Chapter 10 - Breaking down the barriers to functional foods, supplements, and claims

Abstract

The worldwide functional food and dietary supplement market is enormous, with the former expected to increase from about $30/0billion in 2017 to over $440billion in 2022 and the latter to increase from $133.1billion in 2016 to $278.02billion by 2024. However, in the United States, the Food and Drug Administration (FDA) has resisted accommodation of these new markets as a result of the checkered history of fraudulent claims for (sometimes, dangerous) foods, marked by a half-century of battles for truth in labeling and safety in pursuit of consumer protection. In continuing this fight, the FDA refuses to officially recognize the concept of functional foods and has raised the bar too high for premarket notification for dietary supplements. However, these FDA actions have had the reverse effect of protecting the consumer by indirectly encouraging some manufacturers to bypass regulatory oversight and openly market products with claims with, at best, thinly supporting safety and efficacy data. This chapter describes the history of the functional foods and dietary supplement movements, the current status, and a plan for resolution of the impasse created by the FDA's Procrustean attempts to apply historical regulatory standards.