The U.S. Food and Drug Administration (FDA) issued preliminary guidance on December 7 regarding factors that distinguish liquid dietary supplements from beverages. The guidance seeks to make clear the characteristics which determine whether a manufacturer should label their product as a dietary supplement or a food product.
The FDA notes two concerning trends that the agency has seen from beverage marketers. First, beverages being marketed as dietary supplements despite packaging and labeling which represent a food product. The second trend that concerns the FDA is the increased use of “novel” ingredients such as botanicals, which may not be approved as food additives.
The document provides a few guidelines for beverage marketers:
1.) Beverages are conventional foods that may not be marketed as dietary supplements. The FDA considers a liquid product’s name, packaging, serving size, and recommended conditions of use, as well as other representations about the product, to be important determinants of whether the product is represented as a conventional food and may not be marketed as a dietary supplement.
2.) Ingredients in beverages and other conventional foods are subject to the Federal Food Drug and Cosmetic Act's (FFDCA) requirements for substances added to food. The FDA is concerned that some of the novel ingredients that are being added to beverages and other conventional foods may cause the food to be adulterated because these added ingredients are not being used in accordance with an approved food additive regulation and may not be GRAS for their intended use.
3.) Beverages and other conventional foods may not carry unauthorized labeling claims and must carry the appropriate mandatory labeling. The FDA’s general food labeling requirements are located in Title 21 of the Code of Federal Regulations, Part 101, and additional guidance can be obtained from the Food Labeling Guide http://www.fda.gov/FoodLabelingGuide, which is available on the FDA website.
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