FDA Publishes Guidance on Liquid Dietary Supplements and Beverages and Issues Warning LettersDecember 10, 2009
Last week FDA published a new guidance document titled “Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and other Conventional Foods.” The guidance document includes a discussion of the factors that FDA uses to determine whether a liquid is a beverage (i.e., a conventional food) or a dietary supplement and a reminder to manufactures and distributors about the ingredient and labeling requirements of the Federal Food, Drug, and Cosmetic Act (FDC Act).
Of particular note in the guidance document is FDA’s statement that it will consider the “packaging” of a product in its consideration of whether the product is a dietary supplement or a conventional food. Just before publishing the guidance, FDA also issued three Warning Letters to companies marketing liquid dietary supplements in large bottles that were intended to be consumed in quantities equivalent or almost equivalent to the average total daily drinking fluid intake. The extent that FDA will now consider packaging in the determination of whether a product is a dietary supplement is unclear, but it does appear that FDA is looking to packaging as a factor in determining how to classify a product.