Rockville, MD—The U.S. Food and Drug Administration (FDA) has issued a draft guidance intended to help manufacturers determine whether liquid products should be labeled as beverages or supplements.

The need for such guidance is strong, FDA implied, noting an increased presence of drinks labeled as dietary supplements, though their labeling/packaging is closer to that of conventional foods. And, several new beverages contain new botanical ingredients and extracts that may not be approved as food additives. Some beverage makers are also using established ingredients in amounts that far exceed their traditional levels. To top it off, some beverages that incorporate novel ingredients are using label claims that they should not, placing them in violation of the Federal Food, Drug and Cosmetic Act.

“Even when the label of a liquid product characterizes it as a dietary supplement, the product may not in fact be a dietary supplement,” the agency stated.

FDA suggested the following distinctions between beverages and liquid dietary supplements:

• “Liquid products can be represented as conventional foods as a result of factors such as their packaging, the volume in which they are intended to be consumed, their product or brand name, and statements about the product in labeling or advertising.” So, liquids that are sold in bottles and cans that look like soda cans, bottles of water or fruit juice bottles indicate that they are intended for use as conventional foods, the agency said adding, “Liquid products that suggest through their serving size, packaging, or recommended daily intake 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 U.S., are represented as beverages.” The lesson? Finished product makers should pay attention to how a liquid product is named and packaged as well as its serving size recommended conditions of use.

• Novel ingredients added to conventional foods must be generally recognized as safe (GRAS) or have premarket approval from the FDA in the form of a food additive petition. And, FDA raised the question of whether adding older ingredients to new liquid products in higher than normal levels are safe.

• Products cannot make unauthorized health claims or have false/misleading labeling. In the case of beverages, labeling cannot indicate that they will treat, cure or mitigate diseases. Those bearing unauthorized nutrient content claims are considered misbranded.

The guidance, entitled Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods, is available for review at www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ucm192702.htm. Comments on the draft are due early this month (February 2, 2010).

Published in WholeFoods Magagzine, Feb. 2010