Regulation of  Functional Food


Functional foods are generally considered to offer additional benefits beyond basic nutrition that may reduce the risk of disease or promote optimal health[1]  The FLAVR SAVR tomato, a tomato which took longer to ripen and thus extended its life, was the first genetically engineered crop product to be granted a license for human consumption.[2]  Increasing vitamins, reduce fat, adding omega-3 are all different ways to convert conventional foods into functional foods.  As biotechnology advances, so do the ways in which humans can continue to enhance the food produced today.


Since this is inherently a new way of growing food, how do we make sure that it meets the minimum standards for health and safety for general public consumption?  From a legal perspective, there is no separate regulatory category for functional food.  It is subject to the same regulatory requirements as any other food, which is governed by the Federal Food Drug and Cosmetic Act (FFDCA).[3]  This means that a functional food may be regulated as drug or food.  If it is regulated as a food it can fall under one of the following categories:  conventional food, dietary supplement, special dietary use, or medical food.[4]



 A drug is defined by the FFDA as “a product intended to diagnose, prevent, treat, or mitigate disease.” If functional food is classified as a drug, it must go under greater regulatory scrutiny than food.  The food must be demonstrated to be safe and effective for their intended use (e.g. clinical trials), and may bear only FDA-approved labeling.


Today, since functional food is still in essence “food”, it does not make sense to hold it to this level of regulation.  However if food does go on to boast that it can prevent or cure disease, it may make sense to put it through this level of scrutiny.


Conventional Food

Conventional food is described by the FFDCA as a product used primarily for taste, aroma, or nutritive value, and in a conventional food form.  In this category, the ingredients in the food must be generally recognized as safe for their intended use.  If a substance is a food additive, it requires pre-market clearances from FDA.


A conventional food may be freely marketed on the basis of taste, and enjoys some flexibility by not needing to be pre-approved by the FDA before releasing to market nor accompanied by a disclaimer.


Dietary Supplement

A dietary supplement is a product intended to supplement the diet which must contain one or more “dietary ingredients” (e.g., vitamins), be intended for ingestion, labeled as a dietary supplement.  Safety requirements for dietary supplements are less stringent than those for conventional food. The safety standard for dietary supplements provides that dietary supplements must not present “a significant or unreasonable risk of illness or injury” under the conditions of use.[5]


Food for Special Dietary Use

This category of food is food intended for supplying dietary needs, such as weight loss medication.  While the definition seems a bit broad, the FDA has some restrictions on the level of nutrients that differentiate food for special dietary use from other food. 


Medical Food

Medical food is food intended for use under the supervision of a physician for the dietary management of disease with distinct nutritional requirements.[6]  The ingredients of medical food must be generally regarded as safe for their intended use.  Medical food is entitled to the most flexibility of all when dealing with regulation, but is permitted in extremely defined circumstances.


As biotechnology becomes more and more relevant in the food humans grow and it, it will most likely, if it has not already, challenge the boundaries of the current existing categories and may warrant its own category in the near future so that the safety and quality of the new products can be properly managed.




[1]What are functional foods?


[3]US Food and Drug Administration,

[4], 37

[5] FFDCA § 402(f)(1)