FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages


Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action.

The US Food and Drug Administration (FDA or Agency) has raised concerns regarding the increase in the marketing of liquid products with a variety of ingredients and intended uses, some of which are marketed as dietary supplements and others as conventional foods. To assist members of the dietary supplement and beverage industries in distinguishing between these two product categories and complying with the regulatory requirements applicable to each, FDA issued draft guidance in 2009 and, most recently, in January 2014 issued two final guidance documents. These documents, entitled, “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” together update the Agency’s December 2009 draft guidance entitled, “Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.” The final guidance documents are consistent with the 2009 Draft Guidance, but provide greater detail with respect to distinguishing dietary supplements and beverages. Thus, they are valuable resources for beverage and liquid dietary supplement companies navigating the often muddy food and dietary supplement regulations.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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