Evaluating eating behavior treatments by FDA standards

A Janet Tomiyama,Traci Mann,Britt Ahlstrom

doi:10.3389/fpsyg.2013.01009

Abstract

Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients’ time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (2) How dangerous is the condition the intervention is treating? (3) Is the treatment effective? (4) Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine.

Highlights

Obesity rates in America have more than doubled in the last 30 years, and currently one third of adults are considered obese, and another third are considered overweight (Flegal et al, 2012)
We argue that examining behavioral interventions using the criteria of the Food and Drug Administration (FDA) is a useful exercise for identifying unanswered research questions on the efficacy and effectiveness of behavioral treatments
Under an FDA framework, dieting might be prescribed along with label information about the importance of adherence for the treatment’s effectiveness, including information that even with 100% adherence, weight loss may plateau, as noted above. In this Perspective article, we considered whether viewing behavioral interventions through the lens of FDA regulations is worthwhile

Summary

Evaluating eating behavior treatments by FDA standards

Reviewed by: Jacob Burmeister, Bowling Green State University, USA Michael R. Behavioral treatments for obesity are not evaluated by the same criteria as pharmaceutical drugs, even though treatments such as low-calorie dieting are widely prescribed, require patients’ time and investment, and may have risks. The Food and Drug Administration (FDA) has a procedure for evaluating drugs, in which drugmakers must answer the following questions: (1) Is the treatment safe? (4) Is the treatment safe and effective for large numbers of people? We argue that using this framework to evaluate behavioral interventions could help identify unanswered research questions on their efficacy and effectiveness, and we use the example of low-calorie dieting to illustrate how FDA criteria might be applied in the context of behavioral medicine

INTRODUCTION

FDA and Dieting

Findings

DISCUSSION