FDA issues final guidance distinguishing liquid dietary supplements from beverages

SILVER SPRING, Md. — The Food and Drug Administration earlier this week issued final guidance for the industry on distinguishing liquid dietary supplements from beverages. "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," the agency stated. "This guidance describes the factors that distinguish liquid products that are dietary supplements from those that are conventional foods."

According to the FDA, the most obvious representations about a product’s use are claims made for the product in its labeling and advertising. "However, a product’s name, packaging, serving size, recommended daily intake and other recommended conditions of use and composition, as well as marketing practices and representations about the product outside its labeling and advertising, can also be important determinants of whether the product is represented as a conventional food (and, thus, may not be marketed as a dietary supplement)," the agency wrote. "Although in some circumstances a single factor may be determinative of whether the product is represented as a conventional food, … in most circumstances a combination of factors would determine whether the product is represented as a conventional food."

The following is a run-down of the differentiators, as defined by the FDA: 

• Labeling and advertising: Generally, products that bear statements that the product is intended to “refresh” or “rehydrate” represent the product for use as a beverage, i.e., a conventional food;


• Product name: Product or brand names that use such conventional food terms as “beverage,” “drink,” “water” or “soda” represent the product as a conventional food;


• Product packaging: Packaging characteristics that should be considered include the size, shape, color and design of the container or other packaging, the volume of liquid it holds, whether it is reclosable or designed to be consumed in a single serving, and the similarity of the packaging to packaging used for common beverages;


• Serving size and recommended daily intake: Liquid products that suggest through their labeled serving size and/or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods;


• Composition: Adding common dietary supplement ingredients to a beverage does not make it a dietary supplement per se. Products that are consumed primarily for taste rather than nutrition or health-related purposes are beverages;


• Other representations about a product: Other representations about a product include, for example, representations in publicly available documents, such as statements made in filings with government agencies such as the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office. 

"FDA intends to consider all relevant factors in context when determining whether a product is represented as a conventional food," the agency stated.