LU ZHAO, WENDAN WANG
Burdock Group Consultants
859 Outer Road, Orlando, FL 32814, USA

Abstract

This article focuses on current regulations that address functional foods in the U.S., the largest functional food ingredient market worldwide. The term “functional food” originated from FOSHU (Food for Special Health Uses) in Japan. The term migrated to the U.S. and the Europe, but with no legislative definitions in these countries. In the U.S., depending on how a product is marketed and depending on the nature of any claims made, functional foods may be regulated by FDA as conventional foods, dietary supplements, medical foods, or “food for special dietary use”. The scope of the article is to discuss how limitations in regulations in the U.S. could hinder functional food development, by making horizontal comparison to current medical food regulation in the U.S. on one hand, and on the other by vertical comparisons to recently updated health food regulation in China, as an example of functional food regulation in emerging economies.

INTRODUCTION

The current cost and accessibility of health care in the U.S. is such that consumers are increasingly turning to supplements and functional foods for general health maintenance and reduction in risk of disease. Consumers often do so at the advice of their doctors, who have, in the past, only been incentivized for providing care, not promoting health. Additional key growth drivers of the dietary supplement market include an aging population, growing consumer interest in health and wellness, increasing discretionary income as the economy recovers, and newer formats for supplements that appeal to consumers who do not like the traditional pill and capsule formats (a).

Unlike some Asian countries such as Japan and China from which the concept of functional food was originally developed (functional food is regulated as FOSHU (Food for Special Health Uses) in Japan, and mostly regulated as Health Food in China), but there is no legislative or official (regulatory) definition of functional food in EU, U.S., or other western countries. In the U.S., this would require an amendment to the Federal Food Drug and Cosmetic Act (FFDCA), passed by Co ...