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Beverage or supplement?

This article was originally published in The Tan Sheet

Executive Summary

FDA is uncertain whether Shannon Mineral's Coolwater Trim containing SuperCitriMax (garcinia cambogia) is a dietary supplement because it is "in a liquid form with a serving size comparable to that of an ordinary beverage," the Center for Food Safety & Applied Nutrition writes in response to a 75-day premarket notification filed by the Irish marketer. While differentiation between supplements and foods is not a new concern for FDA, the explicit reference to serving size may be a sign that the agency is considering using a product's serving size to help determine whether it is a supplement or conventional food, according to attorney Marc Ullman of Ullman, Shapiro & Ullman. Botanical ingredients in products meeting the definition of a conventional food must either be generally recognized as safe for food at the added dosage or approved by FDA through the food additive process. Both Ullman and the Council for Responsible Nutrition note the letter is not a warning but a reply to an "unusual" new dietary ingredient notification...

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