In mid-January FDA issued two important guidance documents, Distinguishing Liquid Dietary Supplements from Beverages (http://tinyurl.com/m443cla)
and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (http://tinyurl.com/nhwqz26). I will discuss the guidances in detail below but will start with the parts that are particularly interesting:
First, in addition to outlining the attributes that FDA will consider when determining whether a product is classified as a beverage or a liquid dietary supplement, the guidance on distinguishing beverages and dietary supplements also provides some interesting comments on the types of claims that may be used on beverage labels. The guidance notes that in addition to authorized health and nutrient content claims, certain structure function claims may also be made about conventional beverages. However, FDA reminds the reader that structure function claims on foods and beverages are only permissible when the claimed effect derives from “the product’s character as a food—its taste, aroma or nutritive value.”The document goes on to state that if the structure function claim promotes the product for another use that may involve a physiological effect, then the product may be considered a drug. This is not a new provision. Past conversations I have had with current and former FDA staff members indicated that “nutritive value” refers to conventional nutrients such as carbohydrates, fat, protein, fiber, vitamins and minerals. This makes me wonder whether this guidance indicates that FDA objects to claims about gut health and digestive regularity as seen on some yogurt and fermented beverage products.
- Product labeling and advertising. If the product is promoted to “refresh” or “rehydrate”, then it is a beverage even if its label includes a supplement facts box.
- Product names. If the product name includes terms such as “beverage”, “drink”, “water” or “soda”, the product is a beverage, not a dietary supplement. FDA notes that the term “tea” is not used exclusively for beverages; implying that some teas may be dietary supplements but the other criteria must also be considered.
- Product packaging size, shape, color, design, whether it is recloseable and the volume it holds is a factor to be considered in classifying a product as a beverage or liquid supplement.
- Serving size and recommended intake. The guidance states that Americans consume about 1.2 liters of water and other beverages daily. If the serving size of a liquid product makes up a significant portion of 1.2 liters, then the product would be considered a beverage and not a liquid dietary supplement.
- Recommendations and directions for use. If a product is recommended to quench thirst, it would be a beverage. If the directions were similar to ‘take one tablespoon three times per day, it is probably a dietary supplement.
- Marketing practices. Advertising that compare the product to other beverages or suggest that it can substitute for a beverage or if metatags are used that bring the product up in searches for beverages, then the product is a beverage and not a dietary supplement.
- Composition. FDA noted that simply adding a dietary ingredient that is only permitted in dietary supplement products to a conventional food does not transform that food into a dietary supplement. The agency gives the example that adding ginkgo to a conventional beverage does not cause that product to be classified as a dietary supplement.
- Other information including information found in patents or filings with the Security and Exchange Commission.
“We are concerned that some of the novel substances that are being added to conventional foods, including beverages, may cause the food to be adulterated because these added substances may not be GRAS for their intended use and are not being used in accordance with a food additive regulation prescribing conditions of safe use. In addition, some substances that have been present in the food supply for many years are now being added to conventional foods at levels in excess of their traditional use levels or in new types of conventional foods. This trend raises questions as to whether these higher levels and other new conditions of use are safe.”