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December 8, 2009

Liquid Dietary Supplement vs. Beverage -- FDA Guidance

What is a beverage?  Beverages are conventional foods that should not be marketed as dietary supplements. And dietary supplements are not supposed to be represented as conventional foods.  It's a matter of getting the product, the label, and the marketing plans to line up on the same side of the line.  The line is blurry.  FDA released draft industry guidance yesterday to help make it clearer:

Guidance for Industry: Factors that Distinguish Liquid Dietary Supplements from Beverages, Considerations Regarding Novel Ingredients, and Labeling for Beverages and Other Conventional Foods

. . . The Food and Drug Administration (FDA) has observed and become concerned about two trends in the marketing of beverages.  First, we have seen an increase in the marketing of beverages as dietary supplements, in spite of the fact that the packaging and labeling of many liquid products represent the products as conventional foods.  Products that are represented as conventional foods do not meet the statutory definition of a dietary supplement in section 201(ff) of the FFDCA (21 U.S.C. 321(ff)) and must meet the regulatory requirements that apply to conventional foods. 

Second, FDA has seen a growth in the marketplace of beverages and other conventional foods that contain novel ingredients, such as added botanical ingredients or their extracts.  Some of these ingredients have not previously been used in conventional foods and may be unapproved food additives. In addition, ingredients that have been present in the food supply for many years are now being added to beverages and other conventional foods at levels in excess of their traditional use levels or in new beverages or other conventional foods.  This trend raises questions regarding whether these ingredients are unapproved food additives when used at higher levels or under other new conditions of use.  Some foods with novel ingredients also bear claims that misbrand the product or otherwise violate the FFDCA.

read the whole thing

 

December 8, 2009 in supplements | Permalink

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