Whether a beverage or a dietary supplement, liquid products are marketed more than ever before--now containing a wider array of ingredients, for many more intended uses and including traditional food substances, but at levels far exceeding previously used amounts. So how does one know if a liquid product is a beverage or a dietary supplement? And what regulations must be followed? To answer those questions, FDA has issued nonbinding recommendations in two new guidances this month: Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. FDA hopes that these guidances will help the industry avoid misbranding with inconsistent product category labeling and adulteration for failure to meet the proper regulations.
When distinguishing between beverages and dietary supplements, as a general rule, dietary supplements are meant to supplement the diet, and beverages are for quenching thirst and providing fluid, nutritive value, taste or aroma. FDA's Guidance sets out the following factors to consider in distinguishing between the two types of liquid products: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations and directions for use, marketing practices, and composition of the liquid product. The Guidance provides examples of how the factors can come into play in a determination. It is likely that a combination of factors, not one, will be determinative of a product's category. For example, even if the label of a liquid product contains a Supplement Facts Panel, it could still be considered a "beverage" if it also contains a statement that the product "refreshes," or the product could be a "food" if the label contains a picture of the liquid being poured onto a salad. The product name could also be determinative that a product is likely a "beverage", if the product name contains conventional terms for beverages, like "drink", "soda", "orange juice", "iced tea", "bottled water", or "coffee". The product packaging is another determinant and, if the packaging is reclosable, is shaped similar to a common beverage package, or contains a single serving, then it is likely a "beverage". The serving size or recommended daily intake may also indicate which category a liquid product falls under. For example, if the product is intended to be consumed all at once or contains a significant part of the entire daily drinking fluid intake for the average person then it is likely a "beverage". Interestingly, marketing practices, another factor, such as metatags for "sodas," "juices" or "beverages," or paying for store shelf placement with other beverages could be determinative of a "beverage". But the product is not necessarily a "beverage" if the marketing says the product should be taken with a meal, since dietary supplements are often recommended for use along with a meal. Finally, the composition of a liquid product may be determinative, although there is a lot of overlap now with both categories containing amino acids, proteins, and vitamins. Similarly, merely adding a dietary ingredient does not make a product a "dietary supplement".
Once the factors are considered to determine whether a liquid product is a "beverage" or a "dietary supplement", the type of product controls which regulations must be met. For beverages, a substance can be generally recognized as safe ("GRAS") for its intended use based upon generally-available evidence of safety recognized by experts. But unless GRAS for its intended use or exempt, substances intentionally added to "beverages" are "food additives", which require premarket approval based upon safety data. FDA issues regulations for approved food additives that specify the conditions for which the substance is safe and can be used. Accordingly, non-dietary ingredients added to supplements, such as binders, excipients and fillers, however, must meet food additive requirements or be GRAS. On the other hand, dietary ingredients included in dietary supplements are not required to be GRAS and are exempt from food additive regulations but still must not be adulterated, and, if new, must meet new dietary ingredient requirements. No matter a "beverage" or "dietary supplement", the guidances remind the industry to make sure the labeling is not false or misleading, and if included, to make sure health claims, nutrient content claims, and structure function claims are proper.