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FDA News

FOR IMMEDIATE RELEASE
P04-34
March 25, 2004

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FDA Releases Acrylamide Data and Final Acrylamide Action Plan

The Food and Drug Administration (FDA) today released new data on acrylamide levels in more than 750 new food samples. These data expand the agency's ability to assess the extent to which this chemical is present in the food supply and its public health impact. In addition, the FDA has made available the final version of its action plan to evaluate the risk associated with acrylamide and examine ways to potentially reduce levels of acrylamide in food.

The chemical acrylamide was reported in food in April 2002 by Swedish scientists. Acrylamide is a natural byproduct in certain carbohydrate-rich foods that forms when these foods are fried, baked, or roasted at high temperatures. Although initial reports of acrylamide's presence in some foods raised concerns because of possible links with increased risk of cancer in some laboratory animals, it was largely unknown how pervasive it was in the food supply, and its true public health significance for humans.

To date, Acrylamide is known to cause cancer and reproductive problems in animals at high doses and is a neurotoxin in humans at high doses. Based on the current understanding of the science, FDA continues to advise consumers to eat a balanced diet, choosing a variety of foods that are low in trans and saturated fat and rich in high fiber grains, fruits and vegetables.

Since 2002, FDA has released an Action Plan to guide activities on acrylamide; performed research in the areas of methodology, toxicology, and acrylamide formation; and periodically released new data on acrylamide levels in food.

These new data results almost triple FDA's database of acrylamide levels in food. The new data are consistent with previous findings showing higher levels of acrylamide in potato-based and other carbohydrate-rich products processed at high temperatures and lower levels of acrylamide in dairy foods and infant formulas. The novel finding in the most recent sampling is the presence of acrylamide in black olives, prune juice and Postum, a powdered beverage.

"Acrylamide is an issue that FDA has followed very closely and has made rapid progress in understanding the science," said FDA Deputy Commissioner Lester M. Crawford, D.V.M., Ph.D. "The action plan and the new samples illustrate FDA's proactive stance with the issue of acrylamide in food, which until recently was relatively unknown in foods."

FDA is expanding its acrylamide testing program and plans to conduct tests on approximately 40 new infant formula samples. Although results from other infant formula samples tested by FDA indicated the products contain no acrylamide or trace amounts of acrylamide, the FDA will conduct further tests because of the importance of formula as a sole source food for many infants.

Most of the new data were taken from samples used as part of the FDA's FY03 Total Diet Study (TDS) survey. The TDS is an ongoing FDA program that determines levels of various contaminants and nutrients in more than 200 core foods (ready-to-eat) in the U.S. diet. Foods are collected from grocery stores and fast food restaurants and prepared table ready (i.e., cooked if required by TDS recipe) for analysis. Looking at the level of acrylamide in these foods will more accurately assess exposure to the U.S. consumer.

The final version of the Action Plan for Acrylamide in Food reflects the progress of research on acrylamide at FDA and the recommendations from a 2003 Food Advisory Committee meeting. In response to the committee's recommendations, the action plan contains more details about planned toxicology and epidemiology studies, risk communication activities, and coordination of acrylamide research. Specifically, the action plan addresses details on study timelines; the rationale for the use of brand-name data versus blinded data; and plans to incorporate factors such as ethnic and geographic groups into future exposure assessments.

FDA will share its expanded insights on acrylamide with the scientific community through the publication. In contribution to the acrylamide research community, the FDA is also citing publication of two recent research papers on FDA's methodology for measuring acrylamide and analytical issues associated with measuring acrylamide in coffee, a technically challenging food matrix. In addition, FDA's National Center for Toxicological Research (NCTR) has completed the first two of a series of studies, to support FDA's risk assessment, in its research initiative on acrylamide toxicology.

FDA's final action plan for acrylamide in food and new sampling data can be found at http://www.cfsan.fda.gov/~lrd/pestadd.html#acrylamide.

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