Date: May 01, 2014
This article is reprinted with the permission of Packaging Digest magazine. It first appeared in the April 2014 issue, which can be viewed here.
The size, shape, color, and design of a package are among the factors that the U.S. Food and Drug Administration (FDA) uses to determine if a beverage is a liquid dietary supplement or a conventional food (albeit a beverage).
In this respect, FDA's concern is aimed at beverage manufacturers who are trying to market their products as dietary supplements. As a result, beverage manufacturers and distributors should be cautious when deciding on these factors since, if liquid dietary supplements are considered by FDA to be represented as conventional beverages through their packaging or other means—such as labeling or advertising—they may be considered misbranded, and subject to regulatory action, including withdrawal from the marketplace.
FDA published an industry guidance in January 2014 on how to distinguish liquid dietary supplements from beverages. Read the guidance at:http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm381189.htm.
In the guidance, FDA discusses seven factors that the agency considers when determining if a liquid product is a conventional beverage or a liquid dietary supplement: 1) labeling and advertising; 2) product name; 3) product packaging; 4) serving size and recommended daily intake; 5) recommendations and directions for use; 6) marketing practices; and 7) composition.
Packaging can convey messages about how the product is intended to be used that are indicative as to whether the product should be considered a supplement or a beverage. In addition to size, shape, color, and design, FDA also considers the volume of liquid that the package holds, whether it is reclosable, if it is a single serve size, and the similarity of the packaging to that of conventional product packaging.
FDA provides as an example a liquid product packaged in a red, 12-ounce, pop-top aluminum can with a silver stripe. Even if this product is labeled as a "cola supplement," the packaging could lead consumers to believe that the product is a cola-flavored soft drink, and, hence, acceptable in FDA's view. However, other factors, such as listed serving size and recommended daily intake information, could help support a determination that the product is not represented as a conventional food despite the packaging design.
The ideal is to prevent conventional beverages (or foods) from taking advantage of dietary supplement rules. The designation of a liquid product as either a dietary supplement or a conventional food or beverage determines how it is regulated. Ingredients added to conventional foods and beverages are required to be the subject of a food additive regulation or generally recognized as safe (GRAS).
However, under the Dietary Supplement Health and Education Act of 1994 (DSHEA) manufacturers or distributors of a "new dietary ingredient" (NDI), or of a dietary supplement that contains a NDI, are required to submit a premarket notification to FDA at least 75 days before introducing the supplement into interstate commerce or delivering it for introduction into interstate commerce. There is an exception to the notification requirement, and that is if the NDI and any other dietary ingredients in the dietary supplement "have been present in the food supply as an article used for food in a form in which the food has not been chemically altered."
Moreover, dietary ingredients used prior to July 1994 are not considered NDIs, and may be used without further clearance or approval, and may be used without further clearance of approval.
Bottom line: Don't get caught as a "tweener," that is, between a supplement and a conventional food product. Know what you are marketing and why. Then ensure that all regulatory requirements are met for the product that is intended to be marketed, and that the agency will not perceive the product as being marketed as something that it is not.