The Supplement Shambles

Although the public needed the protection provided by accurate labeling, proof of safety and evidence of benefit, the food supplement industry effectively prevented such legislation from being passed in the U.S. Congress in 1994. It accomplished this with a successful multimillion-dollar campaign urging Americans to "Write to Congress today, or kiss your supplements good-bye!" This false message resulted in the Dietary Supplement and Health Education Act of 1994, which created a protected new category for the estimated 20,000 vitamins, herbs, minerals, and anything else that had been sold as a supplement before October 1994.

Top experts in herbal medicine and dietary supplements decried the lack of public protection. The 1994 regulations took good care of the multibillion-dollar supplements industry, but many scientific reviews concluded that they left the public in the lurch. Here's what the November 1995 issue of Consumer Reports said about what that law allowed: Products can be sold with no testing for efficacy or effectiveness; and supplement manufacturers do not have to prove the safety of their products already on the market.

To get around the now-illegal promise of far-reaching benefits, indirect rather than direct claims often are made. Claims are couched, for example, in comments from satisfied users who describe how the product cured their illness or produced other benefits. Such implicit claims are beyond reach of the law because they are indirect rather than explicit. The FDA is allowed to halt production of a product not when the manufacturer fails to show that it is safe and effective, but only after the FDA itself proves the product to be dangerous to people's health.

More recently, the U.S. Government Accountability Office (GAO) conducted an investigation. The GAO 2010 report indicated that dietary supplement products often were still promoted with deceptive and unfounded disease-related claims, encouraging consumers to use the products to prevent or treat diabetes, cancer, heart disease, Alzheimer's disease, and other serious conditions. The GAO investigation also found that most of the herbal supplement products tested were contaminated with heavy metals such as lead or pesticide residues, but usually at low levels.

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