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GAO: Dietary Supplements Pose Risk to Older Americans

October 17, 2001

• Anti-Aging Supplement DHEA Doesn't Work, Study Finds • Gero Vita Promoter Settles FTC Charges • Human Growth Hormone Promoter Settles FTC Case • GAO: Dietary Supplements Pose Risk to Older Americans

The millions of older Americans who take dietary supplements marketed as "anti-aging" therapies may be putting their physical and financial health at risk, a report by the General Accounting Office (GAO) warns.

In a report prepared for Sen. John Breaux (D-La.), chairman of the Senate's Special Committee on Aging, the GAO found that as many as 4 out of 10 seniors have used herbal dietary supplements, spending some $5.8 billion in 1999, the most recent year for which figures are available.

The agency identified several potential problems with the increasing usage of the largely unregulated substances:

• Drug interactions Since older persons are more likely to be using prescription drugs, there is a higher likelihood of harmful interactions.
• Pre-existing conditions Older persons are more likely to have medical conditions that can be aggravated by dietary supplements.
• Contamination Government studies have found evidence that 1 in 10 herbal products are contaminated with heavy metals, pesticides, or both. While potentially dangerous for all users, such contamination could be especially harmful to older persons with pre-existing conditions.
• "Displacement" Individuals with serious medical conditions may rely on supplements and other unproven alternative treatments, ignoring traditional treatments.
• Financial loss Most older persons are on a fixed income and many can ill afford the money they spend on supplements.
• Inaccurate labeling Supplements may contain much more or much less of the active ingredients than indicated on the label. Too much is dangerous since it may result in an overdose. Too little results in economic loss, since the consumer is effectively paying for nothing.

Sales of dietary supplements have soared since 1994, when lobbyists won passage of legislation that limits federal oversight of the supplement industry. Although prosecutors occasionally go after products that they claim are dangerous or are being illegally marketed, such actions have had little effect on overall sales.

In the past few years, the Food and Drug Administration (FDA) has targeted such products as "Cholestin," a red yeast product with lovastatin that was claimed to lower cholesterol. It has also taken action to halt sales of a product called the "Stimulator," which supposedly relieved pain from sciatica, swollen joints, carpal tunnel syndrome and other chronic conditions. An estimated 800,000 were sold between 1994 and 1997.

Recently, the agency has moved aggressively against companies selling comfrey after finding that many of the supplements contain alkaloids that can cause liver damage. Despite the FDA's warnings that supplements containing comfrey are adulterated and unlawful, many companies continue selling the supplements, forcing the FDA to pursue individual companies, an expensive and time-consuming process.

A copy of the report (GAO-01-1129) is available on the GAO Web site.

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