T97-45 Judith Foulke: (202) 205-4144 September 23, 1997 Consumer Hotline: (800) 532-4440 FDA PUBLISHES FINAL DIETARY SUPPLEMENT RULES FDA today published final rules that will give consumers more complete information in the labeling of dietary supplement products. These rules implement some of the major provisions of the Dietary Supplement Health and Education Act of 1994. The Act requires FDA to develop labeling requirements specifically designed for products containing ingredients such as vitamins, minerals, herbs or amino acids intended to supplement the diet. The new rules require these products to be labeled as a dietary supplement (for example "Vitamin C Dietary Supplement") and to carry a "Supplement Facts" panel with information similar to the "Nutrition Facts" panels that appear on most processed foods. The rules also set parameters for use of the terms "high potency" and "antioxidant" when used in the labeling of dietary supplements. Required information on the "Supplement Facts" panel will include: * An appropriate serving size. * Information on 14 nutrients, when present at significant levels, including sodium, vitamin A, vitamin C, calcium and iron; and * Other vitamins and minerals if they are added or are part of a nutritional claim on the label. * Dietary ingredients for which no Reference Daily Intakes (RDI's) have been established. * If the product contains a proprietary blend of ingredients the total amount of the blend and the identity of each dietary ingredient in the blend (although amounts of individual ingredients in the blend are not required). The rules also specify a minimum type size and flexible formats. The rule requires that the labels of products containing botanical ingredients identify the part of the plant used to make products. In addition, the source of the dietary ingredient may either follow the name or be listed in the ingredient statement below the "Supplement Facts" panel. When the terms "high potency" and "antioxidant" are used on a food label, the following applies: "High potency" may be used to describe a nutrient when it is present in a food product including dietary supplements, at 100 percent or more of the RDI established for that vitamin or mineral. "High potency" may also be used with multi-ingredient products if two-thirds of the nutrients that are in the product are present at levels that are more than 100 percent of the RDI. "Antioxidant" may be used in conjunction with currently defined claims for "good source" and "high" to describe a nutrient where scientific evidence shows that following absorption of a sufficient quantity, the nutrient (such as vitamin C) will inactivate free radicals or prevent free radical-initiated chemical reactions in the body. ####
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