FDA Guidance Differentiates Liquid Dietary Supplements from Beverages
The U.S. Food and Drug Administration (FDA) has issued two final guidance
documents for industry on distinguishing liquid dietary supplements
from beverages. Titled “Distinguishing Liquid Dietary Supplements From
Beverages” and “Considerations Regarding Substances Added to Foods,
Including Beverages and Dietary Supplements,” the documents update
2009 draft guidance intended “to help dietary supplement and beverage
manufacturers determine whether a liquid food product is properly classified
as a dietary supplement or as a beverage, and to remind the industry of legal
requirements regarding the substances that may be added to either type of
product.”
In “Distinguishing Liquid Dietary Supplements from Beverages,” FDA describes
the factors characterizing liquid products deemed dietary supplements and
those characterizing beverages deemed conventional foods. These include
product claims, names, packaging, serving size, recommended daily intake,
conditions of use, and product composition, as well as statements or graphic
representations in labeling, advertising and other marketing practices,
including promotional websites, and social media. For example, use of the
terms “beverage,” “drink,” “water,” or “soda” in the marketing or the product
name would render the product a conventional food. Representation as a
conventional beverage can also be implied by the size, shape, color, and
design of the container or other packaging.
“Considerations Regarding Substances Added to Foods, Including Beverages
and Dietary Supplements,” reminds industry about the different regulatory
requirements under the Federal Food, Drug, and Cosmetic Act for ingredients
used in these two types of products. For beverages, ingredients must be either
GRAS (generally recognized as safe) or approved as food additives. For dietary
supplements, any substance considered a new dietary ingredient (NDI) must
have a pre-market NDI notification to FDA; non-dietary ingredients such as
binders would need either food additive approval or GRAS status for their
intended use. The agency noted that some of the novel substances added to
conventional foods, including beverages, “may cause the food to be adulterated
because these added substances may not be GRAS for their intended use and
are not being used in accordance with a food additive regulation.”
