Distinguishing Liquid Dietary Supplements from Beverages

Legal Alerts

Distinguishing Liquid Dietary Supplements from Beverages

Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements

Published: Tuesday, January 14, 2014

Editor's Note: To clarify legal requirements in the face of growth in liquid dietary supplements that contain botanical extracts and/or ingredients, FDA published two final guidance documents to (1) help determine if a liquid product is a dietary supplement or a beverage and (2) remind the industry of legal requirements regarding substances that may be added to these types of products. "Distinguishing Liquid Dietary Supplements from Beverages" describes factors that characterize liquid products as dietary supplements including product claims, names, packaging, serving size, recommended daily intake, conditions of use, product composition, and statements or graphic representations in labeling and advertising. The classification of a liquid product as a dietary supplement impacts what can be said about it, what ingredients can be added, and what claims can be made.

Food and Drug Administration

Distinguishing Liquid Dietary Supplements from Beverages   

I. Introduction
We are issuing this guidance to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage. This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods.  Further, this guidance reminds manufacturers and distributors of dietary supplements and beverages about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their respective ingredients and labeling.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word "should" in Agency guidance means that something is suggested or recommended, but not required.

In this guidance, "we" refers to FDA and "you" refers to manufacturers and distributors of dietary supplements and beverages.

II. Background
We have observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses.  Some of these products are marketed as dietary supplements, and others as conventional foods.  Some products may be misbranded because their labeling or other representations made about them are inconsistent with the product category under which they are being marketed.  In addition, products may be excluded from the dietary supplement category because of representations that they are for use as conventional foods.  This guidance is intended to describe the factors to consider when determining whether a liquid product should 

Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements 

I. Introduction

We are issuing this guidance for two purposes.  The first purpose of the guidance is to remind manufacturers and distributors of conventional foods about the requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional foods, including beverages. "Substance" is defined in FDA's food additive regulations to include foods and food components consisting of one or more ingredients (21 CFR 170.3(g)).  Thus, a "substance" for purposes of the regulations and this guidance may be a food (e.g., an apple) that can be eaten on its own as well as used as an ingredient in other foods, or it may be a food that is used only as a component of other foods (e.g., flour).  A second purpose of the guidance is to remind dietary supplement manufacturers and distributors that the same requirements apply to certain substances that are added to dietary supplements -- namely, those that are not dietary ingredients as defined in section 201(ff)(1) of the FD&C Act (21 U.S.C. § 321(ff)(1)).

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidance describes the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word "should" in Agency guidance means that something is suggested or recommended, but not required.

In this guidance, "we" refers to FDA and "you" refers to manufacturers and distributors of foods, including beverages and, where applicable, dietary supplements (see Section III.B).

 II. Background

We have seen a growth in the marketplace of beverages and other conventional foods that contain novel substances, such as added botanical ingredients or their extracts.  Some of these substances have not previously been used in conventional foods and may be unapproved food additives.  Other substances that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels, or in new beverages or other conventional foods.  This trend raises questions regarding whether these new uses are unapproved food additive uses.

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