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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