P99-8 FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE Print Media: 202-205-4144
March 23, 1999
Consumer Inquiries: 888-INFO-FDA
The "Supplement Facts" panel will provide information such as the quantity of specific nutrients in vitamin and mineral products, and the part of the plant used in herbal products. It will be similar in format to the "Nutrition Facts" panel that appears on most processed foods.
"Today's action represents yet another step in FDA's continuing work to carry out the provisions of the new dietary supplement law. With this innovative label, consumers will have the information they need to make informed choices across the entire spectrum of dietary supplements," said Jane E. Henney, MD, FDA Commissioner.
Specifically, the "Supplement Facts" panel will show the following:
Herbal products will be identified by the common or usual name and the part of the plant used to make the supplement (such as root, stem or leaf). If the common or usual name is not listed in Herbs of Commerce, published by the American Herbal Products Association, the Latin binomial name such as Tercoma mollis.HBK or Cecropia obstusifolia Bert. will be listed.
All ingredients in the product will be declared in the ingredient statement or within the "Supplement Facts" panel.
A statement of identity will appear on the front panel of the product label. The statement must use the terms "dietary supplement" or a term identifying the contents of the product, such as "Vitamin C supplement" or "Herbal supplement."
The new labeling rule implements some of the major provisions of the Dietary Supplement Health and Education Act of 1994. The rule was published September 23, 1997, with an effective date of March 23, 1999, giving industry 18 months to comply. Products labeled prior to March 23 can continue to be sold until stocks are depleted. Some companies have already introduced products with the new labels.
"FDA is pleased that industry has responded so positively to this new labeling provision. We've already seen the labels on many products and expect that consumers will be well served as use of the "Supplement Facts" panels expands to all dietary supplement labels," said Joseph Levitt, Director of FDA's Center for Food Safety and Applied Nutrition.
FDA plans to survey dietary supplement products on the market to check for compliance with the new labeling rules. Also, through a variety of means, FDA will provide consumers with information on how to use the new "Supplement Facts" panels.