What Can Your Food Do For You? (And Should FDA Let It?): An Overview of the Regulatory Regime (or Lack Thereof) Surrounding Functional Foods

Abstract

Foods that provide a health benefit beyond basic nutrition, otherwise known as “functional foods,†may hold the key to better short- and long-term health for many Americans. In recent years, American consumers have grown more and more interested in the possibility of using foods, along with the traditional healthcare system, to promote well-being, reduce the risks of disease, and lower overall costs of care. In response, the food industry and, increasingly, the biotechnology industry have developed and marketed more and more products purporting to be functional foods of one type or another, making myriad claims as to their effects on health or the human body. The problem is that, unlike in Japan where there is a formalized regulatory system for approving the separate category of functional foods, the United States Food and Drug Administration does not even recognize the term. Instead, the FDA approves or rejects such products on a case-by-case basis under one of its currently existing regulatory categories, including conventional foods, dietary supplements, medical foods, foods for special dietary use, or, if necessary, drugs. The current regime, marked by a multitude of available labeling claims, all with different substantiation standards, as well as multiple federal agencies exercising regulatory control, lacks consistency and promotes both consumer and manufacturer confusion. Moreover, the lines between the current regulatory categories are blurry, and some are viewed as more favorable to manufacturers than others, which creates incentives for the marketing of products under regulatory categories to which they do not truthfully belong. This can lead to claims being made directly to consumers that are misleading, inaccurate or unsubstantiated. In order to take advantage of the enormous benefits that foods can provide and the potential for a vast amount of quality consumer education through food labeling, significant changes must be made to the current regulatory system surrounding functional foods.