The U.S. Food and Drug Administration (FDA) issued a highly anticipated guidance document on liquid dietary supplements this morning, with its current position on how it will distinguish between such products and conventional beverages.
The document, titled “Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages” finalizes FDA’s late 2009 draft guidance on the same subject. The guidance is not binding on the agency or the industry, but it is intended “to help dietary supplement and beverage manufacturers and distributors determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage.” FDA has “observed an increase in the marketing of liquid products with a wide array of ingredients and intended uses. Some of these products are marketed as dietary supplements, and others as conventional foods.”
Whether FDA considers a product to be a dietary supplement or conventional food has many important ramifications for the product itself, the company making it, and the company distributing it. Different rules apply to each category, including how the product must be labeled, what ingredients can be in it, how it is manufactured, and what claims can be made about it. A product labeled as a dietary supplement may be adulterated and misbranded, and therefore subject to regulatory enforcement, if FDA believes it should be a beverage because of the factors outlined below.
Factors That FDA Will Consider
The guidance contains a list of factors that FDA will consider when determining whether a product is a conventional food (beverage) or a liquid dietary supplement. Summarized briefly, the eight factors include:
Labeling and advertising. This includes statements and graphics on product labels, labeling, and advertising, including Web sites and social media.
Product name. Examples of terms that generally would be considered to represent a liquid product as a conventional food when used in the product’s name are “orange juice,” “apple cider,” “bottled water,” “iced tea,” and “coffee,” in addition to more generic terms, such as “beverage,” “drink,” “water,” or “soda.”
Product packaging. Packaging characteristics that should be considered include the size, shape, color, and design of the container or other packaging, the volume of liquid it holds, whether it is reclosable or designed to be consumed in a single serving, and the similarity of the packaging to that used for common beverages.
Serving size and recommended daily intake. Liquid products that suggest through their labeled serving size and/or recommended daily intake (e.g., “Drink up to three 16-ounce bottles per day”) that they are intended to be consumed in amounts that provide all or a significant part of the entire daily drinking fluid intake of an average person in the United States are effectively being represented as conventional foods.
Recommendations and directions for use. Recommendations or directions to use a product as a thirst quencher may mean the product is being represented as a beverage, as they encourage consumers to use the product in place of other beverages, such as fruit juice, water, or soda.
Marketing practices. Examples of promotional activities that could cause FDA to regulate the product as a conventional food include those that favorably compare the product to a category of beverages (e.g., sodas) or market the product based on typical beverage criteria like taste, refreshment, and thirst-quenching ability.
Composition. While FDA notes that there is some obvious overlap between ingredients used in dietary supplements and those used in conventional foods, when a product marketed as a dietary supplement consists in significant part of conventional food components unrelated to its claimed nutritional or health benefit as a supplement and the product is essentially a copy of a common beverage with a dietary ingredient added, FDA intends to consider whether the composition, along with other factors, cause the product to be a conventional food.
Other representations. Importantly, FDA notes that this catch-all category includes representations made in publicly available documents, such as statements made in filings with the U.S. Securities and Exchange Commission or the U.S. Patent and Trademark Office.
Powdered Drink Mixes
The guidance document clarifies the agency’s position that powdered premix and liquid concentrate supplement products generally will not be considered beverages when they are labeled as dietary supplements, unless they are otherwise represented as being for beverage use or as alternatives to beverages.
The guidance document also reminds marketers that they are responsible for ensuring the ingredients used in their beverages or liquid supplements are appropriate for that particular product. It points interested parties to a second guidance document, also published today, titled “Guidance for Industry: Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” That second document complements FDA’s main guidance by reminding manufacturers and distributors about the requirements of the Federal Food, Drug, and Cosmetic Act regarding substances added to conventional foods, including beverages.
Both guidance documents will be published in the Federal Register on January 14, 2014 and are available for comment.
Why it matters: FDA continues its increased enforcement against dietary supplement products. A single word, ingredient, manufacturing step or even the shape of a container can mean the difference between a legal and illegal product. FDA guidance documents like this offer manufacturers and distributors insight into how FDA interprets murky areas of the law, and with that information comes an opportunity to make changes to products before any enforcement action, or to launch new products that will result in consumer buzz rather than FDA stings.