On January 13, 2014 the Food and Drug Administration (FDA) released a new guidance to assist in determining whether a liquid product should be classified as a dietary supplement or a beverage.1 The guidance contains FDA’s non-binding recommendations; it does not establish legally-enforceable responsibilities, but rather describes the agency’s current thinking.
The regulatory requirements for ingredients and labeling of beverages and dietary supplements can differ, and FDA believes that a product may be misbranded if the labeling or other representations made about the product are inconsistent with the product category under which it is being marketed. In addition, an ingredient that is properly added to a dietary supplement may or may not be properly added to a conventional beverage. To be lawful for use in a conventional beverage, FDA states an ingredient must be used in conformity with a food or color additive regulation prescribing the conditions of its use in food, be generally recognized as safe for its intended use, or qualify for one of the other exceptions to the food additive definition.2
The following is FDA’s list of factors it may consider3 in assessing whether a product should be categorized as a conventional beverage or a liquid dietary supplement. Although in some circumstances a single factor may be determinative, most of the time FDA reviews a combination of factors and the overall context of the product in making its determinations.
- FDA opines that the most obvious representations about a product’s use are made in its labeling and advertising. Consider the statements and graphics (e.g., symbols and pictorial serving suggestions) on the product’s label, labeling, and advertising—including social media—when evaluating the intended use of the product. Words such as “refresh” or “rehydrate” may suggest the product for use as a beverage.
- FDA states that in some instances, product or brand name alone may be sufficient to establish that a product is represented for use as a conventional beverage. Product or brand names that use terms such as “beverage,” “soda” or “water” may be viewed by FDA as representation that the product is a conventional beverage or food.
- The FDA may consider the packaging of a product to convey a message about how it is to be used—considering the size, shape, color, and design of the packaging, the volume of liquid it holds, whether it is designed to be consumed in a single serving, and the similarity of the packaging to common beverages.
- Consider whether the practical result of the labeled serving size and/or total recommended daily intake is that the product will be used as a beverage to replace ordinary sources of drinking fluid.
- Are the recommendations and directions for use consistent with a dietary supplement or a conventional beverage? For example, a recommendation or direction that one tablespoon be taken three times per day could be consistent with a dietary supplement, even if the product’s packaging is similar to that of a common beverage.
- Examples of marketing practices identified by FDA that may represent a liquid product as a conventional beverage include: “labeling, advertising, or other promotional activities that favorably compare the product to a category of beverages (e.g., sodas), market the product as an accompaniment to a meal, or market the product based on typical beverage criteria like taste, refreshment, and thirst-quenching ability; the use of metatags that result in the product’s appearing in the results of an electronic search for sodas, juices, or other beverages….”
- Does the product consist mostly of conventional beverage components unrelated to its claimed nutritional or health benefit? FDA indicated that it intends to consider whether the composition of a liquid product—along with other factors—represents the product as a conventional beverage.
- Other representations that might cause the FDA to consider a product a conventional food include ones made about the product in publicly-available documents such as SEC and patent/trademark filings.
1 Food and Drug Administration, Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages (2014), available at http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/UCM381220.pdf.
2 See Food and Drug Administration, Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (2014), available at http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/IngredientsAdditivesGRASPackaging/UCM381316.pdf
3 This information is only a summary of FDA’s present thinking on the subject and is not exhaustive of FDA’s rules, regulations, or guidance. This document is not legal advice and should not be relied upon in making decisions that may have legal consequences. If you have questions or need legal advice, seek the advice of counsel licensed to practice in the jurisdiction in which your question arises.