September 22, 1997
(Revised 9/24/97)
Contact: Mary Burnette, 202-872-1488
FINAL DIETARY SUPPLEMENT LABELING REGULATIONS
"The dietary supplement industry can and will proceed to implement full nutrition labeling for our products now that FDA has published final dietary supplement labeling regulations, said John Cordaro, President and Chief Executive Office of the Council for Responsible Nutrition (CRN). "The new label format will help consumers better understand and compare dietary supplements," he added.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) required FDA to develop new nutrition labeling regulations specifically for dietary supplements. FDA proposed those regulations in December 1995, and has now published final regulations. The regulations will become effective in 18 months.
CRN has prepared a sample dietary supplement label, illustrating the format required by the new regulations (copy attached). Dietary supplements are to be identified by the term "dietary supplement" as a part of the statement of identity, however, the term dietary may be replaced with a term describing the type of supplement e.g. calcium supplement. Dietary supplement nutrition labeling differs from nutrition labeling for conventional foods in several ways:
-- The "facts box" for dietary supplements will be titled "Supplement Facts". For conventional foods, the box is titled "Nutrition Facts."
-- Only substances present in the product will be listed in the nutrition label for dietary supplements. Food labeling, in contrast, is required to list a substantial number of basic nutrients, whether or not they are present in the product, resulting in a nutrition label filled with "zeroes", in some cases.
-- Substances without a "Daily Value" (DV) may be listed in dietary supplement nutrition labeling with the footnote "Daily Value not established." A heavy bar will separate nutrients with a DV (above the bar) from substances without a daily reference value (below the bar). Only the nutrients above the bar are permitted in nutrition labeling for conventional foods. Examples of substances which will appear below the bar are: omega-3 fatty acids, amino acids, antioxidants such as bioflavonoids or polyphenols, and botanicals.
-- Sources of dietary supplement ingredients may be listed in the nutrition facts box, instead of in the ingredient list, to better inform consumers. For example, the label could list "Vitamin E (as d-alpha-tocopheryl acetate)." Food labels, by comparison, could use only the term "vitamin E" in the Nutrition Facts box, and the source material would have to be listed separately in the ingredients list.
DSHEA required that the part of the plant used in the product be identified on the label for botanical ingredients. In addition, FDA had proposed to require the Latin name as well as the common name for botanical ingredients. However, the final rule eliminates the requirement for the Latin name for botanicals that are listed in Herbs of Commerce, a publication of the American Herbal Products Association.
The FDA regulations also set parameters for the terms "antioxidant" and "high potency," when used in nutrient content claims such as "high in antioxidants" or "high potency formula." The agency had originally proposed to limit nutrient content claims for antioxidants to those with an established Daily Value, namely vitamin C, vitamin E, and beta-carotene. In the final regulations, however, FDA allows use of the term in nutrient content claims for any vitamin or mineral which protects against free radical damage. In addition, the term "antioxidant" may be use in statements of nutritional support for a wide variety of substances with known antioxidant activity. The term "high potency" may be used for a single ingredient dietary supplement that contains at least 100 percent of the DV. The term "high potency" may also be used for multi-ingredient products if two-thirds of the DV nutrients in the product are present at 100 percent of the DV, or more.
CRN is sponsoring an industry-wide workshop on the final regulations, at which FDA officials and industry counsel will review the provisions of the regulations and answer questions regarding implementation. The workshop will be held on October 21 in Washington, D.C., after companies have had ample time to study the final regulations and analyze their impact on current product labeling.
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