FDA Differentiates Between Liquid Dietary Supplements and Beverages
The U.S. Food and Drug Administration (FDA) finalized “Distinguishing Liquid Dietary Supplements from Beverages,” a guidance aimed at helping manufacturers to determine whether a product in liquid form is a dietary supplement or a beverage.
The Food, Drug, and Cosmetic Act (FD&C Act) defines beverages as conventional foods. Under the FD&C Act, dietary supplements cannot be represented for use as a conventional food (and therefore a beverage) or as a sole item of a meal or the diet. Representation of a product as a conventional food can be a result of its product or brand name, its packaging, the serving size or recommended daily intake, and even statements in its labeling or advertising.
Labeling and Advertising: Statements, such as “refresh” or “rehydrate”, may cause a product to be considered a conventional food. Images may also represent a product as a conventional food. As an example, FDA states that “an ad or label with a picture of a liquid product being poured onto a green salad would represent the product as a salad dressing.”
Product Name: Examples of terms used in product names that could cause a product to be considered a conventional food include: beverage, drink, water, soda, tea, coffee, and juice.
Product Packaging: The size, shape, color, and design of a container all influence how a product is classified.
Serving Size: FDA estimates that U.S. consumers drink an average of 1.2 liters of fluid a day. If a product is intended to make up a significant amount of a consumer’s daily intake, it may be represented as a conventional food.
Recommendations and Directions for Use: The FD&C Act defines dietary supplements as products that are intended to supplement the diet. Examples of intentions that could lead to a product being represented as a conventional food include: to quench thirst, to provide nutritional value, or to provide taste and aroma.
It’s important to know the difference between dietary supplements and conventional foods because misclassifying a product can have severe consequences. FDA has different labeling and ingredient regulations for dietary supplements and beverages. If a product is mislabeled, it may be deemed misbranded. If a product includes unapproved ingredients, FDA may consider it to be adulterated.
FDA’s May 2012 warning letter to Rockstar, Inc. provides a good example. Rockstar’s coffee products contained Ginkgo, which is allowed as an ingredient in dietary supplements but is an unapproved food additive for conventional foods. Despite Rockstar’s use of the term “energy supplement” and labeling their products with a “Supplement Facts” panel, FDA stated that Rockstar’s coffee products could not be considered dietary supplements because:
- The statement of identity of the products included “coffee”, which represents a beverage.
- The label stated “Enjoy this fully refreshing beverage super chilled.”
- The packaging and appearance of the products resembled a typical canned beverage.
Because FDA considered Rockstar’s coffee products as beverages and not dietary supplements, Rockstar’s use of Ginkgo made the products adulterated under the FD&C Act.
Registrar Corp is an FDA compliance firm that assists food and beverage companies with U.S. FDA regulations. Registrar Corp can review product labels for FDA compliance and can help a company to determine whether its product is a supplement or conventional food. If you have any questions about FDA’s regulations for beverages and supplements, or if you would like assistance, contact Registrar Corp at +1-757-224-0177 or through the 24/7 Live Help service: http://www.registrarcorp.com/livehelp.