Dietary supplements are widely available in pharmacies and other retail outlets but their availability is not necessarily proof that they are safe. Currently, because of a 1994 regulation, dietary supplements are regulated like foods rather than drugs, which means that they are considered to be safe unless proven otherwise. While most dietary supplements are safe when used as recommended, they typically do not go through the clinical testing process that characterizes pharmaceutical products.
As the market size in the United States approaches $18 billion in sales, and new products surge onto the market (about 1,000/per year), concern is growing at the US Food and Drug Administration (FDA) and elsewhere about occasional problem products. A new report from the Institute of Medicine (IOM) and the National Research Council of the National Academies tackles the problem of a safety framework for dietary supplements within the current regulatory environment. The committee interpreted the Dietary Supplement Health and Education Act (DSHEA) language to mean that the FDA does not need direct evidence of actual harm to people to take action.
“The committee offers a science-based approach by which the FDA can use different kinds of available data to better evaluate the safety of supplement ingredients, such as in vitro studies or information on similar substances” said Dr. Joseph Lau, professor at the Tufts University School of Medicine who served on the committee that worked to create a framework for evaluating the safety of dietary supplements.
The report of the committee calls for supplement makers and the public to ramp up their reporting of health problems related to supplement use. Dr. Lau, known for his work on evidence-based medicine, said the committee also determined “that the lack of reporting hampers the agency’s ability to monitor supplement safety and the report suggests some solutions, including manufacturers reporting adverse events as well as product labeling that includes a toll-free number for consumers and health professionals to use.”
The IOM is the coun