Policy highlights from Tufts University Friedman School of Nutrition

04/16/04

Expert Panel Takes on the Challenge of Creating a Framework for Evaluating the Safety of Dietary Supplements

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 country's leading source for science-based advice on medicine and health. This report was done at the request of the FDA which sought a scientific and regulatory framework to oversee the safety of dietary supplements. The committee was made up of academic researchers, and scientists from the US Department of Agriculture, the American Cancer Society and the National Institutes of Health.

For more information please see the following IOM web pages:
Dietary Supplements: A Framework for Evaluating Safety
http://www.iom.edu/report.asp?id=19578

Dietary Supplement Ingredient Prototype Monographs
http://www.iom.edu/subpage.asp?id=19554

Is Organic Food Really Better For You?

"National standards for organic food production are now well established and consumers can be confident in the organic label. It clearly represents food produced in an environmentally responsible way," said Kathleen Merrigan, keynote speaker at the First World Congress on Organic Food. But has it been proven that this food is better for consumers, as many believe?

"We just don't know," said Merrigan, PhD, assistant professor at the Friedman School of Nutrition Science and Policy at Tufts University. "With both organic food sales and organic acreage increasing, research has to keep pace. Currently, there's little published research that shows how the safety of organic foods compares to the safety of conventional foods." To address that gap, the First World Congress on Organic Food convened recently and called on organics expert Merrigan.

"The new research frontier is determining whether there are health and nutritional benefits of organic foods," said Merrigan. "For the most part, the US government has not funded organic research. In 1997, the Organic Farming Research Foundation undertook an analysis of all USDA funded research and found that less than one tenth of one percent was spent on research directly pertinent to organic agriculture."

Merrigan says it comes as no surprise that there has been little research comparing organic to conventionally grown food despite the strong consumer demand for this kind of information. At the First World Congress on Organic Food, Merrigan reviewed recent studies that found organic food to have fewer pesticide residues, higher levels of omega 3 fatty acids, and higher levels of some secondary plant metabolites that may play a role in cancer prevention. "This research is not conclusive," she advised, "but tantalizing." She called for a comprehensive set of credible, peer-reviewed scientific studies to highlight the organic "difference."

In 1990, Congress passed the Organic Foods Production Act (OFPA) which required the US Department of Agriculture (USDA) to develop consistent, uniform national standards for organic food products. The National Organic Program (NOP) is a marketing program within the USDA's Agricultural Marketing Service. While the NOP and/or OFPA regulations ban, for example, the use of genetic engineering or ionizing radiation in organic production and handling, neither address food safety or nutrition.

Professor Merrigan was formerly the administrator of the US Department of Agriculture's Agricultural Marketing Service and was the staff author of the Organic Foods Production Act of 1990, which mandated national organic standards and a program of federal accreditation.

Source: Eurekalert & others

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