What Did Pew Health Group Find in its Review of the U.S. Food Additive Regulatory Program?

In the November 1, 2011, edition of the peer-reviewed journal Comprehensive Reviews in Food Science and Food Safety (CRFS), Pew Health Group published a rigorous analysis of the U.S. food additive regulatory program. For this examination, Pew developed two novel methods to estimate the number of chemicals allowed in human food and the number of affirmative safety decisions for these substances. Key among the findings is that more than 10,000 chemicals were allowed in human food as of January 2011.

One-third of these chemicals (more than 3000) were approved by manufacturers or the Flavor and Extract Manufacturers Association (FEMA) Expert Panel. The remaining two-thirds were cleared by a federal agency—either the Environmental Protection Agency (EPA) (in the case of pesticides) or the U.S. Food and Drug Administration (FDA) (for all other chemicals). Since many of FDA's safety decisions covered multiple chemicals (sometimes hundreds of them), simply counting the number of chemicals overestimates the agency's contribution. Therefore, the article includes a complementary method that suggests that manufacturers and a trade association may have made the majority of affirmative safety decisions.

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Pew's analysis found that the legal framework Congress created in 1958 has not kept pace with science and the food industry, essentially limiting FDA's ability to effectively regulate chemicals added to food. The gaps in regulatory safeguards suggest that in many cases public safety is in the hands of the food manufacturers rather than FDA.

Four primary areas of concern were revealed through this analysis:

• FDA is unaware of a large number of chemical uses in food and, therefore, cannot ensure that safety decisions regarding these uses were properly made.

• Food manufacturers are not required to notify FDA of relevant health and safety studies, thereby placing FDA in the difficult position of tracking safety information for more than 10,000 chemicals with limited resources and information.

• The agency's expedited approach to reviewing safety decisions since 1995 occurs with little public engagement.

• FDA lacks the resources and information needed to identify and prevent potential health problems or to set priorities for systematic reevaluation of safety decisions made during the past half-century.

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