Review of the Scientific Basis for Safety Decisions on Hazards of Substances Added to Food

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In 2010, supermarkets carried an average of 38,718 different items on their shelves. Such diversity did not appear overnight—our modern food supply and its production system have grown increasingly complex, especially with the growth of processed foods in the mid-20th century. As a result, a significant number of the foods that make up the modern diet contain added chemicals. These chemicals are commonly known as food additives and perform many roles, including preserving and enhancing flavor, enhancing taste, preventing spoilage, and packaging the food.

The Food Additives Amendment of 1958 requires either the Food and Drug Administration (FDA) or a manufacturer to determine that a chemical’s use is safe before it is added to or comes in contact with food. The law specifies that a chemical is safe when there is “reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.” This language is wrought with ambiguity, and many in the scientific and public interest communities have questioned how FDA utilizes and interprets data when the agency determines the safety of a chemical’s use in food.

To help answer this question, in April 2011 Pew Health Group convened a workshop bringing together more than 80 experts from government, industry, academia and public interest organizations to examine the principles underlying the development and use of scientific evidence to identify and characterize chemical hazards. The workshop, “Enhancing FDA’s Evaluation of Science to Ensure Chemicals Added to Human Food Are Safe,” was cosponsored by the Institute of Food Technologists and the journal Nature. In the November 1, 2011, issue of the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety, Pew published a proceeding of the discussions.

Based on the workshop discussions, Pew observed that:

• FDA’s guidance regarding safety decisions does not reflect the latest developments in science and academic research. Since manufacturers are themselves permitted to determine that a new substance is “generally recognized as safe” based on FDA’s testing guidelines without actually involving the agency, it is essential that these guidelines be kept current.
• FDA often has to make premarket safety decisions based on incomplete information. Once a chemical is approved, however, FDA does not have the resources to systematically evaluate scientific developments relevant to that chemical among the thousands of substances within its purview. Furthermore, manufacturers are under no obligation to notify the agency of potential health problems to which they might become aware.