Jan 16

FDA Issues Guidance on Distinguishing Liquid Dietary Supplements from Beverages

On January 16, 2014, the U.S. Food & Drug Administration (“FDA”) published a guidance document entitled “Distinguishing Liquid Dietary Supplements from Beverages” (“Guidance”). Found here, the Guidance is aimed at explaining to industry how dietary supplements and beverages differ.

Beverages are considered a type of conventional food, which differ from dietary supplements in both labeling and the ingredients that are permitted. For example, beverages differ from dietary supplements in that the labels of these products bear nutrition facts panels, as opposed to supplement facts panels, and the products are also distinguished by claims made in labeling. For example, the Guidance document notes that beverages are intended primarily to “to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).” Guidance at 6. By contrast, dietary supplements are products that are intended to supplement the diet and promote health in various ways. Accordingly, the claims that may be made in the labeling of beverage products are somewhat more limited than those made for dietary supplements.

In addition to differences in labeling, including claims, beverages differ from dietary supplements by the ingredients that are permitted. Under federal law, dietary supplements must contain one or more dietary ingredients, which include vitamins, minerals, herbs and amino acids. 21 USC § 321(ff)(1). As explained in the Guidance, “to be lawful for use in a conventional food, [an] ingredient must be used in conformity with a food or color additive regulation prescribing the conditions of its use in food, be GRAS for its intended use in food, or qualify for one of the other exceptions to the food additive definition.” Guidance at 7. Accordingly, the ingredients permitted in foods are more limited than those that may be used in dietary supplements.

In sum, whether a product is properly marketed as a beverage or a dietary supplement will depend on a number of factors, including labeling, intended use, and ingredients, among other things. Thus, when developing a product to bring to market or importing a product into the United States, it is important to ensure that these factors are considered to ensure that the product is properly regulated. If you have any questions about the differences between beverages and dietary supplements or how you can successfully market products in compliance with the laws and regulations enforced by the FDA, please contact us at contact@giannamore-law.com.

FDA Lawyer, dietary supplement

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