This past October, the office of the inspector general of the Department of Health and Human Services issued two reports underscoring the need for improved oversight of the marketing of dietary supplements and improved surveillance of their effects. The reports add to a mounting body of evidence documenting a serious public-health problem.
Use of dietary and herbal supplements has grown dramatically in recent years in the United States. In 2007, according to the National Center for Complementary and Alternative Medicine, $14.8 billion was spent on nonvitamin, nonmineral, natural products, such as fish oil, glucosamine, and Echinacea—equivalent to approximately one-third of total out-of-pocket spending on prescription drugs. Of that total, $4.4 billion was spent on herbal supplements. Data from the National Health and Nutrition Survey for 2003 to 2006 indicate that one-half of American adults use dietary supplements and 20 percent use a supplement with at least one botanical ingredient.
Many people think that because herbs are natural, and because they are being marketed and sold legally, they must be safe and effective. Furthermore, surveys of the public indicate that most people believe these products are regulated by the U.S. Food and Drug Administration. In fact, both assumptions are mistaken.
In 1994, Congress passed the Dietary Supplement Health and Education Act, with heavy backing from the dietary supplements industry. By defining herbal supplements and botanicals as dietary supplements, DSHEA exempted them from the more rigorous standards used by the FDA in regulating food, drugs, and medical devices—essentially leaving it up to the industry to regulate itself. This single piece of legislation opened the floodgates to a rapid expansion in the sale of dietary supplements.
Between 1994 and 2008, the number of dietary supplement products on the market increased from 4,000 to 75,000. In the first 10 months of 2008, the FDA received nearly 600 reports of serious adverse events (including hospitalization, disability, and death) from these products and 350 reports of moderate or mild adverse events. However, the FDA believes that these reports are drastically underreported and estimates that the annual number of all adverse events is 50,000.
Two highly-respected physician-scientists, Donald Marcus of Baylor College of Medicine and Arthur Grollman of Stony Brook University, have been drawing attention to the dangers of herbal supplements for more than a decade. In a recent article in the Archives of Internal Medicine, they noted, “Even when the agency [FDA] identifies an unsafe product, it lacks authority to mandate its removal from the market because it must meet the very high legal requirement to demonstrate a ‘significant or unreasonable’ risk. That is why it took FDA more than 10 years to remove from the market ephedra-containing herbal weight-loss products that had caused hundreds of deaths and thousands of adverse events.”