On January 14, 2014, FDA issued final guidance to help companies determine whether a product qualifies as a “dietary supplement” or “conventional food” as defined by the federal Food, Drug & Cosmetic Act (FD&C). While dietary supplements and conventional foods are both considered “foods” under the FD&C, there are important differences in the regulatory requirements that apply to foods that qualify as “dietary supplements.” The FDA final guidance issued last week,Distinguishing Liquid Dietary Supplements from Beverages, updates FDA’s earlier 2009 draft guidance and, in general, provides greater detail than the draft guidance.
There are important differences in the regulatory requirements that apply to dietary supplements versus conventional foods. The final guidance elaborates on factors that FDA considers in determining the regulatory classification of a liquid product. These factors are discussed below.
- Product Labeling and Advertising Claims—FDA will consider statements and graphics (e.g., symbols, vignettes, pictorial serving suggestions) on a product’s label, labeling, and/or advertising. A product that is marketed as a dietary supplement could be considered a conventional food if it bears claims that the product is intended to “refresh” or “rehydrate,” for example, as these statements likely represent the product for use as a beverage.
- Product Names—FDA believes that certain terms, such as “beverage,” “drink,” “water,” or “soda,” are exclusive to conventional foods and, thus, when used in a product name, represent the product as a conventional food. Where a term is not, in FDA’s view, associated exclusively with conventional foods, the term could be used in conjunction with a dietary supplement product. As an example, the final guidance indicates that products described as “teas” could be either dietary supplements or conventional foods.
- Packaging Design—FDA also will consider packaging characteristics to help determine whether a product should be classified as a conventional food or a dietary supplement. For example, whether a 12 ounce liquid product comes in reclosable packaging would be an important consideration to FDA, as a 12 ounce non-reclosable package more closely resembles a beverage, rather than a dietary supplement.
- Serving Size and Recommended Daily Intake—Like the 2009 draft guidance, the FDA’s final guidance emphasizes that if a product is represented to provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States, the product likely will be viewed as a conventional food.
- Recommendations or Directions of Use—Similar to advertising claims that a product is intended to “refresh” or “rehydrate,” recommended uses for a product that are similar to the purpose of beverages will characterize a product as a conventional food, according to FDA. For example, FDA noted that recommendations or directions to use a product as a thirst quencher can be considered recommendations or directions to use the product as a beverage. Vice versa, recommending that a product be used to supplement the diet in a manner consistent with other dietary supplement directions (e.g., take one tablespoon three times a day) could be a factor in determining that a product is a dietary supplement.
- Marketing Practices—Marketing the product in a manner that causes the product to be compared to conventional food beverages–such as by paying for the product to be displayed in the beverage section of retail stores, using metatags that cause the product to appear in the results of an electronic search for conventional foods, or marketing the product based on taste, refreshment, or thirst-quenching ability—would likely cause FDA to categorize the product as a conventional food.
- Ingredient Composition—FDA noted that it intends to consider the composition of a product as an important factor in determining if a product is a conventional food or dietary supplement (e.g., does a product that is marketed as a dietary supplement consist in significant part of conventional food components unrelated to the supplement’s claimed nutritional or health benefits).
- Other Product Representations—These could include representations about a product’s purpose made in publicly available documents, such as statements made in filings with government agencies, including the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
FDA has stressed that, “in most circumstances a combination of factors would determine whether the product is represented as a conventional food.” The final guidance also clarifies that FDA will generally view powdered premix products intended to be added to liquids and that are labeled as dietary supplements to be appropriately characterized, so long as the product is not represented for beverage use or as an alternative to beverages.
Further, the guidance emphasizes FDA’s intention to ensure that foods are marketed in the proper form to prevent manufacturers from improperly adding ingredients to conventional foods under the mistaken notion that the product is a dietary supplement.According to the guidance, “[m]erely adding an ingredient listed as a dietary ingredient in section 201(ff)(1) of the FD&C Act to a product universally recognized as a beverage does not by itself transform that beverage into a dietary supplement.” As an example, the guidance explains that adding a botanical, such as ginkgo to Kool-Aid, would not automatically create a product that could be marketed as a dietary supplement. Any ingredient added to a conventional food, regardless of whether that product is properly marketed as a conventional food, must be added in conformance with food additive regulations, be generally recognized as safe under the intended conditions of use, or otherwise be exempt from the definition of food additive.
FDA’s final guidance was published on the same day as guidance entitled FDA’s Considerations Regarding Substances Added to Food, Including Beverages and Dietary Supplements. See our Food and Drug Law Access blog post here for information on how FDA evaluates whether ingredients in liquid products meet FDA food additive requirements. FDA’s release of the two related guidance documents this week suggests that liquid products can expect to receive more intense regulatory scrutiny as a result of FDA enforcement priorities. Companies that market liquid products should carefully consider the new FDA guidance in determining whether their products qualify as liquid dietary supplements versus beverages, and ensuring that product formulations and labeling comply with the requirements that apply to products in the respective category.