WASHINGTON—One-third of the more than 10,000 substances that may be added to human food were made by food manufacturers and a trade association without review by the U.S. Food and Drug Administration (FDA), according to a report published today in the journal Comprehensive Reviews in Food Science and Food Safety.
The report, spearheaded by the Pew Health Group, illustrates potential problems with the U.S. food additive regulatory program that was established by Congress more than 50 years ago. It goes on to say the current policy does not stand up well to scrutiny based on today’s standards of science and public transparency.
The research also found that the FDA developed an expedited process in the mid-1990’s that essentially eliminated the opportunity for public involvement in decision making prior to FDA’s safety determination. This shift doubled the rate of industry requests for FDA review. In contrast, standard operating procedure for other federal regulatory decisions regarding drug, workplace, and environmental safety requires public notice and an opportunity to comment.
“While the shift to a new regulatory process—one in which companies make safety decisions and ask FDA to confirm them—has sped up agency review, it has also bypassed the public," said Tom Neltner, Food Additives Project director in the Pew Health Group. “Subjecting safety decisions to comment from competitors, academic scientists, public interest groups and the general public can result in stronger protections for consumers. In an age of growing demand for government transparency, there is virtually no meaningful opportunity for participation in decisions about large classes of substances added to the food supply."
Another article in the journal summarized a workshop, co-sponsored by the Institute of Food Technologists and the journal Nature, examined how FDA evaluates the potential hazards posed by substances food additives. The two-day session, held in April 2011, brought together science and food policy experts from government, industry, academia and public interest organizations to discuses the need for clear procedures to develop validated toxicological tests and regularly revise guidance documents to reflect advances in science; opportunities to improve academic research to make it more usable for regulatory decision making and enhance coordination between federal agencies; and challenges to reassessing a chemical’s safety after it is on the market.
