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Bodyshop: Report says FDA lacks authority over supplements

The Food and Drug Administration does not have the information, resources or recall ability necessary to adequately regulate dietary supplements, according to a Government Accountability Office report released earlier this month.

Congress requested the evaluation of how the FDA regulates these popular products. The Nutrition Business Journal reports that 79 percent of adult Americans take dietary supplements.

The GAO listed a number of areas in which the FDA has little oversight. For example, supplement companies don’t have to tell the FDA what products they sell or the ingredients they use.

The report did note that in 2007, the FDA began requiring dietary supplement manufacturers to report “serious adverse events” such as hospitalizations, birth defects or death. The agency also issued Good Manufacturing Practices specific to the industry. GMPs outline how manufacturers must establish controls and testing to ensure that products have consistent identity, purity and strength. In the case of herbal and botanical goods, tests must ensure that the correct plant species are being used.

The Center for Science in the Public Interest, a consumer advocacy group, has long called for the FDA to more strictly regulate supplements.

“It’s like the Wild West, and the bad guys know they don’t have to take the sheriff seriously,” said the center’s legal director, Bruce Silverglade.

The Council for Responsible Nutrition, a supplement industry trade group, agrees that the FDA needs more resources, President Steve Mister said.

“It is time for the FDA to focus its energy and resources on inspections and enforcement actions directed at the small minority of companies that are giving those in the majority a black eye,” Mister said.

The report also says the FDA does too little consumer education on the safety and efficacy of dietary supplements. Polls show a majority of Americans incorrectly believe a government agency must approve supplements before they are marketed to consumers.

Unlike drugs, which must be approved for safety and efficacy before entering the market, dietary supplements marketed before 1994 are presumed safe. The FDA must demonstrate that a product presents a significant or unreasonable risk to the public to get it off the market.

The GAO recommends that the FDA seek more authority to require more information from dietary supplement makers, provide guidance on what ingredients must be documented and determine what can be marketed as supplements or foods.

The agency welcomes the report “as a means of calling attention to the challenges that the agency faces” in regulating dietary supplements, FDA spokeswoman Susan Cruzan said.