Final rule issued on dietary supplement labeling

More than two years in the making, a final rule on dietary supplements has finally been issued. It takes effect March 23, 1999, and it applies to products containing ingredients such as vitamins, minerals, herbs or amino acids intended to supplement the diet.

FDA's rules require the term "dietary supplement" be included in the statement of identity, although manufacturers may include the name of the dietary ingredient (such as "Vitamin C Supplement") as the identifier. Dietary supplements must carry a "Supplement Facts" panel on the label similar to the Nutrition Facts panel found on food products. It would list items such as calories, fat and cholesterol, as well as any vitamin or mineral that's part of a nutritional claim on the label or that's added for supplementation purposes. The panel also must list dietary ingredients for which no Reference Daily Intakes (RDIs) have been established. If the product contains a proprietary blend of ingredients, the ingredients and the total amount of the blend must be listed. Minimum type sizes are 4.5 points for packages less than 12 sq" and 6 points for packages of 12 to 40 sq". The 4.5-point type may be used on packages of less than 20 sq" where more than eight dietary ingredients are listed on the nutrition label. Labels of products containing botanical ingredients must identify the part of the plant used. The source of the dietary ingredient may either follow the name or be listed in the ingredient statement below the Supplement Facts panel. The term "high potency" may be used to describe a nutrient present in a food or dietary supplement at 100% or more of the RDI for that vitamin or mineral. The term also may be used with multi-ingredient products if two-thirds of the nutrients are present at levels more than 100% of the RDI.

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