FDA Requires Stricter Labeling for Supplements

One of the U.S. Food and Drug Administration's (FDA) chief concerns about vitamins and dietary supplements is the potential for manufacturers of these products to mislead the public. The most serious problem, of course, is false medical claims. Unfortunately no reasonable middle ground has been reached between the FDA's hard-line official stance on medical claims and supplement makers' desire to tout their products for every known medical condition—often without clinical evidence.

Another FDA concern is the content and integrity of supplements, specifically:

• What is contained in the package?
• What is the recommended dosage?
• How pure is the product?
• How much should consumers take?

New labeling laws just taking effect have addressed these concerns. As of March 23, 1999, consumers began to see more complete information on labels of dietary supplement products, including an information panel titled "Supplement Facts," a clear identity statement, and a complete list of ingredients. The "Supplement Facts" panel provides 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.

"This represents yet another step in FDA's continuing work to carry out the provisions of the new dietary supplement law," said FDA Commissioner Jane E. Henney. "With this innovative label, consumers will have the information they need to make informed choices across the entire spectrum of dietary supplements."

Specifically, the new "Supplement Facts" panel shows the following:

• The manufacturer's suggested dosage size.
• Information on nutrients when they are present in significant levels, such as vitamins A and C, calcium, iron and sodium, and the percent Daily Value where a reference has been established—similar to nutrients listed in the "Nutrition Facts" panel on food labels.
• All other dietary ingredients present in the product, including botanicals and amino acids—those for which no Daily Value has been established.

Herbal products are now 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 or Cecropia obstusifolia Bert. will be listed.

All ingredients in the product are now also declared in the ingredient statement or within the "Supplement Facts" panel. In addition, 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.

By Angelo Depalma