The Machinery of Modern Regulation
In 2016, the Food and Drug Administration gained authority to regulate electronic cigarettes. By 2022, the agency had authorized exactly 23 vaping products out of more than 6.5 million applications submitted. This isn’t bureaucratic incompetence. It’s what happens when Congress writes deliberately vague laws and expects agencies to fill in thousands of pages of technical details.
The FDA’s vaping saga shows a basic tension in American governance. Legislators write broad laws because they don’t have the technical know-how to craft detailed rules about complex industries. They hand that work off to agencies staffed with scientists, economists, and subject matter experts. But this creates its own mess: unelected officials making decisions that affect millions of lives and billions in commerce.
Understanding how regulatory agencies actually put congressional mandates into practice means looking at three phases: rulemaking, enforcement, and judicial review. Each phase has different players, different incentives, and different constraints that shape what actually happens.
The Rulemaking Gauntlet
When Congress passed the Family Smoking Prevention and Tobacco Control Act in 2009, it gave the FDA authority over “tobacco products” without defining what that meant for emerging technologies. The agency spent seven years figuring out whether e-cigarettes qualified, then issued a “deeming rule” bringing them under FDA jurisdiction. That rule alone required 499 pages and addressed 135,000 public comments.
The Administrative Procedure Act requires agencies to publish proposed rules, accept public feedback, and respond to “significant” comments before finalizing regulations. This process typically takes 18 months for simple rules. Complex regulations can drag on for years. The FDA’s premarket tobacco application standards took nearly four years to develop because the agency had to balance public health goals against First Amendment commercial speech protections and Fifth Amendment due process requirements.
Industry groups submitted detailed technical studies arguing that certain flavor restrictions would violate trade secret protections. Public health advocates provided data on youth vaping rates. The agency’s final rule reflected compromises between these competing demands, resulting in regulations that satisfied neither side completely but survived legal challenge.
Enforcement Reality Versus Regulatory Intent
Rules on paper don’t automatically become rules in practice. The FDA’s Center for Tobacco Products employs roughly 650 people to oversee an industry with annual revenues exceeding $15 billion. Enforcement requires picking priorities, and those choices reveal agency values that may differ from what Congress intended.
Look at the agency’s approach to unauthorized vaping products. Rather than pursuing criminal prosecutions, the FDA has relied mostly on warning letters and import alerts. Between 2020 and 2023, the agency sent warning letters to 800 companies but referred only 12 cases for criminal prosecution. This pattern reflects resource limits, prosecutorial discretion, and agency judgment about what violations actually pose public health risks.
The enforcement gap becomes particularly obvious with online sales. Federal law prohibits selling tobacco products to minors, but the FDA lacks authority to directly regulate internet platforms. The agency must work through state attorneys general and credit card companies to restrict youth access. This roundabout approach has proven less effective than direct retail inspections, which the agency can conduct under its own authority.
Judicial Guardrails and Agency Discretion
Courts review agency actions under standards that give regulators significant leeway while preserving judicial oversight. The Supreme Court’s Chevron doctrine tells judges to defer to reasonable agency interpretations of ambiguous statutes. But “reasonable” doesn’t mean “unlimited,” and recent court decisions have narrowed agency discretion in subtle but important ways.
The D.C. Circuit’s 2021 decision in American Vapor Manufacturers Association v. FDA shows these constraints. The court upheld the FDA’s authority to require premarket applications but criticized the agency’s failure to provide clear guidance about approval standards. The ruling forced the FDA to publish additional guidance documents explaining how companies could demonstrate that their products provide “appropriate protection of public health.”
This judicial pressure operates through procedural requirements rather than telling agencies what to do. Courts rarely tell agencies what policies to adopt, but they frequently require agencies to better explain their reasoning or consider additional factors. The result is more deliberative policymaking but also longer delays before final rules take effect.
The Democratic Accountability Problem
Regulatory agencies occupy an awkward position in American democracy. Agency officials aren’t directly elected, but they make decisions that can reshape entire industries. The FDA’s vaping rules affect public health outcomes, economic competition, and individual liberty. Who should make such consequential choices?
Presidential oversight provides one answer. Agency heads work at the president’s discretion, and White House review through the Office of Information and Regulatory Affairs creates some political accountability. But this system works imperfectly. The FDA’s tobacco regulations span multiple administrations with different priorities, creating policy zigzags that undermine regulatory predictability.
Congressional oversight offers another mechanism for democratic control. House and Senate committees regularly haul agency officials before cameras to explain their decisions. These hearings can influence agency behavior, but they’re also theatrical performances that prioritize soundbites over substantive policy evaluation. The real oversight happens in quieter appropriations negotiations and confirmation battles that receive less media attention.
The FDA’s experience with vaping regulation demonstrates both the necessity and the limitations of technocratic governance. Complex policy problems require specialized expertise that most legislators lack. But expert judgment involves value choices that democratic theory suggests should be made by elected officials. The challenge is designing oversight mechanisms that preserve both technical competence and democratic accountability without paralyzing the regulatory process entirely.