FDA issues final beverage guidance

CRN applauds final guidance, which achieves its objective to help companies determine whether products in liquid form are properly classified as dietary supplements or beverages.

The Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, applauds the Food and Drug Administration (FDA) for issuing its guidance, “Distinguishing Liquid Dietary Supplements from Beverages.” The final guidance achieves its objective to help companies that manufacture or distribute dietary supplements and/or traditional beverages “determine whether a product in liquid form is properly classified as a dietary supplement or as a beverage,” thoughtfully addressing previous confusion about the distinctions and delivering much-needed clarity for manufacturers and marketers to appropriately classify and label their products.

“We greatly appreciate FDA taking into serious consideration our earlier concerns about the Draft Guidance for distinguishing dietary supplements from beverages that we expressed in our written comments in February 2010 and in ongoing discussions with the agency,” said Steve Mister, president and CEO of CRN. “This Final Guidance is an instructive roadmap for both the dietary supplement and the conventional food industries to ensure that the intended uses of our products are being clearly communicated to the consumer, and we call on all companies to take notice of FDA’s position as they position their products in the marketplace.”

The guidance provides clarity for what distinguishes dietary supplements from beverages and takes into consideration CRN’s previous issues of concern by eliminating volume as a sole determinant of whether a product is a dietary supplement or beverage. CRN believes it is the right approach for FDA to consider a combination of factors, such as “product or brand name, packaging, serving size and total recommended daily intake, composition, recommendations and directions for use, statements or graphic representations in labeling or advertising, and other marketing practices.” CRN also applauds the agency for paying special attention to powders, concentrated liquids and effervescents that are added to water or other liquids and the unique considerations for these products.

“This is how we address the issues and grow as an industry—by identifying problems and maintaining a strong dialogue with our regulators,” said Mr. Mister. “CRN is committed to honoring this milestone guidance by educating the dietary supplement industry, and continuing to collaborate with the agency as it seeks to better enforce the law and set the responsible industry apart from the bad players so consumers can make educated choices about products for their health.”


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