Food & Health

Food & Health

Research

Sherzod Abdukadirov, Scott King, David Wille | May 17, 2016
Over the past few years, the federal government and local governments have increasingly turned to “nudges” as solutions to many problems caused by behavioral biases. Such efforts often run into opposition owing to their paternalistic nature, but nonpaternalistic nudges can be equally effective at improving consumers’ choices. In contrast to paternalistic nudges, nonpaternalistic policies do not impose policymakers’ errors on consumers if policymakers misdiagnose the underlying behavioral bias, and they thus avoid harming consumers by pushing them toward suboptimal choices.
Eric Sun, Kelly Ferguson | Apr 20, 2016
In 2002, Congress passed the Medical Device User Fee and Modernization Act, with the aim of pushing the FDA to speed up the approval process for medical devices. This law levied large user fees on medical device manufacturers in exchange for the promise of shorter review times by the FDA. Whether the act has resulted in shorter review times has been unclear. This study conducted a regression analysis to address this question, using data on FDA review times for devices seeking approval between 1991 and 2012.
Jerry Ellig, James Broughel, Spencer Bell | Mar 09, 2016
For more than three decades, presidents have required executive branch regulatory agencies to identify the systemic problems they wish to solve when issuing major regulatory actions. The first principle in Executive Order 12866, which governs executive branch regulatory review, is that an agency shall “identify the problem that it intends to address (including, where applicable, the failures of private markets or public institutions that warrant new agency action) as well as assess the significance of that problem.” This principle reflects the sensible notion that before proposing regulation, regulators should understand the root cause of the problem the proposed regulation is supposed to solve.
Joseph V. Gulfo, Jason Briggeman, Ethan Roberts | Feb 02, 2016
Despite rapidly advancing technology and patients’ increasing desire to try new drugs and devices, the FDA has strayed significantly from the statutorily defined safety and effectiveness standards for drug approvals. The FDA now very often demands proof of clinical utility, including survival and disease outcomes, as a requirement for premarket approval.
Jayson L. Lusk | Dec 10, 2015
Betcha can’t eat just one.” The slogan of the bestselling potato chip brand was not just an advertising success—it also revealed a deeper behavioral economic insight. For some people, the current, acting person seems to lack the self-control we imagine the person will desire in the future. The fleeting pleasure of a salty, crunchy chip in the present outweighs the future desire to fit into a pair of skinny jeans. The trouble is not that consumers are overly impatient per se, rather that choices are inconsistent and desires change over time. A decision is made to eat a tasty chip today with the expectation that a diet will start tomorrow. But when tomorrow becomes today, another chip awaits and the diet is put off until another day.
Richard Williams, Robert Graboyes, Adam Thierer | Oct 21, 2015
A new paper for the Mercatus Center at George Mason University shows why the current system of medical device approval discourages technological innovation and ultimately affects patient choice. The approval process could be improved by introducing competition for approval—a process that already exists in the European Union.

Testimony & Comments

Richard Williams, Michael L. Marlow, Edward Archer | Apr 12, 2016
The case examined here is the package of regulations that met the initial legal requirements provided by the Nutrition Labeling and Education Act of 1990 (NLEA, Public Law 101-535). This act gave the FDA the authority to require nutrition labeling of most foods regulated by the Agency and to require that all nutrient content claims (e.g., “high fiber” or “low fat”) and health claims be consistent with agency regulations.
Todd Nesbit | May 18, 2015
A new public interest comment by economist Todd Nesbit, written for the Mercatus Center at George Mason University, demonstrates that the proposed rule fails to show a need for the rule, fails to properly assess the benefits of the rule, and does not consider alternatives to the rule. The regulatory impact analysis should be improved to account for these failures.
Sean Mulholland | Feb 16, 2015
Under the authority of the Clean Water Act (CWA) of 1972, the Environmental Protection Agency (EPA) is proposing new technology requirements for all new and existing dental practices that use dental amalgam, which is the main source of mercury discharges into publicly owned treatment works (POTWs). The proposed rule would require dental offices to use amalgam separators and best management practices (BMPs) for capturing mercury and other metals before they are discharged into POTWs.
Michael L. Marlow | Jun 27, 2014
This public interest comment estimates the range of annual benefits (costs avoided) associated with e-cigarette use as $15.6 billion to $49.2 billion and that 2.4 million to 6.4 million smokers may potentially become ex-smokers by using e-cigarettes. Estimates are based on a range of quit rates from the current literature and assume all smokers interested in quitting use e-cigarettes. Even a fraction of estimated benefits (costs saved) are substantial. These estimates indicate the FDA is jeopardizing public health by not estimating benefits associated with e-cigarettes using data from readily available studies on their efficacy as harm-reduction tools.
Todd Nesbit | Mar 04, 2014
It is not clear based on the FDA’s analysis whether its proposed rule is in the best interest of society. FDA makes no attempt to estimate the benefits of the regulation, and the analysis of the costs is very likely biased downward due to questionable assumptions and omissions. Further, changes of behavior are only selectively considered—discussing them when logically leading to benefits but dismissing the costs associated with those changes in behavior.
Richard Williams | Jun 20, 2011
This comment analyzes the Food Safety and Inspection Service’s proposed rule concerning mandatory inspection of catfish and catfish products.

Research Summaries & Toolkits

Speeches & Presentations

Mercatus Regulatory Studies


Charts

The purpose of Food and Drug Administration’s Devices and Radiological Health Program is to provide assurance of the safety, effectiveness, and quality of medical devices. The work of the Devices Program is carried out by the FDA’s Center for Devices and Radiological Health, plus field work done by the FDA’s Office of Regulatory Affairs (ORA). Most observers, and particularly the FDA, believe that user fees have been successful in helping the Devices Program meet its performance goals in reducing “the total time it takes to make decisions.” But the evidence presented here suggests that greater capacity and spending for the Devices Program over the last decade has not yet led to an increase in the number of new-product applications and reviews.

Experts

Podcasts

Richard Williams | May 24, 2016
Richard Williams talks about his recent Politico op-ed on why the new nutrition labels won't help people make healthier choices.

Recent Events

Please join the Mercatus Center at George Mason University for the first of a two-part series reviewing the basic features of the Regulatory Flexibility Act and related amendments and how regulatory flexibility analysis is intended to work in the context of federal rulemaking.

Books

Media Clippings

Keith Hall | Aug 08, 2013
Keith Hall, a researcher at George Mason University’s Mercatus Center, finds that nearly all jobs created in the past few months have been part-time gigs.
Keith Hall | Aug 07, 2013
Moody’s Mark Zandi and the Mercatus Center’s Keith Hall, have suggested that the law’s effects can be seen in recent jobs data, after a few months of high part-time job creation.
Jerry Ellig | Jul 30, 2013
Jerry Ellig discusses White House efforts to shape behavior…
Tyler Cowen, Alexander Tabarrok | Jun 12, 2013
His goal is to put online in the next 5 to 10 years an entire series of courses that cover the basic sweep of his field.
Donald J. Boudreaux | Jun 27, 2012
Don Boudreaux explains how industrial capitalism has been the greatest anti-pollutant.
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