By Riëtte van Laack –
On January 13, FDA announced the availability of two guidances concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” Both guidances are derived from FDA’s 2009 draft guidance “Factors that Distinguish Liquid Dietary Supplements From Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods.”
Compared to the 2009 draft guidance, the final guidance “Distinguishing Liquid Dietary Supplements from Beverages” provides considerably more information, including specific examples, on the factors FDA considers when determining whether the product is a conventional food or a dietary supplement. As mentioned in the draft guidance, FDA considers labeling and advertising, product name, product packaging, serving size and recommended daily intake, directions for use, marketing practices and composition. Where the draft guidance merely listed these factors, the final guidance discusses each factor and provides specific examples.
Although these examples are helpful, they do not always provide insight into FDA’s reasoning, and some of the distinctions do not appear logical. For example, the Agency does not explain how it decided that the terms iced tea and coffee “generally would be considered to represent a liquid product as a conventional food,” whereas the use of the term tea is not “associated exclusively” with a conventional food. Another point of confusion is FDA’s assertion that it strains “common sense to interpret DSHEA as authorizing the creation of a dietary supplement whenever any dietary ingredient is added to any conventional food.” However, FDA does not appear to have a problem with the marketing of that dietary ingredient as a dietary supplement to be added to a “liquid delivery system,” provided that they are not represented as an alternative to beverages or for beverage use.
Although in most circumstances a combination of factors will determine whether the product is represented as a conventional food, FDA appears to take the position that use of the term “refresh” or “rehydrate” foreclose dietary supplement status because such statements represent the product for use as a beverage, taste, refreshment, and thirst-quenching ability. Also, product names that use conventional food terms such as “beverage,” “drink,” “water,” or “soda” cause the product to be a conventional food.
Of course, the guidance includes the boilerplate language that guidance and does not establish “legally enforceable responsibilities.” Nonetheless, FDA can be expected to refer to this guidance in warning letters and other “enforcement actions.” Manufacturers and distributors of liquid dietary supplements would be well advised to review the final guidance and consider possible repercussions for their business.
The guidance concerning distinction between beverages and liquid dietary supplements still includes a relatively short section related to the regulatory requirements for ingredients for beverages and dietary supplements. However, to highlight this issue and “improve accessibility” FDA issued a separate guidance on this subject. According to the Federal Register notice, this guidance is intended to remind manufacturers and distributors of conventional foods and dietary supplements about the requirements for substances added to conventional foods and non-dietary ingredients (e.g., excipients) added to dietary supplements. This guidance does not contain anything new and merely summarizes long-established requirements and regulations.