate date of the FDA regulations coinciding with the industry’s inception, vaping advocates face an uphill battle in the corridors of power, one that may require adopting the hardball tactics of their opponents.