NCL urges FDA to stop misleading labeling of dietary supplements

This letter is submitted by the National Consumers League to bring to the attention of the Office of Special Nutritionals, Center for Food Safety and Applied Nutrition, Food and Drug Administration, possible mislabeling of a wide range of dietary supplements containing isoflavone-based ingredients. These products are intended to provide phytoestrogen support to women. As the enclosed study reprinted in the Journal of Nutrition[1] illustrates, all but a few of these products contain far less isoflavones than claimed on their labels.

The National Consumers League is a national nonprofit consumer organization that has represented consumers and workers in the marketplace for over 100 years. NCL has been a major participant in the regulatory, legislative, and public policy arena on drug and health concerns throughout the century. It provides information and educational materials to consumers so they can make wise health decisions, including the safe and effective use of pharmaceuticals and dietary supplements. As you know, NCL has held two stakeholder roundtables on dietary supplements, one co-sponsored by the Food and Drug Administration. In addition, in 2000, we commissioned Princeton Research to survey women and physicians about the use of dietary supplements to treat conditions as women get older.

As baby boomers age, large numbers of U.S. women are entering menopause. When vasomotor and other symptoms of menopause arise, hormone replacement therapy is frequently prescribed by physicians. FDA-approved drugs have provided various degrees of relief to millions of women for many years. However, many women try other therapies as an alternative to conventional HRT. Women in the U.S. spend approximately $200 million dollars per year on nonprescription dietary supplement therapies for symptoms associated with menopause, and often, as our research shows, are reluctant to discuss this with their physicians.

The largest subcategory within this group of dietary supplements is that of products containing isoflavones. These products have recently been heavily marketed to address symptoms associated with menopause and have combined sales of $75 million. Unfortunately, these isoflavone supplements, marketed under the Dietary Supplement Health and Education Act of 1994, do not require pre-market approval before being released on the U.S. market. Moreover, limited budgets have constrained the FDA Center for Food Safety and Applied Nutrition, Office of Special Nutritionals, in its ongoing efforts to ensure the efficacy and proper labeling of these supplements.

The enclosed recent peer-reviewed article appearing in the Journal of Nutrition (April 2001) analyzes the content of known active phytoestrogens for thirty-three commercially available soy isoflavone supplements. For example, Estroven® (distributed by Amerifit Nutritionals) and New Phase/Sunsource (distributed by Chattem) appear to have known active phytoestrogens present in a small fraction of the amount claimed on their labels and well below the amount considered necessary to have a beneficial effect on women during menopause. Women taking many of these products may be receiving phytoestrogens well below efficacious levels and possibly of no true benefit. Estroven® was found to contain 7.8 milligrams of isoflavones per tablet while claiming 50 milligrams. Similarly, New Phase/Sunsource was found to contain 8.6 milligrams per tablet while claiming 80 milligrams. Considering that Estroven® is heavily promoted through television advertising, we believe this issue requires your attention.

Further, a number of the labels for these products boldly promote soy content, and yet only a very small percentage of content appears to come from soy plants. A close review of the labels reveals that many contain isoflavones derived from Kudzu (identified by its Latin name “pueraaria lobata root extract”). While there may be some soy isoflavones in these products, the major and meaningful source of isoflavones is likely Kudzu. We feel the label is misleading to consumers.

NCL urges FDA to contact the companies that market the products analyzed in the Setchell study, which found them to be misleading as to the label claim for soy and/or isoflavone content, and ask for the products to be brought into line with their label claim or removed from the market.

[1] Setchell, K.D.R. et. al., “Bioavailability of Pure Isoflavones in Healthy Humans and Analysis of Commercial Soy Isoflavone Supplements, Journal of Nutrition, April 2001, (4 Suppl), pp. 1365-755.

The National Consumers League, founded in 1899, is America's pioneer consumer organization. Our mission is to identify, protect, represent, and advance the economic and social interests of consumers and workers. NCL is a private, nonprofit membership organization. For more information, visit www.nclnet.org.